HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm〜43cm).

Device Description

HD 3161 Blood Pressure Monitor measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.

AI/ML Overview

The provided document is a 510(k) premarket notification for the BioCare Asia HD 3161 Blood Pressure Monitor. It presents a comparison of the proposed device with a predicate device, the U-RIGHT TD-3127 Blood Pressure Monitoring System (K100658), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the predicate device's performance as the acceptance criteria for most metrics, aiming for substantial equivalence. The key performance criteria for blood pressure monitors are accuracy and measurement range.

Acceptance Criteria (from Predicate Device)	Reported Device Performance (HD 3161)
Measurement Range:
Systolic: 50 - 250 mmHg	Systolic: 50 - 250 mmHg
Diastolic: 30 - 180 mmHg	Diastolic: 30 - 180 mmHg
Pulse: 40 – 199 beats per minute	Pulse: 40 – 199 beats per minute
Accuracy:
Pressure: ±3mmHg or ±2% of readout value	Pressure: ±3mmHg or ±2% of readout value
Pulse: ±4% of reading value	Pulse: ±4% of reading value
Operating Temperature & Humidity:
Temperature: 32~~104°F (0~~40°C)	Temperature: 32~~104°F (0~~40°C)
RH: 15% to 90%	RH: 15% to 90%
Storage Temperature & Humidity:
Temperature: 23~~122°F (-5~~50°C)	Temperature: 23~~122°F (-5~~50°C)
RH: 15% to 95%	RH: 15% to 95%
Electrical Safety: IEC 60601-1:2005, IEC 60601-1-11:2010, EN 1060-1:2002, EN 1060-3:2005	PASS
EMC Conformity: IEC 60601-1-2: 2007	PASS
Biocompatibility: ISO 10993-5:2009, ISO 10993-10:2010	PASS
FCC Compliance: FCC 47 CFR Part 18, ANSI C63.4: 2009	PASS
Performance & Clinical Test Standard: IEC 80601-2-30:2013, AAMI / ANSI / ISO 81060-2:2013	Met (implied by "PASS" through substantial equivalence and clinical test mention)

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

The document mentions "PERFORMANCE & CLINICAL TEST" under IEC 80601-2-30:2013 and AAMI / ANSI / ISO 81060-2:2013. However, it does not explicitly state the sample size used for any clinical test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any clinical study mentioned. It only indicates that these tests were performed and passed.

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications for any clinical test. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference invasive or non-invasive method.

4. Adjudication Method for the Test Set:

The document does not provide any information about the adjudication method used for any clinical test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is not typically applicable to a standalone blood pressure monitor, which directly measures physiological parameters rather than requiring human interpretation of medical images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the regulatory submission is for a standalone device (the HD 3161 Blood Pressure Monitor). Its performance, as demonstrated by meeting the listed standards, is a standalone performance validation. The device itself performs the measurement and provides the readings without needing human interpretation of the underlying signal for the final blood pressure value.

7. The Type of Ground Truth Used:

While not explicitly detailed, for blood pressure monitor validation according to standards like AAMI/ANSI/ISO 81060-2, the ground truth is typically established through simultaneous or near-simultaneous measurements by a validated reference method, often using auscultation by trained observers (using a stethoscope and sphygmomanometer) or sometimes invasive arterial pressure monitoring in specific clinical settings. The document implies that the device's accuracy was compared against such a standard in the "PERFORMANCE & CLINICAL TEST."

8. The Sample Size for the Training Set:

The product is a blood pressure monitor that uses an oscillometric method. This method usually involves pre-programmed algorithms based on physiological principles and validated against clinical data. The document does not specify a "training set" sample size in the context of machine learning, as this device does not appear to be an AI/ML product in the sense of continuously learning from a vast dataset. Instead, its accuracy is validated against established medical device performance standards.

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

As explained in point 8, the concept of a "training set" in the context of machine learning is generally not applicable here. The fundamental algorithms for oscillometric blood pressure measurement are based on established physiological understandings and bioengineering principles. The "ground truth" for the development and validation of these algorithms would historically have involved extensive clinical studies comparing oscillometric readings to direct intra-arterial measurements or meticulous auscultatory readings. The document implies that the device's design and fixed algorithm adhere to the principles validated by the predicate device and the relevant international standards (IEC 80601-2-30:2013, AAMI / ANSI / ISO 81060-2:2013).

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

September 8, 2014

BioCare Asia Corporation Ltd. c/o Dr. Ke-Min Jen Official Correspondent No. 260, Mayun Road New District Suzhou. Jiangsu. 215129 P.R.C.

Re: K141924

Trade/Device Name: HD Blood Pressure Monitor, Upper Arm Type: 3161 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 5, 2014 Received: July 16, 2014

Dear Dr. Ke-Min Jen:

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. 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 statutes and regulations administered by other Federal agencies. You must comply

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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours

Arthell Stein

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

Enclosure

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K141924

Page 1 of 1

510(k) Number (if known): K141924

Device Name: __ HD Blood Pressure Monitor, Upper Arm Type: 3161

Indications For Use: HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm〜43cm).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use X

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K141924 Page 1 of 4

Summary of Safety and Effectiveness

(According to 21 CFR 807.92)

510(k) Summary for K141924_

	Submitter's information

Name	:	BioCare Asia Corporation Ltd.
Address	:	No.260, Mayun Road, New District, Suzhou, Jiangsu, 215129, P.R.C
Phone number	:	+86 (512) 6809-1772
Fax number	:	+86 (512) 6809-7761
Representative person	:	Albert Chen / Administrator
FDA Registration	:	# 3003979308
510k Contact person	:	Dr. Jen, Ke-MinTel: +886-3-5208829 Fax:+886-3-5209783Email: ceirs.jen@msa.hinet.net
Date of preparation	:	July 1, 2014
Device name
Trade name	:	BioCare Asia HD 3161 Blood Pressure Monitor
Device name	:	HD Blood Pressure Monitor, Upper Arm Type: 3161
Common name	:	Blood Pressure Monitor
Classification
Classification name	:	Non-Invasive Blood Pressure Monitoring System
Regulation number	:	21CFR Section 870.1130
Class	:	II (Two) performance standards
Specialty	:	Cardiovascular
Product code	:	DXN

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Predicate devices

U-RIGHT TD-3127 Blood Pressure Monitoring System (K100658) TaiDoc Technology Corporation

Device Information

Device description: HD 3161 Blood Pressure Monitor measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Indication for use: HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm~43cm).

Test Summary:

1. ELECTRIC SAFETY, EMC and Biocompatibility test reports,

General safety	IEC 60601-1:2005	PASS
	IEC 60601-1-11:2010	PASS
	EN 1060-1:2002, EN 1060-3:2005	PASS
EMC conformity	IEC 60601-1-2: 2007	PASS
Biocompatibility	ISO 10993-5:2009	PASS
	ISO 10993-10:2010	PASS
FCC 47 CFR Part 18	ANSI C63.4: 2009	PASS

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K141924

Page 3 of 4

2. PERFORMANCE & CLINICAL TEST

IEC 80601-2-30:2013

AAMI / ANSI / ISO 81060-2:2013

Comparison with predicate device and conclusion

Similarities:

Comparison item	Proposed device	Predicate device
Applicant	BioCare Asia Corporation Ltd.	TaiDoc Technology Corporation
Trade name	BioCare Asia HD 3161 Blood PressureMonitor	U-RIGHT TD-3127 Blood PressureMonitoring System
Model name	HD 3161	TD-3127
510K number	New listing	K100658
Technologicalcharacteristics	Oscillometric method	Oscillometric method
Measuring method	Oscillometric method, automaticinflation and measurement	Oscillometric method, automaticinflation and measurement
Sensor	Semiconductor gauge sensor	Semiconductor gauge sensor
Rapid air release	By an active electronic control valve	By an active electronic control valve
Systemanatomical sites	Upper arm	Upper arm
Display and userinteraction	LCD monitor	LCD monitor
Power source	Batteries or AC adapter	Batteries or AC adapter
Measurement range	Systolic 50 - 250 mmHgDiastolic 30 - 180 mmHgPulse 40 – 199 beats per minute	Systolic 50 - 250 mmHgDiastolic 30 - 180 mmHgPulse 40 - 199 beats per minute
Pressure accuracy	Pressure: ±3mmHg or ±2% of readoutvalue	Pressure: ±3mmHg or ±2% of readoutvalue
Pulse accuracy	±4% of reading value	±4% of reading value
Operating temperatureand humidity	Temperature: 32~~104°F (0~~40°C)RH:15% to 90%	Temperature: 32~~104°F (0~~40°C)RH:15% to 90%
Storage temperatureand humidity	Temperature: 23~~122°F (-5~~50°C)RH:15% to 95%	Temperature: 23~~122°F (-5~~50°C)RH:15% to 95%
Cuff material	Cuff: nylon (PVC bladder, non-latex)Biocompatibility:ISO 10993-5:2009, ISO 10993-10:2010	Cuff: nylon (PVC bladder, non-latex)Biocompatibility:ISO 10993-5:2009, ISO 10993-10:2010

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K141924

Page 4 of 4

Differences:

Comparison item	Proposed device	Predicate device
Dimensions(LWH) mm	134.8(L)x94.6(W)x31.5(H) mm	150(L) × 96(W) × 66(H)mm
Weight	425g (w batteries)	250g
Memory	2 * 90 measurements	100 measurements
Auto shutoff	90 sec after last key operation	180 sec after last key operation

Summary with predicate device and conclusion

The new device, HD 3161 Blood Pressure Monitor is substantially equivalent to the U-RIGHT TD-3127 Blood Pressure Monitoring System (K100658) and they are the same upper arm type of the blood pressure monitor.

The intended use and the indications for use of the HD 3161 Blood Pressure Monitor as described in its labeling are the same as the predicate device and the two devices are intended to be used in the same measurement range; in addition, there are the same operating and storage environments.

The HD 3161 Blood Pressure Monitor and the predicate devices are substantially equivalent in all of the technological characteristics of patient contact materials, performance, biocompatibility function, mechanical safety, standards met, electrical safety, and EMC.

The main differences for the two devices are overall dimensions, including dimensions, weight, memory, and the time of auto shutoff. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

BioCare Asia Corporation Ltd. believes this information and the referred documentation to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.

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).