Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.

Device Description

The proposed device, Wrist 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 wrist 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 5 models, which are BP165W, BP180W, BP186W and BP 188W. 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 text describes the acceptance criteria and a clinical study for the Wrist Type Automatic Blood Pressure Monitor (Models: BP165W, BP180W, BP186W, BP188W) by Shenzhen Jiacom Technology Co., Ltd.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
Clinical Accuracy: ISO 81060-2 Second Edition 2013-05-01 (Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type)	"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." (Specific numerical results are not provided in this document, only compliance with the standard.)
Basic Safety and Essential Performance: 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)	"The test results demonstrated that the proposed device complies with the following standards." (Implied compliance with this standard.)
Electromagnetic Disturbances: 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)	"The test results demonstrated that the proposed device complies with the following standards." (Implied compliance with this standard.)
Home Healthcare Environment Requirements: 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)	"The test results demonstrated that the proposed device complies with the following standards." (Implied compliance with this standard.)
Particular Requirements for NIBP: 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)	"The test results demonstrated that the proposed device complies with the following standards." (Implied compliance with this standard.)
Biocompatibility - In Vitro Cytotoxicity: ISO 10993-5:2009 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)	"No Cytotoxicity, sensitization, or irritation"
Biocompatibility - Irritation and Skin Sensitization: ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization)	"No Cytotoxicity, sensitization, or irritation"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states that a clinical accuracy study was conducted according to ISO 81060-2:2013. This standard details the requirements for clinical validation of automated non-invasive sphygmomanometers. While the specific sample size, country of origin, and whether the data was retrospective or prospective are not explicitly stated in this document, adherence to ISO 81060-2:2013 generally implies:

A minimum of 85 participants for clinical testing to ensure a statistically robust evaluation (as per the standard's requirements for phase II testing).
A prospective study design, as the standard describes a protocol for conducting direct comparisons against a reference measurement.
Data provenance would be from the site where the clinical validation was performed, but the specific country is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Again, the document does not explicitly state the number or qualifications of experts. However, for a clinical validation study adhering to ISO 81060-2:2013, the ground truth (reference blood pressure measurements) is typically established by trained observers (experts) using a mercury or auscultatory sphygmomanometer. The standard requires the observers to be trained and qualified, often with specifications regarding their experience and successful completion of a training program to minimize inter-observer variability.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

For clinical validation studies following ISO 81060-2:2013, the standard dictates that reference blood pressure measurements be taken simultaneously by at least two trained observers using an auscultatory method. If there is a significant discrepancy between the two observers' readings, a third observer might be involved (though the standard prioritizes agreement between the initial two). So, a 2 (two trained observers) method is implied, with potential for adjudication if specified by the study protocol compliant with the standard.

5. 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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor is there any mention of "AI assistance" or "human readers" in the context of blood pressure measurement in this document. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool requiring human interpretation.

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

Yes, the primary clinical validation conducted was a standalone performance study of the device's algorithm. The document states that the "clinical accuracy of the proposed device was evaluated per... ISO 81060-2 Second Edition 2013-05-01." This standard specifically assesses the automated device's ability to measure blood pressure without human intervention (other than proper placement and initiation of the measurement), comparing its readings to simultaneously obtained reference measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for the clinical validation would be expert reference measurements obtained using a validated auscultatory method (e.g., mercury sphygmomanometer) as mandated by the ISO 81060-2:2013 standard.

8. The sample size for the training set

The document does not provide any information about a "training set" or algorithm development. The information focuses on the clinical validation of an already developed device. Automatic blood pressure monitors based on oscillometric techniques often rely on established algorithms and calibration methods rather than machine learning "training sets" in the contemporary sense.

9. How the ground truth for the training set was established

As no training set is described in the provided information, the method for establishing its ground truth is also not mentioned.

Summary

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March 2, 2018

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

Re: K172972

Trade/Device Name: Wrist Type Automatic Blood Pressure Monitor, Models: BP165W. BP180W, BP186W and BP188W Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 30, 2018 Received: February 1, 2018

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, 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 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

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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.

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.

M& Hillelement

for 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) K172972

Device Name

Wrist Type Automatic Blood Pressure Monitor, Models: BP165W, BP180W, BP186W and BP188W

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: K172972

1. Date of Preparation: 01/16/2018
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: Wrist Type Automatic Blood Pressure Monitor Common Name: Wrist Blood Pressure Monitor Models: BP165W, BP168W, BP180W, BP186W and BP188W

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.

న. Identification of Predicate Device

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510(k) Number: K131569 Product Name: Electronic Blood Pressure Monitor, PG-800A Series

Non-Clinical Test Conclusion 6.
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.
A 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
Product Code	DXN	DXN
Regulation Number	21 CFR 870.1130	21 CFR 870.1130
Class	II	II
Intended Use	Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.	PG-800A Series Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.
Measurement Site	wrist	wrist
Patient Population	Adult	Adult
Measurement Item	Systolic Pressure, Diastolic Pressure, Pulse Rate	Systolic Pressure, Diastolic Pressure, Pulse Rate
Measurement Method	Oscillometric	Oscillometric
Component	LCD / Key / Cuff / MCU / Pump / Batteries	LCD / Key / Cuff / MCU / Pump / Batteries
Blood Pressure Range	30 ~ 280 mmHg	30 ~ 280 mmHg
Pulse Rate Range	40 ~ 200 bpm	40 ~ 199 bpm
WHO BP Classification	YesPer WHO Classification	YesPer WHO Classification
Wrist circumference	13.5-19.5 cm	13.5-19.5 cm
Particular Performance	Comply withIEC 80601-2-30:2009 andISO 81060-2:2013	Comply with ANSI/AAMI SP10
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
Biocompatibility	No Cytotoxicity, sensitization, or irritation	Comply with ISO 10993 requirements
Software Level Concern	Moderate	Moderate

Table 1 Comparison of Technology Characteristics

The proposed device and its predicate devices have the identical indented use, components, principle and

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performance. The difference between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.

1. Substantially Equivalent (SE) Conclusion
  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).