May 28, 2019 ℅ Dave Yungvirt CEO Third Party Review Group ... · The SVM-7200 series Vital Signs Monitor is intended for monitoring and alarming of physiologic parameters, including

U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 0 3

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www.fda.gov

Nihon Kohden Corporation

℅ Dave Yungvirt

CEO

Third Party Review Group, LLC

25 Independence Blvd

Warren, New Jersey 07059

Re: K190468

Trade/Device Name: Nihon Kohden SVM-7200 series Vital Signs Monitor

Regulation Number: 21 CFR 870.2300

Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm)

Regulatory Class: Class II

Product Code: MWI, DXN, DQA, FLL

Dated: April 25, 2019

Received: April 26, 2019

Dear Dave Yungvirt:

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.

May 28, 2019

http://www.fda.gov/

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

K190468 - Dave Yungvirt Page 2

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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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

information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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

(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Matthew Hillebrenner

Director (Acting)

Division of Cardiac Electrophysiology, Diagnostics

and Monitoring Devices

Office of Cardiovascular Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

for

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

http://www.fda.gov/Training/CDRHLearn

http://www.fda.gov/DICE

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)K190468

Device NameNihon Kohden SVM-7200 series Vital Signs Monitor

Indications for Use (Describe)The SVM-7200 series Vital Signs Monitor is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, non-invasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

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]

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K190468 Traditional 510(k) – SVM-7200 Series Vital Signs Monitor

Nihon Kohden Corporation Page 1 of 12

510(k) Summary K190468

Sponsor: Nihon Kohden Corporation

1-31-4 Nishiochiai, Shinjuku-Ku

Tokyo, Japan 161-8560

Contact: Natalie J. Kennel

NJK & Associates

Address 13721 Via Tres Vista

San Diego, CA 92129

Phone (858) 705-0350

Fax (858) 764-9739

email [email protected]

Date Prepared: May 22, 2019

DEVICE INFORMATION:

Proprietary Name: Nihon Kohden SVM-7200 series Vital Signs Monitor

Common Name: Vital Signs Monitor, Patient Monitor

Classification: Monitor, Physiological, Patient, (without arrhythmia detection

or alarms) Class II

Product Codes: MWI, DXN, DQA, FLL

Regulations: 21 CFR 870.2300

Predicate: Capsule Technologies SmartLinx Vitals Plus Patient Monitoring

System (K171751)



Reference Device: Nihon Kohden Bedside Monitor, BSM-6000 series (K080342)



PRODUCT DESCRIPTION:

The SVM-7200 series Vital Signs Monitor is intended to be used by clinicians, doctors,

nurses, and medically qualified personnel for measuring noninvasive blood pressure

(NIBP), noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), body

temperature (TEMP) of one patient at a time. The monitors can be used in the

specialized health care environment such as hospitals, clinics, special medical facilities,

independent surgery centers, multitherapy facilities and wards. Adults, children and

neonates can be monitored using this device.

The SVM-7200 series monitors have an eight-inch TFT color display and two modes;

spot check and continuous mode. The monitor can operate with either a wired or wireless

LAN connection. The models included are:

Model Name

Screen Size

(inch) Parameters

SVM-7230 8 Masimo SpO2, NIBP, Temperature

SVM-7250 8 Nellcor SpO2, NIBP, Temperature

SVM-7260 8 Nihon Kohden SpO2, NIBP, Temperature

The thermometer options include the commercially available Covidien FILAC 3000

Thermometer or Exergen TAT-5000S Temporal Scanner.

INDICATIONS FOR USE:

The SVM-7200 series Vital Signs Monitor is intended for monitoring and alarming of

physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and

mean arterial pressure), pulse rate, non-invasive functional oxygen saturation of arteriolar

hemoglobin (SpO2), and temperature, on adult, pediatric, and neonatal patients in

hospital environments when used by clinical physicians or appropriate medical staff

under the direction of physicians.

TECHNOLOGICAL CHARACTERISTICS – SUBSTANTIAL EQUIVALENCE:

Table 1 is a detailed comparison of the Nihon Kohden SVM-7200 Series Vital Signs

Monitor and its predicate, SmartLinx Vitals Plus. The Nihon Kohden SVM-7200 Vital

Signs Monitor is substantially equivalent to the SmartLinx Vitals Plus Patient Monitoring

System, other than the minor differences described below. These differences do not raise

questions regarding safety or efficacy.



Table 1 Comparison of the Nihon Kohden SVM-7200 Series Vital Signs Monitor to its Predicate

Characteristic

SmartLinx Vitals Plus

Predicate Device (K171751)

SVM-7200 Series Vital Signs Monitor

Subject Device

Indications for

Use

The SmartLinx Vitals Plus Patient

Monitoring System is intended for

monitoring and alarming of physiologic

parameters, including non-invasive blood

pressure (systolic, diastolic, and mean

arterial pressure), pulse rate, functional

arterial oxygen saturation (SpO2), and

temperature, on adult, pediatric, and

neonatal patients in hospital environments

when used by clinical physicians or

appropriate medical staff under the

direction of physicians.

The SVM-7200 series is intended for monitoring

and alarming of physiologic parameters,

including non-invasive blood pressure (systolic,

diastolic, and mean arterial pressure), pulse rate,

non-invasive functional oxygen saturation of

arteriolar hemoglobin (SpO2), and temperature,

on adult, pediatric, and neonatal patients in

hospital environments when used by clinical

physicians or appropriate medical staff under the

direction of physicians.

NIBP

Measurement

Oscillometric design for Spot Check and

Intervals Mode measurements.

Oscillometric design for Spot Check and

Intervals Mode measurements.

SpO2 Monitoring Masimo SpO2 for Spot Check

measurements and Continuous

Monitoring with the following features:

1) Pulse tone pitch varying with oxygen

saturation

2) SpO2 alarm delay

3) SpO2 sensor off alarm

Masimo SpO2, Nellcor SpO2, or Nihon Kohden

SpO2 for Spot Check measurements and

Continuous Monitoring with the following

features:

1) Pulse tone pitch varying with oxygen

saturation

2) SpO2 alarm delay

3) SpO2 sensor off alarm

Temperature

Measurement Two different thermometry options:

1) Covidien FILAC 3000 thermometer

2) Exergen TAT- 5000S temporal scanner

Two different thermometry options:

1) Covidien FILAC 3000 thermometer

2) Exergen TAT- 5000S temporal scanner

Alarms Configuration, annunciation, and

acknowledgement of physiological and

technical alarms for (Sys, Dia, MAP,

Pulse Rate, SpO2, and Temp).

Alarms are visibly annunciated and

acknowledged on the screen.

Alarms are audibly annunciated via

speaker.

Configuration, annunciation, and

acknowledgement of physiological and technical

alarms for (Sys, Dia, MAP, Pulse Rate, SpO2,

and Temp).

Alarms are visibly annunciated and

acknowledged on the screen.

Alarms are audibly annunciated via speaker.

Energy Source Battery type: Lithium-lon

Power Supply: 100-240V AC, 50-60 Hz

Battery type: Lithium-Ion

Power Supply: 100-240V AC, 50-60 Hz



These differences between the subject device and predicate are describe below:

1. NIBP Measurement Ranges: The SVM-7200 has a higher end cut-off for systolic,

diastolic and mean arterial pressure ranges for adults, pediatrics, and neonates as

compared to the predicate. The subject device complies with the NIBP standard IEC

80601-2-30.

2. SpO2 Monitoring: The SVM-7200 offers additional SpO2 probe options as

compared to the predicate which only offers the Masimo SpO2 probe. The SVM-

7200 can be used with its own Nihon Kohden SpO2 and Nellcor SpO2 pulse oximeter

probes. All three SpO2 probe options were tested with the subject device which

complies with the SpO2 standard IEC 80601-2-61.

3. Operating Conditions: The SVM-7200 has a lower minimum operating

temperature of 5°C as compared to 10°C of the predicate and reference devices. Also,

the subject device has a lower maximum operating humidity of 85%, while the

predicate and the reference device have a maximum humidity of 95%. This very

minor difference should not affect the general functionality of the device and has no

effect on safety or effectiveness. The subject device has been tested and complies to

IEC 60601-1.

4. Storage Conditions: The SVM-7200 has a higher maximum storage temperature

of 65°C, as compared to 50°C of the predicate. Also, the subject device has a higher

maximum storage humidity of 95% while the predicate has a maximum humidity of

90%. This very minor difference should not affect the general functionality of the

device. The subject device has been tested and complies to IEC 60601-1.

Since some of the features are not exactly the same between the subject device and the

predicate, a reference device, the Nihon Kohden Bedside Monitor, BSM-6000 series

(K080342) is utilized to provide technical information to help address the safety and

effectiveness of the different characteristics. The methods used to test the SVM-7200

series Vital Signs Monitor are according to the same standards as the cleared reference

device BSM-6000 and have been deemed acceptable. Also, the BSM-6000 series

incorporates the NIBP module, SpO2 module and firmware of the same design as the

SVM-7200 series which controls the operation of NIBP (including measurement ranges)

and SpO2 monitoring. Additionally, the storage conditions of the BSM-6000 series

bedside monitor are the same as for the SVM-7200 series Vital Signs Monitor and the

method used to test the maximum storage temperature and humidity is the same.

PERFORMANCE TESTING

Performance testing for the Nihon Kohden SVM-7200 series Vital Signs Monitor

includes software verification and validation test which encompassed software unit

testing, integration level testing, and system level testing. A system test was also

performed per the software requirements specification. A summative usability validation

has been conducted with the subject device in a simulated environment. Testing to

compliance standards for electrical and electromagnetic safety was also performed.



Traceability has been documented between all system specifications to validation test

results. Table 2 lists the performance testing to compliance standards for the VSM-7200

series Vital Signs Monitor.

Table 2 Performance Testing to Standards

Performance

Characteristics Standard Number Standards Title

General IEC 60601-1:2005 +

CORR.1:2006 + CORR.

2:2007 + A1:2012 (with

CAN/CSA C22.2 No.60601-

1:14)

Medical electrical equipment - Part 1: General

requirements for basic safety and essential

performance

EMC IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General

Requirements for Basic Safety and Essential

Performance - Collateral Standard: Electromagnetic

Compatibility - Requirements and Tests

Usability IEC 60601-1-6:2010 + Amd

1:2013

Medical Electrical Equipment - Part 1-6: General

Requirements for Basic Safety and Essential

Performance - Collateral Standard: Usability

IEC 62366:2007 +

Amendment 1:2014

Medical devices -- Application of usability

engineering to medical devices

Alarms IEC 60601-1-8:2006 &

A1:2012

Medical electrical equipment - Part 1-8: General

requirements for basic safety and essential

performance - collateral standard: General

requirements, tests and guidance for alarm systems

in medical electrical equipment and medical

electrical systems

Patient

Monitoring

IEC 60601-2-49:2011 Medical electrical equipment – Part 2-49: Particular

requirements for the basic safety and essential

performance of multifunction patient monitoring

equipment

NIBP IEC 80601-2-

30:2009+A1:2013

Medical electrical equipment – Part 2-30: Particular


performance of automated non-invasive

sphygmomanometers

Temp ISO 80601-2-56:2009 Medical Electrical Equipment - Part 2-56: Particular

Requirements for the Basic Safety and Essential

Performance of Clinical Thermometers for Body

Temperature Measurement

SpO2 ISO 80601-2-61:2011 Medical electrical equipment – Part 2-61: Particular


performance of pulse oximeter equipment

Software IEC 62304:2006 +

Amd1:2015

Medical Device Software - Software Life-cycle

Processes

Wireless and Co-

Existence

AAMI TIR69: 2017 Technical Information Report Risk management of

radio-frequency wireless coexistence for medical

devices and systems.



Performance

Characteristics Standard Number Standards Title

Wireless and Co-

Existence

ANSI IEEE C63.27-2017 American National Standard for Evaluation of

Wireless Coexistence

ANSI IEEE C63.4-2003 American National Standard for Methods of

Measurement of Radio-Noise Emissions from Low

Voltage Electrical and Electronic Equipment in the

Range of 9 kHz to 40 GHz.

CLINICAL ACCURACY VALIDATION

The Nihon Kohden SVM-7200 series Vital Signs Monitor incorporates clinical

subsystems from Masimo, Nellcor and Nihon Kohden for SpO2 monitoring, from

Covidien and Exergen for temperature measurement, and from Nihon Kohden for NIBP

monitoring. New clinical accuracy validation testing was not necessary as these

subsystems along with their accessories have been previously validated and cleared. This

510(k) leverages the previous clinical accuracy data from the predicates, as shown in

Table 3, for all of the clinical functionalities in the subject device.



Table 3 SVM-7200 Series Clinical Subsystems in SVM-7200 Series with Corresponding Subsystems in Predicates

Patient

Monitoring

Subsystem

Data Collection Method Subsystem Cleared in 510(k) SVM7200 Model

Method Component 510(k)

Device Name

Manufacturer

SVM-

7230

SVM-

7250

SVM-

7260

Oxygen

Saturation

(SpO2)

Masimo

Masimo

Board,

Algorithm

K053269

K080342

Masimo Set Rad-8 Pulse Oximeter

Masimo

BSM-6000

Nihon Kohden

X

Sensor cable

(connection

cord)

K080342

K151080

BSM-6000 (for JL-632P)

Nihon Kohden

CSM-1901(for JL-631P)

Nihon Kohden

X

Probes

K040214

K060143

K992340

SpO2 probe

Masimo X

Oxygen

Saturation

(SpO2)

Nellcor

Nellcor

Board,

Algorithm

K060576

K080342

N-600X

Nellcor

BSM-6000

Nihon Kohden

X

Sensor cable

(connection

cord)

K151080 CSM-1901

Nihon Kohden X



Patient

Monitoring

Subsystem



Device Name

Manufacturer

SVM-

7230

SVM-

7250

SVM-

7260

Probes K052186

K012891

SpO2 probe

Nellcor X

Oxygen

Saturation

(SpO2)

Nihon Kohden

Nihon

Kohden

Board,

Algorithm K080342 BSM-6000 Nihon Kohden X

Sensor cables

(connection

cord)

K082785 BSM-9100

Nihon Kohden X

K163459 GZ-140P

Nihon Kohden X

Finger probes K043517 ZS-940P

Nihon Kohden X

Multisite

probes K043517

ZS-940P

Nihon Kohden X

Disposable

probes

K120888 PSG-1100

Nihon Kohden X

K151080 CSM-1901

Nihon Kohden X

K163459 GZ-140P

Nihon Kohden X



Patient

Monitoring

Subsystem



Device Name

Manufacturer

SVM-

7230

SVM-

7250

SVM-

7260

Non-invasive

Blood Pressure

monitoring

(NIBP)

(inflation

mode)

Nihon

Kohden

iNIBP

(inflation)

Board,

Algorithm K163459

GZ-140P

Nihon Kohden X X X

Sensor cables

(air hoses) K082785

BSM-9100

Nihon Kohden X X X

Cuffs –

Reusable and

disposable

K163459 GZ-140P

Nihon Kohden X X X

Non-invasive

Blood Pressure

monitoring

(NIBP)

(deflation

mode)

Nihon

Kohden

NIBP

(deflation)

Board,

Algorithm

K914092

K011918

K032749

K080342

BSM-2101

BSM-2302

OPV-1510

BSM-6100

Nihon Kohden

X X X

Sensor cables

(air hoses)

K151080 CSM-1901

Nihon Kohden

X X X

K082785 BSM-9100

Nihon Kohden

Cuffs –

Reusable and

disposable

K163459 GZ-140P

Nihon Kohden X X X



Patient

Monitoring

Subsystem



Device Name

Manufacturer

SVM-

7230

SVM-

7250

SVM-

7260

Body

Temperature

(TEMP)

Covidien

Board,

algorithm K003313

FILAC FAS TEMP

Covidien X X X

Thermometer

probe K003313

FILAC FAS TEMP

Covidien X X X

Accessories K003313 FILAC FAS TEMP

Covidien X X X

Body

Temperature

(TEMP)

Exergen Thermometer K011291

K171751

Temporal Scanner

Exergen

SmartLinx Vital Plus Patient Monitoring

Capsule Technologies

X X X



CONCLUSION

Based on a review of indications for use, technological characteristics, safety and

performance testing, the Nihon Kohden SVM-7200 series Vital Signs Monitor is as safe

and effective as the SmartLinx Vitals Plus Patient Monitoring System for the intended

use described above. Furthermore, the minor differences do not raise new concerns of

safety and effectiveness. Therefore, the data provided shows that the subject device is

substantially equivalent to the predicate.

Documents

May 28, 2019 ℅ Dave Yungvirt CEO Third Party Review Group ... · The SVM-7200 series Vital Signs Monitor is intended for monitoring and alarming of physiologic parameters, including