Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

Device Description

The proposed device, Arm Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.

The proposed blood pressure monitor includes 9 models, which are BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, and BP-JC312. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.

AI/ML Overview

The provided document describes the acceptance criteria and a clinical study conducted for the Arm Type Automatic Blood Pressure Monitor to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical accuracy of the device was evaluated according to the standard ISO 81060-2:2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type." While the document states the device complies with the standard requirements, it does not explicitly list the detailed acceptance criteria and reported device performance from the ISO 81060-2:2013 standard within the provided text.

However, based on the general information provided for blood pressure monitors, the key performance metrics and their accuracies are stated:

Acceptance Criteria / Performance Metric	Reported Device Performance
Blood Pressure Accuracy	± 3 mmHg
Pulse Rate Accuracy	± 5%

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

The document states that a clinical investigation was conducted according to ISO 81060-2:2013. The ISO 81060-2 standard specifies a minimum of 85 subjects for clinical validation. Although the exact number used in this specific study is not explicitly mentioned, it can be inferred that at least 85 subjects were used to comply with the standard.

Sample Size for Test Set: Not explicitly stated, but ISO 81060-2:2013 requires a minimum of 85 subjects.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "clinical investigation... has been conducted."

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

The ISO 81060-2 standard requires that the simultaneous auscultation method, performed by human observers, serves as the reference standard (ground truth). This typically involves multiple trained observers.

Number of Experts: Not explicitly stated in the document, but ISO 81060-2:2013 generally requires at least two experts (trained observers) for simultaneous auscultation.
Qualifications of Experts: Not explicitly stated. For ISO 81060-2, the observers must be trained and validated against a mercury sphygmomanometer.

4. Adjudication Method for the Test Set

The ISO 81060-2 standard (which this study followed) uses a simultaneous auscultation method where mercury sphygmomanometers are used in conjunction with the test device. This involves multiple observers (typically two) taking measurements simultaneously and independently. If there's a significant discrepancy between their readings, a third observer might be involved or the measurement discarded.

Adjudication Method: Implicitly, the method follows the procedures outlined in ISO 81060-2 for simultaneous auscultation, which includes specific rules for reconciling or handling differences between observers' readings to establish the reference blood pressure. This could be considered akin to a 2-observer consensus (or 2+1 if required) process for establishing ground truth.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes the validation of a non-invasive blood pressure monitor, which is a standalone measurement device, not an AI-assisted interpretation tool for human readers.

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

Yes, a standalone performance evaluation was done. The clinical investigation directly assessed the accuracy of the automated blood pressure monitor against the reference standard (human auscultation) without human interpretation of the device's output influencing the measurement. The device's "algorithm only" performance (the oscillometric technique's ability to measure blood pressure) is what was validated.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation was expert consensus (or reference) measurements obtained via simultaneous auscultation using mercury sphygmomanometers, as mandated by the ISO 81060-2 standard.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set or its sample size. This type of blood pressure monitor relies on a pre-defined oscillometric algorithm. While the algorithm itself would have been developed and potentially refined using a dataset, information on this "training set" is not part of this medical device submission document, which focuses on the validation of the final product.

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

As no information is provided about a training set, the method for establishing its ground truth is also not available in this document.

Summary

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January 26, 2018

Shenzhen Jiacom Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K172896

Trade/Device Name: Arm Type Automatic Blood Pressure Monitor BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 25, 2017 Received: December 28, 2017

Dear Diana Hong:

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. Iisting 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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Page 2 - Diana Hong

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

. A. Wilhelm

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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Indications for Use

510(k) Number (if known) K172896

Device Name

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172896

1. Date of Preparation: 12/20/2017
1. Sponsor Identification

Shenzhen Jiacom Technology Co., Ltd

No.A6 Building, silicon valley power, Qinghu park, Longhua street, Bao'an district, Shenzhen, Guangdong, 518109, China

Establishment Registration Number: Not yet registered.

Contact Person: Luo Tianfeng Position: Registration specialist Tel: +86-755-29015600 Fax: +86-755-29575792 Email: zhongjingming@szjiakang.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Arm Type Automatic Blood Pressure Monitor Common Name: Arm Blood Pressure Monitor Models: BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

Regulatory information: Classification Name: Noninvasive blood pressure measurement system Classification: 2 Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular

Intended Use Statement:

Device Description

The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.

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న. Identification of Predicate Device
510(k) Number: K131558 Product Name: Electronic Blood Pressure Monitor
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
A AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
A IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
A IEC 80601-2-30 Edition 1.1 2013-07, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
1. Clinical Test Conclusion

The clinical accuracy of the proposed device was evaluated per the following standard. The test results demonstrated that the proposed device comply with the standard requirements.

ISO 81060-2 Second Edition 2013-05-01, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type.

1. Substantially Equivalent (SE) Comparison

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Item	Proposed Device	Predicate Device
		K131558
Product Code	DXN	DXN
Regulation Number	21 CFR 870.1130	21 CFR 870.1130
Class	II	II
Intended Use	Arm Type Automatic Blood PressureMonitor is a digital monitor intended foruse in measuring blood pressure and pulserate in adult patient population vianon-invasive oscillometric technique inwhich an inflatable cuff is wrapped aroundthe arm. It can be used at medical facilitiesor at home. The intended armcircumference is 22-32 cm.	Electronic Blood Pressure Monitor isintended to measure the systolic anddiastolic blood pressure as well as thepulse rate of adult person vianon-invasive oscillometric techniquein which an inflatable cuff is wrappedaround the arm. It can be used atmedical facilities or at home. Theintended arm circumference is 22-32cm.
Measurement Site	Upper arm	Upper arm
Patient Population	Adult	Adult
Measurement Item	Systolic Pressure, Diastolic Pressure, PulseRate	Systolic Pressure, Diastolic Pressure,Pulse Rate
MeasurementMethod	Oscillometric	Oscillometric
Component	LCD / Key / Cuff / MCU / Pump /Batteries	LCD / Key / Cuff / MCU / Pump /Batteries
Size	BP310A:L133.2mmW102.6mmH65mm	PG-800B6D:L138mmW121mmH83mm
	BP313A: L137mmW121mmH90mm
	BP351A: L136mmW95mmH65mm
	BP362A: L133mmW103mmH63mm
	BP366A: L145mmW105mmH53mm
	BP369A: L130mmW108mmH53mm
	BP380A: L125mmW71mmH61mm
	BP389A: L141.7mmW96.5mmH53mm
	BP-JC312: L137mmW121mmH90mm

Weight	BP310A: Approx. 390g(with batteries)	PG-800B6D:About 430g excluding batteries
	BP313A: Approx. 313g(with batteries)
	BP351A: Approx.412g(with batteries)
	BP362A: Approx.362(with batteries)
	BP366A: Approx 405g(with batteries)

Table 1 Comparison of Technology Characteristics
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	BP369A: Approx.415g(with batteries)BP380A: Approx.368g(with batteries)BP389A: Approx.368g(with batteries)BP-JC312: Approx.417g(with batteries)	Systolic pressure, diastolic pressure,unit of pressure, pulse rate, pulseindicator, date, time, WHO BPclassification indicating bar, lowbattery indicator, memory
Display	Systolic pressure, diastolic pressure, unitof pressure, pulse rate, irregular heartbeat,pulse indicator, date, time, WHO BPclassification indicating bar, low batteryindicator, memory
Blood PressureRange	30 ~ 280 mmHg	30 ~ 280 mmHg
Blood PressureAccuracy	3 mmHg	3 mmHg
Pulse Rate Range	40 ~ 200 bpm	40 ~ 199 bpm
Pulse RateAccuracy	$\pm$ 5%	$\pm$ 5%
WHO BPClassification	YesPer WHO Classification	YesPer WHO Classification
Arm circumference	22-32mm	22-32mm
ParticularPerformance	Comply withIEC 80601-2-30:2009 and ISO81060-2:2013	Comply with ANSI/AAMI SP10
Power Supply	four AA batteries	four AA or LR6 batteries
Voltage	6V	6V
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Patient-contactcomponent andmaterial	Cuff: TeryleneTube: Polyvinyl chloride (PVC)	Cuff – NylonEnclosure - ABSKey - ABS
Biocompatibility	No Cytotoxicity, sensitization, or irritation	Comply with ISO 10993requirements
Software LevelConcern	Moderate	Moderate
Labeling	Conforms to 21CFR part 801	Conforms to 21CFR part 801

The size, weight, and Pulse Rate Range of proposed device and predicate device are different. But the difference is very slight, and size, weight and Pulse Rate Range of proposed device is clearly indicated in user manual. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.

The proposed device displays the irregular heartbeat, while the predicate device does not display. The

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function of irregular heartbeat display has been validated per Software testing. Therefore, will not result in any safety and effectiveness issue of the proposed device.

The SP10 standard is no longer an FDA recognized consensus standard for evaluating the safety and performance of NIBP system, therefore the particular performance proposed device was conducted according to IEC 80601-2-30, the test results demonstrated that the proposed device meet the requirements of IEC 80601-2-30. In addition, the clinical investigation of the proposed device has been conducted according to ISO 81060-2:2013 to demonstrate the clinical accuracy. Therefore this difference on the particular performance will not affect the safety and effectiveness of the proposed device.

The patient contact components and materials of the proposed and predicate device are different. But both of them comply with ISO 10993 requirements. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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).