K Number

Device Name

VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH

Manufacturer

BIOCARE CORP.

Date Cleared

2009-10-21

(161 days)

Product Code

DXN

Regulation Number

870.1130

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K910852

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement and does not mention any AI or ML techniques.

Therapeutic

No
The device is a monitor that measures noninvasive blood pressure and pulse rate, which are diagnostic functions, not therapeutic ones.

Diagnostic

The device measures noninvasive blood pressure and pulse rate, which are physiological parameters, but it is not explicitly stated that it provides a diagnosis or aids in making a medical diagnosis. Instead, it seems to monitor vital signs.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "compact, battery-powered monitor" and measures blood pressure using a cuff and oscillometric method, indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The BioCare vTrust 701DH NIBP monitor measures noninvasive blood pressure and pulse rate. This is a direct measurement of physiological parameters from the body, not an analysis of a sample taken from the body.
Intended Use: The intended use describes measuring blood pressure and pulse rate, which are vital signs, not analyzing a biological sample for diagnostic purposes.

Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

DXN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper arm or limb

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified medical providers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Performance Characteristics and Results:

Environmental performance and stability: Passed.
- Storage conditions: ≤± 3 mmHg (±0.4 kPa) for storage, ≤± 4 mmHg for in use. Max deviation -3.4 mmHg.
- Operating conditions: ≤± 3 mmHg (±0.4 kPa) for storage, ≤± 4 mmHg for in use. Max deviation ± 3 mmHg.
- Vibration and shock: ISTA-1A (14,200 vibratory impacts, 10 drop test) - no visible damage, SD ≤8 mmHg.
- Stability - Voltage range: Red light for low battery (25 mmHg/sec.
- Electrical safety: Complied with IEC 60601-1, 1988; Amendment 1, 1991; & Amendment 2, 1995.
Performance: Passed.
- Electronic manometers - Range: 0 mmHg to at least 260 mmHg by visual inspection. Cleared for 0~300 mmHg.
- Resolution: 1 mmHg by visual inspection. Cleared for 1 mmHg.
- Accuracy of pressure measurement: Ambient temp 10°C~40°C; RH: 15%~90%. Pressure stages: 50, 100, 150, 200, 250, 300 mmHg. Cleared for ≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use. Max deviation ±3 mmHg.
- Repeatability: Cuff-Link simulator test. Adult: SYS120/DIA80/MAP90 mmHg, 80 BPM. Neo: SYS80/DIA50/MAP62 mmHg, 120 BPM. Average difference ≤± 5 mmHg. Max deviation 5 mmHg.
- 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. Cleared for ≤6 mmHg/min. Max deviation 1.2 mmHg/min.
- Pressure transducer accuracy: Ambient temp 10℃~40℃; RH: 15%~90%. Pressure stages: 50, 100, 150, 200, 250, 300 mmHg. Cleared for ≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use. Max deviation ±3 mmHg.
- 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.
Requirements for inflation source and pressure control valves: Passed.
- Inflation source: pressure~300mmHg≤10s. Cleared for inflate at 5 mmHg/sec, Speed test: Inflation > 5 mmHg/sec.
- Automated valves-Release rate: rapid exhaust with fully-opened valve. 260mmHg → 15mmHg ≤10 sec or 150mmHg → 5mmHg ≤5 sec. Cleared for deflate at 25 mmHg/sec.
- IEC 60601-1-2-30 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. Deflated time ≥30 sec; mean≤± 5 mmHg. Results: average for adults 34 sec / for neonates 42 sec; - 4mmHg. 2. In long term automatic mode (single fault condition): Deflated time ≤30 sec; release cuff pressure to below 15mmHg(adult)/ 5mmHg(neo.). Results:

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).

Summary

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

ર-।

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-invasive
blood pressure monitor	507 non-invasive vital signs
monitor
Device
Classification	Class II	Class II	Equivalent	Negligible
Classification
Panel	Cardiovascular	Cardiovascular	Equivalent	Negligible
Intended Use
(Indications for use)	Monitor non-invasive blood
pressure and pulse rates	Monitor non-invasive blood
pressure and pulse rates	Equivalent	Negligible
Anatomical sites	Upper arm or limb	Upper arm or limb	Equivalent	Negligible
Device Description
Technology -
measurement
methodology	Oscillometric measure upon
inflation	Oscillometric measure upon
inflation	Equivalent	Negligible
Materials	Cuff: neoprene (non-latex)	Cuff: neoprene (non-latex)	Equivalent	Negligible
Energy used	Recharge NiMH battery or
AC adapter	Recharge NiMH battery or
AC 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-invasive
blood pressure monitor
Image: proposed device	507 non-invasive vital signs
monitor
Image: 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
Automatic
Measurement 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
Operating
environment	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
Storage
environment	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 bpm
or ±2% of reading	Pressure: ±2mmHg or 2%
of reading; Pulse: ±2 bpm
or ±2% of reading	Equivalent	Negligible

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.

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

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 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	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	25 mmHg/sec	mmHg/sec	Passed	PS-1040245-T
4.3.2	Electrical safety:	IEC 60601-1, 1988; Amendment
1, 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 by
visual 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	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	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/Dia
3.4/-4.5	Passed	Section 20
Clause	Performance Characteristics	Max. permissible error
or acceptance criteria	Max.
deviation	Passed/Failed	Reference to
documentation
of 255(=3*85) observations			SD:
Sys/Dia
5.23/4.64
mmHg
4.5	Requirements for inflation source and pressure control valves
4.5.1	Inflation source: pressure~300mmHg≤10s	NIBP pressure calibration: inflate at 5
mmHg/sec
Speed test:
Inflation > 5 mmHg/sec		Passed	PS-1040245-T
4.5.4.
3.B	Automated valves-Release rate: rapid
exhaust with fully-opened valve	260mmHg $\rightarrow$ 15mmHg
≤10 sec or
150mmHg $\rightarrow$ 5mmHg
≤5 sec	deflate at 25
mmHg/sec	Passed	PS-1040245-T
IEC
6060
1-2-
30	Automatic cycling function

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
In long term automatic mode (single fault condition)
In short term automatic mode (stat mode) | 1. deflated time ≥30 sec; mean≤± 5 mmHg;
deflated time ≤30 sec; release cuff pressure to below 15mmHg(adult)/
5mmHg(neo.);
deflated time≥2sec.
after each
determination | 1. average for adults 34 sec / for
neonates 42 sec; -
4mmHg;
Summary of performance testing-Bench & Clinical results

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.

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.

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

Indications for Use

510(k) Number (if known): KO91414

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

Indications For Use:

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