The Wrist Type 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 cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.

Device Description

The proposed device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. The Wrist Type Blood Pressure Monitor can automatically complete the inflation, deflation and measurement of systolic and diastolic blood pressure as well as the pulse rate of adult person. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data; User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result; User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure. diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Wrist Type Blood Pressure Monitor (K162616). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving stand-alone safety and effectiveness through extensive, detailed clinical trials with the rigor typically seen for novel devices.

Therefore, the information available is primarily related to demonstrating equivalence to the predicate device, particularly regarding adherence to relevant performance standards for blood pressure monitors. It does not contain the granular detail about acceptance criteria, test set characteristics, expert qualifications, or multi-reader studies that would be present in a submission for a novel AI device with complex image analysis or diagnostic capabilities.

Here's an attempt to extract and interpret the information based on the provided document, addressing the requested points. Please note that many points cannot be fully answered due to the nature and scope of this 510(k) submission for a blood pressure monitor.

Acceptance Criteria and Device Performance (as demonstrated for a blood pressure monitor)

The primary acceptance criteria for a blood pressure monitor, as indicated by compliance with ISO 81060-2:2013, relate to the accuracy of blood pressure measurements.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO 81060-2:2013)	Reported Device Performance (YK-BPW1)
Blood Pressure Accuracy within ±5 mmHg (Mean difference and standard deviation requirements per ISO 81060-2:2013, though specific statistical values are not detailed in this summary beyond the general ±5mmHg statement).	"The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2013 within the ±5mmHg." (Page 6) Note: Table 2 shows a general "BP Accuracy: ±3 mmHg" which typically refers to the device's inherent precision, not the clinical validation results against a gold standard as per ISO 81060-2. The clinical conclusion on page 6 is more relevant for the acceptance criteria.
Pulse Rate (PR) Accuracy (not explicitly detailed in acceptance criteria, but measured)	PR Range: 40-199 bpm (Table 2)
Non-Clinical Test Compliance	IEC 60601-1:2012 (General safety) IEC 60601-1-2:2007 (EMC) ISO 80601-2-30:2013 (Specific for automated non-invasive sphygmomanometers) ISO 10993-5:2009 (Biocompatibility - cytotoxicity) ISO 10993-10:2010 (Biocompatibility - irritation/sensitization) (Page 5-6)
Substantial Equivalence to Predicate Device	Demonstrated through comparative tables for product code, regulation, class, intended use, application site, patient population, measurement items, principle, main components, BP/PR ranges, operation/storage conditions, data storage, performance standard, cuff size, power supply, voltage, electrical safety, EMC, biocompatibility, labeling, and software level of concern. (Pages 6-8)

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

Sample Size: "There were 150 subjects been selected to participate in the trial." (Page 6)
Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. It can be inferred that it was likely conducted in China, given the manufacturer's and submission correspondent's locations.
Retrospective or Prospective: Not explicitly stated, but clinical validation studies for device accuracy are typically prospective to ensure controlled measurement conditions per the standard.

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

The ground truth was established by "Auscultation... with the qualified calibrated mercurial sphygmomanometer used as control group." (Page 6).
The document does not specify the number or qualifications of the individuals (experts or clinicians) who performed the auscultation measurements. For ISO 81060-2:2013, typically two independent observers (clinicians trained in auscultation) are required to take measurements.

4. Adjudication Method for the Test Set

Not explicitly described. For ISO 81060-2:2013, the standard dictates how the reference measurements are obtained and compared, often involving simultaneous auscultation by multiple observers. An explicit adjudication method beyond this standard protocol is not mentioned.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools (e.g., in radiology) where human-in-the-loop performance is being evaluated. This device is a standalone measurement device (blood pressure monitor), not an AI-assisted diagnostic tool.

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

Yes, the primary clinical validation was a standalone performance test of the device's accuracy. The device (Wrist Type Blood Pressure Monitor, YK-BPW1) operated autonomously to measure blood pressure, and its readings were compared against the established gold standard (auscultation). This is inherent to the type of device.

7. The Type of Ground Truth Used

Clinical Measurements via Auscultation: The ground truth was established by human auscultation using a qualified calibrated mercurial sphygmomanometer (a medical standard for manual BP measurement). This represents expert consensus/clinical gold standard.

8. The Sample Size for the Training Set

This document describes a clinical validation study and non-clinical tests for a medical device (blood pressure monitor), not a machine learning or AI algorithm in the sense of needing a distinct "training set." The device's underlying algorithm is pre-programmed based on known oscillometric principles. Therefore, there is no explicit "training set" sample size mentioned or implied for this type of device submission.

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

As there is no "training set" in the context of an AI algorithm being trained, this question is not applicable to the information provided for this blood pressure monitor. The device's design and internal algorithms are based on established biometric measurement principles.

Summary

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March 9, 2018

Xuzhou Yongkang Electronic Science Technology Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. LiYuan Town, TongZhou District, Beijing, 101121 China

Re: K162616

Trade/Device Name: Wrist Type Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: January 21, 2018 Received: January 25, 2018

Dear Ray Wang:

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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 mediation-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.A. Willemsen

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K162616

Device Name Wrist Type Blood Pressure Monitor

Indications for Use (Describe)

The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Tab #3 510(k) Summary

This 510(k) Summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K162616

1. Date of Preparation
  01/21/2018
Sponsor 2.

Xuzhou Yongkang Electronic Science Technology Co., Ltd

4F Building C8, 40 Jingshan Road, Econonic and Technolgical Development Zone, Xuzhou, Jiangsu, China Establishment Registration Number: Not yet registered or the Number Contact Person: YanLi Li Position: General Manager Tel: 86-516- 87892766-631 Fax:86- 516-87892766 -606 Email: lyl(@yonker.cn

Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd.

5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Wrist Type Blood Pressure Monitor Common Name: Blood Pressure Monitor Model(s): YK-BPW1

Regulatory Information:

Classification Name: System, measurement, blood-pressure, non-invasive; Classification: II; Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

Indication For Use Statement:

Device Description 5.

The proposed device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor.

The Wrist Type Blood Pressure Monitor can automatically complete the inflation, deflation and measurement of systolic and diastolic blood pressure as well as the pulse rate of adult person. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data;

User can set the time as year, month, day, hour and minute;

User can enable or disable the function of voice broadcast about measurement result;

User can select the unit of the measurement: mmHg or KPa;

The device has the data storage function for data reviewing, including the data of systolic pressure. diastolic pressure, pulse rate and measurement time.

The device has low power indicator to indicate the states of low batteries power.

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1. Identification of Predicate Device
  Predicate #

510(k) Number: K131569

Product Name: PG 800A Series Electronic Blood Pressure Monitor Manufacturer: Shenzhen Pango Electronic Co., Ltd.

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:

IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.

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.

ISO 80601-2-30:2013, 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 trials for YK-BPW1 were performed according to ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.

There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device.

The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2013 within the ±5mmHg.

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9. Substantially Equivalent (SE) Comparison

Table 1 General Comparison

ITEM	Proposed Device	Predicate DeviceK131569	Remark
Product Code	DXN	DXN	SE
Regulation No.	21 CFR 870.1130	21 CFR 870. 1130	SE
Class	2	2	SE
Intended Use	The Wrist Type 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 cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.	The 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.	SE
Application Site	Wrist	Wrist	SE
PatientPopulation	Adult	Adult	SE
MeasurementsItem	SYS,DYS,Pulse	SYS,DYS,Pulse	SE
Principle	Oscillometric	Oscillometric	SE
MainComponent	LCD / Key / Cuff / MCU / Pump / Batteries	LCD / Key / Cuff / MCU / Pump / Batteries	SE

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ITEM	Proposed Device	Predicate DeviceK131569	Remark
BP Range	20-280 mmHg	30-280 mmHg	SE
BP Accuracy	$ \pm $ 3 mmHg	$ \pm $ 3 mmHg	SE
PR Range	40-199	40-199 bpm	SE
OperationCondition	5-40 °C15%-80% RH50kPa~105kPa	5-40 °C30%-80% RHAtmosphere Pressure	SE
Storage Condition	-20-55 °C$ \le $ 90% RH50kPa~105kPa	-20-55 °C10%-90% RHAtmosphere Pressure	SE
Data Storage	SYS, DIA, PR, Measurement Time, No.	SYS, DIA, PR, Measurement Time, No.	SE
PerformanceStandard	Comply with ISO 80601-2-30	Comply with AAMI SP10	SE
Cuff Size	310 x 75 mm	30.8 cm (length) x 8 cm (width)	Analysis
Power Supply	2 x AAA	Two AAA or LR03 Batteries	SE
Voltage	3V	3V	SE

Table 2 Performance Comparison

Analysis

The proposed device is substantially equivalent to the predicate device. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

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ITEM	Proposed Device	Predicate Device	Remark
		K131569
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
Label andLabeling	Conforms to FDA Regulatory Requirements	Conforms to FDA RegulatoryRequirements	SE
Level of Concernof the Software	Moderate	Moderate	SE

Table 3Safety Comparison

10. Substantially Equivalent (SE) Conclusion

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

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).