BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel. It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.

Device Description

BPA-002 Electronic Blood Pressure Monitor for Upper Arm uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of measurement. At the same time, the measurements are displayed on the LCD display for 60 seconds. There is a maximum pressure safety setting at 280mmHg. The device will not inflate the cuff higher than 280mmHg. It will display an irregular heartbeat symbol if an irregular heartbeat was detected during the measurement process. In addition, it has LCD backlight. After 60 seconds without operation, the blood pressure monitors turn off automatically

AI/ML Overview

The provided text describes the Jinxinbao Electronic Co., Ltd, Electronic Blood Pressure Monitor for Upper Arm, Model BPA-002. Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Acceptance Criteria (from Accuracy row of the comparison table)	Reported Device Performance (from Accuracy row of the comparison table)
Pressure Accuracy	±3mmHg	Pressure: ±3mmHg
Pulse Accuracy	≤5%	Pulse: ±5%

Study Information

The device BPA-002 is stated to be compliant with the SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/ (Manual, electronic or automated sphygmomanometers) standard for clinical testing. This standard outlines the requirements for validation of automated sphygmomanometers.

Sample size used for the test set and the data provenance:
The document does not specify the exact sample size or the data provenance (e.g., country of origin, retrospective or prospective) for the clinical tests mentioned under "SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/". The AAMI SP10 standard generally requires a specific number of subjects (e.g., 85 subjects with specific blood pressure ranges) for validation, but these details are not provided in this submission summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number or qualifications of experts used to establish ground truth. For AAMI SP10 compliance, ground truth is typically established by trained human observers using auscultatory methods, but the specifics are not detailed here.
Adjudication method for the test set:
The document does not describe the adjudication method used for the test set. For AAMI SP10 compliance, a specific protocol for comparing automated readings against human observers' readings (often involving multiple observers for auscultatory ground truth) is followed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is a blood pressure monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The clinical test mentioned, "SP10:2002/(R) 2008&ANSI/AAMI SP10:2002/A1:2003/", specifically assesses the standalone performance of the automated blood pressure monitor without human intervention in the measurement process, beyond initial cuff placement. The device's algorithm performs the measurement and displays the result.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For blood pressure monitors validated against the AAMI SP10 standard, the ground truth for blood pressure measurements is typically established by trained human observers using auscultatory methods (e.g., stethoscope and manometer), often with a double-blinded or an agreed-upon protocol between multiple observers (expert consensus for the auscultatory readings).
The sample size for the training set:
This document describes evaluation of a medical device, not a machine learning algorithm that requires a "training set" in the traditional sense. The device is based on oscillometric technology and validated against established standards.
How the ground truth for the training set was established:
As there is no "training set" in the context of a machine learning algorithm as per the question, this is not applicable. The device's underlying principles are based on established oscillometric blood pressure measurement techniques rather than a trained AI model.

Summary

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K130232 Jinxinbao Electronic Co., Ltd

Section 5 510(k) Summary

(As required by 21 CFR 807.92(a))

5.1 Submitter Information

SEP 17 2013

· Company: Jinxinbao Electronic Co.,Ltd
· Address: No.38, Huanzhenxi Road, Dagang Town, Nansha, Guangzhou, China

· Phone: 086-20-34938449

· Fax: 086-20-22865301
· Email: xhoucc@jxb-htb.net

· Contact: Jiacheng Guo, General Manager

· Date: November 15, 2012.

5.2 Device Information

· Trade/Proprietary Name: Electronic Blood Pressure Monitor for Upper Arm, Model

BPA-002

· Common Name: Blood Pressure Monitor

· Classification: Device Class: 2

Review Panel: Cardiovascular

Name: Non-invasive Blood Pressure Measurement System

Regulation Number: 21 CFR 870.1130

Product Code: DXN

· Predicate Device: Fully Automatic Digital Blood Pressure Monitor, Model BP-1307.

K120554

· Device Description:

BPA-002 Electronic Blood Pressure Monitor for Upper Arm uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by

an internal pump in the device. The systolic and diastolic blood pressures are

determined by oscillometric method and silicon integrate pressure sensor technology.

The deflation rate is controlled by a preset mechanical valve at a constant rate. The Page 1 of 5

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K130232 Jinxinbao Electronic Co., Ltd

pressure of the cuff is completely released automatically at the end of measurement. At the same time, the measurements are displayed on the LCD display for 60 seconds.

There is a maximum pressure safety setting at 280mmHg. The device will not inflate the cuff higher than 280mmHg. It will display an irregular heartbeat symbol if an irregular heartbeat was detected during the measurement process. In addition, it has LCD backlight. After 60 seconds without operation, the blood pressure monitors turn off automatically

· Intended Use:

It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.

Item	Subject Device	Predicate Device
Device Name	Electronic Blood PressureMonitor for Upper ArmModel BPA-002	Fully Automatic DigitalBlood Pressure MonitorModel BP-1307(K120554)
	Method of Measurement	Oscillometric	Oscillometric
	Inflation Method	Automatic Internal Pump	Automatic Internal Pump
	Deflation Method	Preset Mechanical Valve ata Constant Rate	Preset Mechanical Valve ata Constant Rate
Anatomical Site		Upper Arm	Upper Arm
Range of Measurement	Pressure:0mmHg~~280mmHgPulse:30~~160 Beats/minute	Pressure:0mmHg~~300mmHgPulse:30~~180 Beats/minute

5.3 Comparison of Required Technology Characteristics

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Portugues of	Jinxinbao Electronic Co., Ltd	K130232
Accuracy	Pressure: ±3mmHg	Pressure: ±3mmHg
	Pulse: ≤5%	Pulse: ±5%
Operating Conditions	Temperature: 5℃~40℃	Temperature: 5°C ~40°C
	RH: 15%-85%	RH: <85%
Storage Conditions	Temperature: - 10 ℃~60 ℃	Temperature: - 10°C~55°C
	RH: 15%~85%	RH: <95%
Power Supply	4 Batteries Size AA	4 Batteries Size AA
Display	Liquid Crystal Digital	Liquid Crystal Digital
	Display	Display
Cuff Size	Arm Circumference:	Arm Circumference:
	22~30cm	22-36cm
Unit Weight	About 430g ( Without	About 395g ( Without
	Batteries)	Batteries)
Sets of Memory	99 Memories in three	120 Memories in two
	groups	groups
Irregular Heart Beat	Yes	Yes
Detection
Low Battery Indicator	Yes	Yes
Last 3 Results Average	Yes .	Yes

Brief Summary:

The BPA-002 Electronic Blood Pressure Monitor for Upper Arm incorporates the same fundamental technology characteristics and design with the predicate device, such as measurement method, inflation and deflation method, anatomical site, power supply, display, irregular heart beat detection, low battery indicator and last 3 results average. Though they differ in the concrete parameters of measurement range, accuracy, cuff size and sets of memory, such differences will not influence the intended use of the subject device and will not lead to safety and effectiveness concerns.

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5.4 Discussion of Tests Performed

· Clinical Tests:

Subject device BPA-002 is compliant to the SP10:2002/(R) 2008&ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.

· Non-Clinical Tests

The subject device was tested to evaluate its safety and effectiveness according to the following standards:

a. Electrical Safety Test according to IEC 60601-1, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.

b. Electromagnetic Compatibility Test according to IEC 60601-1-2:2007, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests.

c. Biocompatibility Test according to ISO 10993-5: 2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization.

d. Performance Effectiveness Test according to SP10:2002/(R) 2008&ANSI/AAMI SP 10: 2002/A 1: 2003/ (Manual, electronic or automated sphygmomanometers.

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5.5 Conclusion:

First, the subject device BPA-002 Electronic Blood Pressure Monitor for Upper Arm enjoys the same intended use and similar technological characteristics with the predicate device. Besides, the performance safety and effectiveness of the subject device has been verified in accordance with the above FDA recognized standards, thus being considered to be as safe and effective as the predicate device. In a word, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 17, 2013

Jinxinbao Electronic Co., Ltd c/o Ms. Helen Nan, General Manager Wenzhou Cytech Information Service Co., Ltd. RM-404, Bldg. 7, Jinhuichang Homeland, Liuhongqiao Rd. Wenzhou City, 325000, Zhejiang Province. CHINA

K130232 Re:

Electronic Blood Pressure Monitor for Upper Arm, Model BPA-002 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: Undated Received: August 7, 2013

Dear Ms. Nan:

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

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Page 2 - Ms. Helen Nan

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

Owen P. Faris -S

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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Jinxinbao Electronic Co., Ltd

Section 4 Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BPA-002 Electronic Blood Pressure Monitor for Upper Arm_ Device Name:

Indications for Use:

It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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

OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clwez

Digitally signed by Owen P. Faris -S Date: 2013.09.19 14:21:12 -04'00'

Page 1 of _ 1_

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).