Gambro Prismaflex' Tm HF 1000 Set/ HF 1400 Set / JAN Z0 · Special 510(k) Notification Gambro Prismaflex' Tm HF 1000 Set/ HF 1400 Set / / JAN Z0 510(K) SUMMARY SUBMITTER: Gambro Renal

Special 510(k) Notification

Gambro Prismaflex' Tm HF 1000 Set/ HF 1400 Set / /JAN Z0

510(K) SUMMARY

SUBMITTER: Gambro Renal Products10810 West Collins AvenueLakewood, CO 80215USA

CONTACT: Thomas B. Dowell, Manager Regulatory AffairsPhone: (303) 231-4094Fax: (303) 542-5138

DATE PREPARED: October 21, 2004

DEVICE NAME: Prismaflex HF 1000 SetPrismaflex HF 1400 Set

COMMON/UNUSUAL NAME: Hemofilter and Blood Tubing SetHigh Permeability Hemodialyzer

CLASSIFICATION NAMES: High Permeability Hemodialysis System Accessory

CLASSIFICATION PANEL: KDI Gastroenterology - Urology

CLASSIFICATION: Class II per 21 CFR 876.5860

PREDICATE DEVICES: Gambro Prisma HF1000 Set K011221Gambro Prismaflex M60/M100 Set K041005

SUBSTANTIAL EQUIVALENCE:

The proposed Prismaflex HF 1000 and HF 1400 sets are substantially equivalent to thePrisma HF 1000 sets and Prismaflex M60/M100 sets currently on the market. Themodifications in the proposed devices are substantially equivalent in design, function,composition, and operation, to the predicate devices that have FDA clearance under 510(k)'sK011221 and K041005.

DEVICE DESCRIPTION:

The Prismaflex disposable sets are sterile disposable extracorporeal circuits containing aPAES hemofilter/dialyzer and fluid circuit for use with the Prismaflex control Unit. ThesePrismaflex disposable sets allow the following fluid management and renal replacementtherapies to be performed:

* SCUF : Slow Continuous Ultrafiltration* CVVH: Continous Veno-Venous Hemofiltartion* CVVHD : Continous Veno-Venous Hemodialysis* CVVHDF: Continuous Veno-Venous Hemodiafiltartion

Confidential Page 63

Records processed under FOIA Request #2016-4467; Released by CDRH on 07-25-2016.

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or call 301-796-8118.


Gambro Prismaflex T M HF 1000 Set / HF 1400 Set

INDICATIONS FOR USE:

The Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providingcontinuous fluid management and renal replacement therapies. The system is intended forpatients who have acute renal failure, fluid overload, or both.

TECHNOLOGICAL CHARACTERISTICS:

The proposed device configurations have the same technological characteristics and aresimilar in design, function, and operation, to the currently marketed configurations.

SUMMARY OF NON-CLINICAL TESTS and CONCLUSION:

In vitro testing was conducted to compare the performance of the proposed deviceconfigurations to the predicate configurations. The results of the in vitro testing demonstratethat the proposed configurations are substantially equivalent to the predicate configurationsand are suitable for the intended use.

SUMMARY OF CLINICAL TESTS and CONCLUSION:

Not applicable




Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICESPulcHatSeve

Food and Drug Administration9200 Corporate BoulevardRockville MD 20850

JAN - 6 2005

Mr. Thomas B. DowellManager Regulatory AffairsGambro® Renal Products10810 W. Collins AvenueLAKEWOOD CO 80215

Re: K042938Trade/Device Name: PrismaflexTM HF 1000 Set and PrismaflexTM HF 1400 SetRegulation Number: 21 CFR §876.5860Regulation Name: High permeability hemodialysis systemRegulatory Class: IIProduct Code: 78 KDIDated: December 16, 2004Received: December 17, 2004

Dear Mr. Dowell:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.



This letter will allow you to begin marketing your device as described in your Section 510(k)

premarket notification. The FDA finding of substantial equivalence of your device to a legally

marketed predicate device results in a classification for your device and thus, permits your device to

proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please

contact the Office of Compliance at one of the following numbers, based on the regulation number at

the top of this letter:

21 CFR 876.xxxx (Gastroenterology/Renal/Urology) 240-276-0115

21 CFR 884.xxxx (Obstetrics/Gynecology) 240-276-0115

21 CFR 892.xxxx (Radiology) 240-276-0120

Other 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR

807.97). You may obtain other general information on your responsibilities under the Act from the

Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800)

638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/ldsma/dsmamain.html

Sincerely yours,

Na/ncyMC fr4gdon~Director, Division of Reproductive,

Abdominal, and Radiological DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure



Special 510(k) NotificationGambro Prismaflex T HF 1000 Set / HF 1400 Set

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): <0 - 1?Device Name:

PrismaflexTM HF 1000 SetPrismaflexTM HF 1400 Set

Indications For Use:


Prescription Use / Over-The-Counter Use

(Part 21 CFR 801 Subpart D) WIOR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft)Division of Reproductive, Abdominal,and Radiological Devjci

510(k)CNumberntialPa

ConfidentialPae6



0 o'¾ 9 3Sv//9

"GAMBRQ. Renal Products

1081 0W. Col fns AvenueDecember 21, 2004 Lakewood. Cobredo 8021 5 USA

Tel 303-232-6800

Joshua Nipper, (Biomedical Engineer) Gastroenterology and Renal Devices BranchFood and Drug AdministrationCenter for Devices and Radiological HealthOffice of Device EvaluationDocument Mail Center (HFZ-401)9200 Corporate BlvdRockville, Maryland 20850

Subject: K042938PrismafleX'Tm HF 1000 and HIF 1400 Sets

Dear Mr. Nipper,

Please find the revised page of the draft IFU for the Prismaflex HF 1 000 and HF 1400Sets attached to this memo. As you requested, I have included the information regardingcreatinine clearance, which will be added to the table in the released IFU. The values arealso shown in the response letter dated December 16, 2004 in question 1 (d).

If you have any additional questions please call me at 303-231-4094.

Attachment:

Revised Draft Instructions for Use, page 47

Sincerely,

Thomas B. DowellManager Regulatory AffairsGambro Renal Products



CARACTERISTICAS CARATTERISTICHE PRISMAFLEX PRISMAFLEXDEL FILTRO DEL FILTRO HF1000 SET HF1400 SET

CARACTERISTICAS FISICAS CARATTERISTICHE FISICHE NOMINELLA FYSISKA KARAKTARISTIKASupermike etectiva Superfinti effettita Efinkiyti ya 1 m

~1.4 me

0 sterna de la bbra Mhameda) 0 inferno della fibra (bagnata) Ire kapihlardiamener tf() 215 pm

Enpesor de la pared de la fibre Speasore parete della fibr. Tiocklek av kopilldrvagg 50 pm

RENDIMIENTOS INVITRO' PRESTAZIONI IN VITRO • IN VITRO PRESTANDAVolumen de nebade sangfulneo Volume di priming ematico Blodvolying 8i m ±10% 102 ml 10%

Caldl de presMin samgre (post-dilucidin) Perdita di carno enntico (postdiluizione) Blod tryckfall (postdilition)±20% *20%

(sangre botina, Htc*. 32%, Cp*..... 60 gIl, 370C) (sangue beie, Hut .. 32% CGp t g/l, 607C) Ibint bids, Htcl* - 32%S Cp.' *.60 g/l, 37C)

QB* = 1 00 mtmin, QUF" .. ' 2 L/h 0C" = 1 00 mVmin CUF* = 2 Lih CB' = 100 miminO QUFR . = 2 Uh 37 mmHg 29 mmHg

OR" = 200 ml/min, OUF' .l.2 L/h S* " = 200 dimiFn, OU.F'.= 2 L/h QBC* = 200 mflmin ON F'...= 2 Uh 51 mmHg 41 mmHg

QB = 300 nimin, UF ... = 2 Lil QS" -300 ml/mtn OUF''* = 2 L/ h B'" =300 mlrmin, QUF.' = 2 LU, 06 mmHg 53 mmtg

*B = 400 mVmin, CU.F '. = 2 L/b CS. = 400 m0min, OUF' . *= 2 L/lh QS' = 400 mVmin, CUF'* = 2 L/h 81 mmHg 64 mmHg

C'" = 450 m' min, OUF. 2 = 2 L/ CS" =450 mI/minm. CUF' ' = 2 L/h QCS'- =450 mI/mim QUF''· = 2 Li, 69 mmlHg

Tranmnitancia Coefficneitte di sieving Sinlingkoefficient

(plasma boyino, Cp 0 g/I, 37' C) (plasma boytins Cp 60 gIl, 37' C) (boyi/ plasma, Cp 60 04, 37 TC)

CS'' = 100 mI/min, CUF*'' = 20 mI/min QS' = 100 m/min QUF"' = 20 n/min QBS' = I0 mi/min, UF''' = 20 mumin

-Ura Uea 'Urea I

Creatinina Crealinina -Ktreatiin

-Vdtamina SI 2 Vltamina 12 -Vitamin S12 1

uInlina -Inulina Inl in I-Alb mina -Albumina Albumin <0 01

IValores medics caracteristicos medidos en laboratorio sobre un muestro de lotes esterilizados. Los valores pueden variar en funci6n del paciente, asi como de suestado clinico. / Tipid valori medi oftenuti da test di laboratorio su campioni di lotti sterili. I risultati possono variare a seconda del paziente a della diverse condizionicliniche, / Vanliga medelvarden erhmllna vid laboratorietest av post-steriliserade prov-partier. Resultater kan variera beroende pD patient och kliniska fOrutsttningar.

CVVHD CLEARANCES (Continuous veno-venous heamodialysis) Clearances versus inlet dialysale flow rate (317°C)CLAIRANCES EN CWHD (Hemodialyse veino-veineuse continue) Clairances au bain de dialyse, a dAbit entree dialysat (370C)CVVHD CLEARANCES (Kontinuierliche veno-venose Hamodialyse) Clearancewerte abhangig von der Dialysierflussigkeit-Einlalrate (37'C)ACLARAMIENTOS EN CVVHD (Hemodialisis veno-venosa continua) Aclaramientos con bard de diAlisis a 37'CCVVHD CLEARANCE (Emodialisi veno-venosa continua) Clearance con dialisato a 37°CCWHD CLEARANCE (Kontinuerlig veno-vends hemodialys) Clearance mot dialysatfldde (37oC)KLARINGEN IN CWHID (Continue veno-veneuze hemodialyso) Klaringen, snelheid van de dialysaataanvoer (37°C)ACILARAMENTO EM CVVHD (HemodiAaise veno-venosa continua) Aclaramento numna soluf~o dialise a 37°CD RFCWHD-CLEARANCE (Continuous veno-venous hemodialysis) Clearanceverdi versus inngangsdialyseflow rate (37°C)CWHD CLEARANCE (Kontinuerlig vene-vene haemodialyse) Clearance kontra flowhastighed for indlebsdialysat (37°C)CWHD (Continuous veno-venous hemodialysis) Clearance-arvot sissan tulevaan dialysaatin virtaukseen verrattuina (37°C)

PRISMAFLEX PRISMAFLEXHFIOO SET HF1400 SET

Q/QOS" = 100 ml/min QB/QS" = 200 ml/minOUF** = 0 ml/min QUF * = 0 ml/min

QDj . . (I/h) I 2.5 4 8 1 2.5 4 8

Urea / UrLe / Harnstoff / Urea / Ureum/Karbamid / Ureia / Karbamtd / Virtsahappo (±10%) 16.5 41 62 88 16.6 41 65 119

VitB12 (20%) 16.2 36 48 63 16.5 38 55 84

nulin / Inuline / Inulina / Inuliini (± 20%) 16.0 32 42 52 15.4 35 46 69

_rc4Vxit 012= (±r 20%)a s' lirte~+; vx;,,%e._ l&5 ql( (, gq I b,.U 41 &5 IlUltrafiltration flow rate (on PRISMAFLEX system, the ultrafiltration flow rate = fluid removal flow rate + replacement flow rate + pro blood pump flow rate) /D1bit d'ultrafiltration (sur le systems PRISMAFLEX, le debit d'ultrafiltration correspond au debit de prelevement de liquide + debit de solution de r6injection+ le d6bit de la pompe pre-pompe sang (PBP)) /Ultrafiltrationsfl ulrate (belmn PRISMAFLEX-System ist die JltrafiltrationsfluBrates die Flussigkeitsentfernungsfluflrate + Subsit utionsfluBrate+ Pra-Blutpumpen Flurfrate) /Flujo de ultrafiltratidn (en el sistema PRISMAFLEX el flujo de ultrafiltracidn corresponde al flujo de extraccidn de fiquido mas el frujo de solucibn de reinyeccidn+ mas el flujo de infusione pre-bomba de sangre (PBP)) /Flusso di ultrafiltrazione (il sistena PRISMAFLEX calcola it flusso di ultrafiltrazione net seguente modo: flusso di rimozione del fluido + flusso di reinfusione+ flusso dell'infusione pre-pompa sangue (PBP)) /Ultrafiltrationshastighet (pA PRISMAFLEX, ultrafiltrationshastighet = hascighet pA vatskeborttag frAn patient + hastghet pA ersattningsldsning+ preblodpumps flodeshastighet) /Ultrafiltratie-snelheid (op PRISMAFLEX -systeem: de ultrafiltratie-snelhoid = vochtverwijderings-snelheid + substitutie-snelheid + pre bloedpcmp snelheid) /Fluxo de ultrafiltragao (no sistema PRISMAFLEX, o fluxo de ultrafiltraq0o corresponde a0 dabito de recolha de I'quido + debito de solugco de reposigao+ taxa de fluxo pre bomba de sangue) /Flow-rate for ultrafiltrasjon (pA PRISMAFLEX-systemet: flow-rate for ultrafiltrasjon tilsvarer flow-rate for vaekefjerning + flow rate for reinjeksonsvaeske) /Flowhastighed for ultrafiltration (pm PRISMAFLEX-systemet er flowhastigheden for ultrafiltration hig med ftowhastigheden for vaskeudlob+ flowhastigheden for erstatningsvagske + pre-blodpumpe flowhastighed) /Ultrafiltrausnopeus (tama nopeus PRISMAFLEX-jarjestelmassa = nesteen ulostulovirtaus + korvausnesteen virtausnopeus + esi-veri-pumppu (PBP) virtausnopeus)

47



SERVICES Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES


JAW ' 6 2005

Mr. Thomas B. DowellManager Regulatory Affairs

Gambro® Renal Products10810 W. Collins AvenueLAKEWOOD CO 80215

Re: K042938Trade/Device Name: PrismaflexM HF 1000 Set and PrismaflexTM HF 1400 Set

Regulation Number: 21 CFR §876.5860

Regulation Name: High permeability hemodialysis system

Regulatory Class: 11

Product Code: 78 KDIDated: December 16, 2004Received: December 17, 2004

Dear Mr. Dowell:

We have reviewed your Section 510(k) premarket notification of intent to market the device

referenced above and have determined the device is substantially equivalent (for the indications

for use stated in the enclosure) to legally marketed predicate devices marketed in interstate

commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to

devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,

and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).

You may, therefore, market the device, subject to the general controls provisions of the Act. The

general controls provisions of the Act include requirements for annual registration, listing of

devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA),

it may be subject to additional controls. Existing major regulations affecting your device can be

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may

publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean

that FDA has made a determination that your device complies with other requirements of the Act

or any Federal statutes and regulations administered by other Federal agencies. You must

comply with all the Act's requirements, including, but not limited to: registration and listing

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic

product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.



This letter will allow you to begin marketing your device as described in your Section 510(k)

premarket notification. The FDA finding of substantial equivalence of your device to a legally

marketed predicate device results in a classification for your device and thus, permits your device to

proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please

contact the Office of Compliance at one of the following numbers, based on the regulation number at

the top of this letter:

21 CFR 876.xxxx (Gastroenterology/Renal/Urology) 240-276-0115

21 CFR 884.xxxx (Obstetrics/Gynecology) 240-276-0115

21 CFR 892.xxxx (Radiology) 240-276-0120

Other 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR

807.97). You may obtain other general information on your responsibilities under the Act from the

Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800)

638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrhI/dsmLadsmamain.html

Sincerely yours,

Nancy C.BrogdonDirector, Division of Reproductive,

Abdominal, and Radiological Devices

Office of Device EvaluationCenter for Devices and Radiological Health

Enclosure

-2



Special 510(k) NotificationGamnbro PrismafleXTm HF 1000 Set I HF 1400 Set


510(k) Number-(if knownV 1( KO V-4 1 3

De~vice Name:

PrismafleXTm HIF 1000 SetPrismaflexw HF 1400 Set

Indicationis For Use:

The Prismnaflex Set is indicated for use only with the Prismaflex Control Unit in providingcontinuous fluid management and renal replacement therapies. The system is intended forpatients who have acute renal failure, fluid overload, or both.

Prescription Use W1ROver-The-Counter Use ____

(Padt 21 CFR 801 Subpart 0) at/R(21 CFR 801 Subpart C)


Concurrence of GDRH, Office of Device Evaluation (ODE)

Dvsion of Reproductive, Abdominal,and Radiological Devi

510(k) Number ______

ConfidentialPae6



DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

$+4


Mr. Thomas B. DowellManager Regulatory Affairs NOV 1 6 2004Gambro Renal Products10810 West Collins AvenueLAKEWOOD CO 80215

Re: K042938Trade Name: Gambro PrismaflexTM HFI000 and HF1400 SetsDated: October 21, 2004Received: October 25, 2004

Dear Mr. Dowell:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above. We cannot determine if the device is substantially equivalent to a legallymarketed predicate device based solely on the information you provided. To complete the reviewof your submission, we require the following additional information:

(b)(4) Confidential and Proprietary Information



Page 2 - Mr. Thomas B. Dowell





The deficiencies identified above represent the issues that we believe need to be resolved beforeour review of your 510(k) submission can be successfully completed. In developing thedeficiencies, we carefully considered the statutory criteria as defined in Section 5 13(i) of theFederal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device.

We also considered the burden that may be incurred in your attempt to respond to thedeficiencies. We believe that we have considered the least burdensome approach to resolvingthese issues. If, however, you believe that information is being requested that is not relevant tothe regulatory decision or that there is a less burdensome way to resolve the issues, you shouldfollow the procedures outlined in the "A Suggested Approach to Resolving Least BurdensomeIssues" document. It is available on our Center web page at:http://www.fda.gov/cdrh/modact/leastburdensome.html

You may not market this device until you have provided adequate information described aboveand required by 21 CFR 807.87(1), and you have received a letter from FDA allowing you to doso. If you market the device without conforming to these requirements, you will be in violationof the Federal Food, Drug, and Cosmetic Act (Act). You may, however, distribute this device forinvestigational purposes to obtain clinical data if needed to establish substantial equivalence.Clinical investigations of this device must be conducted in accordance with the investigationaldevice exemption (IDE) regulations.

If the information, or a request for an extension of time, is not received within 30 days, we willconsider your premarket notification to be withdrawn and your submission will be deleted fromour system. If you submit the requested information after 30 days it will be considered andprocessed as a new 510(k); therefore, all information previously submitted must be resubmittedso that your new 510(k) is complete. Please note our guidance document entitled, "Guidance forIndustry and FDA Staff FDA and Industry Actions on Premarket Notification (510(k))Submissions: Effect on FDA Review Clock and Performance Assessment". The purpose of thisdocument is to assist agency staff and the device industry in understanding how various FDA andindustry actions that may be taken on 51 0(k)s should affect the review clock for purposes ofmeeting the Medical Device User Fee and Modernization Act. You may review this document athttp://www.fda.gov/cdrhImddufina/,ouidance/1219.html.

The requested information, or a request for an extension of time, should reference your above510(k) number and should be submitted in duplicate to:

1//





Food and Drug AdministrationCenter for Devices and

Radiological HealthDocument Mail Center (HFZ-40 1)9200 Corporate BoulevardRockville, Maryland 20850

If you have any questions concerning the contents of the letter, please contact Mr. Joshua Nipperat (301) 594-1220. If you need information or assistance concerning the IDE regulations, pleasecontact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet addresshttp://www.fda.g~ov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Carolyn tNeuland, Ph.D.Chief, Gastroenterology and Renal

Devices BranchDivision of Reproductive, Abdominal,

and Radiological DevicesOffice of Device EvaluationCenter for Devices and Radiological Health



Thomas B. DowellManager Regulatory AffairsGambro Renal Products10810 West Collins AvenueLAKEWOOD CO 80215

Re: K042938Trade Name: Gambro Prismaflex TM HFL000 and HF1400 SetsDated: October 21, 2004Received: October 25, 2004

Dear Mr. Dowell:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above. We cannot determine if the device is substantially equivalent to a legallymarketed predicate device based solely on the information you provided. To complete the reviewof your submission, we require the following additional information:





L/zI




Page 3 -Mr. Thomas B. Dowell

The deficiencies identified above represent the issues that we believe need to be resolved beforeour review of your 5 10(k) submission can be successfully completed. In developing thedeficiencies, we carefully considered the statutory criteria as defined in Section 5 13(i) of theFederal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device.

We also considered the burden that may be incurred in your attempt to respond to thedeficiencies. We believe that we have considered the least burdensome approach to resolvingthese issues. If, however, you believe that information is being requested that is not relevant tothe regulatory decision or that there is a less burdensome way to resolve the issues, you shouldfollow the procedures outlined in the "A Suggested Approach to Resolving Least BurdensomeIssues" document. It is available on our Center web page at:http://www.fda.gov/cdrh/lmodact/leastburdensome.htmI

You may not market this device until you have provided adequate information described aboveand required by 21 CFR 807.87(l), and you have received a letter from FDA allowing you to doso. If you market the device without conforming to these requirements, you will be in violationof the Federal Food, Drug, and Cosmetic Act (Act). You may, however, distribute this device forinvestigational purposes to obtain clinical data if needed to establish substantial equivalence.Clinical investigations of this device must be conducted in accordance with the investigationaldevice exemption (IDE) regulations.

If the information, or a request for an extension of time, is not received within 30 days, we willconsider your premarket notification to be withdrawn and your submission will be deleted fromour system. If you submit the requested information after 30 days it will be considered andprocessed as a new 5 10(k); therefore, all information previously submitted must be resubmittedso that your new 5 10(k) is complete. Please note our guidance document entitled, "Guidance forIndustry and FDA Staff FDA and Industry Actions on Premarket Notification (5 10(k))Submissions: Effect on FDA Review Clock and Performance Assessment". The purpose of thisdocument is to assist agency staff and the device industry in understanding how various FDA andindustry actions that may be taken on 5 1 0(k)s should affect the review clock for purposes ofmeeting the Medical Device User Fee and Modernization Act. You may review this document athttp://www.fda. gov/cdrh/nidufmnaA~uidance/lI 21 9.htrnl.

The requested information, or a request for an extension of time, should reference your above5 10(k) number and should be submitted in duplicate to:




DEPARTMENT OF HEALTHAND HUMAN SERVICES



Radiological HealthDocument Mail Center (HFZ-401)9200 Corporate BoulevardRockville, Maryland 20850

If you have any questions concerning the contents of the letter, please contact Mr. Joshua Nipper

at (301) 594-1220. If you need information or assistance concerning the IDE regulations, please

contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-

free number (800) 638-2041 or at (301) 443-6597, or at its Internet addresshttp://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

/s/Carolyn Y. Neuland, Ph.D.Chief, Gastroenterology and Renal

Devices BranchDivision of Reproductive, Abdominal,

and Radiological DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

cc: HFZ-401 DMCHFZ-404 510(k) StaffHFZ-470 DRARDD.O.

HFZ470:JoshuaNipper:j cn:1 1.16.2004

FILE COPYOFFICE SURNAME DATE OFFICE SURNAME DATE OFFICE SURNAME DATE

IZ0V I .... ..- IIV kI I -- I II

U.S. GPO 1986-169-0896-/6



DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service


Radiological HealthOffice of Device EvaluationDocument Mail Center (HFZ-401)9200 Corporate Blvd.

October 25, 2004 Rockville. Maryland 20650

GAMBRO RENAL PRODUCTS 510(k) Number: K(04293810810 WEST COLLINS AVE. Received: 25-OCT-2004LAKEWOOD, CO 80215 Product: GAMBRO PRISMAFLEXATTN: THOMAS B. DOWELL HF1000 AND HF1400

SETS

The Food and Drug Administration (FDA), Center for Devicesand Radiological Health (CDRH), has received the Premarket Notification yousubmitted in accordance with Section 510(k) of the Federal Food, Drug, andCosmetic Act(Act) for the above referenced product. We have assigned yoursubmission a unique 510(k) number that is cited above. Please referprominently to this 510(k) number in any future correspondence that relatesto this submission. We will notify you when the processing of your premarketnotification has been completed or if any additional information is required.YOU MAY NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVEA LETTER FROM FDA ALLOWING YOU TO DO SO.

On May 21, 2004, FDA issued a Guidance for Industry and FDA Staff entitled,"FDA and Industry Actions on Premarket Notification (510(k)) Submissions:Effect on FDA Review Clock and Performance Assessment". The purpose of thisdocument is to assist agency staff and the device industry in understandinghow various FDA and industry actions that may be taken on 510(k)s shouldaffect the review clock for purposes of meeting the Medical Device User Feeand Modernization Act. Please review this document athttp://www.fda.gov/cdrh/mdufma/guidance/l2l9.html.

Please remember that all correspondence concerning your submission MUST besent to the Document Mail Center (DMC)(HFZ-401) at the above letterhead address.Correspondence sent to any address other than the one above will not beconsidered as part of your official premarket notification submission. Also,please note the new Blue Book Memorandum regarding Fax and E-mail Policyentitled, "Fax and E-Mail Communication with Industry about Premarket FilesUnder Review". Please refer to this guidance for information on current faxand e-mail practices at www.fda.gov/cdrh/ode/a02-Ol.html.

You should be familiar with the regulatory requirements for medical deviceavailable at Device Advice http://www.fda.gov/cdrh/devadvice/". If you haveother procedural or policy questions, or want information on how to checkon the status of your submission, please contact DSMTCA at (301) 443-6597 orits toll-free number (800) 638-2041, or at their Internet addresshttp://www.fda.gov/cdrh/dsmamain.html or me at (301)594-1190.

Sincerely yours,

Marjorie ShulmanSupervisory Consumer Safety OfficerOffice of Device EvaluationCenter for Devices and Radiological Health



Special 510(k) NotificationGambro Prismaflex Tm HIF 1000 Set /HF 1400 Set


Gambro Prismaflex TM

HF 1000 Set / HF 1400 Set

Confidential Page 1 ~.



Special 510(k) NotificationGamnbro PrismafleXTM HF 1000 Set / HF 1400 Set

TABLE OF CONTENTSSECTION PAGEI. Letter to the FDA (including copy of User Fee Cover Sheet) ............ 3-5

II. Pre-market Submission Cover Sheet ............................... 6-9

Ill. Product Description/Specificatiofls...............................10-22A. Description ................................................ 11-14B. Technical drawings..........................................15-19C. Components parts and materials ............................... 19-22

IV. Labeling.....................................................23-27A. Product label for Prismaflex HF 1 000 set............................24B. Product label for Prismaflex HF 1400 set............................25C. Package insert................................................26D. Proposed marketing literature .................................... 27

V. Device Perform ance ................................ .......... 28-33A . U ltrafiltration ......... .............................. . ......... 29B. Blood pressure drop ................................ ........... 30C . C learances ........... ..................... ............... 31-32D. Sieving coefficient .......................................... .3

VI. Sterilization Inform ation ......................... .......... .... 34-39A. Sterilization process ............................... ............ 3653B. Sterilization validation method and SAL...................... ... 36 7C. Ethylene oxide residuals ........................... ............. 3D. Pyrogen testing ...................................... ......... 38E. Packaging information.............................. ............ 39

VII. Summary of Design Control Activities ............................. 40-44A. Summary of design controls ................................... 41-42B. Declaration of conformity with design controls ..................... 43-44

Vill. Statement of Equivalence and Comparative Data......................45A. Statem ent of equivalence .......................... ............. 46B. Comparison table ........................................... 75

C. Predicate device labeling and package inserts ..................... 54-60D. FDA 510(k) clearance letters for predicate devices ................. 61-61

IX. 501(k) Sum m ary .............................................. 62-64

X. Truthful and Accurate Statement ................................ 65-66

xi. Indications for Use Statement ................................... 67-68

Appendix A Prismaflex HF10O0/HF1400 Sets Instructions for Use.............69-78Appendix B Prismaflex HF1000/HF1400 Sets Proposed Marketing Literature .... 79-80Appendix C Prismaflex M60/M100 Instruction for Use ...................... 81-89Appendix D Prisms HF1 000 Instructions for Use ......................... 90-102Appendix E Predicate Devices 51 0(k) Substantial Equivalence Letters ....... 103-1 08

Confidential Page 2




Gambro Prismaflex TM HF 1000 Set / HF 1400 Set

SECTION I

Letter to the FDA(including copy of the User Fee Coversheet)

Confidential Page 3



"GAMBRO. Renal Products

October 21, 2004

10810W Collins Avenue

Lakewood, Colorado 80215 USA

Tel 303-232-6800

Food & Drug AdministrationCenter for Devices & Radiological HealthOffice of Device EvaluationDocument Mail Center (HFZ-401)9200 Corporate BoulevardRockville, MD20850

RE: Special 510(k) NotificationGambro PrismaflexTM HF 1000/HF 1400 Sets

Dear Sir/Madame:

This Premarket Notification (Section 510(k)) is to request FDA authorization to commerciallyTM HF 1000 Sets and HF 1400 Sets, which are

In accordance with Section 510(k) of the Federal Food, Drug and Cosmetic Act, and inconformance with 21 CFR 807, this Premarket Notification is being submitted prior to the datewhen Gambro Renal Products proposes to introduce these devices into interstate commerce forcommercial distribution.

The medical devices are being submitted in this 510(k) Notification by virtue of the fact that theyare substantially equivalent in design, function, composition, and operation, to other acute renalcare devices, which were or are currently in commercial distribution in the United States. Weconsider the information in this notification to be confidential

Please feel free to contact me at (303) 231-4094 (telephone) or (303) 542-5138 (fax) if you haveany questions or require additional information regarding this Premarket Notification.

Sincerely your

Thomas B. DowellManager Regulatory AffairsGambro Renal Products : '

cc: Emmanuelle MoulinFrancesco Bardelli

Page 4

(b)(4) Confidential and Proprietary Information(b)(4) Confidential and Proprietary Information




Gambro Prismaflex TM HF 1000 Set/ HF 1400 Set

ForTm Annoved:eOM NOD 0590l51 ELxpration Date: Aouut 31 2006 Sier Liost i ri for 0MB Siatement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATION PAYMENT IDENTIFICATION NUMBER:

MEDICAL DEVICE USER FEE COVER SHEET Write the Payment Identification Number

A completed Cover Sheet must accompany each original application or supplement subject to fees. The following actions must be taken to properly submit your

application and fee payment:

1. Electronically submit the completed Cover Sheet to the Food and Drug Administration (FDA) before payment is sent.

2. Include a printed copy of this completed Cover Sheet with a check made payable to the Food and Drug Administration. Remember that the Payment

Identification Number must be written on the check.

3. Mail Check and Cover Sheet to the US Bank Lock Box, FDA Account, P.O. Box 956733, St Louis, MO 63195-6733. (Note: In no case should payment

be submitted with the application.)4. If you prefer to send a check by a courier, the courier may deliver the check and Cover Sheet to: US Bank, Alto: Government Lockbox 956733, 1005

Convention Plaza, St. Louis, MO 63101, (Note: This address is for courier delivery only. Contact the US Bank at 314-418-4821 if you have any

questions concerning courier delivery.)5. For Wire Transfer Payment Procedures, please refer to the MDUFMA Fee Payment Instructions at the following URL:

httt:I/www.fda. oV/cdrh/lmdufmalfaOsahtml#3. You are responsible for paying all fees associated with wire transfers.

6. Include a copy of the completed Cover Sheet in volume one of the application when submitting to the FDA at either the CBER or CDRH Document Mail

Center.

1. COMPANY NAME AND ADDRESS (Include name, street address, city, 2. CONTACT NAME

state, country, and post office code) THOMAS DOWELL

GAMBRO RENAL PRODUCTS 21 E-MAiL ADDRESS

10810 WEST COLLINS AVENUE tom.dowellus.gambro.comLAKEWOOD, CO 80215

2.2 TELEPHONE NUMBER (Include Area Code)303-231 4094

1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)841155786 2.3 FACSIMILE (FAX) NUMBER (Include Area Code)

303-542-5138

3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; if you are unsure, please refer to the application descriptions at the

following web site: http://www fda.gov/oclmdufma

Select an application type: ~~~~~~~~~~~3.1 Select one of the tyoes below:Select an app licatio pe

Premarket notification (510(k)); except for third party reviews Oniinal Application

[] Biologics License Application (BLA) Supplement Types:

El Premarket Approval Application (PMA) [] Efficacy (BLA)

[] Modular PMA [] Panel Track (PMA, PMR, POP)

El Product Development Protocol (PDP) El Real-Time (MA, PMR, POP)

El Premarket Report (PMR) -l 180-day (PMA, PMR. POP)

4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determining this status.)

D YES, I meet the small business criteria and have submitted the NO, I am not a small business

required qualifying documents to FDA

4.1 If Yes, please enter your Small Business Decision Number:

.IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE APPLICABLE

EXCEPTION.

[] This application is the first PMA submitted by a qualified small business, El The sole purpose of the a]ppliction is to support conditions of useincluding any affiliates, parents, and partner firms for a pediatric population

El This biologics application is submitted under section 351 of the Public Health E] The application is submitted by a state or federal government

Service Act for a product licensed for further manufacturing use only entity for a device that is not to be distributed commercially

6 IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WERE WAIVED DUE TO SOLE USE IN A PEDIATRIC POPULATIONTHAT NOW PROPOSES CONDITION OF USE FOR ANY ADULT POPULATION? (If so, the application is subject to the fee that applies for an original

premarket approval application (PMA).)

D~ YES 9 NO

7. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION (FOR FISCAL YEAR 2005)

Form FDA 3601 (08/2003)

Confidential Page 5Page





Special 510(k) NotificationGamnbro PrismnafleXrm HF 1 000 Set / HF 1400 Set

SECTION II

Pre-Market Submission Coversheet

Confidential Page 6

6( 6f



Special 510(k) NotificationGamnbro PrismafleXTm HF 1000 Set!/ HF 1400 Set

CENTER FOR DEVICES AND RADIOLOGICAL HEALTHPre-market Submission Cover Sheet

Date of Submission: October 21, 2004 FDA DOCUMENT NUMBER: NOT YET ASSIGNED

Section A Type of Submission

051 0(k) M IDE 5! PMA 51 PMVA Supplement - Regular5510(k) ddI infomation IDE Amenment FEPMA Amenment LiPMA Supplement - Special

5 IDE Supplement 5 PMA Report UPMA Supplement - 30 dayo IDE Report 5 ~~~~~~~PMA Supplement - Panel Track

Section Bl Reason for Submission - 51Ojk)S Only

ol New device E5 Additional or expanded 0 Change in technology, design, materials,indications or manufacturing process

o] Other reason (specify):

Section B2 Reason for Submission - PMAs Only

ol New device S1 Change in design, component, S1 Location change.

o] Withdrawal or specification: S1 Manufacturer

o1 Additional or expanded indications 5] Software E5 Sterilizer

o Licensing agreement 51 Color Additive 5l PackagerFC Other (specify below) 51 Distributor

El Labeling change:5 Indications 1S Process change: El Report submission:

EJ instructions S] Manufacturer S] Annual or periodic

o] Performance Characteristics El Sterilizer U1 Post-approval study

o1 Shelf life S1 Packager 51 Adverse reaction51 Trade name 5! Device defect

E5 Other (specify below) 5 Response to FDA correspondence (specify below) C5 Amendment5 Request for applicant hold

ol Change in ownership S Request for removal of applicant holdol Change in correspondent S Request for extension

U_ Request to remove or add manufacturing siteo! Other reason (specify):

F1 Expansion I extension of study 5~sgnF Deemed approved

5 IRB certification E5 Informed consent El Deficient final report

5 Request hearing 5] Manufacturer 5l Deficient progress report

• Request waiver 5 Manufacturing 51 Deficient investigator report

L] Termination of study U1 Protocol - feasibility 51 Disapprovalo Withdrawal of application 5l Protocol- other 5l Request extension of

5Unanticipated adverse effect 51 Sponsor time to respond to FDAS7 Request meeting

5Emergency use: 5l Report submission: I OL submissions only:5 Notification of 5] Current investigator 5 Change in lOt style

emergency use 5] Annual progress 5] Request for protocol waiver5- Additional information 51 Site waiver limit reached

5_ FinaloOther reason (specify):

Confidential Page 7



Special 510(k) NotificationGambro Prismaflex Tm HF 1000 Set / HF 1400 Set

FDA Document Number: Not Yet Assigned

Section C Product Classification

Product code: KDI C.F.R. Section: Device class:21 CFR 876.5860

El Class I [ Class ilEl Class III E] Unclassified

Classification panel: Gastroenterolog - Urology

Section D Information on 510(k) Submissions

Product codes of devices to which substantial equivalence is claimed: Safety and effe ene data:safety and effectiveness data:

[]510(k) summary attached

L] 510(k) statement

1 KDI 2 KDI 3 4

5 6 7 8

Information on devices to which substantial equivalence is claimed:

510(k) Number Trade or proprietary or model name Manufacturer

I K011221 1 Prisma HF1000 1 Hospal Industrie

2 K041005 2 PrismaflexM60/M100 Sets 2 Hospal industrie

3 3 3

4 4 4

Section E Product Information - Applicable to All Applications

Common or usual name or classification name:

Trade or proprietary or model name Model number

I Gambro Prismaflex TM HF1000 Set 1 HF 1000

2 HF 14002 Gambro PrismaflexvM HF1400 Set

FDA document numbers of all prior related submissions (regardless of outcome):

1 2 3 4 5 6

7 8 9 10 1112

Data included in submission: [ILaboratory testing Q] Animal trials fl Human trials

Indications (From labeling):

The Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and renalreplacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Confidential Page 8



Special 510(k) NotificationGambro Prismaflex TM HF 1000 Set / HF 1400 Set

FDA Document Number: Not Yet Assigned

Confidential Page 9




Special 510(k) NotificationGambro Prismaflex TM HF 1000 Set/ HF 1400 Set

SECTION III

Description of Devices





PRODUCT DESCRIPTION AND SPECIFICATIONS





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Special 510(k) NotificationGambro PrismaflexTm HF 1000 Set HF 1400 Set

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

uontlcientlal Page 16









Special 510(k) NotificationGambro Prismaflex TM HF 1000 Set HF 1400 Set











C. COMPONENTS PART AND MATERIALS





Special 510(k) NotificationGambro PrismaflexTM HF 1000 Set/ HF 1400 Set











SECTION IV

Labeling





A. PRODUCT LABEL FOR HF 1000 SET

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Special 510(k) NotificationGambro PrismaflexTM HF 1000 Set/ HF 1400 Set

B. PRODUCT LABEL FOR HF 1400 SET

prismafleX

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C. PACKAGE INSERT

The Instructions for Use is attached as appendix A.


Le[



Special 51 0(k) NotificationGambro PrismafleXTm HF 1000 Set /HF 1400 Set

0. PROPOSED MARKETING LITERATURE

The proposed marketing literature is attached as appendix B

Confidential Page 27 'So



Special 51 0(k) NotificationGamnbro Prismnaflex~ HF 1000 Set! HIF 1400 Set

SECTION V

Device Performance

Confidential Page 28q I



Special 510O(k) NotificationGamnbro Prismnaflex~ HF 1000 Set! HF 1400 Set










Special 510(k) NotificationGambro Prismaflex Tm HF 1000 Set / HF 1400 Set
















SECTION VI

Sterilization Information


q1



Special 51 0(k) NotificationGamnbro PrjsmafleXTm HF 1000 Set IHF 1400 Set

STERILIZATION INFORMATION

A. STERILIZATION PROCESS






B. VALIDATION METHOD








160




Special 510(k) NotificationGamnbro PrismnafleX Tm HF 1000 Set / HF 1400 Set






E. PACKAGING INFORMATION






SECTION VII

Summary of Design Control Activities





SUMMARY OF DESIGN CONTROL ACTIVITIES











B. DECLARATION OF CONFORMITY WITH DESIGN CONTROLS





M,,E ' !tJ(i[E

Tel 7

Fax , ' :,, SECTION VII

D. DECLARATION OF CONFORMITY WITH DESIGN CONTROLS

I, Jean-Philippe Bret, im my capacity as Qua/idy Assurance Manager. certify Ihat, asrequired by the risk analysis, all verification and validation activities were'performted by appropriate designated individuals and the insuits demonstmfkd thorthe predetermined acceptance criteria were met.

Meyzieu, July 5. 2004

Jean Phi/i e BRE7 tQualify A.¢strance Manage-t

GAMBR~ Hspal ln~usride

L. Jean-Philippe Bret, in my capacity as Quality Assurance Manager, cerIify Iha! lb,,Gainbio Hospal Industde manufacluring facilitv is in conformance with the des!Incontrol procedure requirements as specified in 21 C:P 820.30 and the records aOt?available for review.

Meyzieu, July 5, 2004

Jean Philippe BRETQuality Assurance ManagerGAMBRO hIospal lndte

KAHUSPAL INDUST RIE





SECTION VIII

Statement of EquivalenceAnd Comparative Date


IbJ



Special 510(k) NotificationGamnbro PrismafleXTm HF 1000 Set!I HF 1400 Set

STATEMENT OF EQUIVALENCE & COMPARATIVE DATA

A. STATEMENT OF EQUIVALENCE

Gambro believes the proposed Prismaflex HIF 1000/HF 1400 sets are substantiallyequivalent to the current Prisma HF 1000 sets and Prismaflex M60/M100 sets.The current Prisma HIF 1000 sets and Prismaflex M60/M100 sets have been cleared formarketing/sale in the United States under respective 510(k) notifications K01 1221 andK04 1005.

The modifications in the proposed Prismaflex HIF 1000O/HF 1400 sets are substantiallyequivalent in design, function, composition and operation to the current Prisma HIF 1000sets and Prismaflex M60/M 100 sets.

These modifications detailed in this submission do not affect the intended use or alterfundamental scientific technology of the device.






B. COMPARISON TABLE


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Special 510(k) NotificationGambro PrismafleXTm HF 1000 Set/ HF 1400 Set

C. PREDICATE DEVICES LABELING AND PACKAGE INSERTS

Confidential Page 54 1 i -�



Special 510O(k) NotificationGambro PrismafleXTm HF 1000 Set / HF 1400 Set

PRISMAFILEX M60 SET I PRISMAFLEX MIOO SET




Special 510O(k) NotificationGambro PrismafleX'Tm HF 1 000 Set! HIF 1400 Set

prisma-flex

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PRISMA HIF 1000 Pre Set

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PACKAGE INSERTS

PREDICATE PRISMAFLEX M60/MIOO Sets

The Instructions for Use for the M60/M100 predicate devices are attached as appendix C.

PREDICATE PRISMA HIF 1000 Set

The instructions for Use for the HF1000 predicate devices are attached as appendix D.


/2



Special 510(k) NotificationGambro PrismafleXTm HF 1000 Set / HF 1400 Set

D. FDA 510(k) CLEARANCE LETTERS FOR PREDICATE DEVICES

The 510(k) clearance letters for the predicate devices are attached as appendix E.

Confidential Page 61 (r



Special 510(k) NotificationGamnbro PrisMafleXTm HF 1000 Set! HF 1400 Set

SECTION IX

510(k) Summary


DQ5-



Special 510(k) NotificationGamnbro PrismafleXTm HF 1000 Set! HF 1400 Set

510(K) SUMMARY

SUBMITTER: Gamnbro, Renal Products10810 West Collins AvenueLakewood, CO 80215USA

CONTACT: Thomas B. Dowell, Manager Regulatory AffairsPhone: (303) 231-4094Fax: (303) 542-5138

DATE PREPARED: October 21, 2004

DEVICE NAME: Prismnaflex HIF 1 000 SetPrismnaflex HIF 1400 Set

COMMON/UNUSUAL NAME: Hemnofilter and Blood Tubing SetHigh Permeability Hemodialyzer

CLASSIFICATION NAMES: High Permeability Hemodialysis System Accessory

CLASSIFICATION PANEL: K~l Gastroenterology - Urology

CLASSIFICATION: Class 11 per 21 CFR 876.5860

PREDICATE DEVICES: Garnbro, Prisma HF1000 Set K01 1221Gamnbro Prismaflex M60/M100 Set K041005

SUBSTANTIAL EQUIVALENCE:

The proposed Prismaflex HIF 1000 and HIF 1400 sets are substantially equivalent to thePrisma HIF 1000 sets and Prismnaflex M60/M 100 sets currently on the market. Themodifications in the proposed devices are substantially equivalent in design, function,composition, and operation, to the predicate devices that have FDA clearance under 510(k)'sK01 1221 and K041005.

DEVICE DESCRIPTION:

The Prismnaflex disposable sets are sterile disposable extracorporeal circuits containing aPAES hemnofilter/dialyzer and fluid circuit for use with the Prismaflex control Unit. ThesePrisnnaflex disposable sets allow the following fluid management and renal replacementtherapies to be performed:

* SCUF : Slow Continuous Ultrafiltration* CVVH :Continous Veno-Venous Hemofiltartion* CWVHD : Continous Veno-Venous Hemodialysis* CVVHDF :Continuous Veno-Venous Hemodiafiltartion





INDICATIONS FOR USE:


TECHNOLOGICAL CHARACTERISTICS:

The proposed device configurations have the same technological characteristics and aresimilar in design, function, and operation, to the currently marketed configurations.

SUMMARY OF NON-CLINICAL TESTS and CONCLUSION:

In vitro testing was conducted to compare the performance of the proposed deviceconfigurations to the predicate configurations. The results of the in vitro testing demonstratethat the proposed configurations are substantially equivalent to the predicate configurationsand are suitable for the intended use.

SUMMARY OF CLINICAL TESTS and CONCLUSION:

Not applicable





SECTION X

Truthful & Accurate Statement


/2



Special 510(k) NotificationGamnbro PrismnafleXTm HF 1000 Set! HF 1400 Set

PREMARKET NOTIFICATIONTRUTHFUL AND ACCURATE STATEMENT*

(As required by 21CFR 807.87 (k))

I certify that, in my capacity as Manager Regulatory Affairs, Gambro Renal Products,

I believe to the best of my knowledge, that all data and information submitted in the

premarket notification are truthful and accurate and that no material fact has been

omnitted.

Thomas B. DowellTyped Name

DatedI

Number not yet assigned

Premarket Notification (510(k)) Number

Confidential Page 66jp



Special 51 0(k) NotificationGamnbro PrismafleXTm HF 1000 Set!/ HF 1400 Set

SECTION Xi

Indications For Use Statement






510(k) Number (if known):

Device Name:

Prismaflex TM HF 1000 SetPrismaflexTM HF 1400 Set



Prescription Use __AN/OROver-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)






prismaflex

HF 1000 SETHF 1400 SET

Instructions for useNotice d'utilisationGebrauchsanweisungFoileto de utiiizaci6nistruzioni per FusoHandhavandeinstruktionerGebru iksaanw izingHstrucbes de uso3ruksanvisningBrugsanvisning

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140

PRISMAFLEX HF1000120 4W ni~Jmn

imE~~~~~~~~~~ o mUmin

.S~nr 1013/iU-

~60

40~.- ' QB/OS = 100 mLrmnlin

0,o so 100 150 200 250 300 350 400 450 500

PTM I TMP (mig)

160

o PRISMAFLEX HF1400/ =450 mrdnrn

120

QB/QS = 300 m~~~~~min

m~men 78 mUminE 80

CY ~~~~~~~~~~~~46 mL/min40 CS~~~~~~~0/QS 1200 ntnIL un

20

20

0 100 200 300 400 5(00

PTM I TMP (mmHg)

'in vitro" ultrafiftration with blood (values t15 %)(Bovine blood at 37'C, Hot 32 %, Protein concentration 60 q,)Ultmftltratbon is controlled! by the PRISMAFLEX Systemn and is independent of the ultrasiltnation coeificicent OCUF)Utl'altratimoion au sang 'in "ir" (valelirs &±. 1 5%)(Sang de bceif A 37'O, Hilmatocrite = 32 %, Goncentration prot~ique = 60 gAl)12ultraifitration est rnaitisee p Ie systenme PRISMAFLEX at esAt Indepnendents du coefficient d'uftralfitrationi QCUF)Ultrafifltation mit Blut "in vitro" Waetso bei t 15 %)(Pindearblut bei 37rc. I-kt 32 %, Protein-Kontentraftion 60 g/l)Die Ultralfnirtion wird von der PRISMAFLEX Masichne sui derncrihbingen Waiet gehafteni und h~ngt mndch vomUltrafitratonskoeflizemen Q(UF) ab.Ultrafiltracion con sangr "in vito` (vakores a ± 1 5%)(Sarngre lbovina a 37'C, Hematocritoi 32 %, Conmcn'ridin prothica - 60 gAl)La ufirafiltratin comntolada pWr .i sistemia PRIESMAFLEX, es indepencidiene del cofitciente de ufftrafiltreian QCUF)

Uftrafiltravone con sangue "-in vitro" (valor at~ 15 %)(Sangue bovinoi a 370C, ernatocrito = 32 %, Concentrazione proteica =60 gAl)L'ulftnrfihtiazione A controllata dat Slitena PRISMAFLEX ed A indipendente call coefficiente di ultrafiltrazicorw QCUF)"In vitro' ultrafilltration med blod (varden ± 15 %)(Bovint clod vid 37rC, Hct 32 %, Proteinkon~centrartion 60 gI I)Ultrefitrationen kontrollerea cv PRISMAFLEX syatemnet och a, obenorende av koefficientein tdr ultrafiltration (KUF)-Ultrafiftratie met 'in vitro'-bloodl (waarden op ± 15 %)(Runderbloedl 3TC, Henmatocre~,iotard = 32 %, Eiwstgehalte = 60 g/l)Uhitrfiltratie nodt geontioleerd door be PRISMAFIIX Systeem en is onafnakelijk, van clo ultraflltmstie coefficnint.A ultrafiltrago con sangue 'In viò (vloires a ± 15 %)(Sangue bovino A temperatura de 37rc, Hemcttcrito = 32 %, ConcentragAo protdica =60 g/l)A uftraffiftrsva conbolada peio sisems PRISMAFLEX cc independente do coetIiciet dos ultraiftraAo. QCuF)"In jr"utaita~n mec! bloct ("erier 15 %A)(Bovint lod tedi 3rC. Hot 32 %, proteinkonscntrealaon 60 94lUltrafiftras~on kontrolleres av PRISMAFLEX-systcmet, og er avhcngig cv ultiraltras~onskoeftfsuctcn (KUF)"In vlr"utaiteigmed blodl (v&rdicr ± 15 %)(Bovint bled tedl 37tC, Hat 32 %, proteink~oncenirto 60 g/l)Ultraflftrenngen styres at PRISMAFLEX-systemet og er uafthriqit at koeffloenten for unltrautrering (KUF)Veren ultrafiltraatio 'in vitro (arvo ± 15 %)

(a. ~~~~~~~~~~(Riaavan StG verta. Hct 32 %, pot:eiinipitoisuus 60 g/l)Ultraflitraatio tanahtuu PRISMAYLEX-oh~ausysikisn a~lisena a sc on rippumaton ultrafitnittion kertoinlesta (KUF)

70 /33



* A 5-liter bag is provided to be connected to the end of the blood return line toDErl NITION OF SYMBOLS USED ON LABELING Initially collect priming solution, during priming. Then, during teatment, this bag is

used to collect ultrafihrate and/or used dialysate (connection at effluent ine). OtherOF PRODUCT sterile 5 and 10 liter bag and sterile, non pyrogenic spkes can be orpaed separately.

* All line connectors are compatiblewith the ISO 594/1 & 2 international standards

FLOT manufacturing batch number coooerning conical ftngs.* The fluid pathways of the PRISMAFLEX Set are guaranteed sterile and non

pyrogenic.

sterilized by ethylene oxide (EtO); followed · The PRISMAFLEX HF1 00O/HF1 400 Set is sterilized by ethylene oxide (EtD).by the sterilization date Deamration Is such that EtO residuals comply with the ones described in ISO

10993-7.

expiration date of the product *Expiration date: Please refer to product label.* The PRISMAFLEX Set is manufactured by HOSPAL Industrie, Meyzieu, France.

p f In this document the hemofilter/dialyzer will be referred to as "filter".product for single use only

A Read instructions before using the product. INDICATIONS

A Caution Federal law (USA) restricts this device to sale by or on the orderof a physician. The PRISMAFLEX Set is indicated for use only with the PRISMAFLEX Control Unit in

pro'riding continuous fiui! management and renal replacement therapies. The systemis intended for patients who have acute renal failure, fluid overload, or both.

This set is intended for use in the following veno-venous therapies: SCUF ; CWH

DEFINITION OF EXPRESSIONS USED CWHD; CWHDF

IN THIS MANUAL All treatments administered via the PRISMAFLEX Set must be prescribed by aphysician. The size, weight, state of uremia, cardiac status, and general physicalcondition of the patient must be carefully evaluated by the prescribing physician

In this ocument: before each treatment.

A "Warning" is used to alert the user/operator not to take a certain action which, The PRISMAFLEX HF100D0/HF1 400 sets should be restricted to patients with a bodyif taken, can cause a potential hazard and result in a serious adverse reaction, injury weight greater than 30kg (661b).or death.

A 'Caution" Is used to alert the user/operator to take a certain action to protect

against a potential hazard, which, if ignored, could have an adverse effect on the CONrRAINDICATIONSpatient or on the device.

'Note" is used as a reminder to the user/operato r on normalI treatment activity andon what is a suitable action In a particular situation. The a no known contraindcations to continuous renal replacement therapies.

SCUF Slow Continuous UltraFiltrationCVVH Continuous Veno-Venous Henrofit rationCVVHD: Continuous Veno-Venous HemoDialysis CAUTIONS AND WARNINGSCVVHDF: Continuous Veno-Venous HemoDiaFiltrationPredilution: addition of replacement fluid to the blood stream upstream to the filterPostdilution: addition of replacement fluid to the blood steam downstream to the filter Note: Additional warnings and cautions pertaining to the PRISMAFLEX system

are included in the PRISMAFLEX Control Unit Operatorls Manual.

PRODUCT DESCRIPTION A Cautions1. Carefully read these Instructions for Use and the PRISMAFLEX Control Unit

* The PRISMAFLEX HF10O/HF1400 Setisa disposable, extracorpe ircuilfor Operator's Manual before using this product.use with the PRISMAFLEX System. 2. Store the PRISMAFLEX Set in a dry place, between 0° C (32" F) and 30" C(86" F).

· The PRISMAFLEXHF10OO0/HF1400Setconsistsofa PAES hollowfiberhemofilter/ 3. Sane sofrents and other c/rricas, if usd in contact wit the filter couid damagedialyzer' arid tubing lines. the set. No chemical of this type should be used without permission of the

manufacturer. The following are especially forbidden* This filter is permanently connected to a blood access line (red-striped), a blood a) halogenated rmatic and aliphatic solvents;

return line (blue-striped, a dialysate inlet line (green-striped) and an effluent outlet b) ketonic sokent.line (yellow-striped).

4. To prevent contamination, this PRISMAFLEX Set must be used as soon as its* The other tines of the set include: ~~~~packaging and sterilization cape are removed.

- a replacement solution line (purple-striped)cpDo noiuse thisset if th packaginais damaed,- a pre blood pump line (white striped) 5. pro blood pump line (white strped) S. ~~~Do not use this set if the Packaging is damaged, it the sterilization caps am

-an anticoagulant line (syringe) missing or loose, or if any of the lines in the set are kinked.6. Do not try to remove the filter from the cartridge plate.* The configuration of the PRISMAFLEX set allows the following uses depending

on the configuration of the automated clamps on the machine : 7. Destroy this set after single use, using aseptic technique for potentially

- purple circuit : replacement in pre or post dilution (CVVH and CWHDF), contaminated equipment Do not resteize.- green circuit: S. Use aseptic techniques when handling all blood and fluid lines in the set.

'dialysete in CWHD and CWHDF sa. Use only prescribed dialysate and replacement solutions with the PRiSMAFLEX* replacement in post dilution in CWVH. System. These solutions must have a denity similar to that of saline solutions

* The pre blood pump line allows the addition of infusion solution close to the end (close to 1) in order to avoid error in mhe volumes used for fluid exchange.

of the patient access line and before the blood pump. This can be used as an 91,. In CWHD and CWHDF modes, the use of non sterile dialysate could induce risks

additional pre-dilution infusion to the replacement circuit. of bacterial and pyrogeni contamination for the patient. In the United States,- The PRISMAFLEX Set provides for a specific small volume deseraion chamber in dealyser should conform to AAMI standard R.

which blood sedimentation wirl take p.ace in most of the cases : this matches with r oc. In OCWH modes and CWHDF, if a commercially available replacement solutionthe normal operaton of the device, s used, it must be labeled as intended for intravenous injection

2 71



10. Connect the PRISMAFLEX Set to a patent via venous blood access and retunm In general terms, introduction of air in the dialysate circuit should be minimised

devices. A double-lumen venous catheter is the recommended blood access throughout the course of the treatment, especially when replacing dialysate

devce; however, two single-lumen venous catheters can also be used. There solution bags.are 3 possible accesses for PRISMAFLEX System therapies: subclavien, jugular 27. Hypothe rmia must be monitored in all CRRT treatments, and special attention

or femoral vein. should be paid when increasing exchange volumes above 2 Llh; it may be

11. Duingirningandoperation, obaervedoselyforlealkage aticntsandconnectiorr necessary to warm the patient because of hypothermia.

within the set, notably the bags. Leakage can cause blood loss or air embolism. 28. The blood return line (btue-stripe) is equipped with a Luer-lock connection nearIf leakage cannot be stopped by tightening the connections, replace the set. the blue sample site.

This connector is intended to join the extension line of a blood warmser. Refer to12. Before connecting the blood return line to the patient, check for absence of the specific Instructions for Use and strictly follow detailed Instructions for set

air between the segment of line inserted in the air detector and the patient- up of this line. Do not ue this connection for any other purpose.end of the return line.

29. Do not attach/connect the extension line of a blood heater to the return lineIf air is present in this part of the return line, connect the access tine to the downstream of the air detector. The PRISMAFLEX System cannot detect airpatient and start the blood pump while leaving the return line connected to introduced in the line downstream of the air detector.the collection beg. Purge the air present in the end-part of the return line, thenstop the blood pump. Disconnect the return line from the collection bag, and A Warningsconnect it to the patient.

If the amount of air in the bloodcircuit is too large, reprime the ciduitcompletelyr 1. The use of operating procedures other than those published by the manufacturerbefore patient connection, or the use of accessory devices not recommended by the manufacturer can

result in patient injury or death.13. After priming is complete, do not remove the pressure pods from the pressure

sersor housings. If pods are removed, tihie setmust be changed orthe Daphragm 2. Use only PRISMAFLEX Sets with the PRISMAFLEX Control Unit The use of non-

Reposition procedure performed (refer to PRISMAFLEX Control Unit Operator's PISMAFLEX Sets can result in patent injury or death.Manual) 3. Should acute allergic reactions (first-use syndrome) occur In patients receiving

treatment via the PRISMAFLEX HF1000,HF1400 Set Immedlately stop the14. If the patient is not immediately connected to the PRISMAFLEX Set after primingtometaddinsraporaeitrvtonEX ng ~~~~~theatmenfi and administer appropriate intewventien,

s complete, flush the set with at least 1 000 ml priming solution (saline oralkalne Solution (IpH Ž47.3) with heparin added) prior to connecting the patient. 4. Do not allow air to enter te blood compartment of the fter after piming is started.This requires use of a new bag of priming solution. If a large amount of air enters, the set must be replaced.

5. Since drugs can pass through the membrane of the filfer, the dosage of associatedIBe, Use ae21 -gauge or smaller needle to obtain blood/fluid samples or remove

drug treatments must be adjusted for patients on continuous renal replacementtrapped air from the PRISMAFLEX Set. Use of larger needles can cause holes therapy.in the sample sites, insulting in blood loss or air embolism. 6. To assure adequate filter performance, it is recommended that the set be changed

15b. The following plastic needle is compatible with the PRISMAFLEX access every 24 hours of use. However, the set must be changed after 3 days (72 hours)sites: MEDIC MB -5005 (MediSystem), and/or the maximum process volume of blood (780L) whichever occurs first.

16. The PRISMAFLEX Control Unit may not be able to detect disconnections of Continued use beyond these limits (either 72 hours or 780L) could result in

the set from the patient's catheter. Carefully observe the set and all operations ruptur of the pump segments, With risk of patient injury or death.while using the PRISMAFLEX System for a patient treatment.

17. Due to the nature of use of the PRISMAFLEX Set (low blood flow rates, extendedtreatment time, and other special factors), the possibility for coagulation SPECIFICATIONSwithin the blood flowpath is substantially enhanced. Give careful attention tothe possible medical hazards associated with coagulation of The blood flowpathand comply with the minimum blood flow rates specifications of each filter Se. Tables at end of document.(see the "Filter Operating Specifications" section).

18. Filter performance specifications require a minimum blood flow rate, specific SET MATERIALS

to each filter, to avoid risk of hemoconcentration. (See "Filter Operating PAES hollow fiber : PolyarylEtherSulfoneSpecifications" section.) Housing and headers : Polycarbonate

19. During use, closely monitor the patient's clotting parameters, especially when Potting compound : Polyurethaneincreasing The amount of anticoagulant delivered or after changing the Tubing material Plasticized polyvnyl chloride (PVC)anticoagulant syringe.

Cartridge : PETG20. To assure proper anticoagulant flow control, only the following syringes are

permitted: Terumo (30 mi), 3 S (Barton0 (30 ml), ED 30 Plastipack (30 ml), RR Note: The following information is available from the manufacturer upon request:Prontosiringa (30 ml), Ico Gamma Plus (30 ml), Dispomed (30 m), Ico Gamma - information about test methods used to obtain performance characteristicsPlus (20 nl), Ico Sterlt (20 ml), BD 20 Plastipack (20 ml), Terumo 20 (20 ml), * the numberand range ofparticlesin the effluent from the diyZerpreparedasRR 20 (20 ml), Monoject 20 (20 ml), BD 10 (10 ml), Terumo 10 (10 ml), Fresenius recommended for clinical ueLuer lock (30, 20 and 10 cc). The use of other syringes can be a hazard for *the types and amounts of residue from the sterhifration processthe patient. Particularly I there is no Luer-ock on the syringe, the seal betweenthe syringe and the heparin line can no longer be guaranteed.

21. When not using the pre blood pump infusion circuit, it is recommended toclamp this circuit close to its connection to the acces line; this will prevent INSTRUCTIONS FOR USEthe sedimentation of blood into the pre blood infusion line.

22. Always inspect the blood flowpath for signs of clotting before returning the Note : Use the set by following the detailed on-ine instrvctkor provided by theblood in the set to the patient. If clotting is suspected, do not return the bloo PRISMAFLEX Control Unit. Additional information Is available in the PRISMAFLEXto the patient. Control Unit Operator's Manual.

23. In case of re-circulation mode, the set must be replaced whenever patientreconnection is not possible within at moat Stew aminutes. Note : a TMP > 40 kPa (300 ramrig) does not allow a higher ultrafiltration.

In case of poor blood return, the Set Must be replaced. Perform the following procedures when the appropriate instructions appear on theIn all cases, it is essential to raprime the set with fresh saline immediately display of the PRISMAFLEX Control Unit.before patient connection.

24. The PRISMAFLEX set offers a specific design of the deaeration chamber which Load Setaims to trap air before blood is returned to the patient.

25. The PRISMAFLEX Set is not designed for a heater to be connected to the 1. Remove the set from the packaging support. Holding the filte r vertcally (so that

replacement solution line. A heater generates air bubbles which collect n the the label i the regt way upi, carefully snap the st cartridge into the cartridgereturn deaeration chamber Therefore, it is recommended not to use a heater carrier (canter of front panel).on the replacement solution line. 2. Attach the 3 pressure pods to their proper pressure housings. Press effluent line

into blood leak detector; snap discharger ring into its guide.26. The PRISMAFLEX set is not designed for a heater to be connected to the

dislysate solution line. A heater generates air bubbles which collect in the 3. Temporarily hang access/effuent Y lie on Priming hook.filtrStel/dlysate compartment of the filter and decrease diffusive pedormance 4. Place dsearation chamber in its holder; attach chamber monitor line to returnof the device. Therefore it is recommended not to uses heater on the dislysate pressure pod.solution line. 5. Insert return line into air detector and return line clamp.

372 (3



6. Connect return line to effluen.t beg. A. With Blood Return7. Open effluent scale; hang ,oliectiorweffluent bag. Close scale. Noee:S. Cautoio no. 22.

Prepare and Connect Solutions Note:; A sterile spike connector may be required.

I . Hang bag of priming solution (saline or alkaline solution(IPH- Ž 7.3) with added I1. Turn off the power. Clamhp the access linel(red-stripad) and disconnect frflmrthe50O~lU heparlnillter) on priming hook (left cornr hook top of front pane!). Connect patient. Attach the eccass mie toea 1 -liter beg of sterile saline. (Use spike onnectoraccess (recD/effluent (yellow) Y-llne to priming solution bag. If needed.) Unclamp the access line.

2. If required, connect PM blood pump (PBP) line (white) to PreblOOdpup rPB (P) 2. Press the return clamp button (left side ofthe return line clarnpassembly) endbag; hang bag on Its wae hold in the 'in" position. With the other hand, remove the return line (blue-

3. Hang replacement solution (CWH. CVVHDF) on purple scale hook. Connect striped) from the return line clamp.replacement solution line (purple) to replacement solution bag. 3. Visually check the the fluid level in The dearation chamber, lIfthe level is below

4. In CWHD/CWVHDF hang diatyate on green scale hook. Connect dialyste line the horizontal line remove the excess air through the sample site on The(green). In CW1-H hang replacement solution on green scale hook (postdiclution chambler monitor line (chamber monitor line connects the deaeretion chambderreplacement). Cortoect green striped line to bag. with the return pressure port on the control unit) as follows:Note : See Caution no. 9 a, b4 c. a. Insert a sterile, 20 gauge needle attached to a 5S-cc syringe into the sample

5. Connect anticoagulant line to filled anticoagulant syringe. Install syringe in pump, site on the chamber monitor line.(see Help) b. Aspirate air/blood until fluid level is at the horizontal line on the dlearation

6. Unclamp any clamped lines. Verify all connections wer seur. Press PRIME to chamber.start automatic priming. 4. Remove the pump crank from its holder on the rear panel1. I nsert crank into the

rotor of the blood pump and turn clockwise until suff icient blood is returned to

Prime Set the patient.

Noter: See Cautions na 11 through 14, cauetionsi no. 25,26 and 29, and Warning no. 4. A Warning: The alarm system is disabled. Visually check for air in the blood

Priming includes multiple self-tiests and takes approximately 1 0 minutes. After the rtr ieutltepteti icnetd

cycle is complete1. Exanmlne set carefully to be certain all connections are secure, all lines are S. Clamp the return line (blue-striped) and disconnect from the patient. Clamp lines

unobstructed, and there are no leaks tinthe tubing. to all begs.2. Leave priming solution art prime collection bags attachedl until ready to connect 6. Press the two clips of the cartridge carrier to release the cartridge. Starting with

patient the peristalfic pump, ineed the pumpn cra nk into the rotor and turn each pump

3. Continue chosen treatment Iby following the Instructions on the display of thecunrlk..PRISMAFLEX Control Unit. 7. When the pump segments are free, grasp the cartridge and poull out to disengage

the lines from the pinch valves. Take the set off the control unit and discard asThe PRISMAIFLEX Set must be carefully deaerated. usual.

Anticoagulatiorn Considerations fiots, Renmaiing solutionls may be used with a new set, it desired.

Mote: Se Cautions no. 17 through 20 and Warning no. 6. A Warning: Ensure patient is disconnected fop, set before remowrng set from

Initiate anticoagulation of the blood fiotopath, as prescribed by the physician. During control unit.use, mnrntor the patient's clotting parameters; adjust the anticoagulation settings onthe PRISMARLEX Control Unit, eccording to the physician' prescription. If prescribed.do not forget to Infuse a loading dose of anticoagulant immediately otter patent B. Without Blood Return

connection. ~~~~~~~~~~~~~~~~Note: The patient will lose the blood contained in the blood flowpsth during aAnticoegulatlon plays a n important part in extending filter life by fretring plugging manual termination without blood retrn.,and clotting.

1. Turn off the power. Clamp the access line (red-striped) and return line, blue-Change Set Procedure striped) and disconnect from the patient.

To remove this set, load a new set and continue with prese.nt treatmnt 2. Clamp lines to all bags.

Pres 'STOP" from the Status screen, then press 'CHAJ'GE SET" and follow the 3. Press the two clips of the cartridge carrier to release the cartridge. Starting withon-line instructions, the blood pump, insert the pump crank into the rotor and turn each pump

counterclockwise.

N(5 : Oprtr0nrtr01 o t h ain rt isoretni eie 4. When the pump segments are free, grasp the cartrdge art pull out to disengage(seCaution no. 22. the lines from the pinch valves. Take the set off the control unit and discard as

usual.Temporary Disconnection Procedure

To temporarily disconnect the patient from the set:

Press "STOP' from the Status screen, then press "TEMP DISCON" and follow the SPECIAL PROCEDURES IN CASEon-line instructions.

Note: Operntormust return bloodinr the set to the patient and immediately reprirre OFrCOMPLICATIONith set via on-ine instructions. (see Cautions no- 22 and 23.)

End Treatment Procedure ~~~~~Filter Membrane Blood Leaks

Blood leaks through the filter memnbrane are automaticaflly detected by the PRISMAFUEXTo end the present treatment and remove this set Control Unit alarm sYstem. A warning alarm is generated and blood loss is limnituedPress 'STOP" from the Status screen, then press "END TREATMENT' and follow by immediate stoppage of all pumrps.the on-line instructions. To retumn blood to the patient, proes STOP hrorn the alarm screen. then press CHANGOE

Note: Operator can return blood to the patient prior to disconnecting, if desired. SET from the Stop screen and follow the on-line instructions.(See Caution no. 22.)

External Blood Leaks

MANUAL TERMINATION Note :See Cautions no. 15, 16 and 20.

External bloodl leakage may not be immnediatey identified by monitoring equipmentM~n..lmrminti., My be ~cessry dueto poer nsor an larm f the and coulId resul t in significan.t blood loss, Check the filter end all connections of the

PIManulE termnationit mayhe neesary dureentls oh Powerlssor ifarnin.tepalarofthe disposable turnings during treatmesnt to min imizej the risk of leakage. If an externalsReqiSMFed. nrIUi.Te lr centls h prtrIamaultriain blood leakage is observed, immdiately stop the blood pump. Initiate corrective

is required. ~~~~~~~~~~~~~~action by securing connection or replacing the PRISMAFLEX Set

Mokte: The, tlwnisrcina'salo fojdrn 'Trcbleshootin,' n the PRISM44ZLEX It nwecssar, adin ister adequate rplacement solutio to the patent to compcensiateControl Unit Operator's Manual, for blood loss.

4 71 ~~~~~766



Hypersensitivity Reactions 2. Setting and monitoring the treatment operating parameters according to themanufacturer's recommendations specified for each type of PRISMA Set and

Note: See Warning no. 3. to the patients needs and tolerance.

Should acute allergic reactions (first use syndrome) occur within thetratfewmnutes 3. Strit adherence to all WARNINGS andCAUTIONSgiven byte manufacturerof the treatment, It Is important to react immediately by discontinuing the session in the Instructions for Use'.and adminietering appropriate treatment.

Adverse reactions may occur due to the complex Interaction between blood andthe artificial surfaces of the entire extracorporeal circuit. These reactions may alsobe precipitated andeor exacerbated by other external factors involved with the WARRANTY AND LIMITATION OF LIABILITYindividual patient's specific disease process and the treatment of renalinsufficiency. Certain types of adverse reaction may occur due to operationalfactors associated with the treatment Therefore, proper management of the fluid a) The manufacturer warrants that the PRISMAFLE(Set has been manufactured inremoval, electrolyte balance, anticoagulation and blood flow rate as well as accordance with its specifications and in compliance with good manufacturing

monitoring of the overall treatment parameters are essential to avoid side-effects practices, other applicable industry standards and regulatory requirements.which may be associated with hemodlalysis I hemofiltration therapies. If provided with the lotserial number of the defective product, the manufacturer

Hypersensitivty reactions have been observed during dialysis. Symptoms of a willbyreplacementorcreditremedymanufacturngdefectsintePRISMAEXhypersensitivity reaction may be gastrointestinal, mucocutaneous, respiratory, Set becoming apparent before the expiration data.cardiovascular or systemic in nature and range from very mild to severe. Suchsymptoms have been described as anaphylactic-Ilke reactions within the first few b) The warranty under paragraph a) above is in lieu of, and to the exclusion of, any

minutes. Manifestations include nausea, malaise, weakness, a sensation of burning other warranty, whether written or oral, express or implied, statutory orotherwise,

or heat throughout the body, profuse perspiration, respiratory distress and in some and there are no warranties of merchantability or other warranties, which extendinstances hypotension and ca rdiopulmonary arrest. Should a combination of such beyond those described in paragraph a) above. The remedy set out above for

symptoms appear, particularly at the start of the treatment session, it is important manufacturing defects is the sole remedy available to any person due to

to react immediately by discontinuing the session and administering appopriate defects in the PRISMAFLEX Set and the manufacturer shall not be liaobe for

treatment. Blood in The extracorporeal circuit must not be returned to the patient. any consequential or incidental loss, damage, injury or expense arising directly

Extra care must be taken when treating patients who have exhibited possible or indirecty from the use of the PRISMAFLEX Set whether as a result ot anyhypersensitivity symptoms during previous treatments, or patients who have a history detect therein or otherwise.of being highly sensitive and allergic to a variety of substances. A physician mustbe consulted to evaluate the risk and prescribe the appropriate precautions if a c) The manufacturer shall not be liable for any misuse, improper handling, non-possible sensitivity is suspected. compliance with warnings and insbuctirns, damage ansing from events after the

manufacturer's release of the PRISMAFLEX Set, failure or omission to inspectThe fiolowing tactors are corsidered essential to minimize the rsk of a hypersensitivity the PRISMAFLEX Set before use in order to ensure that the PRISMAFLEX Set isreaction and other side-effects, in proper condition, or any warranty given by independent distributors or dealers.

1. Strict adherence to the set-up, priming and rinsing procedures detailed in themanufacturer's Instructions for Use. d) The manufacturer is HOSPAL Industne, Meyzieu, France.

5

74 ] /3':



CARACTERISTIQUES PRItsmArFLEx PRISMAFLEXFILTER DATA DlU FILTRE FILTER-OATEN HFIOOG11 SET HF14OC1SET

emKAL nrca CHARCTfISTICS CARACTESUUnUES PfiTSIRli PIITUKAMEIE EIGEHNWAFIU

Etffcti. surface area Sudulceffincte Efliek~ee Oberhiche Ia1 in

Fiber thermal diamnelu w-et) uearne, de alfibis (huminde) lnneendurchnnsstr (feuch!l 215 PM

Ribr wal irtaicess Epal60eur de pMur de lafibgre Wandstllrke 50 PMn

IN VITRON PUFRNMARS POPORNACES IN VITRO' INI VITRO IEISTUKGU 1m %t l Ia

Blood prolomvla volu Velma. do .tb* p ml BsttffhIn

Bled m *.p Wet dilatlel P~frind de de.rip sal " W feeffiU.N Blet firckshftiI IPeartdIISI**I

(buvine blcod. Htc ... 32S, Cp....50 Vf. 37C) (sang de bitt. Hen .. "32¶.C-... g/I. 37'C) (Rindorblut.n .... 32, Pt""'60 gIll. S7C)

OR.. = 100 niami.. COU''. =21.Lt US" = 100 Memn/minou1' = 2 LAn 0' . lOG mmn/n. QUIP"' = 2 LAb 37 nmmtg 29 mmnlg

02" =200 nnmImi 1F.. O' =2 1db OS" = 200 ml/rin, Our,.. = 2 tUl alB- 200 mi/a/in, QUf'' = 2 ill 5' amlo 41 mmnig

OB'' =400 mn/ui n, GOPF.. =2 LUl OS" = 400 amnm/nOUP" =2 LA GB" = 400 Vmi/t/. QUFi = 2 LAb 011mmg 64minnil

SkuIle aedlficlood Truind~mitue swtk.fftiwfl

(box/e, proema Cg 60 gA/37' C) (p/asma dea bou Co 60 gil. 37' C) (Rfiaderplasma, Pt St gil 37' C)

08'' '1I00 mljmi/n. OUF. = 20 Munoln OS" 1 00 mmimn OUP '20 mifminn OS' . 000 mlum/ni.OUP" 20 mrmn/en

- tisa =UWas - larnstionI

-Creatimme, = Crtlmin.n Kneto/nin

-V/tamn 602 -Viomanne B12 -Viftammin 12

mm- mi/in Inuline no

-Albusmn -Albumine Albumn, coal

CTypical mean values obtained from laboratory trestnng of post-steuilization sample lots. Results may vary depending on patient and clinical conditions. I Valeursmoyennes caracteristiques hereurder au laboratoire Suir uin Ochantillonneges de lots starilisres. Les resultatd;s mnt susaceptibles da varier en fonction du patient et deSon Mtat clinique. / Typidsche Mitteiwrtle, die an strilen Produktien in Labor ermittelt wurden. Die angagebienen Werte kcinnen abhbngig vote Prtientean und denkrinisohern Bedgingungen schwanken.

GENERAL DATA I CARACTERISTIOUES GENERALES I ALLGEMEINE DATEN / CARACTERISTICAS GENERALES I CARATTERISTICHE GENERALI I ALLMAN

DATA I ALGEMENE TECHNISCHE GEGEVENS/I CARACTERiSTICAS GERAIS/ GENERELLE DATA I GENEREU.E SPECIFIKATIONER / YtEISET MITTALISARVOT

C"' PRISMAFO.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~EX PR'MFEHFI10 SET IFiAO SET

Weight I Poide / Gewicht I Peso / Peso I Vikt I Gewicht / Veict / Pleso / Vaegi FrPient 780 g 820 g

Overall dimensions I Dimensions totalesg! Au~ennmaBe I Dimansiones todlars /Dimensioni I Storleik / Totaeir airnetingenIDirmens6os totals I M&lI /Ydlernnl I Ulkom itat

length I longuenir / Lange / Largo I lungthezza I Lfingd I lengte I cconprimento / lengde I Lwangdea I pritu 27 cm 27 cm

widthn / largaeunr rSmite / Ancho / larghtena I Shedd I breedta I largura / bredde I Shrckle / leveys, 22 cm 22 cmn

height / hauteur / H61he / Albuma / aftezza / Hbjd / hoogte / aitting / halyde I Heodes / korkeus 9 cm 9 cm

Blood volume in soC (Volume sang dens la set / Slulivolumerr im Set I Volumeen de saingre en el setl I Volume aremtetid nel set / Blodvo~m iSeate /Hlorevleaetid blood in set / Volumrede sangue no set I EBodvrolum i seft I Blodvolumen i esmtltt/ Veren tIlavus Settees it ¶0%) 165 ml 186 ml

FILTER OPERATING SPECIFICATIONS / CARACTERISTIQUES DE FONICTIONNEMENT DU FILTRE / BETRIEBSPEZIFIKATIONEN FOR DEN FILTER!ICARACTERISTICAS DE FUNCIONAMIENTO DEL FILTRO I CARATTERISTICHE Di FUNIZIONAMENTO DEL FILTRO I ANVANDNINGSSPECIFIKATIONE.RFOR FILTER I FILTERPRESTATIES / CARACTERISTICAS BE FUNCIONAMENTO DO FILTRO / SPESIFIKASJONER FOR BRUK AV FILTER ISPECIFIKATIONER FOR BRUG AF FILTER / FILTTRIN TOIMINTAOMINAISUUDETPFIM LX IPRSA

HF1000 SET HF1400 SET

Maximum flMP' / PTM' Maximnum I Maximum TMP'/ PTM maxima / PTM' massimla I Maximait TMP / 500 mmHgMaximum TMP' / PTM' Mximaso / Maksimme ThIP / Maids. TMP / Maksimi flAP' 66.6 kPa

Maximum blood pressure / Pression sang maximum I Maximum Fifter-Elutdruck / Presi6n sanguirea mAxima I 50m~Presseonea ematica mnessima I Maximalt blodtryck / Maximum btoeddnjk I Pressio sangulneme mAxima I 66.6 RPaMansemaigt blodtrkl / Makes. biodtryk I Mansimit verenpame

Minimum blood how oebel Debit sang minimum I Mindest-BluttlujBrate,/ Flule sanguineo minimnoIRuss rematico mimmo!/ Minlimalt Blodflbde / Minimum Bloredsnelheid / Fluxo sangulneo minino I 5nlmn i 0 imrMinimum blodiflow-arae / Mini. blodbltowhastighed I Min/mi vermspaine,7 Im 0 Im

* Transmembrene pressure!/ Pression transmembraniaire /Tranismembrandruck / Presioni transmemnbrctnica I Pressinone tranismembrana! Transmembrantryck/Trmrsmembraaroruk / Press~c trarismembranArin / Transmembramntrykk / Transmenrbrentryk / Kaivoon varikuttava paineArterial blood flow ratelI Debit sang I Artene/Icr Blutitufi / Flub sangquinee arterial / Flusso ematicotantroso / Arterielft blodfl6de/ Arteriele bloedisnaltieidFluxt de sangue arterial / Arteriall blodf/ow-rafle/ Arteriel blodflowhastighad / Vartimoveremn vin'tausmAtira

46 75



CARACTIERISTICAS CARATrERISTICHE PRISMAFLEX PRISMAFLEXCARACTERISTICAS ~~~~~~FILTERDATA 110 E F10 EDEL FILTRO DEL FILTRO

CAAALTERCAS F"UlS CARATlTRISTlCHtE FlirCRE NOMINELA FYSIMKA KAJK(IRISIIKA

Superficie electar Sunedaca affaltiva Elle'td ya It1 i Am

0 min dC La Tibia (Irtmrdal 0 nemn della fbre (baPuvl ra kaoillrdiaieter (va 215 VmEsWes=r de a pared de ja ibra Sne~sar e plare deli; libya Tijcliak a, kail vagg M PM

ENDIMISTOS Oi VITRO PIRSTAZIONI IN VITRO ' iN VIMO Pr4ESTmNaA vI 81um~lO1% 102 m*1±0%vlam cad. .aeli... VWl.s di Hosmiq esat. Blodati

Caldas -s praslhi .ne (pet-dShm I Paherd iIa di cIce eadmitee llmbwalii) Blied bttcki fallrotdlet)

([ngqemtxmna. R ...32%. ,C'c ' "g/h 37"C) (srgule bvonoHt.... 32%.Cp".... g/L, 3rC) (boviOn blod, Ha...*32%. Cp...6/ gl37i, ) I

GB' =1 00 mn/ian OUP' = 2 . I.6 OS". 166 mni/ir. Uor- = 2 LU 26' = 100 mi/mn., LUF' .:2 L=U 37 mafg 29 mmHg

0' =206 mtrmin. aU F' .=. .Uh OS * 260 rl/rrin. QUF-' ' 2 Libh 08 =2(]0 r[l/irnn.OiF * 2U 6 I2U 51 mmHg 4A mrmrg

QS =4016 rn/ge nUF. 0UP>=2 Uh OS" = 400 mrmn. QUF- · 2 ./h 06' = 400 mirmih. OUF... = 2 LM 61 mmHg 64 mmHg

Tmrh it Ceeffic k di Slimo SIngvie, fficest

(plasma bouAG. CO 60 g 3P. C) (plasma bov'no. Co00 g6I, 37' ) (bonan Pls ma, Co 60 V/. 37 ')

0B' = 10 m ignir OUr.. = 20 mn/mva 0Q' .100 mL/rnml, OUF"' = 20 mL/ijrmn GB" = 1 00 mt/gin. OU F* = 20 r20mLn

Urea -Umea -Urea I

.Creatnlna -cleati.a -KAheriA 1

Vit mina 612 -Viamiva B12 -/jamin 812 1

IntliOa -vulia - auin

-Albamlrna -Albuginna -Albumin <0.01

Valems meadios caractensticos meadidos en laboratono sebre un muestro die totes esterilizados. Los valores pueden vaniar er funci6n del packentet, asi cono tie su

eatado clin co. /Tipici valori modai ottenuti de test di laboratono su cam pioni di lotti slerili. I risultati possono vanare a seconds del paziente a della diverse condizionicdiniche. / Vanriga mecalvirden erhdllna vid taboratorietest ev post-stariliserade prav-partier. Resultaten ken vanera baroende pi patient och diniske fdrutsMitningar.

CVIVHD CLEARANCES (Continuous veno-venous hemodialysis) Clearances versus inlet diatysate flow rate (37°aCCLAIRANCES EN CWHD (Namodialyse veino-veineuse continue) clairances au bain de dialyse, a debit entoAe dialysat (37°C)CWIHD CLEARANCES (Kontinuiertiche veno-ventrse Htimodialyse) Clearancewerte abheangig von den Dialysierlibussigkeit-EinliaBrate (37C)ACLARAMIENTOS EN CWHD (HemodiAlisis veno-venosa continua) Aclaramientos con bano de dialisis a 3 7 °CCVVWHD CLEARANCE (Emodialisi veno-venosa continua) Clearance con dialisato a 37aCCWRD CLEARANCE (Kontinuerlig veno-vends hernodialys) Clearance mot dielysatfl'de (37"C)KLARINGEN IN CWHD (Continue veno-veneuze hemodialyse) Klannggen, snelheid van de dialysastaanvoer (37°C)ACLARAMENTO EM CWHD (Hernodialise veno-venosa continua) Aclaremento nurns soluggo diAlise a 370CCVVHD-CLEARANCE (Continuous vene-venous hemodialysis) Clearanceverdi versus inngangsdialysefilow-rale (37'C)CVVHD CLEARANCE (Kontinuerlig vane-veane humodialyse) Clearance kontra fHowhastighed for indlobsdialysat (37°C)CVVHD (Continuous veno-vernous hemodialysis) Clearance-arvot sisain tulevean dialysaatin virtaukseen verrattuine (37aC)

PRISMAFLEX PRISMAFLEXHFIOO SET HF1400 SET

Q8/QS" = 100 mremfra QB/QS* = 200 ml/minOUP" = 0 mL/min MUP = 0 mt/min

CD . . . . . . /hAf) 1 2.5 4 8 I 2.5 4 8

Uma / Urge / Hanstoff / Urean/lUreum /Karbamid / Ureia / Karbamid / Virtsahappo it 10%) 16.5 41 62 88 16.6 41 65 119

Vit 212 (± 20%) 16.2 36 48 63 16.5 38 55 84

Inulin / Inuline / Inulina / Inulni (i 20%) 16.0 32 42 52 16.4 35 46 69

Ultrafiltration flow rate (on PRISMAFLEX system, the uttrafitration flow rate = fluid removal flow rate , replacement flow rate + pro blood pump flow rate) /Debit d'utraffltration (sur Le systeme PRISMAFLEX, le debri d'utrafiltration correspond au debit de prfetvement te liquide + debit de solution de reinlect/or+ ie debit de la pompe pr*-pornpe sang (PEP)) /UltrafiltratronsfiluBrate (bear PRISMAFLEX-Systern ist die Ultratiltrathonsfluflrates die Flussigkertsentternungsflulrate + Substitutionsfiulurate+ PrA-Elutpumpen Fluretae) IFlujo ae ultra6fitration (an et smtetma PRISMA el flujo de ultrafiltracidn corresponde at flujo de extraccidrn de lieuido mas el flueo de solucibn de reinyecci6n+ mas el fluto de infusione pre-bhomba de sangre (PEP)) /Flusso di ultrafiltrazione (il sisteme PRISMAFLEX caicola il flusso di ultrafiltrazione net seguente mode: flusso di nmozione del fluido + flusso di reinfusione+ flusso del'infusione pre-pompa sangue (PEP}) /Ultrafrtrationshastighet (pi PRISMA, uhtrafiltrationsmlastighet = haslighet pA vatskeborttag frau patient + hastghiet pA ersattningsidsning+ preblodpumps fid:eshasflghet) /Ultratitratie-snelheid (op PRISMAFLEX -sysleom: de umtrattralita-snelthei = vocntverwiiderings-sneheitd + substitutre-snelhieid + pro bloedporemp snelheid) /Fluxo de ultrafittriqao (no sistems PRISMAFLEX, o fiuxo de ultraliltragio corresponds ao dbtbrto de recolha de liquido + dibnrto de solugho de reoposigao+ taxa de iluxo pre bombs de sangue) IFlow-rate for ultrafitrsasjon (pA PRISMAFLEX-systemet: flow-rate for umtrafiltraspen tilvearer flow-rate for vaekefjerning + flow-rate for reinleksionsvmske) !Flowhastighed for ulltrailtration (ph PRISMAFLEX-svstemet er tlowhastigheden for ultrafiltration hig med flowhastigheden for vanskeudlob+ flowhastigheden for erstatningsvmske + pre-blodpumre flowhastighed} /Utraftfitrausnopeus (time nopeus PRISMAFLEX-ianesteirmissa = niesteen ulostutovirtaus + korvausnesteen virtausnopeus + esi-ven-pumppu (PEP) virtausnopeuus)

47 76



FILTER DATA CARACTERISTICAS FILTERDATA PRISMAFLEX PRISMAFLEXFILTER DATA CAATRSTCSFILTERDATA *0 ST HI0SE

DO FILTRO HFIO00 SET HF140D SET

IOMINMAI F'YME EIIENSCIIAPPSR CARACTEdSTrEM F"I CAS HIOMINII.E FISJE EGUSM R

Effeaiel ooervlak Suipslcieeltn, Efkie inoveitatemonal 11 1.4 W

Inw,. vseedd. nat) Doinmetm inferno do f1rm (hlmida) Intern diameter, fiber (vlt) 215 pm

W.anddikltes asl :spessun a di prese da fibra Fibemvegg7kkedss 50 pm

I VITRO PROSTATIES' RBESILTAOS IN VIlmR IN VITRO-ML I10mtl1f1,10 % lO2nl* 1O%

Blow priming nv1 VIIe de urngill lilenid BIerlmimtr.lm

BSid dtdtlib Imu -lPltdildi) emll di proolo pmbmlan, dhee dlhlkt) Bled tUhfil ((Pd dilltl)

(buye blond. His .. 32%. COa .' 50 /. 37'C) Msangi bMvina. Htc' *'32%, Co.... 60 g, 37PC) (bovine bnlod HiC'"32%. COa'". 60tgA 37'C)

OB'' = 100 ni/in. OUP'" = 2 UIh C2QB" = 100 mVI/in. OTIF'*' '2 LU/ OB'' ' 100 ml/rinn. OUF'P'- 2 Li/ 37ammHg 29 mmHg

08 m U = 200 mi/nmnn. CUF.. =2 Lh 08' * ·200 G/min. QUO'. =2Ui 08'' 200 mI/sin., OU*'· * = 2 L/I 51 mmHg 41 mmHg

08'' = 400 ni/gin. 0U0'"' '2 L/h 08'' . 400 mmi/in, OUF"' 2 LUh 0B' = 400 ni/min, GOPU"' = 2 LA/ 81 mmog 64 monHg

SlIurling cliffilcer ,tkin . Sl*leViug Slnilkedfilt

bovne plasmat. Co W 9/I, 37 'C) (Plasma bIaano. Co60 g/I 37' C) (onvin p1smam, C 60 g/I, 37' C}

OB' = 100 na/sin n OPU'' = 20 muslin OQ' ' 100 mi/sin. 0U'i'' = 20 mulmin CB'' = 100 mUmln, OU*"' = 20 mliamin

-Ursum -Untli U Ira

-Crmann. -Creatnlan KXIllnin I

-Vinamne B12 -Vitamina 812 -Vmnanin 812

-mul, - taulna -lai I

- lurnn -Alina -Albumin <0.ol

Typisch germiddelde wararden verkrogen na het testen van staben no sterilisatie. Resultaten kunnen verschilen afrhankelijk van de patient emr de kilnische situate. /Valores rndiios tipoos ronedidos em Jaboratbno somre urns arnostragem de lotes esterilizados. Os resulados podoera vanar cornsomnte o poaciente · S eU estado Cl~nico. /Typiske gjennonsrntrsverdier oppnAdd ved laborntorinetesting av stikkprover av steriliserte lot. Resultatene kan vanere i henhold til pasmnt og kilnikte forhold.

FILTTERIN TEKNISET PRISMAFLEX PRISMAFLEXTIEDOT HF1000 SET HFI400 SET

fOMIMUELL F O SPrrWKATISNER FYIKAAULISET IMELISARVOT

Etfeblinvi overtLadeoreal Tehollinee pinlan Iannois 0., M 1.4 ml

fibreE nmndvendige diameter (videl Kaudun ssolhaaiasqa (kosteana) 215 pM

Fibrenes vmgykklise Kordun senmln iaksuous 50 PMv

IN VI'UO-YDEEVUEt IN VITRO OUINMSEIET"Blsohu..bmIu we..la vulmiuimlfes 81 ml a la % 102 ml * 1 o %

Blowd pe drapeg Wl dIlltel) Vn pa. #tnblmAWMmkl OkeiS

(btine blod, Hic'. ''32%.C0. ... 60 A, 37'C (nauodn ri. H, n.. 32%. C .'.... 60 V. 37"C)

08 = I00 Mi/i, nU F'' = 2 Lih 02' ' = I(00 s/sin, QU'' * 2 UP 37mmHo 29 gmuMg

OB" = 200 migmin. OUT"' = 2 lth 0B" = 200 mimn, OU'." = 2 L/h 51 mmHg 41 mmHg

OB' = 400 mi/sn., OUP.. = 2 LA O8' ' = 400 mi/sl QUF. .UP = 2 Li/ 01 mmHg 64 mmHg

SIIInweilinSi Se1tlk~ml.is

(boinn peasma. COp 60 /I 37' C) (nadeon pasma, C t gV[ 37' C)

'B' = 100 miin QOP" 20 mi/,i OW = 100 mri/n, QOUF'' = 20 mi/mlI

-Kanbamnn -Virsahappo I

-Kreail -KrneaFmn

-Vitmrin 12 -Vitamoil 012-IMu/i -Inuhini

-Albunlr -Albumimni <0.01

TypisKe gennemrnitsvardier, der er opnaet ved fiboratorietest at eftersterllserece provelots. Resultaterne kan vantre afhsengigt at atriebteno og de kliniske torhold. /Jalksteriloiduista laborstonokokeiden rilyte-erista soadut keskiarvot. TuloKset vonvat vaihncella potilaasta ia kliinisista olosumtteista rlippuen.

Hematocrrt / Hinratocote / Hamatonort / Hematocrrio i Ematocrito / Hemotokrit / Hernatoceret / Hematocrlto / Hematokrit / Hazmatokrit / Hernatooritt

.... Protein concentration / Concentration protelique / Protemn-Konzentretion / Concentracidn protela / Goncentrazione protecca / Proteinkoncentratin /Proteins concentratie / Concentragio proteica / Proteinkonsentrasion / Proteinkoncentration / Proteininpitomsuus

• Dialysate flow rate / DGbit dlialysat / DialysatluflBrate / Fluio de liquido de dialisis / Flusso diaallsato / Dialysatfide I Dialysaatsnelhend / Fluxo de soIu.flo de dialise IFlow-rate for dialysevseske / Flowh/astighed for dialysa / Dialysaatin virtausmeara

4877

/I/0c



PRISMAnLEXN is a trademark of GAMBRO LUNDIA AP.GAM.BRO is a registered trademark of GAMERO LUNDLA AS.HOSPAL- is a registered trademark of GAMBAO HOSPAL SWITZERLAND Ltc.The PRISMAFLEX HFIOOO/HF1400 ame protected by one Of More of the following patents/patent applications:- US4861242, US4749619, US5139669, UJS5182868, US5259903, US5449430, US5441636, US5644402, US5722399, US5e79245- 1J35776334E.

US5910252, IJS5762805, US5578223, IJS572577S, US5698090, US52i11849;- EP0441721, EP0466620, EP0490749, EP0611227, EP0611228, EP0678301, EP0701830, EP0829265. EP070604.4. E2P0607301;

- GB2208697;J - 0A12814598, CA203513e, 0A2115414, CA2115415, 0A2158245, 0A2444794, CA2303714, 042119375;- JPI772297, JP3254222, JP3273623, JP117332/96, JP3469287, JP3ISSSO/94, JP3413412, JP3140781:t ~~~- DE P-3828123.6;-FI8811O46;

~~ ~~ - IT-M12002A001390, IT-M12002A001389, lT-MI2O03AO00214, FT-M12003A000212, rTPMI200SAOOQ2I3. IT-MI2003A000216. iT-MO2003AOC016S.IT-MI2003A00211, IT-M02003A000259, rr-M02003A000293, I'l1223781:

7~ -PCT/l203,fl2281, PCT/122004/000055. PCT/182004/000062, P0TA22004/000I 05, PCT/182004/000061. PCt/1B2004/0001 04

7 ~



79



HF'IOOOC>t< ` HF14cZ f

(,~H *Siooott, e l'vrguoellcint (vrder~l it~H ,~(w~~~~w~~ a! ii1 o~oine adrnPC 60 T~l - 37'(. _____________n________

QOii/ran Q, 20 mI/win IHFI 0: N- - 300 m/Io'o Q 60 Tn/niiHF10)

t M. _ 13) 99, Albll 11, 512

PAES hollow fibe'l olyarylethe 'ulto,,e n otl' Ultaliltrat'cn wi blood lir, ltoi-l oie Itcs" hoUSion and hea~ders Pcl.yca'toorna~t al IG Ti5 i Xo or 3 oein ots r emohltalio1fl'11cF tlottllg ompound Pi yuiethane 'Boyce L'6o1 at 37rC Iee'3tcor[ 32°t l'c 60 ./t.

Cartldre PEOGI~~~~~~~~~~~~~~~~~%~I""ii' 3110,3 d coeEO lelldrn oxide)

f I Ite , Stiud, 1110 art ont* Mas[itiuri IMP' lmrtllc/kPat 500/66 6

b Maxnmun blood pesure 3,am Hg/l~,' 500/6066

* Minimuat blood fow 'alePtisttafte HF 1000 %et 75 ttd/nulrt -

P somafex H F 3400 Set 1t40 nol/nain ,

* N3ilr l ,hysIcal c sttaoleriot'e sEffetivte surlace arl IeV3.iol-, al

r'se,at ex o FF1 0 St ' Cleaa sal ts -le t d a-sat boo rate

Prosmnatles FF1400 Se't 1.40rm/ofnnsma~irle'x~l53,2

B~~~~~~~~~~~d ~ ~ ~ Ca dlr omu ,tn¥ tdlloim. ~S~d.dm B

G ~~~~~~Fie Inel r na l diameter Iweti 2) 1= Sf0

-td 32% W G00T B3od

80

/113



prismaflex

M 60 SETM 100 SET

VEMB1t~ N

Instructions ion us.Notice d'uliisalionGebrauchsan eisungIstruzioni pe) F ,s ;

Gebruiksaanwij Irw,

CCE 0-08 6

tt[I

t~~~~~~~~~~~~~g



ENGLISHI

* A 5-liter bag is provided to be connected to the end of the bl ood return line toDEFINITION OF SYMBOLS USED ON LABELING initially cohlect priming solueion, during priming. Then, duringtreatment. this bagis

used to coll Wetutraitrsatend/or used dialysate lconlnectlon at efluen line). Other,OF PRODUCT sterles Sand 10 liter bags and sterile, non, pyrogenic spikes can be ordered separately.

* All line connectors are compratible with the ISO 594/1 & 2 international ala ndrdsd

FLOTI manufacturing batch number concerning conical fittings.* The fluid pathways of the PRISMAFLEX Set are guaranteed sterile and no,

pyrogernic.

sterilized by ethylene oxide (EtO); followed * The PPISMAJLEX M60/M 1 00 Set is sterilized by ethylene oxide (EiG). Deaeretionby the sterilization date is such that ErG res idU.al comiply with the ones described in ISO 1 0993 -7.

* Expiration date Please refer to product lsrabel.

expiration date of the product * The PRISMAFLEX Set is manufactured by HOSPAL. ndutie Meyzieu, Prance.

*in this docu.ment the hemnof iter/dialyzer will be refrrd to as "-filler'

product for single use only

A Read instructions before using the product. INDICATIONS

AN Caution Federal law (USA) restricts this device to sale by or on the ester Th. PRISMAFLEX Set is indicated for use only with the PRISMAFLEX Control Unit inof a physician. ~~~~~~~~~~~~~~~providing continuous fuid, management andc renal replacement therapies. The system

a intended for patients who have acufe rnali failure, fluid overload, or both.

This set is intended for uea in the lollowing veno-enou,, therapieas: SCUF :CVVHCVVHO CWHIUF

DEFINITION OF EXPRESSIONS USED All treatments administered via the PRISMAFLEX Set must be prescribed byIN THIS MANUAL ~~~~~~~~~physicianr. The size, weight, state of unremi, cardiac status, and generls physicaIN THIS MANUAL ~~~~~~~condition ot the patient must be carefully evaluated by the prescribing phyiia

before each treatment.

In this document :The pediatric use of the PRISMAFLEX M(KO Set should be restricted to children with-

A -Warning' is used to alert the user/operator nt to take a certain action which, boy ihtget ha10 22bit taken, can cause a potential hazard and result in a seriou adverse reaction, injury The PRISMAFLEX M100I Set should be, restricted to patients with a body weightor death, greater than 30kg IS6b6:

A "Caution' is used to alert the user/operator to take a certain action to protectagainst a potential hazard, which, it ignored, could have a, adverse effect on thepatient or on the de'nce, CONTRA INDICATIONS'Note" is used as a rminder to the user/operator on noMalm taretment activi ty andon what is a suitable ac.tion in a particular situation. There .ar no known conraMindi.c.atin to continuous rensal repacement therapie.1

SCUF : Slow Continuous UltraFiltrationCVVH : Continuous Vano-Venous HemnofiltrationCVVHD : Continuous Veno-Venous H-emoDialysiaCWHDF: Continuous Veno-Venous HemoDiaFiltration CAUTIONS AND WARNINGSPredilut on : addition ofl replcacment fluid to the blood stream upstream to the titer,Postdilution: addito of replacement fluid to the blood abheam downstream to the tilter Alote : Additionaswanig and caulona pertaining to the PRISMAFLEX system.

are included in the PRISMAFLEX Control Unit Opedrator Menus:.

PRODUCT DESCRIPTION A Cautions

1, Carefully read these instructions for Use and the PRISMAFLEX Control Unit

* The PRISMAFLEX M60/M1iPS Set is a disposable. extracrporalIcircuit for use Operator's Manual before using this product.

with the PRISMAFLEX System. 2 Slots The PRISMAFLEX Set in a airs place, between C' C (32Ž F) end 30' C iSO, F).

* The PRISMAPLEX M60/M1iCO Set consists of a AN69 HF hollow fiber hermofilter S. Some solvents and oteMrm chmcal, it usedinl contact 'Mth the lfiler could camagE

dialyzer' and tubing line, the set. N.o emical of this type should be used wihout pernissioh of the

* This filter is permanently o~nnected to a biond acces line Ired-stripedi, a bloodnfatrrT, ooupar aoa ymbda

return line .bu-tte) diayasate inlet line tgreen-sttcdi and an effluent outlet si ha~ogenated a.romtic and aliphatie sov.lvens

lie (yeliow-stripedi. b) ketonic softents

* The other lines of the set include :4. 'Ic prevent contamsnatiors, tI s PRISMAFLEX Set must be used as soon as its-arplacement solution line (purple-striped'ppackagino ano st61erlztion~ caps are removec.

- pre blood pump I ne (white striped) -. Do not use this st - the psc,,s nP is carnaed If the sterilfization pceap r,

-an anticoagulantline syringe) missino or icr~ose 'it anv of te inca in the set are kinkee

* The configuration of the PRISMAFLEX set allows the folloin uses cependin, C. Do not ty ito remove the lute~ from the csrhatrce plateon the configuratton of the automated Clamps on the macnin ,. Destoy this1, setae mic use., using aseptic techniouc to' ocienrii,-purple circuit reMplacement in pre or post dilution iCVV and COW-i?- soniarinstrec ecloe- Don reeterilize-green circurt E. use aseptiC tearn'iiues ie,- OrduCIC ai bio.. Shc t'uie i~nef r" the sc'

d iv~al/i in OWl-ID and OWHDF. ea. Use only Prescric cntv-''s'no Err re,,o,acenen sltions wIth the PRiSMAPu>ia n .r Post dilutioin in Ol-. Slr These, , ~M,,:a,~,nt ,t ,to

* The pre bloo.c..ump line allws the addition ci inuso solti, ccee to tMI ens idea o Is iii r'-sc to1 ovoi eL e ina f,,ame ue tot fiu cesnan

of the patient accesas lin and before the blood pum.T7n a can Pe uss as a' 9t, in VV.HI she C0

VHE- mo,.. te -se, noste-i dal~tat couei,ueris

additional ore-dilution infusion to tne replacement c, rce of bacteria' ano pyropen co., reinstio- to' the patient. in te untes Stares

* The PHISMACLE)( Set porvides for .a seifcsml ol umea..... ncsrstic ehempe' ciaizsstc shoue Ietr" to, .f,1 siancare RE> $

v.'hieh bloos se wenairwil fake par,,, in' moI oftesae. tn,- 1 an1 w' c l'. ~ OkV 10''''1- ' C- "8CZtll 055 iat- sot555 Ltt

ne, norms: opcraftpn of fne Pavisa. tuse lt s mus 00 -:0010 55'. CTO lnt'sllenlusIn'5



10. Carncetth PISMAFLEX Sbttoam putient vavesoow blod ... ac nd return ln generaI tenms, intmductbin ofairin ttu diya~wteciruit should d mnthimedevices. A double-lumen venious ctheter is the recommended blood access throughout the course of the trratnment. especially when replacing dialysatedeIce however, two single-lumnen venious catheters can also be used. There solution bags.art3 possible accesses for PRISMAFLEXSysterm therpapis: suboclavian, jugular 27. Hypotheria must be monmitord in alI CRAFT treatments, arid speacial attentionor femoral vein, should be paid when increasing exchange volumes above 2 U.h; it may be

11. During priming andoperation. obseive clcaelytor lsakage atiolnts end connectors necessary to warm the patient because of hypothermnia.wihin the set, notably the bags. Leakage can ca.s blood loss or air embolism. 28. The blood return line (blue-stin ped) is equipped with a Luer-lock connection nearIt leakage cannot be stopped by tightening the connections, replace the set- the blue sample site.

line o thepatiet, chck fo absece atThis connector is intended to loin the extension line of a blood warmer. Refer to12. Before connecting the blooad return lntohepincekfrabneofthe specific Instuctions for Use and strictly follow detailed instrirotions for set

air between the segment of line inserted in the air detector and the Patient- up of IThis line. Do not use this connection for any other Purpose.end of the return line.

f ai ispresnt n ths brt o th reurn ine corectthe ass lin tot a 29. Do not attach/~connect the extension line of a blood heater to the return lineIf ar i prsen inthi pat o th reurn ine conec th acesslin tothedownstream ot the air detector. The PRISMAMLEX System cannot detect air

patient and start the blood pump while leaving the return line connected to introduced in the lIne downstream of the air destectorthe collection beg. Purge the air present in the and-parot the return line, thenstop the blood pump. Disconnect the retumn line fromn the cocio bag, arid / Warningsconnect it to the patient.If the amount of air in the blood circuit is too large. reprime the circuit completly 1. The use of operating procdures other than throse Pu blishfed by The manufacturerbetore patient connection, or the use ot ..accesoy devices not recommended by the manufacturer can

13. After priming is complete, do not remove the pressure pods from the preassure result in Patient injury or death.sensor housirngs. If pods ame remvd the set must be changed or the Diaphragm 2. Use honly PRISMAJ LEX Sets with the PRI SMAPLEX Control Unit. The use of non-Reposition pro..cdure performed (reter to PRISMARLDXConitrol UnitOperators PRISMAFLEX Sets can result in patient injury or death.Manu.1l. 3. Should acute allergic reactione Itirst-use syndrome) occur in patients receiving

14. If the patient is not immediately connected to the PRISMMLFEX Set after portiming tatment via the PRISMAFLEX MS0/M1OC Set, nimeredlately stopth Itreatrmentiuis cdiompalet, flush the set with at least 1 000 ml priming solution (saline or and administer appropriate intervention. Pay stpecial attention to patients receivingalkaline solution (pH Ž 7.3) with theparin added) prior to connecting the PatiefAC n ntHy erseniivityReactions seto.)md hw iia legcratos eThis requires use ot a new bag of priming solution. Hpmn ie en n'aeir.

4. Do not allow air to enter Whe blood comhpartment of the filter after priming is started.15a. Use a 21 -gauge cor smaller needle to obtain bljoo/lu sample or remove it a large amount of air enters, the set must be replaced.

trapped air trom the PRISMAFLEX Set. Use of larger needles can cause holesin the sample sites, rsulting in blood loss or air emboliism. 5. Since orugs can pass through the membrane of the fitr the dlosage ot associated

drug treatments must be adurustd tor patients on continuous renal replacement15b. The following plastic needle is compatible with the PRISMAFLEX access therap,

sithes MEDIC Me - 5005 (MediSystem). 6. Io assure adequat titer, perlomance, it is recommended that the set be changed

16. The PRISMAIFLEX Control Unit may not be, able to detect disconnections of every 24 hours of use- Horwever, the set must be changed after 3 days (72 hoursjthe, set from the patient's catheter. Carefully observe the set an~d all operaions and/or the maximu process volume of blood (780L) whichever occurs first.wh ie using the PRISMA]FLEX System tor a patient treatment- Continuec use beyond these limitsr either 12 hours or 7800) could result in

17. Due to the nature of use ot the PRISNrAFLEXSeI (low blood flow rates, axtendec rupture of the pump sregmets, with risk ot patient injury or death.treatment time, and other special factors), the possIbility for coagulationwithin the blood tlowpath is substantially enhanced. Give careful attention tco____________________________________The possible mhedical hazards asociaedme with coagulation of the bloomd flowpdath SE IIA I Nand c.omldy with the minimrum blood! flow rates specifications of each itil, S E ICA ON(See the "Filter Operating Spdecificationus" section).

Isw 18. Filter performance sp. eiiations require a minimum blood flow' rate, specific See Tables at end of cocumen:to each filter, so avoid risk of hemroconcentratin (See "Filter OpemratinSpecificatios setion.) SET MATERIALS

19. During use, closely monitor the patient's clotting parameters, especially when AN69 HF hollow fiear :Acryonitrile and sodium methallyl sulfonateinraigthe amount of anticoagulant delivered or after changing the copolymer

anticoagulant syringe Housing and headsoes Polycarboonate

20. To assure Eproer anticoa.gulant flow contrl only the following syringes are Potting comporun: Polyurethanepermitted: TePrumo (30 mI), 3 S Bertnia) (30 ml), EID 30 Plastnipack 130 rml), RR Tubing maeiP Pasticiz~ed poIlinyl chloride, PVC)Parotsringai rg30 mlf). lco Gamma Plus (30 ml), Dispomred (30 ml). 100 Gamma cartiops PETGPius 120 ml). 1co Star)) 120 ml), SD 20 Plastipack 120 ml), terumo. 20 120 rmntlRR 201(20 ml), Monojet 20)(20 ml), RD 10(1 0 mro, Teruino 1 0)(I0 rml. Fmareseiu Note:; The loliowingpnfrmatihon isaaibl fro. the manufacturer upon request:Luer lock 130. 20 and 10 cc). The use of other syringes can be a hazard to, iniormatron about teal mar/rods used to obtain performanc chiarsctehiticathe patient. Partiularly if there is no Luer-lock on the syringe, the seal betweer,,,e en~e tphrsi teefun h h ilze rprda

the syringe and the hepann line can no longer be guaranteed. mecoroenorec for clinical use

21. When not using the pre biodde pump infusion circuit, it it .arecommnded IC. * the types soc amoaunts of residue from rthe Stenruntmatn processcl amp this circuit clos~e to its connectioen to the access line: tis wili preventthe sedminmenaion of blood into the pie blood infusion line.

22. Always inspect the blood flowpath for signs of clotting before returning thebloodl in the set to the patent If clotting is suspected, do not return the blooc INSTRUCTIONS FOR USEto the patient.

22. In case ci re-ciruation mode, the set must be replaced whenever patient Note : 0,eiscth set by foliowino the ceatered on-line instructions provided by thereconn dretio is not ipossiblea within at most stfew minutes PPISMAFLEX Contro Unit. Additioainfomtation is available in rthe PRISMAFLEXincas of poor blood return, the set must be replaced. Control i/nil Operators ana

al case- it is essential to rephrie the set with fresh saie,mmditleiibe fore pa t iet connection Note a TM>_ - 40 kF-s /200 ,,tHg/ does not show a higher uraffiltration.

24. The PRISMAFTLEX set offersm specifi mdesign of the deaeration, chame'p whic- Felo , 4In 'oi v.ic 'oeurse when the apoproprae instructions appear on theatims to trar- aIr before blood is returned to the patient- ris i-v tt PR SMArLEXCongo- Un:

25'. Vhe PRISMAFLEX Set is not designed for a heater to be connectecm to thy,rn.eo~cmn: solution line A heater generates air bubbles which na0usd ix th Load Se'return oaearation, cham~ber- Therefore, it is recommended nort to use a nearson tnt repiscemernt soltion, line. 1. rreorrel 7"e I' froM the psClsapi~ . suppe Holding the ti tervertically (so that

2t, - T' PRISfVAFLEX set is not designed for a heater to be conctdt lxi tn ', ~rr, I "', rh: wa u carefuiv snap the set cartridge, into the cartrCIodisrae sciu tion lne- A heater generates air bubbles whic o Iiet In ins ertd~ r,r Osnefiitrateosivaael oompWa'imen of the tIlter and dcremase dihusvetpiarmn-s'-4. ."sureh posort tne'r o'cper pr.esuiareousings. Fresa etuent lIn

the ocIxe 'therefo re,t recommea, nded not ro usesI hesel- or'- fns-~c IIc , 'p5Ste wr""-o .I oeer'o" biac, Irg, ring into its guide

soiutdx-vr ... p sceaa/fi~uet Y !ne n oriing op,,



4. Plso. dalesration chenber in Its hold., ettmoh clumber monitor line to ueturn Alisto7h f01 W~hsgrckomu.ki.fthidM 'Tnoubes'hoh~g' hthPRISMAZEXpressure port. Contro/ Unit Operator-s ManuaL

5. Insert return line into air detector and return line clamrp.

6. Connect return line to effluent bag. A. With Blood Return7. Open effluent scale; hang collectiorv/effluent bag. Close scale

Not.e; See Caution no. 22.

Prepare and Connect Solutions Note :A stable spike connector may be required.

1 .Hang bag of priming solution (saline or alkaline solution (pH 7.3) with addedSOOOIU heaparir/iter) on priming hookmlet corner hook top of front panel) Cohnned 1. Turn off the power. C lamp the access I ne (red-striped) and disconnect from theaccess (feci/elfluent (yellow) Y-line to priming solution bag paien Attach the access line to a 1 -liter bag of sterie saline, Itse spike connector

2. If required, connect PBP line (whitel to pm blood pump (PAP) bag; hang bag it needed.) Unclamp the access fina,on its scale. 2. Press the return clamp button (left side of the return line clamp assembly) and

3. Hang replacement solution (CVVH, CVVH-DF) on purple scale hook. Connect hold in the in," position. With the other hand, remove the return ine. (blue-replacement solution line (purple) to replacement solution bag. stipd from the return l ine clamp

4. in OWVHD/CVVHDF hang dialysate on green scale hook. Connect diealyat lin 3. Visually check the the fluid level in the dearation chamber, If the level is below(green). In CWVH hang replacement solution on green scale hook )postdnilutior, the horizontal lne rmove the excess air through the sample sit on thereplacement). Connect green striped line to bEg chamber moinitor line (chamber monitor line connects the deasration chamber

Note : See Caution, no. 9 a, b, c. with the return pressure port on the control unit( as, follows:

5. Connect anticoagulant line to filled anticoaguan syringe. install srnge in pump. a. Insert a sterile, 20 gauge needle attached to a <5-cc Syringe cinto the sample(see Help) site on the chamber monitor line.

6. Unclamp any clamped lines. Verif all conxrneobons. are seun. Press PRIME so b. Aspirate air/blood until f lud level is at the horizontal line on the dearationstart automati.coprming, chamber.

4. Remove the pump crank from its holder on the rear panel. Ineart crank into the

Prime Set rotor of the blood pump anid turn cloclk,,ise until sufficient blood is rturned tothe patient.

None: See Cautions no. 11 thmough 14, cautions no- 25, 26 and 2Q andlWarning na 4AL Warning: The alarm system is disabe. Visually check for air in f le blood

Priming includes multiple selff-testas and takes approximately 10 minutes. After Pthe return line until the patient is draconnectec-cycle is complete :

1. Examine set carefully to be certain all connections are secure, all lines areunobstmucted, and there are no leaks in the tubing- 5. Clamp the return line (blue-stiriped and disconnect from the patient. Clamp line,,

2. Leave.pdrimigsolution and prime collection bag attahed unti readyto connect atogpatient. 6- Press the two clips of the cartridoc carrier to r elease the cartridge. Startring with

3. Continue chosen treatment by followving the instructions on the display of the the peristaltic pump, insert the pump crank into the rotor anid turn each pumpPRISMARLEX Control Unit...rinltkws

7. When the pump segments are tree, oaethe carbtrge and pull out to disengageThe PRISMAFLEX Set must be carefully deerated. the Ineas from the pinch valves It, lac the set ofi the ocontol unit can d dscard as

Anlichoagulation ConsiderationsNote; Remainig solutions mY be used with a new set if iearre,

Niot.: See Cautions no. 17 through 20 and Warinig no. 6.

Initiate anticoagulsaro of the blood filowpath, as prescribed by the physician. Duning AWarning: Ensure aien idscnetdfrom set before re,,movn set ron.use, monitorthe paien' clonhing parameters; adjust the anlcoagulalioan settings on, control unit.the PRISMAFLEX Contro Unit, coi ng to the physician's presc Jripio. It prescribec.do not forget to infuse a loading dose of anticoagulant immediately after patientconnection. B. Without Blood ReturnAnticoagulation playsan imporant partinextending filter lfe byretardingpluggingart clonting. Note: The patient will lose the blooc contained in the blood howpath duringE

manua/. terminatio without blood return.

Change Set Procedure 1- turn ott the, power. Clamp the access line treo-stnpedl atndreturn line (blue-

To remove this set, load a new set and continue with Present trament striped) and disconnect ftrom tne patiet.c

Press 'STOP' from the Status screen, then press "CHAN"GE SET' and ffollo the, 2. Clamp lnes, to al baos

on-line meth~~~~~~~~~~cto~~~~a. ~3. Press h two clips of the cqrir0oe carrier to release the carriog. SAlrting withNote: Oerator can return blood to the patient prior to disconnecting. it oesirhec the bl.oo pump inert the pum crank ino the rotor and turn each pump

(smee Caution no. 22.) oou niercoc kwis,4. When the pump segments are tree, gratec the cartridge and pull out to disengag

Temporary Disconnection procedure the lines from the pinch vaive,_.'tke the, set off the contro unit andt disca,. as

To temporarily disconnect the patient from the set

Press 'STOP" from the Status screen, then press "TEMP DISCON" and follow th,on-line instructions.

Note: Operaormust return bloodmi the set to the, patient and immediately reprmm SPECIAL PROCEDURES IN CASEthe set vi nlieistrutctin. (see Cautions ,io. 22 and 2$.;

OF COMPLICATIONEnd Treatment Procedure

To end the presen.t treatment and remove this set Filter Membrane Blood LeaksPress "STOP" from the Stasus scree, then press "END TREATMENT' anid folio' Blood teaks throucht tHe titer memorane areuoatcls cetecte, butne PRISMAFLEthe on-line instructions.toLnzaamsse,~Ih h eeatoai c , ~Note: Operator can retur blood to the patient prior to colconnecrnp. it osrrec by immrediate storoa:ce of al oumos

(See Cautio no. 2te} rc rerm broodthe bat Inc osti rt. - ETC' i-em the ia~r, scmre. tnet oress CHANGE

SET trom the, Stopscen, r r, ire- to rln ntruciet

MANUAL TERMINATION External Blood Leaks

Note <Se autosn. r

Manual termination may be ncerssaQ cue tc cos E' 1cr v aer'- 1 IPRISMAP EX ControlUnit Thealarm sreentell Etie ceerater its mranja re~m-mot- -xenl oelosn V,0:0vmcaex nt-e0>cT'nrC, ecmo

is recuire arc~. cot-crui in-Eo si~ticez n-0 nSt. Cos tro 5i', :En a ; co .~nEc:-ens cith



dicosposale tubings during treatment to minimize the risk of leakage. 'fan externablood leakage is observe, immediately stop the blood pump. Initiate corrective WARRANTY AND LIMITATION OF LIABILITYaction by securing connections or replacing the PAISMAFLEX Set.

If necessary, adm hnater adequate replacement solution to the patient to compensate a)The manufacturer warrants That the PRISMAPLEX Set has been manufactured infor bl ood loss. accordance with its specifications and In compliance with good manufacturing

practices, other applicable industry standards and regulatory requirements.

If provided with the lotserial number of the defective product, the manufacturer1Wll" Hypersensitivity Reactions w~ill, by replacemenit a, credit, remedy manufacturing detects in the PRISMAFLE

Note : See Warmig no, 3. Set becoming apparent before the expiration date.

bo) The wanmrrat under paragraph a) above is in lieu of, and to thre exciuslan of, any

Should acute allergic reactions (first use syndrome) occurwitthin the finst tew minutes other waranty, whether written or oral, express or implied, statutory or otherwise,of the treatment, it is important to react immediately by discontinuing the session a nd there are no warranie of merchantability or other warranties, which extendandx administering a ppropdriate treatment, beyond those described in paragraph a) above. The remedy set out above for

manufacturing detects is the sole remedy available to any person due toPatients receiving angiotensin converting enzyme (ACE) inhibitos% as medication defects in the PPISMAFLEX Set and the mainufacturer shall not be liable forcan develtop, within the first few minutes cfia treatment, symptoms similar to acute any consequential or incidental loss, damage, injury or expense arising directlyalleric reactionsi ebronchosidasmeceraofsinrway.arlaryrnxct/spnea angioedema, cr indireCtly from the use of the PRiSMAFLEX Set, whether as a issult of anyurticariar nases, vorriting, ciarrfea, rsspirtory arsstabdominal cramping, hyrlriabnon detect therein or otherwise,hypo~volemnic shock and death.

However, for these patients, administration of antihistamines often does not alleviate c) The manufacturer shall not be liable for any misu~se, improper handling, nonthe symptms. I n tis case, reatment ust be stpped and compliancesiwith warningspniandthinstuctiondins damage., arisinga fromgevents aftert r tethe ymptms. n ths cae, reatent ust e stppedanda moe agressve fsl-manufactumrers release of the PRISMAFLEX Set, failure or omission to inspect

line therapy for arn anaphylactoid reaction should be initiated imnmediately afte the the PRISMAFLEX Set before use in order to ensure that te PRiSMlEX Set isonset ci symptomse in proper conditon, or any wanranty given by independent diattibutors or dealers.

Therefore, special anttntion ought to be paid to patients receiving ACE ihilbitorsand/or having already shown similar reactions. d) The manufacturer is HIOSPAL Industrie, Meyzlieu, France.



FILTER DATA CARACTERISTIQUES FILTER-DATENDU FILTRE

NOMINAL PHYSICAL CHARACTERISTICS CARACTERISTIQUES PHYSIQUES PHYSIKALISCHE EIGENSCHAFTENEdfictre surface area Surface efficac Eftedgie Obedlbeh

Fiber inernal diameter (wet) D interne de la fibre (hu mide) Insendurchmessen (feucht,

Fiber wall trhclmesa Eptaseir de parnh de la fibre Wandstarke

IN VITRO PERFORMANCES PERFORMANCES IN VITRO IN VITRO LEISTUNGEN"Blood priming volume Volume de remplissage sang BlutfIllvolumen

Blood pressure drop (post dilution) Perta de charge sang (post dilution) Blut druckabfalt (Postdilution)

(bovine bIod, Hft.... 32%, 6p. ..... 60 g, 37%) (sang de bauf, HIt . 32%, COr .... 60 g/, 37%C) (Rindenblut H kt. '32% Pt. . 60 g/l 37°U

OB** =1 mi/min, OUF'* = 1 Uh OS" = 1 DL/hmin, QUP"- = 1 inO 0F'' =m10 n/mmi U Fu'" = I LIIQB'' = 180 mi/min, OU F"' = 2 L/h OS" = 1 80 ml/min, CU.F * · 2 Lit 0B' ' = 1803 m/mm, GU F... = 2 UL.

O** = 250 nninin CUP''' = 2 Up OS" = 250 mIlain, CU.* = 2 U/- QB' ' = 250 mi/mini, GU '.' = 2 Li,OB'' = 400 rb/min, CU F.'' = 2 L/h OS' = A400 ml/min GUF.'' = 2 L/t GB'" =400 mlmn, U F' *.' = 2 L/h

Sieuing coeffileimt Transmittance Slebkoeflizient(bovine plasma, Op 60 ¢1l, 37' C) plasma de bmuf, Cp 60 g/I, Or C} (Rinderplasma Pt 60C /I 37' C)OB" = 1CO mi/mir, GUF ' = 20 mI/min OS*' t 100 mlmin Cu. 20 min Omi' G' = 100 rmlimni CUF'*' = 20 Im/in

'Urea -Urae -arntl t

-Cretininse C-natnne -Kreatinir,

-Vitamin B12 -Vitamine 812 -Vtrtmin 812-Inule - inne -Inun

-Myoglcis -Myoglobiu -Myoglob n-Albumin -Albumine Albumin

- Typical mean values obtained from laboratory testing of post-sterilization sample lots. Results may vary depending on patient and clinical conditions /Valeursmoyennes caract&istiques nesuaess au laboratoire sur un echantillonnage de lots stfrilis6s. Les resultats sent susceptibles de varier en tonction du patient et deson etat clinique. / Typische Mitteawerte, die an strilen Produkten in Labor ermittelt wurden. Die angegebenen Werte konnen abhangmg veio Patienten und denklinischen Bedingungen schwanken.

GENERAL DATA / CARACTERISTIOUES GENERALES / ALLGEMEINE DATEN / CARATTERISTICH E GE NERALI / AL GEMENE TECHNISCHE GEGEVENS

PRISMAFLEX PRISMAFLEXM60 SET MIRO SET

Weight / Poids / Gewicht / Peso / Gewicht 750 c 8OC g

Overall dimensions / Dimensions totales / Aul~enmaBe I Dimensioni I Totaie afmeingen

length I iongueur / Lange / lunghezza / lenglt 27 cm I 2 cm

width / largeur / breite / larghezza / breedle 22 cm 22 cm

height hauteur / Hehe / altezza / hooglo 9 cm 9 cm

Blood volume in set/ Volume sang dans le set / Blutvolumen ino Set / Volume ematco nel set /Hoeveelheid bloed in set ± 10%VA) 103 no 149 ml

FILTER OPERATING SPECIFICATIONS / CARACTERISTIQUES DE FONCTIONNEMENT DU FILTRE / BETRIEBSPEZIFJKATIONEN FOR DEN FILTER,CARATrERISTICHE DI FUNZIONAMENTO DEL FILTRO / FILTERPRESTATIEE

PRISMAFLEX PRISMAFLEXM60 SET M1OOSET

Maximum TMP' / PTM' Maximum / Maximum TMP' / PTM' mass~mra Maximum TMT- 450 rmi-n61' KV

Maximum blood pressure / Pression sane maximum / Maximum F ile -Eutcrc, rm-:Pressione ematica massime / Maximum bloecdruK . ,¢h k;

Minimum blood flow rate / Debit sane minimum / Minoesz-Biutfluf-rr;e 5murn mlmi/FPoss$ ematico minnme / Minimum Bloeosnelheic

22



CARATTERISTICHE PRISMAFLEX PRISMAFLEXDEL FILTRO FILTER DATA M60 SET M100 SET

CARATTERISTICHE FISICHE NOMINALE FYSIEKE EIGENSCHAPPENSuperficeie etteta Effectiet oppervlak 060 mn 0.90 m2

MW, 0 irterno della fibr (bagnata) Iw vezeldiarn. nat) 240 pm

Spessoire arete dela fibra Wanddilde vzel 50 PM

PRESTAZIONI IN VITRO ¢ IN VITRO PRESTATIESVolumedi priming ematico 11oed priming volume 42 ml ±10% 66 ate 10%

Perdita di Carico ematico (postdilikmcne) Bloed drukdfaliag (Post-dilutie)

(sangue bovirn, Hct . 32%, Ca .... 60 g/, 3TC) bovine bloed, Hi.32%, Cp .. '60. g 37C

OS" ==00 nl/n, OUF" 1 Lh QB- =100 m Omin, 0UF.. = 1 UL 47 mmHg 31 mmHg

OS" ' nrt min. our.. =21fb 08 = 180 MI/hin, QOF" ' = 2 L/h 91 memig 60 mmHg

OS" * 250 mrrinn Oun ... =2 L/h 0 = 250 mImin, QUF . = 2 Uh 73 mmHg

OS" =40 mnminiQUF" .* =2 L/h Q0" =400 mI/man QUF = 2 Ih 166 mmHg

Coefficiente di sieving Sieving colfticient

(plasma bovino, Op 60 9/ 370 (bovirn plasma Cp 60 gIl, 37 Ci

QS" = 166 ml/min CUP" =20iml/mir Q0' = 100 rlmin OUF*... = 20 mI/mir,

-Urea -Ureu, I

-Creatinina -Creatl.. 1

-V'amina B12 -VftamIn 812 1

- mfina -Inuhn, 0.95

-Mioglobia -Myo1lobise 0.55

-Albumina Alb umire < 001

Tipici valori medi ottenuti de test di laboratorio su campioni di crIi sterili. I risultati possoho varmare a seconda del paziente e delle diverse condizioni clinicre. /7ypisch gemiddelde waarden verkregen na het teaten van stalen na sterlisatie. Resultfatn kunnen verschillen afhankelijk van de patient en de klinische situatie.

CWHD CLEARANCES (Continuous veno-venous homodialysis) Clearances versus inlet dialysate flow rate (37'C)CLAIRANCES EN CWHD (fl6modialyse veino-veineuse continue) Clairances au bain de dialyse, a debit entree dialysat (37°C)CWHD CLEARANCES (Kontinuieriche veno-venose Hamodialyse) Clearancewerle abhangig von der Dialysierfldssigkeit-Einlalrate (37

0C)

CWHD CLEARANCE (Emodialisi veno-venosa continua) Clearance con dialisato a 37'CKLARINGEN IN CVVHD (Continue veno-veneuze hemodalyse) Klaringen, snelheid van Ce d alvsaataanvoer (37'C,

PRISMAFLEX PRISMAFLEXM60 SET M100 SET

OB/OS - = 100 ml/min OB/0S" = 10 ml/minOUFr = 0 ml/min OUJF* = OmI/min

QD..' (/h) 1 2Ž ] 1 2.5 4 8

(m/min) 17 , 4; 67 17 42 67 133

Urea/Uree/Harnstoff/Urea/Ureum (± 10%) 17 31 ] 54 17 41 63 95

Vit B12 (±20%) 14 28 16 30 37 45

Inulin / mnulne / nuln / Inulina / Inuline (±20%, 1' 14 23 26 30

Transmembrane pressure / Pression transmembranaire / lransmembrandruck / Pressione transmembrana / lransmembraandruk

Arterial blood flow rate / Debit sang/ Arterieter Blutflul / Flusso ematico arierioso / Aderlele bioesnelheic

Ultrafiltration flow rate (on PRISMAFLEX system, the ultrafiltration fow rate fluia removal how rate + replacement flow rate)/Debit dultrafiltration (sur le systeme PRISMAFLEX, le debit d'ultraflltration correspond au nabil de prelevement de liqulde + debit de solution de reinjection) /Ultrafiltrationsfluerate (bhim PRISMAFLEX -System st die UltrafiltrationstluRrates die Fiussiokeitsentternunosflu3rale + Substitutionsfluorate) /Flusso di ultrafiltrazione (il sisterna PRISMAFLEX calcola il flusso di ultrafiltrazione neo seouenne modo flusso di rimozione del flu/dc. flusso di reinfusione) /Ultrafiltratie-snetheid (op PRISMAFLEX -systeem: de ultrafiltratio-snelheid = vochtverwordeoqncs- snelhemd + subst/futie-snelheid)

Hematocrit / Hematocrite / Himatokrit / Ematocrito / Hematocrie!

Pronein concentration / Concentration protaique / Protein-Konzentrationi / Conicenirazionr orcteics / Ercteine concerat

Diafysaic flow rate / Dbit dialysat / DialysatfluBrate / Flusso diaisato / Dialyssaatsnel -

-his procuct anc oevices incorporating this product are covered ov one or several c! rho --ii ,i, c iE-,le Or et iee eliments oui l constituent sont couvertsoer un Cu plusiours oes brevets suivants : / Dieses Produkt SOWle seine verschieoeren eme e i1n '-h cur i6r ca oeo merere der tolgenden Patente geschDtzt: / Id'orotic aui oescrito c i sistemi e disposilivi ohe lo costiltuisconc sor: copert ca un£ . c, e sEc, ent raeve'd: / Dit procuer en oe systemen en apparaten waarvar

de Produki neeluitrnaakt, valien onder Aen of verschilienoe van de volcenoce aerteo'USC 749619: US 5139669; US 5182868; US5 259903: US 5449430:US 544166 ' 8 5 2 8 576C 8 , V: 5 776 345: USE 910 252: US 4861242: E,411 721: 0C0,441 721: EP0466620;EP0490789: EP 011227:99,671 226 J; 0SE4_ K li642/94: JP 017588:94:JP 1772297

CA 203138: CA 2115415; CA2 115414; CA 1 284 598: FR99 15741: GE 220,88,

Ctie, ranenits nendiel. / D'autres demandes de brevet ont ate decose. / Veo ;e >en1e %t 1i1ie:.. A trCnree ox c atluiMete in fase c

aCE rc.azi e, A raere oatentaanvragen lopen.

22Q~-



100

) ~~~~~PRISMAFLEX M60

E50

30 OiS=100 roj,,s

20

0 50 too ilO 205, 250) 300 350 410 450l 500

PKMOTMP (mnuHg)

120

107 m~rmr

1oo PRISMAFLEX M100

85 n

al

20

o 50 100~~~r 1Sfl 2lif)' 25).' 200 2)' 40' 4"I 500

PTrM ITMP (mmHgl

"In vytro" utrafiltration w~ith bloold (IvIafus 1 5%)(Bovine blood at 37-C, H-ot 32 '¾. Protein concentration 60 g/t,

Ultrafiltration is controlled by the PRISMAFLEX System and is independent of the ultrafiltration coefficicernt IKUF

Ultrafiltration au sang "in vitro" valeurs ± 1690(SanQ de bmuf A 37l0. F-lmatocrite = 32 W. Concentration protfigue = 60 glL'ultrfiltration esat maitrsee parei systeme PRISMAFLEX et mst ind~ponoont, l, .cotticint d'ultrstiltrat,on, (IKUFUltrafiltration mil Slut "in vitro" (Werte be' ± 15 W,(Finderblurt bel 37TC Hkt 32 -¾, Protein-Konzentration 60 g/liDie Ultrafiltration wird von der PRISMAFLEX Masehne, aul dem richtinoon Wen dsatalten und Manol n Cht Von-Ultrafitrationskotfizienten (KUF) at.

Ultrefittrezione Cono sangur 'in vitro" (v.lori 15%,)(Sancue bovino a 3710, ematocrilo = 32 0i. Concentrazione proteics = 60 p'lL'ultralfltrazione A controllate dal S'sterna PRISMAFLEX ed A indipendiente del coett'c ente d, ultrafiltrazione lKUF

-Ultrafiltratie met 'in vitro"-bloed iwoardor, op ± 1 I 6¾

tkundearblnd 3t'C. Hematocretwaaroe, = 32 Y'/. Ewitgeha le = 60 g/iUltrafiltrati wordt gecontroleerd door h.t PRISMAFLEX Systeem er, is onahankliK va, oe ultratiltrabe coefficier,



)~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

In:~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

IS



HEI00 SE

HFI 000 P~ESET

Instructions for useNotice d'utilisation

CebrauchsanweisungFolleto de utilizacio'n

Istruzioni per I'usoGebruiksaanwijzing

H-andhavandeinstruktioner

t K 4<1<~~~~~~~~~~~~~~9



DEFINITION OF SYMBOLS USED ON LABELING tc.d ~ui~ e mut

OF PRODUCT

Insolo us.

LOT manufacturing batch numberALelsisrcinsatsdlaulzakn

sterilized by ethylene oxide (Eta); follow~edbry the sterilization dale

expiration date of the prodiu ________________________t____________

DEFINIZIONE DEI SIMBOLI UTILIZZATI SULLEv.5Ž> ~~product for single use only ETIGHETTE DEL PRODOTTO

A ~~~~~~~~~Read instructions before using the productiLOLOT n~~~~rurenro de lctte di produzione

STE-S-11"TEC asterilizzato con ossido di etalens oxide (EtO).

DEFINITION DES SYMBOLES UTILISES SUR segue la datadi stefliZ2Sfion

UETIQUETAGE DU PRODUIT ~ ~~~~~~~~~~~~data di scaderrza del procotto

LOT ri~~~~um~ro de lot de fabricationmontouso

~~~~EEO s~~tdrilis6 a l'oxyde d'6thylbne (Et01. suivi da ~gr etuin rm eflo

Ia date de strinlisato 24Lger asrzoripiadluo

date de peremption du produil

produit a usage unique FORKIARING AV SYMBOLER

AN ~~~~~Lire les instructions avant utilisation du produit. __

LOT lot Ir.

____________ ___________ ___________ ___________ ___________ ___________steriliserats mad elylenoxid (Eta):

DEFINITION DER AUF DEN PRODUKTETIKETTEN stenliseringsdatum,

VERWENDETEN SYMBOLE aisle g Itighetsdag

FLOT Nummer 6er Fertigungswarrerdids for engangsibruk

F*-T-R-L~i~o1 Sterilisiert mit Athyienoxyd (EtO), gelciptsrkdrerefr avndigvon, Sterilisierungsdaturn b ntkoenafr nbdig

Verfaflsdatum ides Produldes

Nur zum einnahgn Gelbrauch BETEKENIS VAN DE SYMBOLEN

A Aneisungen vor EinsatZLOT partijurrmmer van de leverancier

ISTERILE IS0aes.,teriliseerd mnet ethyleenoxide (Eft)

DEFINICION DE LOS SIMBOLOS UTILIZADOS ltaribsaliaoatum

EN LA ETIQUETA DEL PRODUCTO

Cm nur~~~~njmer de lota de fabricacicinver aerrlocebruik

STERILE I ECaslerilizado por con 6xido de etilerre (EtC A"seguido del fecha de esterilizacidri see d E insICtrutes voor h et gebruii

Th Eis prcuct arn, systesr, and devices incorporating this product are covre doe or Sever, o toetrwigrret Ge orocui c ats 4iamants qui a constituent sortcouverle par ur ou plusiaurs des brevets suiants, / Diasas Produkl sow' sne veso een dim nresc Cure sires acer mahters cr tolgendan Patanta geschuwtr

Este procucto y iosee,,aicnts qua to constritu estb, cubiertos od1cr un Cv.,ECOS c in sicuenre VCene ..nodtro 0m Ceso Itt. a sq~etalt 5 dispositivi ohs IC

ooet::uiscono scnc cocarti as uno o piw dci seguenti braveli: / en...a proue ot ers",tCer' 5: zuuErac'~ sort ct rein rocukt innefattas .v ett cha tiarae av Cofibi sco LietY produkt err de systamen en ...pa.retn warvan dii prooukr eeuC tma :.vai , ro nmu c vcrsortjw eVtC a v.l ~eptentatr5 e3235. 4 4861 242, US84 935 141, US 5236 586, LSSAU41 635.-S E79 2>I CA ~ -P' 5 G7:05220857: EPC030 767. EP 0 525 217, EP 00611 227.

aS2 ,t 1 772297.Ote ~Ealerits pnoino. f Dautras demandesda brevet ont 4tbcess Wet,re' . .. ..<< .r .Eio >!,rrrvroio c a, oztentEs hn aic ceosmitsada / Alr.

rrvr~orafttusneni in fare di approvaziona. / Ancra skaprn. norr:enatvtE Cr

9;



ENGLISH

This product is distributed by:

* AUSTRAUA: GAMBRO Ply Ltd, 3 Hudson Avenue, Baulkham Hills NSW 2154

* BELGIUM: HOSPAL RENAL INTENSIVE CARE, 11 Groenveldstraat, BE-3001Heveriee Ther are no known cortraindications to continuous renal replacement therapies.

* CANADA: HOSPAL-GAMBRO Inc, 9157 Champ d'Eau, CON St Leonard, QuebecH1P 3M3

· UNITED KINGDOM: HOSPAL GAMBRO Ltd, Unit 1 Ermine Business Park, GB- CAUTIONS AND WARNINGSHuntingdon, Cambridgeshire PE2O 80(

* USA: GAMBRO Renal Care Products, Inc, 10810 West Collins Ave, LakewoodCO 80215-44198 Note: Additional warnings and cautions pertaining to the PRISMA system are

included in the PRISMA Control Unit Operator's Manuai

AL Caution: Federal law (USAL restricts this device to sale by or on the orderof a physician.

1. Carefully read these Instructions for Use and the PRISMA Control Unit Operator'sManual before using this product.

DEFINITION OF EXPRESSIONS USED 2. Store the PRISMA Set in a dry piace. between 0' C (32' F) and 30' C (86° F).

IN THIS MANUAL 3. Some solventsand other chemicals, it used in contact with thefiter, could damagethe set. No chemical of this type should be used without permission of themanufacturer The following are especially forbidden:

In this document:- Warning - is used to alert the user/operator not to take a certain action which, a) halogenated aromatic and alphoti olents:if token, can ca.ve a potential hazard and result in a serious adverse reaction, Injury b) ketonic solvntsor death ; 4. To prevent contamination, this PRISMA Set must be used as soon as its package

. Caution · is used to alert the user/operator to take a certain action to proeft and steritization caps are trmved.against a potential hazard, which, it ignored, could have an adverse effect on the S. Do not Us this set ithe package is damaged, it the sterization cape are missingpatient or on the device or loos, or if the hood lines are kinked

,. Note · is used as a reminder to the user/operator on normal treatment activily 6. Destroy this set after singe use, using aseptic techi for potentiallyand on what is a suitabte action in a particular situation. contamied equipment Do not rsterille.

7. Use aseptic ltchnoQues when handing all blood and fluid lines in the set.8. Use only prescribed dialysate and replacement solutions with the PRISMA

PRODUCT DESCRIPTION System. In the United States, dialysate shoulo conform to AAMI Standard RIDEIf a commercially available replacement solution is used, it must be labeled asintended for intravenous injection These solutions must have a density similar

: The PRISMA Set is a disposable, extracorporeal circuit for use with the PRISMA to that of saline solutions (close to 1) in order to avoid errors in the volumesSystem. used for fluid exchange.

* The PRISMA HF1000 Set consists of a PAES hollow fiber hemofilter/dialyzer and The use of a nonsterile dislysate could induce risks of bacterial or pyrogenitubing lines, contamination for the patient.

* This filter is permanently connected to a blood access line lreo-stripedo, a blood 9. Connect the PRISMA Set to a patient via venous blood access ano returrreturn line (blue-striped), a dialyseate inlet line (green-striped) and an effluent outlet devices. A double-lumen venous catheter is the recommended bpood acces!line (yellow-striped). device; however, two smale-lumen venous catheters can also be used. There

*Other lines of the set include a replacement solution line (purple-striped) and an are3psiblaccessesforPRISMASysteTapies subcaviamjugularlernoral veirn

anticoagulant line,

*Aprime collection bag is connected to the end ofthe blood access line to collect 10. Dunng priming and operaton. observe closely for leakage at joints am connectionspriming solution; a 5-liter effluent bag is provided to be connected to the end of within te se, especially for collcton bag and dalysate/firte ports of the Trterthe effluent outlet line to collect ultrafiltrate and/or used dialysate Other sterle Leakage can cause blood loss or air embolm, It kage cannot be stopped5-liter bags and sterile, non pyrogenic spikes can be ordered separately. by lihtein the connections, replace the set

*All line connectors are compatible with the ted 594/1 & 2 international standards 11. Betore connecting the blooor Ine to the patient, check for absence of airconcerning conical fittings. between the segment of lne inserted in the air detector and the patient-enc

of the return ine.U. Twotypes of PRISMA HFIOOO Sets are available ttr IS present in this pan of the return line, connect the access line tote patient

- post dilution : provides for addition of replacement solution after blood leaves and start the blOnd pump while lcaving the return line connected to the priminothe filter solution bag Purge the air present in the end-part of the return line then stop

- pre dilution: provides for addition of r eplacement soluhon before blood enters the blood pump. Disconnect the return line from the priming solution bag. andthe filter connect it to the patient.

· The fluid pathways of the PRISMA Set are guaranteed sterile and non pyrogeni. f the amount o ai i n the blood circuit is too large. reprime the circuit om pelemeI

*The PRISMA HF1000 Set s sterlized by ethylene oxide (EtO. D.eaereaion is such betore Patent connci.that EtO residuals comply with the ones described in ISO 10993-7 12. Afer primind is complete. do not remove the pressure pods from the pressure

sensor housings. It pods are removed the set must be changed or the DiaphragmReposition procedure perorraned refer to PRISMA Control Unit Operator's Manus',

* The PRISMA Set is manufactured by HOSPAL Industnie. Meyzieu. Francs.13. If the patient is not immediately connected to the PRISMA Set after priming is

* In this document the hemofilter/dialyzer will be reterred to as fller, co e, fush the set Wih at least 500 ml priming solution salie or alkalnsoluton )pH ? 73i with hepann addedi prior to connectein the patient This reouirsause of a new bag of prOmino solutor.

14. Use a 20-gauoe or smaller needle to obtain blOnd/fluid samples or remove traipoecINDICATIONS air trom the PRISMA Set Use of larger heedles can cause hoies mn the samp,e

sites resulting in blood loss or air embolsm.

1~, The FRISMA Control Unit may nor be abie to detect oalconneclions of the as;The PRISMA Set is indicated for use only with the PRISMA Control Unit in provding fro The PR at schter. Caretuiry pose ihe set nd ciop s whecontinuous fluid management ans ena replacement therapies The ssrtem is intenceefor patients who have acute renal failure, Tuid overloadc Or t eath the PRISMA System or a paient treatmen

This aet is intended for use in the following veno-venous therapien~: Siow Continuous t.Det h auec s ftePiSSt isppdtc ae.etne1E. Dde toc the -aIure Or use cf the PR)Eh/,A Set (,o. blood fewftl.~- resetenoe¢c

Ultrafiltration (SCUF), Continuous Veno-venous Hemfitrtion lOWS, Contupu, treatment time. ncu other apecia tacoreu the possibi to coagualion wtth-Vano-venous Hemodialysis (CWHDi and Continuo us Vno u eootatirti he rinod frosgar i tubswntati e c ,ecarei tienn to tne eosai brs(CVVH)F, reoiea. nhazaros assciates , ith coacuieatin of the biOOd tiowpath anc oomp.

with the minimum b0oot tios rates saC icatins Of each filter lace the "ilte-Operating Speciticaticn$

~section

Ali teatments admni sterec va the PRISMA Set must be prescribed bus a ohv51cipThe size, weight, atti of uremia, cardiac status an. .e.ersc ihEC81 condition 1C 'i-r ormancE a c a recuire a m, n c ticswrat, rave1.ic Dr oempnoenrc-t See Fire COerat ng SpflOWicatons~ ,etctr

the patient must re carefully evaluated by the prescribinc physician betore sac ntreatment i CEi. ~Jrino use tOsety monitor the oatiev E c,cninc p arameters. espcisliy VThe PR;SMA HP1000 ano HF1000 PRE sets should be rest'iotsto;c caTic-t r,¢r'nean, the , F r c ' &" cod. : ,e i... c o ohc r:a hod weigrt greater than 30Kg ,61b a, r-ccoa is tt,,' ¢,



19. To asscure prope antiloagulant flow control, use only 20-cc B). Stautn, Monojc Load Set(Shnerwood Medical), or Terumno Luer-lock syringes. The use of other syringescan brea hazard for the patient. Particularly if there is no Luer-lock on the syringe. 1 .Remove the set from the tray. Holding fIlter vertically (Soi that the label is the rightthe seal between the syringe and the heparuin line can no longer be guaranteect way up), care.fully soap set cartnidge rinto cartridge carrier (center of front panel).

20. Always inspect the blood towpath for signs of clotin before returning the 2. Attach the 4 pressure pods to their proper pressure housings. Routa appropriateblood in the set to the patient. If clotting is suspected, do not return the blood lines through tubing guides, air bubble detector, return line clamp, sod bloodto the patient. leak detector.

21. In case of temporarycdisoonnection, the set must be repaCed wheneve partteu 3. Connect the effluent barn securely to the effluent line(iyallow-striped). Hang effluentreconnection is not possible within at most a few minutes. bag on yellow scale hook.In case of poor blood reurn, the set must bes replaced. 4, C~heck that the prime collection bag is securely pre-connected to the access lineIn all csees, it is essential to miptume the set with fresh sailine Immediately before (red-striped). Hang prime collection bag on left corner hook (bottom of frontpatient connection. Panel). See diagrams in the Prisma System Operators Manual.

22. The PRISMA Sellis not designed for c heater lo be connected to the replacementsolution line. A heater generetes air bubbles which collect in the return line pressurepod. Therefocre, it is recommended not to use a healer on the replacement Prepare Solutionssolution lie.However, inCWH,itrnay be necessarytowarnlthe ptenteotecauseot hypothermia. 1. Hang ai liter bag of pniming solution (saline or alkaline solution (pH Ž 7.3) with

23. If a heaterhIes beenoconnected totMe dllysaiteinlet line, the PRSMAControtUflit added SOD0lEU helpservirilte on right cornerhook (bottom of front panef).automatic priming sequence will nof extend to the additional segment of line, 2. Connect anicoaegulant line to filled anticoagulant syringe. Install syringe in pump.which v.11 have to be primed befose connection to the PRISMA Set (see operating S. Hang replace ment solubon (CWH, CVV-HDF) on purple scale hook. Hang duiastinstructions supplied with this accessory). (CWHID, CWHDF) on green scale hook. (Bags of up to B liters can be placed

24. Do not connect a blood heater to the return line downstream of the air bubble on scale hooks.)detctr The PRISMAbystern cannirt detec air introdcced in The line dlownstreamof the air detector. Ilc.:secronI.8

25. The blood return line (Iblue-striped) is equipped with a Luer-lock connection nearthe blue sample site.This connection joins the Prismatherrn II Extension Line to the PlISMA Set Connect Lines to Solutionswhen the Prismatherm, II Blood Warmer is used. Refer to the PrImmathemr, IIExtens io Line Instructions For Use and strictly follow detailed instructions for A` Caution :The blood return line (blue-striped) is equipped with a Luer-lockset up of this line Do not use this connection for any other purpose. connection near the blue sample site.

AL Warnings This connecio joins the Pirimathermn If Extension Line to the PRISMA Set whenthe Pnsmatherm It Blood Warmer is used. Refer to the Prismathermi It Extension

1. The use.f opeatingproceduresotherthenthosepublished by themanufacturer Line instructions For Use and strictly followdetailed rnsbutruoans o stup ofthisor the use of accessor devices not recommended by the manufacturer can line. o. not use this connection for any other purpose.result in patient injury or death.

2. Use only PRISMA Sets with the PRISMA Conthrol Unit. The use of non-PHISMASaet can result in patient injury or death. Using sPiKe or Luer connector on applicable lines, connect

3- Should acute allergic reactions (first-use syndrome) occur in patients receivirtg - Return line (blue) to priming solution bag.treatment via the PRISMA Set, immediately stop the treatment and adminisneter heplacemnent solution line (purpie) to replacement solution bag.appropriat intervention, (See 'Adverse reactions" section.)

4. Do not allow air to enter the blood compartment of the filter after priming is Dnialvste line (green) to dialystae bag.started It a large amount of air enters, the set must be replaced.

5. Since drugs can pass through the membrane of the filter, the dosg of ascaedrug treatments must be adjusted for patients on continuous renal replacement Prime Settherpy. Note see Cautins no. 7 0 rhrough 13, cautions no. 23 and 24, and Warning no. 4.

6. -ic assure adequate fileer performance, it e recommended that the set be changercevery, 24 hours of use. Howevr, the set must be changed after 3 days 172 hours;of use. Continued use beyond 72 hours could result in rupture of the pump Priming includes multiple self-tests and takes approximately 8 minutes. After thesegments, with patient injury or death, cycle is complete

1. Examine set carefully to be certain all connections are secure, all tines areunobstructed, and there are no leacks in the tubing.

SPECI FICATIONS 2. Leave priming solution and prime collection bags attached until ready to connectpattiet

See Tables at end of document. 3. Continue chosen treatment by following the instructions on the display of thePRISMA Control Unit

FILTER MATERIALSThe, PRISMA 5cr m~ust be carefully deserated.

PAES hollow fibher Poly~ryiEtherSulfoneHousing and he~aders Polycarbonate

Potting compound :Polyurethane Anticoagulation Considerations

Tubi ng mateoria Plasticized poyvinyt chloride PVC~ Note: Sre Cautions no.16 through 19 and Warningno.. 6.

Cartioge plate and filter bracket Acrylonitrile-butadiane-wistyee lABS.

Initiate ant Icoe.uirion of the blood fiowpath, as prescribed by the physician.Note : The folilowing information is available from~ the manufacrurer upon requrest: During use, monItor the patient's clotting parameters: adjust the anticoagulation* inormation about test methods used to obtain performance characteristics : settings on the PRISMA CoIntol Unit, according to the physician's prescription. It* the numeer andi rag of particles in the effluent from the dialyzer prepare S presoribec. do not torcet1 Itonuse a ioading dose of anticoagulant immediately

reomeoofor clinical use~ after patienIt connecir.1

* the types and amounts of residue from the steflhization process. Anmicoaguiatio pIs Ia an important part In extending filter lfe by retarding pluggingano clotting

ClPirios exoe'ien&Lies rae ontae that, when stanoerd heparIn is used,

INSTRUCTIONS FOR USE iurI s E1 Clr ILL/K, sno conTluou-s infuscio (pre-f ittEi of Sfto 12 U/kg/h iprovide_____ ____ ____ ____ ____ ____ ____ _____ ____ ____ ____ ____ ____ ____ ece uete e-rticcecuirio n fr si forms of continuous renal replacement therapy.

Note : isit the set by following the detailed on-line instructions provioe to thcFRlSMvf Control Unit. Additional information is available in the, PjRISMIA C ntre Chance Set procedureUnit Openratr' Atanuat.

.0'm E ,' e ie a Isc' set anti continue with o'esent treatment

hole :5 TAMF I 4 kFa (300 mml-g) does not allow a higher ultraficltatio . Fc -C , or &teeStte ce c thn, pres "CHANCE SET' and follow the

,.rrc Im the foiloe'inci proceoures when the approprate instruction soce tc fee fte'.' a5"tc{ ,t ico to tee patien peo Po ciconnetrin if desircoiso~r o' " the PR SMA Control Unit.ar;

r' A AI-rtL icaut'ort for c ninuou rena Iprelc~ernet rhe'aje I'. PONtC. 1 PELc0'>-O 'c ci - I hiere kee :i 12~ih s I in.t1 S1

C~~~~~~~~~9



Temporary Disconnection Procedure ditpcsable tubings during treatment to minimize thes risk of leakage. f an externablood leakage is observed, immediately stop the blood pump. Initfiate correctiv

To tempoaiy disconnect the patient from the set action by securing connections or replacing the Prisma Set.

Press 'STOP' from the Status screen, then press "TEMP DISCON" and follow the If necessary, amnirh ster adequate hreplacement solution, to the patent to compensate

on-line instructions, for bloo loss.

Note. Operator must return blood in the sat to thepatient and immediately reprime,the set via on-line instruction4 (see Cautions no. 20 and 21.)) ~ ~~~~~~~~~~~~~~~~~~Adverse reactions

End Treatment Procedure, Adverse reactions may occur due, to the complex interaction between blood endthe artificial Sunlaces of the entire extracoriporeal circuit. These reactions may also

To end the present treatment and samove thtis set be precipitated and/or exacerbated by other external factors involved with the

Press "STOP" from the Status Screen, then press 'END TREATMENT' and follow indirvidual partient's specific disease process and the treatment of renal insufficiency.

the on-line instnictions. Certain type of adverse reaction may occur due to Operational factors associated

Note : Operator can return blood to the patient prior to disconnecing if desired, with the treatment. Therefore, proper ma nagement of the fluid hremval, e lectrolyte

(See Caution, no. 20.) balance. anticoagulation and blood flow rate as wel as monitoring of the overalltreatment parameters are essential to avoid side-effects, which may be associatedwith hfreodilysis / hemofiltration theaies

Hypersensitivity reactions have been observed during dialysis. Symptoms of

MANUAL TERMINATION hypearsnsitivity reaction may be gastrointestinal. rnucocutaneous. respiratory,___________________________________________________________ cardiovascular or systemic in nature and range from very mild to severe. Such

symptoms have been deschibed as anaphylactic-like ractions within the first fiew

Manuel termination may be necessary due to pewer loss or an alarm of the PRISMA minutes. Manifestalion inclu .de nausea, malaise, weakness, a seanesation of burning

Control Unit The alamo screen tells the operator if a manual termination is required. or heat throughout the body, profuse perspIrlation, res piratory d itreas and in some

Ni e:The following instructions ameaalso found in -Trnoublesltooting' in the PRISMA instances hypotension a ndcardiopulmona ry arrett. Should a combination of suchControl Unit Operator's Manual, symptoms. appear, particularly at the start of the treatment session, it is important

to react immediately by discontinuino the session and administering appropriatetreatment. Blond in the extracoriporeal circuit mutt not be returned to the patient.

A. With Blood Return Extra care mnust be taken when treating patiment who have exhibited possiblefhypersensitivity symptoms during previous treatments, or patients who have

Note : See Caution no. 20. history of being highly sensitive and allergIc to a variety of substances. A phyicamust be consulted to evalu~ate the risk and prescribe the appropriate precautions

LbWarning : The slami system is inactivated. Visually check for air in blood itaI..S ,siiy h.Id

return line until the patent is disconinected. The following fedtora am consiadered essntial to minimizeo the risk of a hyipersenfsit, h,reaction and other side-effects-

1 .Turn off power switch. C Impaccess linc ured) and disconnect from patient. Alach I.t~ hnnet h ~-, hn n icod..odtia ntl

access line to a 1 -liter bang of sterile saline. (Use spike connector it needed.) manufacturer's Instructions for Use.,Unclamp access line. 2. Setting and rmontoring the treatment operating parameiters according to the

2. Remove return line (blue) from return line clamp of the PRISMA control un i manufacturer's recommendations specified for each type of PRISMA Set soc

3. Manually turn hblood pump counterclckise unit sufficient blood is returned totoh prnInedad oeae

the, patient. 3. Strict adherencs to all WARNINGS and CAUTIONS given by the manulaciursi

4. Clamp return line (blue) and disconnect from patient. Clamp lines to all bags, in the "instructionso for Use.

5. Press clip at lef Side, ofcartridge carrer. Tug on cartridge assembly while manually) turning each pump counterclockwise.6. When pump se~gmens are free from pump raceways, remove set and discardWA R N Y NDLMT IO

as usual, ARNYADLMTTOOF LIABILITY

B. Without Blood Return

1. Tum off power sMitch. Clamp access lieIt. nd) and retume line (biusi and disonnect a)The manufacturer warrant that the PRISMA Set hras been mhanufatured in

from patient, accordance with its specifications and in c.omplance With good manufacturing

2. Clamp lines to all bags practices, othr applicabl industry standards an, reultryreurements.

3. Follow Steps S and 6 above. Ii provided with the lotiserisi number, of the detective product, the manutacture'

will, by, replacement or credit, remedy, manufacturi ng detects in the PRISM.'Set becoming appareni before the expirati.,on dt

SPECIAL PROCEDURES IN CASEb,) The warnyuder parag1iPh sI atbove i in allu of. and to the exclusion of, any

OF COMPLICATION other warranty, whether written oi oral express or mlied, statutory or otherwseand there are no warranties of merchanaility or othe warranties, which extenbbeyond thcos described in ptlaragrap siabove. The, remedy eel out above fo'

Filter Membrane Blood Leaks manufacturing defects a the sole remedy available to any prerso due ICdefects in t~he PRISMA Set and the manufacturer shall not be liable for any

Bloodleaksthrough thefilter mebrane.are.atomatically detected by the PRSMA. on"s'equntsior inbontjena loss, damage, injury or expenhsearsing drectly orControlUnit alarm system. Awarning alarmis generated andblood n losIs imilec nietyfo h-ueo h RSASt hte sarsl faydfcboy immediate stoppage ofal pumps. therecin for otneries~o n RSASt eh~ nImuto ~ n

T.orturn blood to the patient, press STOP from the alarm screen, then presere,.1tm~`1CHANGE SET hor the Stop screen and follow the on-line instructions.

cI The manufacturer thai' not belable for any misus, iproper handlin,. nor-comnoirance with warnng ao c istructionE. damane ariSino from events she

External Blood Leaks ~~~~~~~~~~~~~the manufactuSre release c the PRISMA Set, failur or omiSsio tor inspectrExternal Blood Leaks ~~~~~~~~~~~~~~the, PRISMA Set befor useinroe to ensure theat tne PRISMA se: Is in props',

Note : See Cautions no. 14. tff and 19. condition, or any warar gier b, inopndeni citibutors or ocaicS

External blood leakage ma~y not be immediatel identifiec by monitoring ecuipnc'and could result in s ionificant biod lost C heck the filter andt a ,hconncti os c' Ira of "h m~Iact ure h, S 05A -nc E ine . tre: i> Franc>



FRANIAISI

Ce produit est distribuk per:

* BELGIQUE: HOSPAL RENAL INTENSIVE CARE, 11 Groenveldstraet,BE -3001, Heverlee

* CANADA: HOSPAL-GAMBRO Inc, 9157 Cheap, dbEau, CDN St Leonard, aI 'y apas de contre-indications connues aux techniques continues d'assistance

Qu/sbec H1 P 3MS rnlel

· FRANCE: HOSPAL S.A, 61 Avenue Tony Garnier, 69007 Lyon

* SUISSE: GAMBRO HOSPAL SCHWEIZ AG, Sargereistrasse 24, AVERTISSEMENTS ET PRECAUTIONSCH -8152 Glattbrugg

Note : des avertsscments et precautions supplremantaires relatifs au systirine

DEFINITION DES TERMES UTILISES PRISMA figurent dans l Manuel d'Utitisation du MoniteurPRISMA

DANS CE MANUEL A Attention1. Avant drutijer le produit, imre attentivament la pr/sente Notice d'Utilisation,

Dans e document: ainsi qua le Manuel d'UtJlisation du Moniteur PRISMA_

, Avertissm.ent - eat utilis4 pour avertir I'opireteur be na psa faire uri action 2. L. Set PRISA doit Cur stock/s dens un endrot see. entia 0"C at 30"C.sp/cifiqus pouvant causer un risque potential qui s'iI est ignor4, peut provoquer 3. Cellains solvents ou eutras produits chimiques au contact du Set PRISMAtne /action ind/sirable, des Ibsions ou la ort; peuvent lendommaqer. Pour toute utilisation de produits de catte nature

. Attention east titilis pour avertir lop/rateur d'agir sp/scitiquement pour proteger I'accord d'HOSPAL elt indispensable. Sont notamment 6 prohiber:le patent contre un risque passible qui, s'il Meit ignore, pourraft avoir un aftet eeinsiraebe a) es solvents a romta iques at a liphatiques halogointscur la patient ou cur le produit; b) lea solvents c~tonigquc.

-Note east utilisb pour rappeler a l'op/rateur lee fonctions normales du traitemant 4. Afin d'6viter toute contamination, le Set PRSMAdoit ftre utiits6 immr biatenmentetla conduite btenir dans une situation particulibre. aprdes avo.r it extreit cc son embellage et aptrs que Ifon alt Out sea prolecteurs

de stirilite5. Ne pas utiliser ce Set si l'embielege unitasre eat encommagrg. .s les protecteurs

DESCRIPTION DU PRODUIT dve stidlitt sont manquants ou mral fix/s, ou si lea tignes a sang sont plicaturese.6. Ce Set eet l usage unique et dolt /stre d/truit apr/s usage, en utlisant des

* Le Set PRISMA at un circuit extracorporal usage unique destin/ a tre utiilics techniques espticues pour le mai~riel patentialent ontmn. 11 na doltavec lv moniteur PRISMA. pee ts retrilis,

* La Set PRISMA HFf1000 ec7 onstitud dun hdrmotltr/dialyseur fibres creuset 7, Utiser une technique assptique crt de Is manipulation des lignes du Set.PAES et de lignes. a. Utiser uniquement evec le syst/sie PRISMA la solution de reinjection et te

* La fitre act an permanence conect/s a une ligne d'mntr/e sang ulcer/ rouge). liquide de dlye st/riles at isotoniques prescrits. En cos d'utilieation d'unesolution d'epuraeton du commerce, elle dolt porter des indications pr/ocisant

line ligrna dv ratour sang (lleer/s bleu), uric ligna dialysat (i/ear/ artd) at uneligne, dv liquids effluent l/ear/sauna). quee eel dastine &s une utilisetion en injection intraveinmu.e. C.. solutions

devront tIre de densite voisine des solutions salines (proches de 1) afin d/sviter* Lea sutres lignes du Set se compcsent d'une ligna de solution de r/injettior lea erreure aOu ms en oeuvre pour lea echanges.

(iser/s viole) et d'une ligne d'anticoagulant. L'utiisotion dun dmilysat non sterile exposerait le patient 6 des dscques deJ~ * Une poche eat connect/se l textr/smit/s de Ia ligne d'entrte sang et sari a contamrnation bact/renne Ou pyrog/nique.recueillir le Liquide deamorgage; une poche de 5 litres at pr/vue pour atre 9. Connecter le Set PRISMA eu patient en utilisant des dispositife d'accs et deconnectbe I'extr/rmit de le ligene de liquids effluent et sear s recueillir reout sang veineux Nous recommandons d'utliser un cea/tar veimeux doubleI'Lultrfiltrat eatou le dialysat uss. D'autres poches de 5 litres str/laes et des lumiere ou daux cathetars Velneux S simple luminre. Lors de traitrrents ral/s/sipertorateure rel/srle et apyro.gnes peuvent /stre tournis separrment avec scste/see PRISMA. i eet possible d'utiliser ta/s accra : la veina sous-

* Tous leas conneclaurs des lignes sont compatibles avec lea normes internationeiec c/enam uuaie ot IemoeleaISO 594/1 & 2 concernant Ies maccords coniques. 10. Lorse I amoregeo et de tutilisetion de 'appareil, v/r/fier soigneusament

* 2 types de Sets PRISMA HF1q0 sont disponiblas ebsenc dv tus eu nivaau des points d:assMble at des conmaiom duSet en prtdiculier au niveau ess pochea et des ernbouts dialysat/filtrat du filtre.

u setnpod dilution: parmet 'oudsoto er/ncinpslvaaLes ululer sequent ae causer des partes de sang ou des eambolies gazeuses.Sidu lseg ena tuti pit eriate asres desconnexions, remnplacer le Set.

- Set pry dilution: permet 'aut de solphuti de r/siniection avant le passage Cu 11. Avant .a connecter sa hins Ce ratour sang au patient, v/rtier I'absence d'airsang dens Ien fitre, le i d segm ent Ca imgne incsrs Cans lv detecteur d eais t I'extrhmit/s patient

* Las compartiments sang at dialyseat du Set PRISMA sont garantis st/nes et de is hn, e ce retour san.apyrooenas. En Gas d pnesence d'ai dens testa pertvi de Ia highn de rtour, connecter la

· La Set PRISMA HF1000 eat st/sils/ & r'oxyde d'/thylbne EtO). La desorption ea li.na d entree sang au patient, mnsre an route Ia pomps a sang en la/ssent laconduite de ftaon que a teux d'EtO r/siduel soit conformas acaeui prescrit aent ligne ce reour connectee s poche de solution selna. Purger lair prsernt densIs norma ISO 10993-7. Ivxtrmaes dIs li onse ae retour puis errStar Ia pompas sang, Deconinecter I

* Date dv pehernption, : sc rtelerar & l'stiquete un/ta/re. Iline c1 retour de is poche de solution saline et l connecter au patient.

En Gas ae presence dune grande quantitfE d'air dane Ie circuit sang, rae/are* Le Set PRISMA eat febritqu/ par HOSPAL Industrie, Meyzieu, France. un ao templesscu circuit entgrnh/vaitun amrad omplet au circuit avnt de branch., le patient.

Dans ce document. is mot 'tiltre" est uti/s/s pour d~signer l'hrmotiltreCia lyseur 12. Ala tin oe I morcace e pat a rer lea pries de pression des logements descepteur, Or pression. En ca de retrait des prices, i est nmcessaire de procedesau chanqemanet ou Set ot au repositionnemrnt du diaphragme de Is prisc Ce

INDICATIONS rreston i Manuel d'Utisaheon du Moniteur PRISMA).13. Si Il phat't ie oeui else connect/ immmdiatament ae Set PRISMA apres qua

;amo ac~x cc timr air it6 eftectu8. ii vet recomamendsoce remplir/rincer S nouveaau.e Set Prisms do/i q tre utilisc uniquement eyec ie miniteur Prisms pour is misc , p, O,-* i 500 mfl cc sli nerou acemlinan)pH a 7.) Epauie -Se avec f,' mOms 50DU rnn Ps solumon saline ou . asathe (dR 1 7.3) heopefine,en ovusre de techniques continues dbassistance renale et de rnaitrise des Liooss -nneom irert eventl r et I orenchement du patient Pour tale, i eat n~cessaieLe systesin est indique pour lea patients affaints d'nsuff sance rense aipu. 06 s e ...ouve.l. pocrhe dv soluto'rcurchaga hydriquc. Cu des daux. 14, Jtih i ,ic -e-icuie 20 C 'C¢ un ale metre plus petit) pour pr/lever aeeCs Set prmert de re/aiser let traitements veino-veineux su.ants: i ltrafiftranor e cltzm oc sane epou cP ftdice Lu Sat PRiSMA ou pour 6tar des bulges dbaicont nuv ante iSCUF. Hdnmofaltrt on veino-venaeuse continue ICWHi. e-rmodCeivsc = utim s

", l uiiies 0e uls ds cahore peal compromerttr I/stanch/site du Set

vemn-vemneuse continue (CWHVD), H nemodietiltratbon vaino-veineuse continue (CWH20

aut U v E :es Ovri eviemVne: Dr Ovcuar sins 0cs panes dv sang ou des empboies

lout ie$ traisements cmunistres la/idc du Set PRISMA doivant itre pDescrite pe 1oi. oe 16 nri-c'ieu- PRISMk/ ne detecte pas les o/connvxionE? ,,eaecn, Avant choue traitement le tradec/n prescipleur opars evaluvr is tallic au'c- ,:ni ESEt a:1i catneter cu patie2 Surveilier attentivamant l Sal et

V v Oi ltaet ur/sm/cue a cardeque etle condition physique generasiec ot, arel: *Get:,, -mere Ct !eraant loets oe Utlisat on cC syste/ma PR.ISMA

1[ r a L~ ¥,e C ~?! aticr c c cu< ,cebits sane taibes. iongue PurieeRSets PlSMA HP100C et HF1000 PRE doivent Stre utiJEs su s'rc zatiet C¢C v i-C7E icS" ll lee !5rCes de toaculation OL

ozice euDfltriuta 00 kc. " Le "sueE mcCIeCuM > aSSociaS al coqeulatior

9 / '7;



totalo ou pairtielle du circuit sang exotent done. l est n6Dcasaire d'.accorer uneattention toute paricfluliore, aux instructions concernant lanticoegulation de Ce PROCEDURE D'UTILISATIONproduit et do resipecter lec dkbits sang minimum sp6citques do cheque type dofilitr (voir tableau .. Caraectinrstiquaes de Fonctionneimen du Filr Im, -)Nt u~fst du Sot dolt 6tro contcmthe ea. ntruCtions dletalif affiCtieS SU'

17. Des spkcificatbons de performances du fil~tr imposment d'utiliasor ar debit sang /lacraa du manlteirPP/SMA e hadcun des chasa, Desmfoin.abomsc~p/&ntsesnirtism ali afthaer tout roJe dh'mocncerenaton (voir tableau C aractbristouoe sont d~sponibies, dens le Manue d'Utisstion du Monitour PRJSMA.de Forctionnrnient du Faire 4)

leI. Pendant l'utilifstion, aurveillor attontivement les psramltres daenticoogulation, Note : Une, PTM > 40 Wea 300 -nnhig)i no dometrc pas dobteni uml ultrafiitratio,du patient, en particulier silol dose d'anticosgulant administeri eel augmentse pius &.diol.ou aprks avoir changi§ Is senngue do 'anticoagulant.

19. Pour obioneir on dbit d'anticoagulant aieut nutiliser quo dos seningues ECue,- du i .. s ntcde pori.,,isiock de 20 cc, do maerque BD. Braun, Monojoet (Sherwoodd Meical) ot;eumo. Eictrlspccdrei-saulocueeeioLtisepopiespprsetLutillsation de seringues d'un atibe type peutcmpmetrla skcurit4 du patient ear lcran du moniteur PRISMAEn paricuir en Cas d'absenee d Loot-lock sur Ia seringue, Ittanchatii dola connexion entro Ia seringue et la ligneo h~parin, n'est plus ga..nlie. Miss en place du Set

20. Toujoors vOriffier que to circuit sang nest pos coegul avant de proceder 1restitution. Si lo circuit est coagol6, no, pas r~infuser lo sang au patient. 1. Ratiro le Set do eon ittui. Tout en meintoenin le litre I a vortale (do legon quo

21. Lots d'un dlbranchmeont temporairs, . lel patient no pout Wre branch6 alI'tiquotta soil lisible), engager avec preceution Ia cassette du Set aur so,.nouveau dine lee minuesde cut swivent, if ost impati det rompiecer lc Set, suppedt (situic ad Centre du panneao avant,.Si la restitution oo l'61ininetion do sang nrest pas do tree borne quast& is.l Set 2. Connector los qualre prisee do preasion dens lee logemants epproprios. Acthermnerdovra &tre rornploit lee lignes dens ou~rs guides, trPacers le ditetu d'air, ls clamp do iain doDans tousles. des, il oat impaiatif deamoreor nouveau le Set eveo do sicrurn retour et le detlectour do tunle seng.phyciologique freis imrnrmdleternent event to brenchemont do patient. 3. Connecter soigneusemert le sac do rocuc I du liquide effluent Itl ligne do

22. Le Sot PRISMAnoast pae configure pour accopter le branchement d'un rechauffeur liquid e olluent (lIser@ aeune). Accrochor, , sac de recueji do ulquide effluent astir Is ligno do solution do reinjetion. Le branchemnent d'un r~chaufteur cur cetto crochet do poson oleune).tigno ongndreroit tine accumulation de bull.s dair dens Ia ligno do rotour sang 4. Vicrifier ha pret-connexion do sc do rocuoll du Iqguide d'amor..age Itl ligno dorttreeso niveau do Ia prise do pression. lliser4 rouge). Acerocher le sac 00 rocuol du liquido d'arnorago eu crochet doII oct done dilioonsili6 d'utiliser un r~chaufteur cut Ia liane do solution do coin gaucho (co bas du penneau avant). Vol ttfguree dans to Manuel d'Ltilisetionreinjection. do Moniteor PRISMANianrnoins, en tritement CVVH, pour ridchdr los probilemes dthypotheormio.it pourra Atre n~eessaire do rtchaouter to patient.

23. En cas d'utilisatfon doun hechauffteur curio. circuit entree dialyst Is proeiduiro Parparation des solutionsdomorogage, autometique du moniteur PRISMA ninttigro pee tamorgapo du j, Soapdndre one poehe dun, ltre do Qiuide demrorgago, solution saline co .alcatiesegment do figne supplomentaire. It soen don:rce. n ico sir do purger cc segment (pH Ž 7.3) startle inaprinnc) (dose d'hedpar'n 5000 Jl/) aud crchet do coin drolldo lhigne osscince u heehautfour avant do to connecter aL Set PRISMA (pout.a baa du pannee avant.eels urivr lee instructions d'utllisation fournisa avrac cot fccossenire)

24. No pea brencher un rechauffteur de sang cur Ia higne do rotour sang en ava1 do Is serngue. d. ane 1d artouseo-sr~ngA 1. rnurene u...atIplrdotetu do bulbis d'air cer le systrnmo PRISMA no pout pas detector ' lairhu dn oss-e uintroduit daens Is ligne on sata du detecteur dai.f 3. Soalgondros po c.ho do soilutio do rdnoto CWH oo CVVHDF) so crochet C

25. La, ligno do rotour sang (fier4h blou) eel acquipic dun connectoor ocr-loc peson violot. Suepuendre Is pocet do d ivalet (CWVHD 00 CWHDF) au Crochet 00situ,4 pras du site do prelacomont. poson cart. (Leas crochets do deposre acoeptent las poches dlune cpadcitic maximrao

Co connoctour pormet do ro.,lleaI ligne doextension Phsrrtem" 1 auSe PRISMA do 5 litros)lors do lutiiseition do rachauffeur do sang Prismathom, II. So rictcre IA Notic Note : volt Attentio if &d'utiiashtion do Ia ligne dox.tonion Priomathorm It et SutvMere crpoloosmontlos instructions dratillwae lore do linstettetion do corse igno. No pea otitiso r conxoce ine u ouinconnecteur d'autres lins.Coneindsig sausltos

A Avertissements A ~~~~~~~~~~~~~Attention: La lions do reto, sang Onstsor bou) oct squibse doun connocto,L Averlissements i~~~~~~~~~~~~~~lot-oc situic prie du site do prale,,erncn

1. Toute procadure d'utilisetion utre quo cellos Nobtises par 1 fa bricent. atin Coa connoteur pormet do roter1 hareqn doxtnsion Phrimetherm II co Set PRISMAquo, lutilication da.ccossoiros non rcommandics per cc dernier. rt~eqnt do lore de'on lu stileon do rachauftlur do sang Priamatherrr II. So riWcere I a Noticeo~mipromottro is samea du patient ou de etroote s vie enanger~s doutilisetion do Ia higne i doxtosion Prsmathorm It at suivro scrupoleusement los

2. Utiliso ...... usivomo~nt lee Sets PRISMA veoc to monitour PRISMA. L'utilsetiori instructions dctaillacs lots do instalattn do cettsoline. Ne pas utilisor podo Sets d'autro provenance rique do conmpromettre Ia cants, do patient cu do connoctoor d autros tintmetr ase vie en dange.,

3. Au ccc oO des ricectione allorius eigu~asyndrome de pnromiero utttsatioriappeiraitraiont pendant lee toutes promlicres minutes do treitement.~ ii taut Efoctuet lea cenn...ions canvrses. en otilleant soi I 1 connectur pertoratoor soil

r6sgir imnridiatormont en anron Ia stance ot en adminitrant on traitement 10 cnnecteu Lerloieppropri4 Voir to ehapitro 'Rieactions ind~sirebli Lignea, fat r bo Irtee bleol a Ia poche do ttouidedmoae

4. I ost imorstit do no pas taiseor entrer dair spras avoir ninite nanorosge. En cue * Cne, do soolo do, celn sciton Nairei violet) h a pucho Cc solution do re icijtior.ddonrhce deair imnPortee romplacor to Set. DoLnsi do dCaivalisord ,erl) .a pocho do dtaysat:

5. Do tell dun tenstart possible des drngoes ou rntidtcannnts tracers la memrndo fill.re . leraitment des patients par iopuration extra rans conti..nue imtque Aoed oone adaptation do Ianpsologie des traeitments maddicemontoos essocia Anrcug . e

6. Pour easeore, d'une bonne performance du tiltre, ilest reonmandic oe rernpace Note : tort Attention r. 1C a 73. Attontion i 23 et 24. et Avortissomont if 4.he Sot apris 24 houres doutilisation; toutetis Cc chengemtent deft obtigatotreaprts 3 jours (72 hooros) d'utilleation. L. poursuito do Nuilisaio a de a d,72h pool conduit s, rua pture des corps do pompo. otnptomotant ansiI La procedure demnorgaepe comrnute one, sn deautotoestsel dur environ minutes-cants do patient ou mettant so vie on dongr. Uno lois Is cycle darnordgee ltmini, pi roccder comma sot

1. nspector ettentivoment Ic Sot pour e vriia litecritsi do torles cccns xosor saSurer cue los Ignosno, srt , pus, obstrues et cahees no latent pus-

SPECI FICATIONS 2. No, dicconnecter ls pocos, .s soolion, asetne / aiceln m e Ic sac oo ereei aI oaioe dumorg~ace coo icrecoc, Ipatient oat pnet a ttr o ...no,7

Volr tebiosox latain eta documen:n .s.Fprot'0roono coH cfnioramont co instroctio t chtcnoe aJ

lecran Io, nntoor PP'SM#l

MATERIAUX DU FILTRE

Fibre crease RAE S Pfoybrv EtherSolrtoLno P.SA C7E r e ep

Cocoille lt cooverCiS Po ycaroonsto

Cello Polyorithanel Anticoagulatior

Maticric C., lignor PVC ichioruree .goyinvie ciustifi Note 7 veit Atto~nricrx 76 700 /vgsor'ti 6.Ceassmetto support do, Mitre ABS .. lsrln itrio-bat~adincetvrozeNote : Los ilenomutions sa~lt-res Sent dls,,cfib,o sat ceanco., adre cfrI&P.

*e~ * nitfloOosss ats, utjlseos pour eter, ~s t cramcrentooos CC ,pot,err.c. ,rococrt C anticoacis'jc C, e o ObIOT aK otocnp -SCrif 'tie,

'to ,br re te ii, Ia,/ tat ss panfxlrcls ObtpiiuS eas j., ,nests,! COllrisVS. o patie-t. etso or fecat s- onticsaauiatiC- s- e nj 75 -lM. en,

Ierkoeì Solon I., rocomtmunacabions pour 05,500 cktniou ....... n.. -L

*i to e ,p Oti eusrtit Cc trout po ztOC&ep 00 5ttonhsatC.C C o e C sofoons



Lan htiCoagulation, associte au debit sanguin doe ha circulation oxtracorporellea onI Pour rostrtuor du sang as patient, appuyor sur Is touche-programma "ARRET" deetfet important auraI durte do via du filtra (colmstage aet coagolatbon progressils. 1'cran dalatrms, pols sur Is touche-programme 'CHANGER SET" de 'tocra

L'expthence clinique" a monrtet qua, pour I'htperin standard, un bolus de 5 1 0 "ARRET"; at suivre lea instruction.stafichtness.UI/kg at one dose da maintien (pr-fihtre) de 3 §12 Ut/kg procurent oneanticoagulation adtquate pour tootes lea modalitia. d'tpuration continue. Flutes sang extreas

Procicltdue de changement du Set Note : vir Attention n 74, 15 at I1.9

Pour tourer ha Set, charger un nouveau Set at continuer he traitement en spurs, Celle-ci pout no pe tro itrnnmtdialement dttectte par Ie moniteur PRISMA at

brocade, comma, suit : ~~~~~~~~~conduire une perte do sang importante. Pour nminhmisr le risque de tulle,Appuyer sur ha touche-programme "ARRET" de Itocran 'SITUATION", puls sur Ia vnfriflr Ie flits at touteels c..onnexions du circuit pendant le traiteminertt Sh una tuhtetouche-programnme "CHANGER SET" at suiere lea inatructions affiches so manifesto. arr~ttr rImbeditoment Ia pompeo A sang. Commancer corrigar Ia

Note : l'paaerctproc/alerie cse alchtrant ASia restitution du ang flu patient situation an saseurarit qua Couls les connexhons sont correctes ou an ramplegaint

avant Ic dalbranchement deccc daner froir Attention n" 20). le Set.Si ntcessairo. eadmn istrer au patient uno soluthon do emplacemnent adtquale pour

Prootdure de dtbranchement temporaire Comnponsor ha parse do sang.

Pour debrauncher Ie Sat ternporairement, procrider commau sut:

Appuyer sur ha touChe-programma "PJRRET" de Itocran "SITUATION", puls sur la Ratinsnesrbetoucho-programnme "DEBRANCH. TEMPORAIRE at suhvr leas instructionsaltfichtaes. L'intoraction, complexeaentra Ia san et leas surfaces artificielles du circuit

Note: lbp/,arteur doit procdderf ls restitution de sanglprtesnt dane lo circuit flu extracorporal pout tire 6'origine do rtactions indtsirablea. Cellas-ci peuvantpatient. Puis feamorcer immn~diatament Ia Set, conformaimant au, instruCtons, gtg~alemnl 6tir dtaclenchtoc Vcu exacerbilas par deautres facteures xtermas iMsaffichaes (voir Attention n" 2Oct 24) au pmorococu pathologioue d'un patient at so traltemtent de linsuffisance rtnaea.

Cerlains types do reactions irrdeirables peuvant Atre osiuata par des factautsspecitiques radesois flu traitemart. Una bonne mailtine de Itelimination du liquide,

Porocedurea pour tarsniner le traitemetnt do lequilibre tioctrclylqe do l'anticoegulation, du Cabcti sang, ainsi qu'unePour terminer l Inctritement en douls at rtinrletI Sat, proctdet commeau sut surveillance rgigoroc do tous leas parametras du treitement, pernmdltront deviater

las ashots cocondairos pouvant tsre aeeocita aux thtrapies d'htmodialyseAppuyar cur Is toucho-programme "ARRET' da Iltcran 'SITUATION", puis cur ha htrnofiltratiorrtouche-progranmor -TERMINER TRAITEMENT" at suivre leas instructions afifichtes. tDes rffaclione d'hyperseci~bilit6 ant Wt observtes durant Ia dialyse. Leaura

Note : lopiarteurpeut proceidet Ia cas dchelant h a restitution du sang au patient sympticnroc povent trhe do nature gastro-inteStinale, cutanto-muqueuse,avant le diAtianchomenrt deccc danernw (sor Attention n" 20). rspiratoire, Casrdio-vascular or u systtmiquo, at ceur h ntansitt beaulAte ltgta 6

savre,. Do tlos synptotmres aot ttt dtcrits comman des rtactione de typeanaphylacticue au ceure des premierces minutes: naueses, malaise, taoblesse,

ARRET MANUEL DU TRAITEMENT sensation, do brtut um w 0 chalour envahissant tout to corps, thranspirationexcesive,____________________________________________________________ dtresso rspitaloit at, dane certains cas, hypotonsion at arrtt cardio-raapiratoire.

Si phosleure ao cas cym-pitmes eons cbservts, en particulier au debut duLlartat mnuel du traitmernst pout s'avtrer ntcessaire suite taune panne do trditement. rcIu imrniditatemsento intorromipant Ia dialysa at en administrant uncourant ou o ne slarmo dtchenchta par le moniteur PRISMA -. cp,, cra laam tre aitnnt aporoprit cc pctiont. L. salng do circuit extracorpocral ne dolt pas, M~eaver it operateur do le ne~sesitt de proctader un arrtlt manual do traittemnt. r~iiiacte au nal'ent.

Not :esistuctan c-desos s tow-il/aakmntdoserviechroitre -Dphlaanae Ulne attention pnart icuir eat ntcessairo ora du traitement des patients syantdo Manual d'Litilisatian du mcniteur PRISMA. prtsentt doe ffvontuels symptbmes. d'hypersensibilitt au cours des traftements,

prec/adents. 00 lee patensprsentant des antecedents do haute sansibiliat 0u

A. Avee restitution du sang au patient dalhergie divrcee substances. Si une sen..ibilitt du patient eat sauspectule, horisque doit rire &vclot par on mtdecin. qui btablira les prtcauthons sptcitiques,

Note:- or-Atrent,on h- 20.dtb a tvan tor prierLee ~lacture curvants sent consifffcl commea essentials pour minimisr Ie risque

A Attention: L.esyatianie d'alarme eat inaac'tire4 S'assurer visoi.1atlenlt do do rtaction d'hyporsensibilitt ou aut.ro alet secondaire.Pabeanc. da.ir done Ia lIgne de raoture sang jusqu'i cc qua le patenrt "oit 1. Respect rrnulieux ace proctdures do misc en place, daemorgage at dodtbranchb. rirgace Cecritea dacne Ic 'Notice d'utiiisation" fourni pat io talbcant.

2.Dttinitier. ose par...nrtres do traitme~nt en tocation des recommendations1. Mettre tinterrupteor, I/O en position hors tension. Camprr Ia ligne d'entrte t.lou $rne, pa 0abricant pour cheque type be Sat PRISMA. sini qua des

(Iior6 rouge) at Ia dtconnecter du patient. Connecter Is rlge d'entrffo6 une busoirs a1 a Is tolernc du patient, et surveillance do ces panramttres.poheln d'un litre de strum physiologique st1rito (au bosom, utiie un connectour S. RespeolCt datutelos sEprecautions (AVERTISSEMENT et ATTENTION) fournicsportorateur). D6.clamper ia lignre daentrto, par , CauriCant call s " Notice dultilisationi

2. Rotiror ha ligne do rotour (liser,6 bleo) du clamp de ia I gno do retour do monliteurPRISMA

3. Faire burner Ia pompe 0 sang manualtlement doen ho sans contrair des aiguiliasd une monrt'oiusqu'a cou'unvoluma sutfisent de alng aitt reestitue so patent. GARANTIES ET LIMITES

4. Ciamber Ia ligno do rotour(Iisert bleu) at la dtconnectot du patient. Clamper as, DE RESPONSABILITEalgne do tootes lea Coches.

B. Appu~yor s~ur he clip situs du cttt gauche du support do c.asstte. Tiror so' a) LO f blabcart ocrantt Icue Ic Set PRISMA a eta fiabricut conformtment flux[ensemble "ca.eaett" tout en flisant toorner chaque pompe man~uellerhnon speitic1,atione techninues. cux tbonet prtiqoos, de fabrication (GMP -Goodacense toeons contraire des aiguilles d'une monro. teanutacturio PRactie et curo normes indutieles sinsi quflux ribgles on

6. ine I oi lee corps doe pompe dtgagt des gorges des pomnpec. retirer le 5cr vieou'et Ie jeter en suivant eos ptoctduraa an usage dense 'htpitai bout reserv do notification, do numtro do lot du praduit dtloctueo,, to tabricart

enan a...&. rm piece ou ternbeumer, tout Sot PRIS MA pracenant des vices

13. Sons restitution du sang au, patient avant is t cae do etemptio..

1. Mettre 'interroptor I/O an position hors tension. Clamper h a lon donirti bl z c~aratie au patacrareF a~ 0,-csocus sappligue an lie at place do tuta autreIslser rouge) ot .Is lign de rebut (teart blau) at lee dtcnoce du ptienth eavrni e cents .Cu i oral.opresee Cu imptiibe. etatursir ou eutr., et fucune

2. Cislmpor tee linos do toutee lea poches. evrvnr'I 1ce~r,,icie Cu. suite. ditterente no cello specifito au paragraphe s~'i cuo sc~r etl P, riteno cempite. cc ecu. recoor legal en presence do vices

3. Soire i!es points Set ci6-dossue. 0 *vmc1 e~t a gaateprevue par io paragrapho a) ci-dessus. Cello, giatni

rcac sI, les labricant en ccc cc eons. Commaod. b/assure Cu depernsos

:ncrece'nn: il I~ul sation do Set PRISM/i

PROCEDURES SPECIALES EN CASc c oso~, EI cece c c tout roc.soosbiiil on cat do mauveise otitisatier

DE COMPLICATIONS - rrEEt a r, ua~i~ . cc nc-ooc es svrie e ts cier0rn c0V'icssronn oe a mi~se on venle du Set PRISMA e"

Furites sang internee ca 0' 00 a contrieCu Sot PR SIVA avant utilisation, pour s'assurer Cue i,SC ' r.Cii a1 ' Ci, i-. CC tociov ,u pour loute aubro asrantie don1ric

L eE "- ta ee cae tra ersi memnbra ne sonht automctio uaeren a rectesczp eItI t 0'C ursa cc 5 nsoocciartE Civolr neantc\etere c'ciartne cu renitour PRISMA. Jne alaurne, so decionche ot aIs tuit car,.es: imeitmetlles par I'srrtt de toutes tee pornpecE d .iC'i orCs V inut.E. rete e Franc,.

r -._ Ar,ccsaluaiisn Ior continuo renal rohllaemrthan, es h r' RCNCC 0.1 CEE~0M( 1 e .c oo -c c19CCri Piisev 1 1t c1551 121'



Prisma HF1000 Ofmax = 81 ml/min80 QB I QS= 180

70

60

50 K 37 mlf~h. QB I QS = 100 ml/min Ofmax = 51 ml/min~ 0 Kuf = 37m/h g)

40

30

20Ku 7 mVI(h.mmHg)

10

00 100 200 300 400 500 600

TMPIPTM (mmHg)

"in vitro" ultrafiltration with blood (values ± 15%)(Bovine blood at 37°C, HIt 32 %, Protein concentration 60 g/tUltrafiltration is controlled by the PRISMA System and is independent of the ultrallttration coefficicent (KUF)

Uitrafiltration au sang "in vitro" (valeurs A t 1596)(Sang de baeuf A 37°C, H1matocrite = 32 %, Concentration prothique = 60 g/I)Lultratiltration est mattdsie par le systbme PRISMA et est inddpendante du coefficint d'uitrafiltration (KUF)

Ultrafiltration mit Blut "in vitro" (Werte bei ± 15 %)(Rinderblut bel 37°C, Hkt 32 %, Protein-Konzentration 60 gIl)

Die Ultrafiltration wird von der PRISMA Maschine auf dem richtingen Weft gehalten und htngt nicht von,Ultrafitrationskoeffizlenten (KUF) ab.

Ultrafitiraci6n con sangre "in vitro" (valores a ± 15%)(Sangre bovine a 370, Hemetocrito = 32 3,, Concentraci6n protdica = 60 G/I)La ultratiltraci6n controlada per el sistema PRISMA, es independiente del coeficiente de ultrafiltracian (KUF)

Ultrafitrazione con sangue "in vitro" (valori a ± 15%)(Sangue bovino a 370, ematocrito = 32 -6, Concentrazione proteica = 60 g/I)L'ultrafiltrazione A controllata del Sistema PRISMA ed A indipendente dal coefficiente di ultratiltrazione (KUF)

"In vitrm" ultrafiltration mod blod (vbrden : 15%)(Bovint blod vid 37cC, Hct 32 -, Proteinkoncentration 60 g/I)Ultrafitrationen kontrollers av PRISMA systemet och Ar oberoende av koefficienten fdr ultrafiltration (KUF)

Ultraftitratie met "In vitro"-bloed (waarden op ± 15%)(Runderbloed 37'C, Hernatoctietwaaide = 32 %, Eiwitgehalte = 60 g/I)Ultrafiltratie wordt gecontroleerd door hit PRISMA Systeem en is onafhankelijk van de ultrafiltratie coefficient.

-J

23 98 1



CARACTERISTIQUES CARACTERISTICASFILTER DATA DU FILTRE FILTER-DATEN DEL FILTRO

NCMINAI PHYSECAL CHARACTERISTICS CARACTERISTIQUES PHYSIQUEIS PHYSIKALISCHE EIGENSCIIFTEN rARACTERISTICAS FIRACAS

Effective surface area Surface efficace Efieklive Oberfiche Supesftce eledita)Fiber internal diamneter 0 interne de la fibre Innendurchimesser SOirterrndoIfibr

Filber wallthblaones Epaisseur de parrot doe lafibre Wancistffrke Espesor de Ia pared deab fibra

IN VITRO PERFORMANCES* PERFORMANCES IN VITRO IN VITRlOLEIS-rUNGENw UNDIMIBITOSEINVITRO'

Blood priminagnvolume Volume de remapllssargesang Blutfifllvolumnui Voharnasede celldelsegangmIed

Blood preasre drop (peod dilution) Perts de charge sang Build1 dilutios) Bhid aruckaldatll (Posildilution) Cafdaes dle prendif sangre fpourd-flucllm

(bovine blood, Hfte ... 32%, C .... 60gA,37=C) (sang de beea t ..H.. 32%, Cp....60 gA, 37tC) (Rinderiblu. fin ... 32%, Pt ... 69/I, 37=0) (sangre bovine, Inc...32%, C .... 60 gl, 37C)

QB" * 1600 allele, DU F. =1 Uhb OS" =1600m~Ini, OUF 11/. z GUB"3 = If60 Umnin, OUF'" =1 lJh OS' l00 rntmain OUF' = I b

QB- =lS8 imVminDU F.. = 2LUh QS" =lt8 im/rni,OU F.. = 2 J1/b11 =B"I80 mliminOUF ... L2 U aS"=laarntkinO UF-" .2 U

OB" = 183 i mInmin, QUIF- = 41/h OS" = 180 rlmirDeU F.. =4 I/h 08' =480 mtnmin, OurJF.. =4 L, QS" =160 mnl/snnn CUF.. .4 IUb

Sieving coefficient Transmaittance Sietakoulf izient Traidiardirtancis

(bovine planmaCG ... f0gI, 37= C) (plasma de baef, Cp .... 60 gA, 37' 0) (Rinderpbeari, Pt .... 0gA. 37= C) (piasnorabno,Cp.... 0g/ir, 37= C)

08"~ = 1600 mI/nin, OU F. =2Oenl/min OS" = 160U mI/mim, OUF".. =20milmin 08" =1I60 mI/rein, C UFP" = 20 mI/mim OS" = 1600 anI/in, OUF- = 20rmlinni

-Urea -Urbe -Hasndle -Urea

-Creainine -Creatinine Kreinir -reatinina

-Vitamin Bf12 -Vtamnonen 812 -vitamin 84 2 -VitarioIn812

-am nline InntnO, -i ndo~n,

-Myogob in =Myoglobine -Myogloctir Meglbobin

-Albumin -Alburanioe =Allbuni, -Albimnrna

TypiCal mean values obtained from laboratory testing of post-sterilization sample lots. Results may vary depending on patient and clinical condlitons./Valeuirs moyennes caracl6ristbques mesur6es au laboratoire Sur uin &chantillonnage de lots st~rilis~s. Les r6sultats sont suesceptibles de varier en fonction du patientet de Son 6lat clinique. / Typische Mittefiwerte, die an strilen Produkten im Labor ermithelt wurden. Die anglegebenen Werte kdnnen abhdngig yam Patienten und denklinischen Bedingungen sohwanken.Valores medios caracteristicos medidos en laboratorio Sobrec un muestreo de lotes esterihizados. Los valores pueden variar en funcidn del paciente. asi comao de suestardo clinico.

GENERAL DATA I GARACTERISTICUES GENERALES I ALLGEMEINE DATEN / CARACTERISTICAS GENERALES / CARATTERISTICHE GENERALIIALIMAN DATA / AIGEMENE TECHNISCHE GEGEVENS

Weight / Poids / Gewicht I Peso / Peso / Vikt / Gewicht 590 g

Overall dimensions / Dimensions totalles; /Aul~enmafle / Dimensiones fotales / Dimensioni / Storlek /TIctal amirntingen

length!/ longueur/ Lange/ largo / lunghezz / llongd / lengte 40 cm

width / largeur /Breife /ancho /largheza/ bredd /breedte 27 cm

height /hauteur!/F-lhe /altura /alteza /hojd /hoogite 12 cm

Blood volume in set / Volume saing donme le set / Blutoolurnen ima Set i Volumen de eangre onci alcst / Volumre ennatic ned setI

Blodlvolyrn I setctl Hoeveedheid bloed in at (± 10%) 128 ml

FILTER OPERATING SPECIFICATIONS /CARACTERISTICUES DE FONCTIONNEMENT DU FILTRE / BETRIEBSPEZIFIKATIONEN FUR DEN FILTER!GARACTERISTICASDIE FUNCIONAMIENTO DEL FILTRO/C ARATTERISTICHE Di FUNZIONAMENTO DEL FILTRO /ANVANDNINGSSPECIFIKATIONERFOR FILTER I FILTERPRESTATIES

Maximum TMP / PT1W Maximum / Maximum TMP'/ PTMVImaxime / PTKVI massima I Maximalt TMP / Maximum TMP' 500 mml-g66.6 kPa

Maximum blood pressure / Pression sang maximum / Maximum Filter-Bl utdrucl< / Presibn sanguinea mtxima 500 mmHg

Pressione ematica massima I Maximalt blcdtryck / Maximum bloeddruk 66.6 kPa

) Minimum blood flow rate!/ Debit sang minimum / Mrindest-Blutflufrate / Flujo sanguinec minimro/Flusso emat icc minimo I Minimalt Blodflide / Minimum Bloedsnelheid 75 mI/min

24 99



CARAT'ERISTICHE FILTERDATA PRISMADEL FILTRO HFIOOSET

CARATTERISTICHE FISCRE NOMINELLA FYSISKA KARAKTABISTIKA NOMINALE FYSIEKE EIGENSCAPPEN

Superfici elletliva Effelm, yla Elteciev opperviak 1 s15 m

2 :interedZllatiba Inr karfiirdameter Inw. vezebld. 215 pm

Speisorepanetedela fibra Tjocklk. lavpillrvagg Wandidilkle veel 50 PM

PRESTAZIONI IN VITRO ~ IN VITRO PRESTMEOA ~ IN VITRO PRESTATIES m81 ml±10%

Volume dl priming emutlee Blodvolyi BlRed priming volume

Perdta di aric, ematieo (postdilukiloae) Blod tryddall (postdilutlom) Bleed drukdallng (Post-dilutie)

(sangue bo~nn, Hit$ .32%, Cp ..... 60 gea. 3rC) (bovint blod, Hicr *. 32%, Cp....60 9/1, 37c) (bovine blled, Htc . '32%, Cp .. 60 gPI, 37'C

0S =lI0mmin0UF. =1 Uh [B" =l DO mnmin, 0UF. =t IL 08* =I00 mlnmin, OUF**=. L=U 34 mmHg

OS" =180 Dmilmin, QUF- =2 F* * B- = L0 m/hlin/ QBU". 2 UP Its = 180 refnan, QUF ... = 2 LUF 60 mmHg

OS" =180 ml/min, QUF.. =4 Uh Q B* = I180 m nria. ..UF =4 LU OB* =180 mnila, QUF'*. =4 LUh 73 mmHg

Trasnittana Sievingkoeffiielet Sieving coefficient

(phama bovine, Cp. ** 60 PA. 37' C) (bevl plasma, Cp ..... 60 gA, 37 °C) (bovme plasma, Cp*..... 60 gll, 37 °C)

QS" = 1 i0 mvlmn, GUF*.. = 20 ml/min QB* = 1Oi0 ml/min, QUF''' = 20 mlm'in Q08 = I O milmin, QUF. * 20 mVmtin

-Urea -Urea -Uream

-Crmatinina -Kneiin -Creatiinne

-Vitamina B12 -VitamiInB 2 -Viamine 812 1

-minlime - milm - Inuline 1

* Mleglobina -Myoglobin -MyOglie 012

-Albumina -Albumin -Albumine 0 01

Tipici valori medi ottenuti da test di laboratorio su campioni di lotti sterili. I risultati possono variare a seconda del paziente e delle diverse condizioni cliniche./Vanliga mnedevdrden erhbllna vid laboratorietest av post-steriliserade prov-partier. Resultaten kan variera beroende pA patient och kliniska fbrutsattningar. /Typisch gemiddelde waarden verkregen na bet testen van stalen na sterilisatie. Resultaten kunnen verschillen alhankelijk van de patient en de klinische situatie.

CVVHD CLEARANCES (Continuous veno-venous hemodialysis) Clearances versus inlet dialysate flow rate (370C)CLAIRANCES EN CWHID (HQmodialyse veino-veineuse continue) Clairances au bain de dialyse, a dobit entree dialysat (378C)CVVHD CLEARANCES (Kontinuierliche veno-vendse Hanmodialyse) Clearancewerte abhongig von der Dialysierflussigkeit-Einlalrate (370C)ACLARAMIENTOS EN CVVHD (HemodiAlisis veno-venosa continua) Aclaramientos con barco de diAlisis a 37=C

CWVHD CLEARANCE (Emodialisi veno-venosa continua) Clearance con dializzato a 37PCCW1HD CLEARANCE QKontinuedig veno-vends hemodialys) Clearance mot dialysatfldde (370C)KLARINGEN IN CWHD (Continue veno-veneuze hemodialyse) Klaringen, snelheid en de van de dialysaataanvoer (37°C)

QB/QS" = 160 ml/ain, QUF* = 10 ml/min

Q0""" (11h) 1 2 2.5

(ml/min) 17 25 42

Urea / Urbe / Harnstofl / Urea / Urea / Urea / Ureum (± 10%) 27 43 51

Vit B12 (±20%) 26 39 45

Inulin / Inuline / Inulin / nulina /I nulina/ Inunin I uie (±20%) 25 37 40

Transmembrane pressure / Pression transmembranaire / Transmembrandruck / Presidn transmembranica /Pressione transrnembrana / Transmembrantryck / Transmembraandruk

Arterial blood flow rate / Dbit sang / Arterieller Blufluf / Fluio sanguineo arterial / Flusso ematico arterioso / Arteriellt blodfldde/ Arteriese bloedsnelheid

Ultrafiltration flow rate (on PRISMA system, the ultrafiltration flow rate = fluid removal flow rate + replacement flow rate) /DWbit d'ultrafiltration (sur le systbme PRISMA, le ddbit dultrafiltration correspond au ddbit de prelevement de liquide + debit de solution de reinjection) /Ultrafiltrationsflul~rate (beim PRISMA-System ist die Ultrafiltrationsflul~rates die FlussiggkeitsentfernungsfluBrate + Substitutionsflu[lrate) /Plujo de ultrafiltracidn (en el sistema PRISMA el fluid de ultrafiltracion corresponde al flujo de extracci6n de I'quido mns el flujo de soluci6n de reinyeccion) /Flusso di ultrafiltrazione ol sistema PRISMA calcola il flusso di ultrafiltrazione nel seguente modo flusso di rimozione del fluido + flusso di reinfusione) /Ultrafiltrationshastighet (pA PRISMA, ultrafiltrationshastighet = hastighet pA vatskeborttag tr~n patient + hastghet pA ersattningslosning /Ultrafiltratie-snelheid (op PRISMA-systeem: de ultrafiltratie-snelheid = voch iverwijderings-snelheid + vervangings-snelheid)

Hematocnt / Hematocrite / Hanmatokrit / Hematocrito / Emalocrito I Hematokrit / Hematocriet

Proten concentration / Concentration protdique / Protein-Konzentration / Concentraci6n protdica /Concentrazione proteica / Proteinkoncentration I Proteoe concentratie

Dialysate flow rate/ E4bit dialysat / Dialysatflullrate / Flujo de liquido de diAlisis / Flusso dialisato / Dialysalflde / Dialysaatsnelheic

25 100



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101

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t ~~~CEt ~~~~~~~~~~SACIo,nt, 12/oo14 0,47245272 0086

0 ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 12W



]DEPARTMENT OF HEALTH &HUMAN SERVICESPulcHatSeve4 ~~~~~~~~~~~~~~~~~~~~~~~Food and Drug Administration9200 Corporate Boulevard

OCT 3 12001 Rockville MD 20850

Mr. Michael Horns Re: KOl1 1221Regulatory Affairs Specialist Trade/Device Name: Prisma FIF 1 000 Set andGAMBRO®& Renal Products Prisma HF 1 000 Pre-Set1081 0W. Collins Avenue Regulation Number: 21 CFR §876.5860LAKEWOOD CO 80215 Regulation Name: High permeability hemodialysis

systemRegulatory Class: 11Product Code: 78 KDIDated: August 1, 2001Received: August 3, 2001

Dear Mr. Hemns:

We have reviewed your Section 5 1 0(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, orttodevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into either class 1I (Special Controls) or class III (P'MA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federl egstr

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor anv' Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing(21I CFR Part 807); labeling (21 CFR Part 80 1); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820);- and if applicable, the electronicproduct radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

103



This letter will allow you to begin marketing your device as described in your 5 10(k) premarketnotification. The FDA finding of substantial equivalence of your device to a legally marketedpredicate device results in a classification for your device and thus, permits your device toproceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Office of Compliance at one of the following numbers, based on the regulationnumber at the top of this letter:

Sxx.lxxx (301) 594-4591876.2xxx, 3xxx, 4xxx, Sxxx (301) 594-4616884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4616892.2xxx, 3xxx, 4xxx, Sxxx (301) 594-4654Other (301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact theOffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbrandingby reference to premarket notification" (21 CFR Part 807.97). Other general information onyour responsibilities under the Act may be obtained from the Division of Small Manufacturers,International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Ci4gdon /Director, Division of Reproductive,

Abdominal, and Radiological DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure

104



GAMBRO Renal Products

510(k) Number 0 //27/

Device Name: Prisma HF 1000

Indications for Use:

"The Prisma Set is indicated for use only with the Prisma Control Unitin providing continuous fluid management and renal replacementtherapies. The system is intended for patients who have acute renalfailure, fluid overload, or both.

(Division Sigi4, {OfI3 /Division of Reproductiv, Abdominal,and Radiologicel DevicsM > T.e e510(k) Number 7"Ci" /tI. use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHERPAGE IF NEEDED)

') Concurrence of CDRH, Office of Device Evaluation (ODE) 105

Regulatory Affairs - Dialyzer Division Prisma HF 1000 Set



10/18/04 MON 17:13 FAX 3015942977 FDA CDRH ODE POS Zo0i

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration9200 Corporate Boulevard

OCT 1 8 04 Rockville MD 20850

Mr. Thomas B. DowellManager Regulatory AffairsGambrot Renal Products10810 W. Collins AvenueLAKEWOOD CO 80215

Re: K041005Trade/Device Name: Ganbro PrismaflexTM System with M60 and. MI00 SetsRegulation Number: 21 CFR § 876.5860Regulation Name: High permeability hemodialysis systemRegulatory Class: IIProduct Code: 78 KDIDated: August 10, 2004Received: August 11, 2004

Dear Mr. Dowell:

This letter corrects our substantially equivalent letter of October 7, 2004 regarding theincorrect product code listed for the Gambro Prismaflex TM System.

We have reviewed your Section 510(k) premarket notification of intent to market thedevice referenced above and have determined the device is substantially equivalent [(forthe indications for use stated in the enclosure)] to legally marketed predicate devicesmarketed in interstate commerce prior to May 28, 1976, the enactment date of the MedicalDevice Amendments or to devices that have been reclassified in accordance with theprovisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approvalof a premarket approval (PMA). You may, therefore, market the device, subject to thegeneral controls provisions of the Act. The general controls provisions: of the Act includerequirements for annual registration, listing of devices, good manufacturing practice,labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class I (Special Controls) or class lB(PMA). it may be subject to additional controls. Existing major regulations affecting yourdevice can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898- Inaddition. FDA may publish further announcements concerning your device in the FederalRegister.

Please be advised that FDA's issuance of a substantial equivalence delermination does notmean that FDA has made a determination that your device complies with other

106



10/18/04 MON 17:13 FAT 3015942977 FDA CDRH ODE POS ]002


requirements of the Act or any Federal statutes and regulations administered by otherFederal agencies. You must comply with all the Act's requirements, including, but notlimited to: registration and listing (21 CFR Part 807); labeling (21 CFJK Part 801); goodmanufacturing practice requirements as set forth in the quality systems (QS) regulation (21CFR Part 820); and if applicable, the electronic product radiation control provisions(sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section510(k) premarket notification. The FDA finding of substantial equivalence of your deviceto a legally marketed predicate device results in a classification for your device and thus,permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),please contact the Office of Compliance at (240) 276-0115. Also, please note theregulation entitled, "Misbranding by reference to premarket notification" (21CFR Part807.97). You may obtain other general infonmation on your responsibilities under the Actfrom the Division of Small Manufacturers, International and Consumer Assistance at itstoll-free number (800) 638-2041 or (301) 443-6597 or at its Internet addresshttv ://www.fda.,ov/cdrh/dsma/dsmamaainhtmnI

Sincerely yours,

Director, Division of Reproductive,Abdominal, and Radiological Devices

Office of Device EvaluationCenter for Devices and Radiological Health

Enclosure

107



10/18/04 MON 17:14 FAX 3015942977 FDA CDRH ODE POS l003

Abbreviated 510(k) NotificationGambro Prismaflex Tm System

Indications For Use510(k) Number (if known): K/- )OO/O -

Device Name:

Prismaflex Tm SystemPrismaflexm M60 SetPrismaflexTM M100 Set


The Prismaflex is indicated for the following use:

continuous solute and/or fluid removal in patients with acute renal failure orfluid overload

All treatments administered by the Prismaflex must be prescribed by a physician.

~) Prescription Use AND/OR Over-The-Counter Use(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)



ivision Sign- G0Division of Reproductiv, Abdominand Radiological Devices

510(k) Number jo 4 00

t08Confidential Pg



DEPARTMENT OF HELI UAISRICES Public Health Service

Memorandum

Front Reviewer(s) 2. Name(s)

Subject: 510(k) Numbr rC)to ta tesujct51-)

ifctin

To: The Record - It is my recommendto httesbet50k oiiain

O]Refused to accept. ohrta euet cet

OlR uires additional information(tethnrfstoacp)

1Thsubstautally equivalent to markete devces

[IINOT substantially equivalent to marketed device-s.

[I Other (eg. empbyegulation, not a device, duplicate, etc.).

Is hisdevce ubjct o Scton 522 postmnarket surveillance?DYSIK

Is hisdeice subject to the Tracking Regulation? DYE

Was clinical data necessaly to support the review oftirZ0kIY7ESElN

is this a prsrpindevice?

[l YE!s VIfN

Was this 5 10(k) reviewed by a Third Party? YFElN

S pecial 5 10(k? fitotfronEDrv obils1YE

Abbreviated 5 10(k)? Please ilotfr n11Die50/olr YSI'

Truthiful and Accurate Statemn[I Rq estedlicoe

WA5 10(O) summary ORD EA 5 1 0(k) statement

Cobnation Product Category (Please see algorithm on H drive 51l0k/Boilers)

Animal Tissue Source D3 YES l•O Material of BiologicalOgf E

The ubmiterrequstsunder 21 CFK 807.95 (docsn'taIPPIY for Scs): cdig9

El No Confidentiality El Confidentiality for 9o day LIcniudC fdetatycedig9

Prediate rodut Coe wih clss -Additional Product Code(s) with panel (optional):

Prediate Poduc Codecwith cDate)

Final Review __ _ _ __ _ _ _ __ _ _ __ _ _ _



SPECIAL 51 0(k): Device ModificationODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE RE: DOCUMENT NUMBER K042938

This 51 0(k) submission contains information/data on modifications made to the SUBMITTER'S ownClassII, ClassIlllor Class Idevices requiring 510(k). The following items are present and acceptable(delete/add items as necessary):

1 . The name and 51 0(k) number of the SUBMITTER'S previously cleared device. (For apreamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described inits labeling HAS NOT CHANGED along with the proposed labeling which includes instructions foruse, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineeringdrawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that theFUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.The changes made were the addition of a new line of dialyzers; to the PrismaflexTM system.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicatedevice including, labeling, intended use, physical characteristics, materials, design, and performancecharacteristics.

5. A Design Control Activities Summary which includes:a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the

device and its components, and the results of the analysisb) Based on the Risk Analysis, an identification of the verification and/or validation activities

required, including methods or tests used and acceptance criteria to be appliedc) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, allverification and validation activities were performed by the designated individual~s) and theresults demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is inconformance with design control procedure requirements as specified in 21 CFR 820.30 andthe records are available for review.

6. A Truthful and Accurate Statement, a 51 0(k) Summary and the Indications for

Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended usefor the device is unaffected by the modification. In addition, the submitter's description of the particularmodification~s) and the comparative information between the modified and unmodified devicesdemonstrate that the fundamental scientific technology has not changed. The submitter has provided thedesign control information as specified in The New 51 0(k) Paradigm and on this basis, I recommend thedevice be determined substantially equivalent to the previously cleared (or their preamendment) device.

(Reviewer's Signature) 74-D4W

revised:3/27/98c.hcLcj

REVISED:3/1 4/95



2

THE 510(K) DOCUMENTATION FORMS ARE AVAILABLE ON THE LAN UNDER 510(K) BOILERPLATESTITLED "DOCUMENTATION" AND MUST BE FILLED OUT WITH

EVERY FINAL DECISION (SE, NSE, NOT A DEVICE, ETC.).

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

K042938

Reviewer: Joshua C. Nipper

Division/Branch: DRARD/ Gastroenterology and Renal Devices Branch (GRDB)

Device Name: Gambro Prismaflex Tm HF1000 and HF1 400 Sets

Product To Which Compared (510(K) Number If Known): K041005 and K01 1221

YES NO

1. Is Product A Device V If NO = Stop

2. Is Device Subject To 510(k)? 1' If NO = Stop

3. Same Indication Statement? v If YES = Go To 5

4. Do Differences Alter The Effect Or Raise New Issues If YES = Stop NEof Safety Or Effectiveness?

5. Same Technological Characteristics? v If YES = Go To 7

6. Could The New Characteristics Affect Safety Or If YES = Go To 8Effectiveness?

7. Descriptive Characteristics Precise Enough? v If NO = Go To 10If YES = Stop SE

8. New Types Of Safety Or Effectiveness Questions? If YES = Stop NE

9. Accepted Scientific Methods Exist? If NO = Stop NE

10. Performance Data Available? V If NO = Request

Data11. Data Demonstrate Equivalence? V Final Decision:

SE

Note: In addition to completing the form on the LAN, "yes" responses to questions 4, 6, 8, and 11, and every "no"response requires an explanation.

¥



3

1. Intended Use:

The Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluidmanagement and renal replacement therapies. The system is intended for patients who have acute renalfailure, fluid overload, or both.

2. Device Description: Provide a statement of how the device is either similar to and/or different from othermarketed devices, plus data (if necessary) to support the statement. Is the device life-supporting or lifesustaining? Is the device implanted (short-term or long-termi)? Does the device design use software? Is thedevice sterile? Is the device for single use? Is the device over-the-counter or prescription use? Does thedevice contain drug or biological product as a component? Is this device a kit? Provide a summary about thedevices design, materials, physical properties and toxicology profile if important.

PRISMAFLEx DESCRIPTIONThe Gambro Prismaflexi'm System is a continuous renal replacement therapy (CRRT) device capable ofdelivering various treatment modalities to patients with acute renal failure or fluid overload.

Available therapies offered by the Prismaflex1"" include:

*Slow Continuous Ultrafiltration (SCUF): Provides fluid removal via ultrafiltration*Continuous Veno-venous Hemnofiltration (CVVH): Provides convective solute clearance by

hemofiltration. Net fluid removal (ultrafiltration) can also be prescribed during CVVH. ThePrismaflex"'T' system can provide either pre-dilution (pme-filter) hemofiltration, post-dilution (post-filter) hemofiltration, or a combination of pre and post dilution hemofiltration.

*Continuous Veno-venous Hemodialysis (CVVHD): Provides diffusive solute clearance byhemodialysis. Net fluid removal (ultrafiltration) can also be prescribed during CVVHD.

*Continuous Veno-venous Hemnodiaf'iltration (CVVHDF): Provides solute clearance by bothconvection and diffusion. Net fluid removal (ultrafiltration) can also be prescribed duringCVVHDF. The Prismaflex TMsystem can provide either pre-dilution (pre-filter) fluid infusion orpost-dilution (post-filter) fluid infusion during CVVHDF, but not both.

The Prismaflexrhl delivery system is loaded with a proprietary cartridge which contains all bloodtubing and a preattached hemodialyzer/hemofilter. Currently, only the M60 and M100 sets have beencleared for use (1K041005). The current submission seeks to add the HF1000 and 1-F1400 Sets to theproduct line. (b)(4) Confidential and Proprietary Information





4

Cq




5




6




7

RECOMMENDATIONI recommend that the Gambro Prismaflex HF1000 and HF1400 Sets be found substantially equivalent(SE) to the predicate devices identified according to 21 CFR § 876.5860.

shua C. Nipper, M.E. /J Date

12




8

EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED

1. Explain why not a device: N/A, is a device.

2. Explain why not subject to 510(k): NIA, is subject to 510(k) regulation.

3. How does the new indication differ from the predicate device's indication: N/A, indication for use is identical.

4. Explain why there is or is not a new effect or safety or effectiveness issue:

5. Describe the new technological characteristics: N/A, no new technological characteristics.

6. Explain how new characteristics could or could not affect safety or effectiveness:

7. Explain how descriptive characteristics are not precise enough: Performance testing is required forhemodialyzers / hemofilters in order to list their performance characteristics in the device labeling.

8. Explain new types of safety or effectiveness questions raised or why the questions are not new:

9. Explain why existing scientific methods can not be used:

10. Explain what performance data is needed: Performance testing in accordance with the FDA guidancedocument "Guidance for the Content of Premarket Notifications for Conventional and HighPermeability Hemodialyzers" should be submitted.

11. Explain how the performance data demonstrates that the device is or is not substantially equivalent:Performance testing, including ultrafiltration rate, pressure drop, and in-vitro solute clearance hasbeen provided which demonstrates that the proposed device is substantially equivalent to thepredicate devices identified.

ATTACH ADDITIONAL SUPPORTING INFORMATION

/3



.a J I~ FOOD AND DRUG ADMINISTRATION

Memorandum

DATE: January 3, 2005

FROM: Joshua C. Nipper, Biomedical EngineerGastroenterology and Renal Devices Branch/DRARD, HFZ-470

SUBJECT: K042938/S 1 - SpecialGambro Prismaflex Im tF 1000 and }IF 1400 SetsGambro Renal Products

CONTACT: Thomas B. DowellManager, Regulatory AffairsGambro Renal Products10810 West Collins AvenueLakewood, CO 80215Phone: (303) 231-4094Fax: (303) 542-5138Email: Tom.Dowell(cius.gambro.com

To: The Record

BACKGROUNDThis is my second review of this special 5 10(k) submission. The first review resulted in the firmbeing sent an additional information (Al) letter dated November 16, 2004. This submissionattempts to address the deficiencies that were identified during the first review. The firm hasrequested a special 51 0(k) because they feel that the proposed device represents a modification totheir existing products. The proposed device is the Gambro Prismaflex HF 1000 and FIF1400Sets to be used with the Gambro Prismaflex TM System, manufactured by Gambro Renal Products("Gambro" or "the firm"). The device is regulated under 21 CFR §876.5860 High permeabilityhemodialysis system, and is a Class II device. The product code for this device is 78-KDI. TheFDA guidance document "Guidance fbr the Content of Premarket Notifications for Conventionaland Iligh Permeability I lemodialyzers" is applicable for the proposed device.

INDICATIONS FOR USEAs stated by firm, "The Prismaflex Set is indicated for use only with the Prismaflex Control Unitin providing continuous fluid management and renal replacement therapies. The system isintended for patients who have acute renal failure, fluid overload, or both."

PRISMAFLEX DESCRIPTIONThe Gambro PrismaflexiM System is a continuous renal replacement therapy (CRRT) device capable ofdelivering various treatment modalities to patients with acute renal failure or fluid overload.Available therapies offered by the Prismaflexim include:

16f



* S low Continuous U.lItra ittration (SC UF): Provides fluici removal Via U I ralfilItrationl* ( tHI m uLiOS Veno0-veno LIS Ii lincfiItration (C VV \/i): pro\ des conIvectiVeC1 i00 CiteCiaranee by

lcrieo Iiltration. Net f]Lu id remlovalI (uIIfltaf1IltrationI) canI aLso bIIS e ~rescrI Ibed LILIIiirn, (VVI II.ihIe Prismnailex systern canl provide either pre-d iliutionl ( refltr)heo0 1tration, post-

diliution (post-tiliter) hemrofiltration, or a combination of pre and post diliution

henofiltration.*Continuous Veno-venrous Hlerodialysis (CVVi-ID): Provides diffusive Solute clearance by

hernodialysis. Net fluid removai (ultrafiltration) can also be prescribed during CVVHD.Cont11inouIs Venro-venouIS H-ernodhihltration (C'VVIIDF): Provides soiute clearance by bothconvection and diiffusion. Net Ilidit removal (Ui tra'ilitration) canl ailso be prescribed durnoru(VVi-IDF. Thie iPrisilaflex'l systemn canl p71`vtie eithier pre-cl itionl (preC-Fliter) fl uiciinfusion or post-dijiution (post-B -iter) fluici infusion ciurina" CVVI 11Fh but nlot both.

I NMh le i'ri smuall cx tielivery systemn is loaded with a proprietary' cartri dge v'hic i contai ns all bloodc

tuhirnu and a preattached hermodialyzer/hernofiltcr. Currently, only the M6) and MI100 sets havebeen Cleared for use (K04M105). 'ihe Ctirrent subminssion seeks to acid the Ill' 1000 and HF! 400Sets to the product line.

Page 2 of 11- Lead Review of 510(k) Application K042938/Sl - Gambro Renai ProductsGamnbro PrismafleXTm HF10OO and HF1400 Sets





Page 3 of 11- Lead Review of 510(k) Application K042938/S'1 - Gambro Renal ProductsGamoro Prismafiex T HFIOOO and HF1400 Sets

/d,



Page 4 of 11- Lead Review of 510(k) Application K042938/S1 - Gambro Renal ProductsGambro PrismafleXm HF1 000 and HF1400 Sets



K042938/S1 - Gambro Renal ProductsGambro Prismaflex Tm HF1000 and HF1400 Sets



Ganmbro PrismafleXTm HF1000 and HF1400 Sets



Page 7 of 11- Lead Review of 510(k) Application K042938/SII - Gambro Renal ProductsGambro Prismaflexm HF1000 and HF1400 Sets



Page 8 of 11- Lead Review of 510(k) Application K042938/S1 - Gambro Renal ProductsGambro Prismaflex Tm HF1000 and HF1400 Sets

~2!



Page 9Sof 11- Lead Review of 510(k) Application K042938/S1 - Ganibro Renal ProductsGambro PrismafleXm HF1000 and HF1400 Sets



Page 10 of 11- Lead Review of 510(k) Application K0429381S1 - Gambro Renal ProductsGambro Prismaflex Tm HF1000 and HF1400 Sets



COMMUNICATIONS LOGI spoke with Mr. Dowell on December 21, 2004 and requested minor updates of the labeling.Originally. Gambro had not included the first page of the labeling revisions with the kfr valuesadded. Mr. Dowell told me that this omission was accidental, and taxed the updated page laterthat day. Mr. Dowell later submitted an updated in-vitro clearance table, with creatinine values"red-lined" into the labeling.

RECOMMENDATIONI recommend that the Gambro Prismatlex HF 1000 and HF 1400 Sets be found substantiallyequivalent (SE) to the predicate devices identified according to 21 CFR § 876.5860.

J, u~ipper M.Date

YEs NoIs the device life-supporting or life sustaining? VIs the device implanted (short-term or long-term)?Does the device design use software? V¢Is the device sterile'? VIs the device for single use? ?Is the device for over the counter (OTC) use? vIs the device for prescription use? vDoes the device contain a drug or biological product as a component? V/

Is this device a kit? ./

Page 11 of 11- Lead Review of 510(k) Application K042938/Sl - Gambro Renal ProductsGambro Prismaflex T HFO000 and HF1400 Sets



1: 44PM GRMBRO NO. 630 P.j'

460

140 PrismaFlex HF1000127 mL/min

120 m-in

E 100 i~1 mLln

E~~~~~~~~~~r/$ 8o mr0 74 mL/minlS 60 n

1'- /QS= 2004 mmlmn

QB/QB = 100 mv,.fn

20 3 L~~r

00 50 100 150 200 250 300 350 400 400 Soo

PTM I TMP (mmHg)

160

140 PrismaFlex HF14008/QB = 450 mL/Mlfr

120

'i 100

60-78m nia~~~~~~~~~~~~~~~~~~~~

40 -QBI/OS 100 rmL/nln

20.

o 1oo 200 300 400 500

PTM / TMP (mmHg)

"In vitro" ultrafillralon with blood (valueS ± 15 %)(Bovine blood at 370Qi Hct 32 %, Proteii concentration O gOA)Ultafltratlon 8 controlled b Ihe PRISMAFLU System and Is Indepeondent oI the Jlraflitratlon coeffioloent (KU6)Ultrafiltration au salng "In viiro" (velOurs h ± 15 %)(Sang de bDuf A 37°0, Hrmatocdto = 32 96, concentUaon prol6Ique= 60 G/)L.'virafrltrstlon eet ma alsae oar Io systbme PRISMAFLEX et ss lfndapendanto du coeftclent d'ultraf.rtradln (KUF)Ullrailtration mlR Blut "In vitro" &WVoro boie 1& %)(RInderblut bel 37C, Hkt 32 %, Proteln-KOnenlatlon 60 W/I)Ole LmraftlIratlon wird von der PaFISMAflSX Maschlnr aut ueCr rcctolngon Wert gehalten und hfnot nloMt vornUltlfltratlonsaKodfllan (KWufl ab.UltrahIltracton con gnora "in VIl"o (valemrs r 15%)(.Sangre bovina a 370C, HeMaIocvto .32 Xi, Ooncenrrtacldn protCtca · O g/I)La ullrafltracftn conlrolada 0or 6l slatome FIISMAFLEX, as indopendlento del coeflelene de utjqfltracIon (KUP)Ultrafiltrazlcne con sengue "in vitro" (valor) a ± 16 %)(Sanrz bovigw A 37P0, ernatocrfto = 32 %, Conclrazlone pratelca = 60 a/l)Lultrafiltrastone 4 Controllate dal Slstmrna PRISMAFLEX ad a Indlpandeo dal coefIclernte dl ultrafiltrazione (KUF)"In vitro" ultrafiltration meod WO (varden · 15 %)(acvmpt b~co Ad 370, MCI 32%, Protarlmanaernrotion 60 o/fUltratiltmationen Rontrolleras av PRISMAFLEX systennet Con lr oboorerdo av koefllclenten for ullrafiltrallon (KUF)-U~oli~tratllsl met "In vltro..bloed (wafrern opt :59-)(Ratdort5 cd 37'C, -eatocrletwaardo o32 %, EIwgemaoe = 60 a/l)Ulflilttrafie Wordt gecontroleord door itt PRI$MAILEX Systaem an IS orlatcankelilk van Oa ultrafiftratie coefici16ntA ultrafiltra;o corn sangue "In vIro" VNalores a * 15 %)rSangue bovIne a rereretrum do a7"C. h-ematdcrlto = 32%, ConenlraQSo promtc = 60 OMA utrallltraqio cornfolada polo slstama PRISMAFISX o 6 independenrc do coelolente de ultflaltraco KJuF)"In vIlrol"-unrafiltrasjon maed blod (verietr = 15%)BAovnt blD oyed S7Ci, Mc' 32 , pIotelnl<or~antrasjon 0 g/I)Ultrafifrraslor kotrodlems av PRISMAFJEX-cyslImt, og er uLvbonglg ov ultraliltmstonsicoafmaenten (KUF)'In vltro"-uttraflltmrng MOOd blod (valera : 15 %)(Bovlnt blad vea 37'0, No 32 9, prolinkoncerlhation 80 gI)Ultrafiltredn~pet ses af PAISMAFLEX-syettrnot og or 4/lhaengigt at koefficiontar for ultrOlltraelrig (KUF)Vertn ultratlltreato "in vitro" (arvat I s5 9)(Ruvaan 5C vorta, MCI 329, protallnlplrolsuus 60 /I)Uflatratmatlo tapahtuu PRSMlA !.0XNahusyl~cikarn aealscna Is S- on rllppumntan dftrafiltrastlon Kovitrfmsta (KUF)

,2S-



DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ServiceFood and Drug Administration

Memorandum

From: Reviewer(s) - Name(s)_________________________________

Subject: 510(k) Number r ITo: The Record - It is my recommendation that the subject 5 10(k) Notification:

El" ~sed to accept.

fRequires additional information (other than refuse to accept).

El Is substantially equivalent to marketed devices.

EINOT substantially equivalent to marketed devices.

Cother (e.g., exempt by regulation, not a device, duplicate, etc.)

Is this device subject to Section 522 Postmarket Surveillance? OYES EM/O

Is this device subject to the Tracking Regulation? DIYES 12NO

Was clinical data necessary to support the review of this 5 10(k)? C YES El NO

Is this a prescription device? MÈS El! NO

Was this 5 10(k) reviewed by a Third Party? DYES

Special 5 10(k)? EY'ES Cl NO

Abbreviated 510(k)? Please fill out form on HDrive 510k/boilers DYES ff7 N0

Truthful and Accurate Statemnent U Requested ED MEnclosed

EA51 0(k) summary OR ClA 5 10(k) statement

El TPho requirod cerliainadsiir o ls I eie

ENhe indication for use form

Combination Product Category (Please see algorithm on H drive 5 10k/Boilers) Al'

Animal Tissue Source U YES E64NO Material of Biological Origin Cl YES EVNO

The submitter requests under 21 CFR 807.95 (doesn't apply for SEs):

El No Confidentiality LI Confidentiality for 90 days C Continued Confidentiality exceeding 90 days

Predicate Product Code with class: Additional Product Code(s) with panel (optional):

(Branch Chief) 0 (B~~ranch Code) (Date)

Final Review:________________________________________(Division Director) (Date)

Revised:4/2/03

Ztj;



FOOD AND DRUG ADMINISTRATION

Memorandum

DATE: November 12. 2004

FROM: Joshua C. Nipper, Biomedical EngineerGastroenterology and Renal Devices BranchIDRARD, I IFZ-470

SUBJECT: K042938 - SpecialGambro Prismaflex TM HF 1 000 and HF 1 400 Sets(Gambro Renal Products

CONTACT: Thomas B. DowellManager, Regulatory AffairsGambro Renal Products108 10 West Collins AvenueLakewood, CO 80215Phone: (303))231-4094Fax: (303) 542-5138Email: Tomn.Dowell~a~us.gambro.com

To: The Record

BACKGROUNDThis is my first review of this special 510(k) submission. rEhe firmn has requested a special5 10(k) because they feel that the proposed device represents a modification to their existingproducts. The proposed device is the Gambro PrismafiexT M HFIOOO00 and HFI1400 Sets to be usedwith the Gambro Prismaflex TM System, manufactured by Gamrbro Renal Products ("Gambro" or"the firm"). The device is regulated under 21 CFR §876.5860 High permeability hemodialysissystem, and is a Class II device. The product code for this device is 78-KDI. The FDAguidanice document "Guidance for the Content of Premnarket Notifications for Conventional andF-lih Permeability Hlemodialyzers" is applicable for the proposed device.

INDICATIONS FOR USEAs stated by firm, "The Prismaflex Set is indicated for use only with the Prismaflex Control UJnitin providing continuous fluid management and renal replacement therapies. The systemn isintended for patients who have acute renal failure, fluid overload, or both."

PRISMAFLEx DESCRIPTIONThe Gambro Prismaflex'T m System is a continuous renal replacement therapy (CRRT) device capable ofdelivering various treatment modalities to patients with acute renal failure or fluid overload.Available therapies offered by the Prismaflex 1 v include:

* Slow Continuous Ultrafiltration (SCUF): ]Provides fluid removal via ultrafiltration* Continuous Veno-venous Hlemofiltration (CVVH): Provides convective solute clearance by

hernofiltration. Net fluid removal (ultrafiltration) can also be prescribed during CVVF1-1The Prismaflex FMsystem can provide either pre-di lution (pre-filter) hem ofiltration, post-

C-/ /



dilution (post-filter) hemofiltration, or a combination of pro and post dilutionhemotiltration.

* Continuous Veno-venous H-emnodialysis (CVVHD): Provides diffusive solute clearance byhemodialysis. Net fluid removal (ultrafiltration) can also be prescribed during CVVHD.

* Continuous Veno-venous Hernodiafliltration (CVVHDF): Provides solute clearance by bothconvection and diffusion. Net fluid removal (ultratiltration) can also be prescribed duringCVVHDF. The Prismaflexi system can provide either pro-dilution (pvc-filter) flUidinfusion or post-dilution (post-filter) fluid infusion during CVVHDF. but not both.

The Prismaflexim delivery system is loaded with a proprietary cartridge wvhieh contains all bloodtubing and a preattached hernodialyzer/hemofilter. Currently, only the M60 and MNI 10(1 sets havebeen cleared for use (K041 005). The current submission seeks to add the HE 1 000 and lIEI 1 400Sets to the product line.

Page 2 of 9- Lead Review of 510(k) Application K042938 - Gambro Renal ProductsGambro PrismafleXm HFI1000 and HF1400 Sets





Page 3 of 9- Lead Review of 510(k) Application K042938 - Gambro Renal ProductsGambro Prismaflex HF1000 and HF1400 Sets

57,



Page 4 of 9- Lead Review of 510(k) Application K042938 - Gamnbro Renal ProductsGamnbro PrismafleXm HFI1000 and HF1400 Sets



Page 5 of 9- Lead Review of 510(k) Application K042938 - Gambro Renal ProductsTMGambro Prismaflex HFIOOO and HFI400 Sets



Page 6 of 9- Lead Review of 510(k) Application K042938 - Gambro Renal ProductsGambro Prismaflex Tm HF1000 and HFI400 Sets



Page 7 of 9- Lead Review of 510(k) Application K042938 - Gambro Renal ProductsGambro Prismaflex T HF1000 and HF1400 Sets



Page 8 of 9- Lead Review of 510(k) Application K042938 - Gambro Renal ProductsGambro Prismaflex TM HFI000 and HFI400 Sets



RECOMMENDATIONI recommend that the Gambro Prismaflex HFI 000 and HF1400 Sets be placed on hold and thatthe firm be sent the aforementioned deficiencies in an additional information (Al) letter. Untilthese deficiencies are answered, the device cannot be found substantially equivalent to thepredicate devices identified according to 21 CFR § 876.5860.

C.shua N ipper, M/ate

Page 9 of 9- Lead Review of 510(k) Application K042938 - Gambro Renal ProductsGambro Prismaflex Tm HF1000 and HF1400 Sets



510(k) "SUBSTANTIAL EQUIVALENCE"DECISION-MAKING PROCESS

Newv Device is compared toAmarketed Device

Descriptive Information Does New Device Have Same NO Dothie Differences Alter the Intenided NC ally

about New or Marketed Indication Statementt - Therapeutic/Diagnosticdetc. Effect YES Equivalent Determination

Device Requested as Needed (in Deciding, May Consider Impact on

4 YES Safety and Effectiveness)?**

New Device Has Same Intended NO

Use and May be "Substantially Equivalent" I 0New Device Has ~

New Intended Use

Does New Device Have Same

Technological Characteristics, NO Could the New

e.g. Design, Materials, etc.? - -- Characteristics Do the New Characteristics

YES Affect Safety or · RaiseNewTypesofSafety YES O0

Effective or Effectiveness Questions?

NO Are the Descriptive NOCharacteristics Precise Enough

to Ensure Equivalence? ·

NO )

Are Performance Data Do Accepted Scientific

Available to Asses Equivalence? YES Methods Exist for

Assessing Effects of NOthe New Characteristics?

YESYES CD YES

Perfonmance Are Performance Data Available NO

D ata R equired To Assess Effects of New

Characteristics? *.*i ES

Performance Data Demonstrate Performance Data Demonstrate

Equivalence? Equivalence?

a YES YES jNONO

"Substantially Equivalent" T oTo Determination To

510(k) Submissions compare new devices to marketed devices. FDA requests additional infornlation if tbe relationship between

marketed and "predicate" (pre-Amendments or reclassified post-Amendments) devices is unclear.

** This decision is normally based on descriptive information alone, but limited testing information is sometimes required.

*** Data maybe in i e 10(k). other5 10(k)s. the Center's classification files, or the literature.

.2--



Internal Administrative Form

YES NO

1. Did the firm request expedited review?

2. Did we rant expedited review?3. Have you verified that the Document is labeled Class Ill for GMP

purposes?4. If, not, has POS been notified?5. Is the product a device?6. Is the device exempt from 510(k) by regulation or policy? v/

7. Is the device subject to review by CDRH?8. Are you aware that this device has been the subject of a previous NSE 77

decision?9. If yes, does this new 510(k) address the NSE issue(s), (e.g.,

performance data)?10.Are you aware of the submitter being the subject of an integrity V,

investigation?11. If, yes, consult the ODE Integrity Officer.

12. Has the ODE Integrity Officer given permission to proceed with thereview? (Blue Book Memo #191-2 and Federal Register 90N0332,September 10, 1991.



SCREENING CHECKLIST

FOR ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS

510(k) Number: /~it~ g~ g 3 "

The cover letter clearly identifies the type of 510(k) submission as (Check the

appropriate box):

Special 510(k) Do Sections l and 2

[3 Abbreviated 510(k) Do Sections 1, 3 and 4

[] Traditional 510(k) or no identification provided Do Sections 1 and 4

Section 1: Required Elements for All Types of 510(k) submissions:

Present or Missing orAde uate Inade uate

Cover letter, containing the elements listed on page 3-2 of the

Premarket Notification 510)] Manual.Table of Contents.Truthful and Accurate Statement.Device's Trade Name, Device's Classification Name and

Establishment Registration Number.

Device Classification Regulation Number and Regulatory Status

(Class I, Class I1, Class III or Unclassified.

Proposed Labeling including the material listed on page 3-4 of the

Premarket Notification [510] Manual.

Statement of Indications for Use that is on a separate page in the

ptemarket submission.Substantial Equivalence Comparison, including comparisons of

the e,,, ATi.with the predicate.

the Act and 21 CFR 807.87 d.

Clas II Crtiiction and Summary

Fi1(k'nancaletficaio o Dik~0sc' t t losrtatemen fo510/

nosrito-ooftedvc(omdificationso wthha dvc)inicalsud .*Sc2 E 0.7i n g~

51 Itdertification of* leal aree reiaedeie

C - May not be applicable for Special 510(k)s.

** - Required for Class III devices, only.

- See pages 3-12 and 3-13 in the Premarket Notification [510)] Manual and the

Convenience Kits Interim Regulatory Guidance.

Section 2: Required Elements for a.SPECIAL 510(k) submission:

59



Present Inadequate

/or Missin

Name and 510) number of the submIttrs own, unmodified

redicate device.

A description of the modified device and a comparison to the

s nsor's redicate device.

A statement tat the intended use~s and idications of the

modified device, as described in its labeling are the same as the

intended uses and indications for the submitter's unmodified

predicate device.

Reviewer's confirmation that the modiiction has not altered the

impact of the modification on the device and its components, and

the results of the anal sis.

b. Based on the Rik Analysis, an identification of the requird

verification and validation activities, including the methods or

tests used and the acceptance criteria to be applied.

c. A Declaration of Conformity with design controls that includes

tefollowm statements:

A statement tat, as requird by the risk analysis, al

verification and validation activities were performed by the

designated individuals) and the results of the activities

demonstrated that the predetermined acceptance criteria wvere

met. This statement is signed by the individual responsible

for those particular activities.

A sttemet tat te mnufacturing facility is in conformance

with the design control procedure requirements as specified

in 21 CER 820.30 and the records are -available for review.

This statement is signed by the individual responsible for

ofeac artion ofcnomiy:E Required Elements for anABEITD50k*sbii

issosited with the 510)rbiclers on te . drive.]nfatue



For a submission, whc relis on a recogied standard without a

declaration of conformity, a statement that the manufacturer

intends to conform to a recognized standard and that supporting

data xvill be available before marketing the device.

For a submission, which relies on a non-recognized standard

reufcured sntandard, ionforde to determgine d sbtntial n

tha su orlence. awl baalbe oie

Fo a Wheisin, com leingtes revie nofn abrvae 1() laset lota

hasno Abbrevisoicated ScetandadDtaFr (lcaed n theaH drie) nitaltegiac

doufctumernts, spcaotolrcgie standards and/rn-ecgid

st ayandadsi whcseented by the soor.vee i re

to determine su ~ ~ ~ ~ ~ reen Iadqut

certadifction of identcal matrial/forulation

b) Strlztonrandoex iratinie d taindinfrmati/ron:

c) SoftwareiDocumentaton deeAn usata

tesWihe checksting the 'resient ora adbequate" columnplas do llnoteuirt addtoa

irAbdnbromiathed Sponsor.s Iateoms wiocthceck in the "Missive ng ors Iadteqgudate"

columnmunstb submiacotteds bfrecosubedstantiverevie adof thnonrcumnient

P sse ndaSree ngic werentdbstesosr

Concurt cc sbyiReview Bra ci picale)

Date: Ak 4 ~ ~ ~ ~ ~ ~ ~~~ -rsetTaeqae

or ~ C



The deficiencies identified above represent the issues that \VC believe need to be resolved

before our review of your 510Wk) submission can be successfully, completed. In developing

the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of

the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of your

device. We also considered the burden that may be incurred in your attempt to respond to

the deficiencies. We believe that we have considered the least burdensome approach to

resolving these issues. If, however, you believe that information is being requested that is

not relevant to the regulatory decision or that there is a less burdensome way to resolve the

issues, you should follow the procedures outlined in the "A Suggested Approach to

Resolving Least Burdensome Issues" document. It is available on our Center web page at:

http:/ /,~wwv.fda.gov/cdth/modact/leastbumdensome.htmI



511() tSflTATIL EQUIVALENCE"UBCSTONMIAK[NG PROCESS

\I;rL~wJ I IC, izcc

D~ci~ttC ~tIi~I~'( Ik~c lcs K I0 I (Avc S,(n No D, tite DiffacticcS Aka d~ Itir h rcdcd Nos t: Sobstalaw

DWcevk±gcqtic,,cd as Ncd~d ES din NaYOndaIct i -'

Devicc II SaftyMAElcdkdCS)?

Use ad Maybe Su dailyEqttiflICtI Na" Devic H-as

Usd lall May b~~~~~~~~~~~ Ne Intended usc

Doe<s New Devi~ v atNO oCkd hth N' otl C' J=tesc

Tacto. i~c~~l Mat asetl raactarsucs Do tire New araactaistics

EtTecti Inss oriei VsesQuestiocAS?

ties NO~~N

DoAccc{ptld Sic~tietic

tol VAlaeS YESa

Methods Exist for

Available ~ ~~I FSAsseSsingZ Effects of NO

A'Aitablc to Mscs d~~~~~~~~~~~~ire New ararcrerisdics

2

YES

©YESAre Cerfonuarne Data Available NO

a ifcd~ ~ ~ ~ ~ ~~ ~ ~~~~~~~~ To Assess Effect of New

p

0'~~~~~~~~~~~~~~~~~~~~~~OaraCtetisties?..

ata Dw~~~~~t"Istfatc V~~~~~pefonrimic Data Dccn Ottastc

t-_qm,3I~~~~~~~~~~~~~m C" yE uiai(ICs-

YCS~~~~~~~E NO

OA ~ ~ ~ ~ O

thisdc~~

~~~~~ iscquircd

-

C I crrtc, c as W isSC( ,l t des



DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service

Food and Drug AdministrationCenter for Devices andRadiological HealthOffice of Device EvaluationDocument Mail Center (HFZ-401)9200 Corporate Blvd.December 17, 2004 Rockville, Maryland 20850

GAMBRO RENAL PRODUCTS 510(k) Number: K04293810810 WEST COLLINS AVE. Product: GAMBROLAKEWOOD, CO 80215 PRISMAFLEXATTN: THOMAS B. DOWELL HF1000 AND

HF1400 SETS

The additional information you have submitted has been received.

We will notify you when the processing of this submission has beencompleted or if any additional information is required. Pleaseremember that all correspondence concerning your submission MUSTbe sent to the Document Mail Center (HFZ-401) at the aboveletterhead address. Correspondence sent to any address other thanthe one above will not be considered as part of your officialpremarket notification submission. Also, please note the newBlue Book Memorandum regarding Fax and E-mail Policy entitled,"Fax and E-Mail Communication with Industry about Premarket FilesUnder Review. Please refer to this guidance for information on currentfax and e-mail practices at www.fda.gov/cdrh/ode/aO2-Ol.html.

The Safe Medical Devices Act of 1990, signed on November 28, statesthat you may not place this device into commercial distributionuntil you receive a letter from FDA allowing you to do so. As inthe past, we intend to complete our review as quickly as possible.Generally we do so 90 days. However, the complexity of a submissionor a requirement for additional information may occasionally causethe review to extend beyond 90 days. Thus, if you have not receiveda written decision or been contacted within 90 days of our receiptdate you may want to check with FDA to determine the status of yoursubmission.

If you have procedural or policy questions, please contact theDivision of Small Manufacturers International and Consumer Assistance(DSMICA) at (301) 443-6597 or at their toll-free number (800) 638-2041,or contact me at (301) 594-1190.

Sincerely yours,

Marjorie ShulmanSupervisory Consumer Safety OfficerPremarket Notification SectionOffice of Device EvaluationCenter for Devices andRadiological Health



GAMBRQ Renal Products

December 16, 2004 10810W. ColnsAvenueLakewood, Colorado 80215 USA

Tel 303-232 6800

Joshua Nipper, (Biomedical Engineer) Gastroenterology and Renal Devices BranchFood and Drug AdministrationCenter for Devices and Radiological HealthOffice of Device EvaluationDocument Mail Center (HFZ-401)9200 Corporate BlvdRockville, Maryland 20850

Subject: K042938GamCath® High Flow Catheter

Dear Mr Nipper,

Enclosed is the official response to your questions related to 510(k) submission K042938.

If you have any additional questions please call me at 303-231-4094.

Attachments:

Revised Pages of the Instructions for Use

Sincerely,

Thomas B. DowellManager Regulatory AffairsGambro Renal Products

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Documents

Gambro Prismaflex' Tm HF 1000 Set/ HF 1400 Set / JAN Z0 · Special 510(k) Notification Gambro Prismaflex' Tm HF 1000 Set/ HF 1400 Set / / JAN Z0 510(K) SUMMARY SUBMITTER: Gambro Renal