Irasema Rivera Regulatory Affairs Specialist Blue Rhino G2-Multi … · 2020-01-07 · Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray (K133597), are identical in

U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 1 2

Silver Spring, MD 20993

www.fda.gov

Cook Incorporated

Irasema Rivera

Regulatory Affairs Specialist

750 Daniels Way

Bloomington, Indiana 47404

Re: K193133

Trade/Device Name: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray

Weinmann-Multi Percutaneous Tracheostomy Exchange Set

Regulation Number: 21 CFR 868.5800

Regulation Name: Tracheostomy Tube and Tube Cuff

Regulatory Class: Class II

Product Code: JOH

Dated: November 8, 2019

Received: November 12, 2019

Dear Irasema Rivera:

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. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We

remind you, however, that device labeling must be truthful and not misleading.

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 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

http://www.fda.gov/

http://www.fda.gov/

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

TDC

Typewritten Text

December 12, 2019

K193133 - Irasema Rivera Page

2

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

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

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-

mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney

Assistant Director

DHT1C: Division of ENT, Sleep Disordered

Breathing, Respiratory and

Anesthesia Devices

OHT1: Office of Ophthalmic, Anesthesia,

Respiratory, ENT and Dental Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products




https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems




https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance




https://www.fda.gov/training-and-continuing-education/cdrh-learn

https://www.fda.gov/training-and-continuing-education/cdrh-learn

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice




mailto:%[email protected]

mailto:%[email protected]

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)

Device NameBlue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray

Indications for Use (Describe)Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

TDC

Typewritten Text

K193133

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)

Device NameWeinmann-Multi Tracheostomy Exchange Set

Indications for Use (Describe)Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

TDC

Typewritten Text

K193133

510(k) SUMMARY K193133

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray

Weinmann-Multi Tracheostomy Exchange Set 21 CFR §807.92

Date Prepared: December 2, 2019 Submitted By: Applicant: Cook Incorporated Contact: Irasema Rivera Rohini Patel Applicant Address: 750 Daniels Way Bloomington, IN 47404 Phone: (812) 335-3575 x105166

Fax: (812) 332-0281 Device Information: Trade Names: Blue Rhino G1-Multi Percutaneous Tracheostomy

Introducer Set/Tray, Blue Rhino G2-Multi Advanced Percutaneous Tracheostomy Introducer Set/Tray, and Weinmann-Multi Tracheostomy Exchange Set

Regulation Number: 21 CFR §868.5800 Regulation Names: Tube Tracheostomy and Tube Cuff Product Code: JOH Device Class: II Review Panel: Anesthesiology Office of Device Evaluation: Division of Anesthesiology, General Hospital, Respiratory,

Infection Control, and Dental Devices (DAGRID) Anesthesiology Devices Branch (ADB)

K193133 Page 1 of 9

Predicate Devices:

• The Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set and Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray were cleared under K133597 on April 18, 2014.

• The Weinmann Tracheostomy Exchange Set was cleared under K180034 on May 7, 2018.

Comparison to Predicate:

The proposed Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray compared to the predicate devices, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray and Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray (K133597), are identical in intended use, principles of operation, technological characteristics, design, and nearly identical in materials of construction and dimensions.

The predicate submissions offered five loading dilators in five French sizes. The set components of the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray subjects of this submission offer a total of seven loading dilators in millimeter sizes. The ink material used to mark the millimeter size of the tracheostomy tube loading dilator has changed, and the outer diameter has changed slightly for three loading dilators. The content of product labeling has changed slightly. The dimensions of the product labels and of the marketing carton of the sets/trays supplied with separately packaged tracheostomy tubes have also changed. The safety and/or effectiveness of the subject device for the modifications to the loading dilators that include two new sizes and outer dimeter changes, and the package and labeling changes are supported by performance testing; and the ink material change supported by biocompatibility testing.

Additionally, predicate submission K133597 offered access dilators in 14 French size and measuring 4.5 or 6.5 centimeters in length. The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray will standardize the access dilator to the 14 French size and 6.5 centimeter length access dilator.

K193133 Page 2 of 9

A comparison between the predicate devices and the subject proposed Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is detailed in Table 1.

Table 1: Substantial Equivalence Comparison Table, Blue Rhino Multi Percutaneous Tracheostomy Introducer Devices

PREDICATE DEVICE SUBJECT DEVICE

Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray; Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray (K133597)

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray; Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray

Regulation 21 CFR §868.5800, Tracheostomy tube and tube cuff IDENTICAL

Product Code JOH, tracheostomy tube and tube cuff IDENTICAL Classification II IDENTICAL

Indications for Use

Intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

IDENTICAL

Contraindicated for Pediatrics Yes IDENTICAL

Recommended Insertion Site Between the first and second tracheal cartilages or between the second and third tracheal cartilages

IDENTICAL

Duration of Use Limited duration (≤ 24 hours) IDENTICAL Placement Percutaneous technique IDENTICAL

Patient Population Adult patients requiring prolonged ventilatory support IDENTICAL

Sterilization EtO, SAL 10-6 IDENTICAL Shelf-Life 3 years IDENTICAL Packaging Thermoform tray with a Tyvek® lid IDENTICAL

Tracheostomy Tube Set or Tray sold individually and co-packaged with a tracheostomy tube IDENTICAL

Blue Rhino G1 and Blue Rhino G2 Dilator (single-staged)

Surface Characteristics

Blue Rhino G1 = Smooth Blue Rhino G2 = Crosshatched handle and longitudinally-grooved distal portion

IDENTICAL

Length 20 cm IDENTICAL Outer Diameter 38 Fr (max) IDENTICAL Material Polyurethane IDENTICAL Depth Markings Yes IDENTICAL Hydrophilic Coating Yes IDENTICAL

K193133 Page 3 of 9

Table 1: Substantial Equivalence Comparison Table, Blue Rhino Multi Percutaneous Tracheostomy Introducer Devices (continued)


Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray; Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray (K133597)

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray; Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray

Loading Dilators

Ink Markings

-- 6.5 mm LOADING DILATOR ONLY NOT FOR CREATION OF STOMA

21 Fr LOADING DILATOR ONLY NOT FOR CREATION OF STOMA

7.0 mm LOADING DILATOR ONLY NOT FOR CREATION OF STOMA









-- 10.0 mm LOADING DILATOR ONLY NOT FOR CREATION OF STOMA

Outer Diameter

-- (6.5 mm) 0.268 in (21 Fr) 0.273 in (7.0 mm) 0.288 in (24 Fr) 0.308 in IDENTICAL (26 Fr) 0.327 in IDENTICAL (27 Fr) 0.345 in (8.5 mm) 0.349 in (28 Fr) 0.375 in (9.0 mm) 0.366 in -- (10.0 mm) 0.412 in

Endhole Diameter 0.110 in IDENTICAL

Material Polyurethane IDENTICAL Ink Material Black, TP 247/65-NT Black, 71860

Guiding Catheter

Size 8 Fr IDENTICAL Material Fluorinated ethylene propylene IDENTICAL Ink #3112 Polyking Black Ink IDENTICAL

Access Dilator

Size 14 Fr, 4.5 cm and 14 Fr, 6.5 cm 14 Fr, 6.5 cm only Material Polyethylene IDENTICAL

Wire Guide

Size 0.052 in IDENTICAL Material Stainless Steel / PTFE IDENTICAL

K193133 Page 4 of 9

The proposed Weinmann-Multi Tracheostomy Exchange Set compared to the Weinmann Tracheostomy Exchange Set (K180034) is identical in intended use, principles of operation, basic technological characteristics, design, and nearly identical in materials of construction and dimensions.

The predicate submissions offered five loading dilators in five French sizes. The set components of the Weinmann-Multi Tracheostomy Exchange Set subject of this submission offers five loading dilators in millimeter sizes. The ink material used to mark the millimeter size of the tracheostomy tube loading dilator has changed, the outer diameter has changed slightly for three loading dilators and the contents of the product labeling has changed slightly. The safety and/or effectiveness of the subject device, specifically for the modifications to the loading dilators are supported by performance testing; and the ink material change supported by biocompatibility testing.

A comparison between the predicate devices and the subject proposed Weinmann-Multi Tracheostomy Exchange Set is detailed in Table 2.

Table 2: Substantial Equivalence Comparison Table, Weinmann-Multi Tracheostomy Exchange Set


Weinmann Tracheostomy Exchange Set (K180034)

Weinmann-Multi Tracheostomy Exchange Set

Regulation 21 CFR § 868.5800, Tracheostomy tube and tube cuff IDENTICAL

Product Code JOH, tracheostomy tube and tube cuff IDENTICAL Classification II IDENTICAL Indications for Use For adult tracheostomy tube exchange IDENTICAL One-time Use Yes IDENTICAL

Recommended Insertion Site Between the 1st and 2nd tracheal cartilages or between the 2nd and 3rd tracheal cartilages

IDENTICAL

Placement Percutaneous technique IDENTICAL Duration of Use Limited (≤ 24 hours) IDENTICAL

Blue Rhino G1 Dilator (single-staged)

Length 20 cm IDENTICAL Outer Diameter 38 Fr (max) IDENTICAL Material Polyurethane IDENTICAL Depth Markings Yes IDENTICAL Hydrophilic Coating Yes IDENTICAL

K193133 Page 5 of 9

Table 2: Substantial Equivalence Comparison Table, Weinmann-Multi Tracheostomy Exchange Set (continued)


Weinmann Tracheostomy Exchange Set (K180034)


Loading Dilators

Ink Markings











Outer Diameter

(21 Fr) 0.273 in (7.0 mm) 0.288 in (24 Fr) 0.308 in (8.0 mm) IDENTICAL (26 Fr) 0.327 in (8.5 mm) IDENTICAL (27 Fr) 0.345 in (8.5 mm) 0.349 in (28 Fr) 0.375 in (9.0 mm) 0.366 in

Endhole Diameter 0.110 in IDENTICAL

Tip Tapered and curved IDENTICAL Dilator Material Polyurethane IDENTICAL Ink Material Black, TP 247/65-NT Black, 71860

Cook Airway Exchange Catheter

Length 45 cm IDENTICAL Outer Diameter 8 Fr IDENTICAL Material Polyurethane IDENTICAL Ink Ink, Amines, C12-14-tert-alkyl IDENTICAL Adapters Luer Lock and 15 mm Adapter IDENTICAL

Sterilization Method Ethylene Oxide IDENTICAL Packaging Tyvek® Pouch IDENTICAL

Device Description:

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray

The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray are designed for percutaneous dilational tracheostomy for management of the airway. The devices allow for single-stage dilation, which is achieved with a single rhino-horn-shaped dilator using an in-and-out motion. Sets and trays include a Blue Rhino G1 Dilator or Blue Rhino G2 Dilator, loading dilators (6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm) an 8 Fr guiding catheter, a 14 Fr access dilator,

K193133 Page 6 of 9

and a wire guide. Sets and trays are available in multiple configurations, which include various set and tray components (Table 1) associated with the procedure and/or for gaining percutaneous access. Table 3: Set/Tray Components, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray

Components

Scalpels Catheter needle Endotracheal tube accessory Split dressing

Syringes Needle holder cup Suture & needle Antiseptic skin pre Lubricating jelly Clamp Needle driver Local anesthetic Gauze sponges Infiltration needles Tracheostomy tube holder

The Blue Rhino G1 Dilator is manufactured as a 38-Fr tracheostomy dilator with a length of 20 cm. This dilator has a depth marking to indicate the skin level, which is placed 11 cm from the distal tip. Another feature of the device is the presence of hydrophilic coating on the distal 11 cm of the device.

The Blue Rhino G2 Dilator is identical to the Blue Rhino G1 Dilator with additional surface modifications, which include a diamond (crosshatched) pattern along the proximal 8 cm of the dilator (handle), and longitudinal grooves covering the distal 10 cm curved portion of the device to the distal tip.

The loading dilators are manufactured in 6.5 to 10.0 mm with a length of 20 cm and are curved at the distal end.

The 8 Fr guiding catheter measures 29 cm in length and is designed with an end hole, a distal ridge, and proximal markings.

The 14 Fr access dilator is manufactured in a length measurement of 6.5 cm.

The wire guide measures 55 cm in length, is manufactured of stainless steel, and is designed with a “J” tip with a 3 mm curve.


The subject device Weinmann-Multi Tracheostomy Exchange Set is comprised of a Blue Rhino G1 Dilator, loading dilators (7.0, 7.5, 8.0, 8.5, and 9.0 mm), an 8 Fr Cook Airway Exchange Catheter, and two Rapi-Fit Adapters.

K193133 Page 7 of 9

The Blue Rhino G1 Dilator supplied with the Weinmann-Multi Tracheostomy Exchange Set is identical to the Blue Rhino G1 Dilator supplied with the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray.

The loading dilators are manufactured in 7.0 to 9.0 mm with a length of 20 cm and are curved at the distal end, and are identical to the tracheostomy tube loading dilators sized 7.0, 7.5, 8.0, 8.5, and 9.0 mm supplied with the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray.

The airway exchange catheter is manufactured as an 8.0 Fr catheter measuring 45 cm in length. The distal end of the airway exchange is characterized by a blunt tip with rounded edges.

Two Rapi-Fit adapters (one with a 15-mm connector, and one with a Luer lock connector) are provided to be used with the exchange catheter for oxygenation when the requirement for oxygen is high in patients but the tracheostomy tube is not in place. The 15 mm Rapi-Fit adapter is designed for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is designed for attachment to a high-pressure jet ventilation oxygen source. The Luer Lock is compatible with a variable connector or the standard Luer fitting of an oxygen tube which is connected to an oxygen source.

Indications for Use:

a. The Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g. ICU or operating room) with the assistance of trained personnel.

b. The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g. ICU or operating room) with the assistance of trained personnel.

c. The Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

K193133 Page 8 of 9

Test Data:

The following tests were performed to demonstrate that the minor dimensional modifications, the additional sizes, the ink material modification of the size-designation statement of the loading dilators, and the packaging dimensions of the subject devices met applicable design and performance requirements and support a determination of substantial equivalence.

• Simulated Use • Security of Attachment Testing: performed in accordance with BS EN ISO 5366:2016.

The pre-determined acceptance criteria were met. • Verification of the outer diameter. • Compression Force Testing. The pre-determined acceptance criteria were met. • Tensile Strength Testing. The pre-determined acceptance criteria were met. • Biocompatibility Testing, ISO Acute Systemic Injection Testing: performed in

compliance with ISO 10993-11:2017; ISO 10993-12:2012. • Biocompatibility Testing, ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP):

performed in compliance with ISO10993-5:2009 and ISO 10993-12:2012. • Biocompatibility Testing, ISO Intracutaneous Irritation Testing: performed in compliance

with ISO10993-10:2010 and ISO 10993-12:2012. • Biocompatibility Testing, ISO Materials Mediated Rabbit Pyrogen: performed in

compliance with US Pharmacopeia Section 151 USP – current version. • Biocompatibility Testing, ISO Guinea Pig Maximization Sensitization Test: performed in

compliance with ISO 10993-10:2013 and ISO 10993-12:2012. • Packaging simulated distribution testing: per ASTM D4169-16. • Packaging seal strength, simulated use testing: per ASTM F188/F1886M-16. • Packaging bubble leak testing: per ASTM F209611. • Packaging seal strength testing: per F88/F88M-15. • Bioburden: per ISO 11737-1:2006. • EO/ECH Residual: performed in compliance with ISO 10993-7:2008.

Conclusion: In conclusion, these tests support a determination of substantial equivalence of the predicate devices to the devices subject of this submission, and do not raise any new questions of the safety and/or effectiveness of the device.

K193133 Page 9 of 9

Documents

Irasema Rivera Regulatory Affairs Specialist Blue Rhino G2-Multi … · 2020-01-07 · Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray (K133597), are identical in