The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). This equipment is intended for use only by qualified medical providers in conjunction with established medical protocols. It is not intended for use in an MRU environment, or in an air transport environment.

Device Description

The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic, diastolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation. The measurement is more quickly and with less patient discomfort than with monitors which measure NIBP during cuff deflation. Cycle time function enables you to pre-set measurement intervals. User can set alarm limits by selectable for high or low range.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Clause	Performance Characteristics	Max. permissible error or acceptance criteria	Reported Device Performance (Max. deviation)	Passed/Failed
4.2.1	Storage conditions: [23°F(-5°C)] for 24 hrs; [122°F(50°C)] for 24 hrs; RH: 90% (noncondensing)	≤± 3 mmHg (±0.4 kPa) ≤± 4 mmHg for in use	-3.4 mmHg	Passed
4.2.2	Operating conditions: Temp: 50°F (10°C)~~104°F(40℃); RH: 15~~90% (noncondensing); Bar. 105kPa~~80kPa (790mmHg~~600mmHg)	≤± 3 mmHg (±0.4 kPa) ≤±4 mmHg for in use	± 3 mmHg	Passed
4.2.3	Vibration and shock: ISTA-standard drop and vibration test IEC 60601-1, sections 21.5 & 21.6	ISTA-1A: 14,200 vibratory impacts; drop test-10 drops; before and after transportation test within ±5 mmHg of the average reading.	no visible damage; SD ≤8 mmHg	Passed
4.2.4.1	Voltage range: Battery-powered devices-indication of battery condition	Red light: low battery; Blue light: batteries are charging; Green light: fully charged	<8.2VDC; 8.2~8.4VDC	Passed
4.2.4.2	Life: Maintain the safety and performance characteristics for 10,000 full-scale cycles. Adult mode: 150 mmHg; Neo. mode: 75 mmHg	≤ 3 mmHg (±0.4 kPa)	2 mmHg	Passed
4.2.5	Electromagnetic compatibility	complied with EC 60601-1-2 (EMC)	N/A	Passed
4.3.1.1	Maximum cuff pressure: Adult: 300mmHg; neonate: 150 mmHg	NIBP pressure calibration: <310 mmHg; Safety test: Release pressure before <320 mmHg	N/A	Passed
4.3.1.2	Release rate: Rapid exhaust: 260~~15 mmHg ≤10s; 150~~5 mmHg ≤5s	NIBP pressure calibration: deflate at 25 mmHg/sec; Speed test: Deflation >25 mmHg/sec	mmHg/sec	Passed
4.3.2	Electrical safety:	IEC 60601-1, 1988; Amendment 1, 1991; & Amendment 2, 1995.	N/A	Passed
4.4.3.1.A	Range: 0 mmHg to at least 260 mmHg by visual inspection	NIBP pressure calibration	0~300 mmHg	Passed
4.4.3.2.A	Resolution: 1 mmHg by visual inspection	NIBP pressure calibration	1 mmHg	Passed
4.4.3.3.A	Accuracy of pressure measurement: Ambient temp 10°C~40°C; RH: 15%~90%; Pressure stages: 50, 100, 150, 200, 250, 300 mmHg	≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use	±3 mmHg	Passed
4.4.3.4.A	Repeatability Cuff-Link simulator test for stability and reproduction of performance Adult: SYS120/DIA80/MAP90 mmHg, 80 BPM Neo: SYS80/DIA50/MAP62 mmHg, 120 BPM	Average difference ≤± 5 mmHg	5 mmHg	Passed
4.4.3.6.A	Leakage: Ambient temp 15°C~~25°C; RH: 20~~85%; Pressure stages: 50, 100, 150, 200, 250 mmHg, wait at least 60 s before reading the values.	≤6 mmHg/min	1.2 mmHg/min	Passed
4.4.4.B	Pressure transducer accuracy: Ambient temp 10℃~40℃; RH: 15%~90%; Pressure stages: 50, 100, 150, 200, 250, 300 mmHg	≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use	±3 mmHg	Passed
4.4.5.B	Overall system efficacy-clinical testing (auscultatory method as the reference Std.) no fewer than 85 subjects with a minimum of 255(=3*85) observations	For systolic and diastolic: mean≤±5 mmHg; SD ≤8 mmHg	Mean: Sys/Dia 3.4/-4.5; SD: Sys/Dia 5.23/4.64 mmHg	Passed
4.5.1	Inflation source: pressure~300mmHg≤10s	NIBP pressure calibration: inflate at 5 mmHg/sec; Speed test: Inflation > 5 mmHg/sec	N/A	Passed
4.5.4.3.B	Automated valves-Release rate: rapid exhaust with fully-opened valve	260mmHg → 15mmHg ≤10 sec or 150mmHg → 5mmHg ≤5 sec	deflate at 25 mmHg/sec	Passed
IEC 60601-2-30	Automatic cycling function 1. In long term automatic mode (normal condition) Adult 120/80(90)[SYS/DIA(MAP)]--long term Neonate 80/50(62)[SYS/DIA(MAP)]--long term 2. In long term automatic mode (single fault condition) 3. In short term automatic mode (stat mode)	1. deflated time ≥30 sec; mean≤± 5 mmHg; 2. deflated time ≤30 sec; release cuff pressure to below 15mmHg(adult)/ 5mmHg(neo.); 3. deflated time≥2sec. after each determination	1. average for adults 34 sec / for neonates 42 sec; -4mmHg; 2. <15sec, safety activates; 3. average for adults 3 sec / for neonates 8 sec; --4mmHg	Passed

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Clinical Testing (Test Set): No fewer than 85 subjects with a minimum of 255 observations (3 observations per subject).
Data Provenance: Not explicitly stated, but the submission is from BioCare Corporation (Taiwan), suggesting the study may have been conducted in Taiwan or a related region. The document does not specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The ground truth for the clinical testing was established using the auscultatory method as the reference standard. This method typically involves trained medical professionals (e.g., nurses, doctors) taking manual blood pressure measurements using a stethoscope and sphygmomanometer. The document does not specify the exact number or precise qualifications (e.g., years of experience) of the experts performing the auscultatory measurements for this study.

4. Adjudication Method for the Test Set:

The document implies that the auscultatory measurements served as the direct reference standard. There is no mention of a separate adjudication process involving multiple experts for the clinical ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focused on assessing the standalone performance of the device against a known reference standard (auscultatory method), not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance study was done. The entire set of performance tests, including bench and clinical results, are for the BioCare vTrust 701DH Noninvasive Blood Pressure Monitor operating as a standalone device, without human-in-the-loop intervention beyond the initial application of the cuff and initiation of measurement. The clinical testing specifically compared the device's readings against the auscultatory method.

7. Type of Ground Truth Used:

For the clinical study, the ground truth was established using the auscultatory method (a recognized clinical reference standard for blood pressure measurement). For other performance characteristics, the "acceptance criteria" themselves served as the ground truth, derived from the ANSI/AAMI SP-10: 2002 standard.

8. Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. Blood pressure monitors like this typically operate based on established oscillometric algorithms rather than being "trained" in the machine learning sense with a distinct training dataset that is then validated on a separate test set. The validation here refers to the device's overall performance against the ANSI/AAMI SP-10: 2002 standard and clinical reference.

9. How the Ground Truth for the Training Set Was Established:

As a training set is not explicitly mentioned or implied in the context of the device's validation, the method for establishing its ground truth is not applicable or provided in this document. The device's underlying oscillometric principle is based on known physiological responses and engineering principles, not typically on machine learning model training.

Summary

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01/6 Koq 1414

510(k) Summary

MAR 11 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.

1. Submitter's Name: BioCare Corporation

Address: 4F, No.12, Lane 5, Sec. 2, Nanshan Rd., Luihu Township, Taoyuan County 33852, Taiwan.

OCT 2 1 2009

Phone: +886-3-2616678

Fax: +886-3-2616679

Contact person: Judy Wei / Administrator

2. Device Name and Classification

Trade name: vTrust " Noninvasive Blood Pressure Monitor, Model 701DH series Common/Usual name: Blood Pressure Monitor

Classification name/Code: Noninvasive Blood Pressure Measurement System-DXN

Classification Panel: Circulatory System Devices Panel (74)

Device Class: II

3. Predicate Device

The predicate device is CSI 507 non-invasive vital signs monitor(K910852) marketed by Criticare Systems, Inc.

4. Device Description

The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation. The measurement is more quickly and with less patient discomfort than with monitors which measure NIBP during cuff deflation. Cycle time function enables you to pre-set measurement intervals. User can set alarm limits by selectable for high or low range.

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5. Intended Use

This equipment is intended to be use only by qualified medical providers in conjunction with established medical protocols. It is not intended for use in an MRI environment, or in an air transport environment.

6. Summary of Technological Characteristics of the Device Compared to the Predicate Device

Both vTrust 701DH blood pressure monitor and 507 non-invasive vital signs monitor is intended to be used in measuring human's Systolic, Diastolic and Pulse rate by oscillometric method. They share similar features and specifications. Performance characteristics of both devices are in accordance with ANSI/AAMI SP-10: 2002.

The substantial equivalence between vTrust 701DH and 507 non-invasive vital signs monitor can be evaluated from several aspects as listed in below Table.

Items	Proposed device	Predicate device	Similarities	Differences
Device name	vTrust 701DH non-invasiveblood pressure monitor	507 non-invasive vital signsmonitor
DeviceClassification	Class II	Class II	Equivalent	Negligible
ClassificationPanel	Cardiovascular	Cardiovascular	Equivalent	Negligible
Intended Use(Indications for use)	Monitor non-invasive bloodpressure and pulse rates	Monitor non-invasive bloodpressure and pulse rates	Equivalent	Negligible
Anatomical sites	Upper arm or limb	Upper arm or limb	Equivalent	Negligible
Device Description
Technology -measurementmethodology	Oscillometric measure uponinflation	Oscillometric measure uponinflation	Equivalent	Negligible
Materials	Cuff: neoprene (non-latex)	Cuff: neoprene (non-latex)	Equivalent	Negligible
Energy used	Recharge NiMH battery orAC adapter	Recharge NiMH battery orAC adapter	Equivalent	Negligible
Weight	650 g	630 g
Dimensions(HWD) mm	190(H) × 90(W) × 50(D)	190(H) × 95(W) × 45(D)
Memory	100 measurements	100 measurements	Equivalent	Negligible
Items	Proposed device	Predicate device	Similarities	Differences
Device name	vTrust 701DH non-invasiveblood pressure monitorImage: proposed device	507 non-invasive vital signsmonitorImage: predicate device
Descriptive characteristics
Inflation & deflation	Automatic control	Automatic control	Equivalent	Negligible
Display	LCD / LED	LED
Parameters	SYS DIA MAP HR	SYS DIA HR
STAT mode	5 min of continuous readings	5 min of continuous readings	Equivalent	Negligible
AutomaticMeasurement Cycles	1, 2, 3, 5, 10, 15, 30, 60min	5, 10, 15min
Auto shutoff	20 min after last key operation	20 min after last key operation	Equivalent	Negligible
System output	RS 232-compatible; digital;mini-din connector	RS 232-compatible; digital;mini-din connector	Equivalent	Negligible
Performance specifications
Standards met	ANSI/AAMI SP-10: 2002,IEC-60601-1, IEC-60601-1-2,ISO 10993	ANSI/AAMI SP-10: 1992,IEC-60601-1, IEC-60601-1-2,ISO 10993	Equivalent	Negligible
Operatingenvironment	Temp: 0°~~45°C (32°F~~133°F)RH:15% to 90%, non-condensing	Temp: 0°~~45°C (32°F~~133°F)RH:15% to 90%, non-condensing	Equivalent	Negligible
Storageenvironment	Temp: -10°~~50°C (14°F~~122°F)RH:15% to 90%, non-condensing	Temp: -5°~~55°C (23°F~~131°F)RH: 15% to 90%, non-condensing
Measurement range	Pressure: 30-300 mmHg;Pulse: 30-300 beats/min	Pressure: 30-300 mmHg;Pulse: 30-300 beats/min	Equivalent	Negligible
Resolution	1 mmHg	1 mmHg	Equivalent	Negligible
Accuracy	Pressure: ±2mmHg or 2%of reading; Pulse: ±2 bpmor ±2% of reading	Pressure: ±2mmHg or 2%of reading; Pulse: ±2 bpmor ±2% of reading	Equivalent	Negligible

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The differences between the two devices list as: weight, dimensions, display, . parameters, cycle time. There are no significant differences that affect the safety and effectiveness. Therefore, BioCare vTrust 701DH non-invasive blood pressure monitor is substantially equivalent to the legally marketed device CSI 507 non-invasive vital signs monitor, K910852.

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7. Determination of Substantial Equivalence is based on an assessment of Performance Data

The performance test protocols and data analysis are following "ANSVAAMI SP10: 2002" standard. In this part, the substantial equivalence is demonstrated by showing conformance to performance requirements in the SP-10 standard. The pressure transducer accuracy and overall system effectiveness were determined and compared to the preset criteria.

Clause	Performance Characteristics	Max. permissible error or acceptance criteria	Max. deviation	Passed/ Failed	Reference to documentation
4.2	Environmental performance and stability
4.2.1	Storage conditions:[23°F(-5°C)] for 24 hrs;[122°F(50°C)] for 24 hrs;RH: 90% (noncondensing)	≤± 3 mmHg(±0.4 kPa)≤± 4 mmHg for in use	-3.4 mmHg	Passed	T-0406-004
4.2.2	Operating conditions:Temp: 50°F (10°℃)~~104°F(40℃);RH: 15~~90% (noncondensing);Bar. 105kPa~~80kPa (790mmHg~~600mmHg)	≤± 3 mmHg(±0.4 kPa)≤±4 mmHg for in use	± 3 mmHg	Passed	T-0406-004
4.2.3	Vibration and shock:ISTA-standard drop and vibration testIEC 60601-1, sections 21.5 & 21.6	ISTA-1A: 14,200 vibratory impacts; drop test-10 drops; before and after transportation test within ±5 mmHg of the average reading.	no visible damage;SD ≤8 mmHg	Passed	T-0406-012
4.2.4	Stability
4.2.4.1	Voltage range:Battery-powered devices-indication of battery condition	Red light: low battery;Blue light: batteries are charging;Green light: fully charged	<8.2VDC8.2~8.4VDC	Passed	PS-1040245-T
4.2.4.2	Life:Maintain the safety and performance characteristics for 10,000 full-scale cyclesAdult mode: 150 mmHg;Neo. mode: 75 mmHg	≤ 3 mmHg(±0.4 kPa)	2 mmHg	Passed	T-0406-004
4.2.5	Electromagnetic compatibility	complied with EC 60601-1-2 (EMC)		Passed	Section 17
Clause	Performance Characteristics	Max. permissible erroror acceptance criteria	Max.deviation	Passed/Failed	Reference todocumentation
4.3	Safety requirements
4.3.1.1	Maximum cuff pressure:Adult: 300mmHg; neonate: 150 mmHg	NIBP pressure calibration: <310 mmHgSafety test:Release pressure before <320 mmHg		Passed	PS-1040245-T
4.3.1.2	Release rate:Rapid exhaust: 260~~15 mmHg ≤10s150~~5 mmHg ≤5s	NIBP pressure calibration: deflate at 25Speed test:Deflation >25 mmHg/sec	mmHg/sec	Passed	PS-1040245-T
4.3.2	Electrical safety:	IEC 60601-1, 1988; Amendment1, 1991; & Amendment 2, 1995.		Passed	Section 17
4.4	Performance
4.4.3	Electronic manometers
4.4.3.1.A	Range: 0 mmHg to at least 260 mmHg byvisual inspection	NIBP pressure calibration	0~300 mmHg	Passed	PS-1040245-T
4.4.3.2.A	Resolution: 1 mmHg by visual inspection	NIBP pressure calibration	1 mmHg	Passed	PS-1040245-T
4.4.3.3.A	Accuracy of pressure measurement:Ambient temp 10°C~40°C; RH: 15%~90%Pressure stages: 50, 100, 150, 200, 250, 300 mmHg	≤±3 mmHg(±0.4 kPa)or 2% of the reading;≤±4 mmHg for in use	±3 mmHg	Passed	T-0406-003
4.4.3.4.A	RepeatabilityCuff-Link simulator test for stability andreproduction of performanceAdult: SYS120/DIA80/MAP90 mmHg, 80 BPMNeo: SYS80/DIA50/MAP62 mmHg, 120 BPM	Average difference≤±5 mmHg	5 mmHg	Passed	T-0406-003
4.4.3.6.A	Leakage:Ambient temp 15°C~~25°C; RH: 20~~85%Pressure stages: 50, 100, 150, 200, 250 mmHg,wait at least 60 s before reading the values.	≤6 mmHg/min	1.2 mmHg/min	Passed	T-0406-003
4.4.4.B	Pressure transducer accuracy:Ambient temp 10℃~40℃; RH: 15%~90%Pressure stages: 50, 100, 150, 200, 250, 300 mmHg	≤±3 mmHg(±0.4 kPa)or 2% of the reading≤±4 mmHg for in use	±3 mmHg	Passed	T-0406-003
4.4.5.B	Overall system efficacy-clinical testing(auscultatory method as the reference Std.)no fewer than 85 subjects with a minimum	For systolic and diastolic:mean≤±5 mmHg;SD ≤8 mmHg	Mean:Sys/Dia3.4/-4.5	Passed	Section 20
Clause	Performance Characteristics	Max. permissible erroror acceptance criteria	Max.deviation	Passed/Failed	Reference todocumentation
of 255(=3*85) observations			SD:Sys/Dia5.23/4.64mmHg
4.5	Requirements for inflation source and pressure control valves
4.5.1	Inflation source: pressure~300mmHg≤10s	NIBP pressure calibration: inflate at 5mmHg/secSpeed test:Inflation > 5 mmHg/sec		Passed	PS-1040245-T
4.5.4.3.B	Automated valves-Release rate: rapidexhaust with fully-opened valve	260mmHg $\rightarrow$ 15mmHg≤10 sec or150mmHg $\rightarrow$ 5mmHg≤5 sec	deflate at 25mmHg/sec	Passed	PS-1040245-T
IEC60601-2-30	Automatic cycling function1. In long term automatic mode (normal condition)Adult 120/80(90)[SYS/DIA(MAP)]--long termNeonate 80/50(62)[SYS/DIA(MAP)]--long term2. In long term automatic mode (single fault condition)3. In short term automatic mode (stat mode)	1. deflated time ≥30 sec; mean≤± 5 mmHg;2. deflated time ≤30 sec; release cuff pressure to below 15mmHg(adult)/5mmHg(neo.);3. deflated time≥2sec.after eachdetermination	1. average for adults 34 sec / forneonates 42 sec; -4mmHg;2. <15sec, safety activates;3. average for adults 3 sec / forneonates 8 sec; --4mmHg	Passed	T-0406-011

> Summary of performance testing-Bench & Clinical results

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8. Conclusions

The BioCare vTrust 701DH non-invasive blood pressure monitor has the same intended use and similar technological characteristics as the CSI 507 non-invasive vital signs monitor (K910852) marketed by Criticare Systems, Inc. Moreover, performance testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BioCare vTrust 701DH non-invasive blood pressure monitor is substantially equivalent to the predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is rendered in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

BioCare Corporation c/o Ms. Judy Wei Administrator 4F, No.12, Lane 5, Sec. 2, Nanshan Rd. Lujhu Township Taoyuan County 33852, Taiwan

OCT 2 1 2009

Re: K091414

Trade/Device Name: vTrust™ Noninvasive Blood Pressure Monitor Model 701DH series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 24, 2009 Received: August 27, 2009

Dear Ms. Wei:

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 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.

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Page 2 - Ms. Judy Wei

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W.M.T.

erBram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KO91414

Device Name: vTrust Blood Pressure Monitor, Model: 701DH Series

Indications For Use:

This equipment is intended for use only by qualified medical providers in conjunction with established medical protocols. It is not intended for use in an MRU environment, or in an air transport environment.

Prescription Use (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

--- (PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON-AMOTHER ------PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.R.

Page 1 of

ion Slan-Off ivision of Cardiovascular Devices

510(k) Number K0914

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).