The device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-36 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.

Device Description

Weony Digital Blood Pressure Monitor WBP Series are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 18 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 360 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter.

The device has irreqular heart beat (IHB) indicator which compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over a specified range.

AI/ML Overview

The provided text describes the 510(k) summary for the Digital Blood Pressure Monitor WBP Series. It details the device, its intended use, comparison to a predicate device, and the non-clinical and clinical tests performed to support substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and study proving adherence to them:

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

The primary standard for clinical validation of automated non-invasive sphygmomanometers, ISO 81060-2:2018, sets the acceptance criteria for accuracy.

Acceptance Criteria (Based on ISO 81060-2:2018)	Reported Device Performance (from text)
Mean difference between the device and reference method is ≤ ±5 mmHg	"The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2." (This is a summary statement, the precise mean difference values are not provided in the text but are implied to be within the standard's limits for both systolic and diastolic pressure.)
Standard deviation of the differences between the device and reference method is ≤ 8 mmHg	(Not explicitly stated in the provided text, but implied by "within acceptable scope specified in ISO 81060-2.")

2. Sample size used for the test set and the data provenance

Sample Size: 85 patients (47 males and 38 females)
Data Provenance: Not explicitly stated, but the submission is from a Chinese manufacturer (WEONY (SHENZHEN) TECHNOLOGY CO., LTD.), so it is highly probable the data was collected in China. The text does not specify if the study was retrospective or prospective, but clinical validation studies for device approval are almost always prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for blood pressure measurements in this context is established by a reference method, not by individual experts' interpretation of images or other subjective data.

Reference Method: "The manual Mercury Sphygmomanometer was used as a reference device."
Number of Experts/Operators: While not explicitly stated, clinical validation of automated sphygmomanometers according to ISO 81060-2 typically requires measurements by trained observers using the reference method. The standard mandates specific procedures for these measurements to ensure accuracy and minimize bias, often involving at least two trained observers taking simultaneous or sequential measurements. The document does not specify the number or qualifications of these observers.

4. Adjudication method for the test set

Adjudication Method: "Same arm sequential method was adopted during the clinical testing." This indicates a direct comparison of the device's reading against the reference standard on the same arm, likely following strict protocols to minimize errors. This isn't an "adjudication" in the sense of resolving conflicting expert opinions, but rather a direct comparison to a gold 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

No, an MRMC comparative effectiveness study was not done. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting data with or without AI assistance. The study is a direct clinical validation of the device's accuracy against a known reference standard (manual mercury sphygmomanometer).

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

Yes, in spirit. The device itself is an automated system based on the oscillometric method. Its primary function is to measure blood pressure without direct human interpretation of raw signals; humans only read the displayed results. The clinical study validates the performance of this automated algorithm in measuring blood pressure. However, the term "standalone" usually refers to AI algorithms in diagnostic contexts. In this case, the device essentially functions as a "standalone" measurement system.

7. The type of ground truth used

Expert Consensus / Reference Standard: The ground truth was established using a manual Mercury Sphygmomanometer, which is considered the gold standard (or a highly accurate reference method) for blood pressure measurement in clinical validation studies. The measurements taken with this reference device are performed by trained personnel, effectively serving as an "expert consensus" or highly accurate reference.

8. The sample size for the training set

Not applicable. This document describes the validation of a traditional medical device (blood pressure monitor) that operates on an established oscillometric principle, not an AI/machine learning model that would require a separate "training set" and "test set" in the conventional sense. The device's algorithm is based on well-understood physiological principles and signal processing, not on learning from a large dataset.

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

Not applicable. As stated above, this device does not utilize a machine learning model that requires a "training set" with ground truth established for learning. Its operational principles are fixed and based on physics and established medical techniques.

Summary

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August 13, 2021

Weony (Shenzhen) Technology Co., Ltd. Lucy Yan Consultant 3rd Floor B. Building 19. He Yi BeiFang YongFa Science & Technology Park, HeYi Community, ShaJing Street, Shenzhen, GuangDong 518104 China

Re: K210671

Trade/Device Name: Digital Blood Pressure Monitor WBP Series: WBP102, WBP103. WBP104, WBP105, WBP106, WBP107 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 13, 2021 Received: July 23, 2021

Dear Lucy Yan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210671

Device Name

Digital Blood Pressure Monitor WBP Series: WBP102, WBP103, WBP104, WBP105, WBP106, WBP107

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Remediation Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C)
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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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WEONY (SHENZHEN) TECHNOLOGY CO., LTD

Product: Digital Blood Pressure Monitor

510(k) Summary

This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.

1 Administrative Information

Submission Date	Jan. 8, 2021
	Submitter's Name: WEONY (SHENZHEN) TECHNOLOGY CO.,LTD.
Manufacturerinformation	Address: Address: 3rd Floor B, Building 19, HeYi BeiFangYongFaScience & Technology Park, HeYi Community, ShaJing Street,BaoAn District, ShenZhen, 518104, P.R. ChinaContact person: Autumn LiuTEL: 86-755-86057437E-Mail: autumn.liu@weony-sz.com
SubmissionCorrespondent	Contact person: Ms Lucy.YanE-Mail: Lucy.yan@aivikon.com3rd Floor B, Building 19, HeYi BeiFangYongFa Science &Technology Park, HeYi Community, ShaJing Street, BaoAnDistrict, ShenZhen, 518104, P.R. China
Establishmentregistration number	NA

2 Device Information

Common name of the device	System, Measurement, Blood-Pressure, Non-Invasive
Trade name of the device	Digital Blood Pressure Monitor WBP Series
Type/Model of the device	WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107
Classification information	Classification panel: CardiovascularClassification name: System, Measurement, Blood-Pressure, Non-InvasiveRegulation Number: 870.1130Device Class: IIProduct Code: DXN
type of submission	510(k) Traditional

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Product: Digital Blood Pressure Monitor

3 Predicate Device Information

Sponsor:	Truly Instrument Limited
Device:	Truly Automatic Arm Blood Pressure Monitor
510(K) Number:	K091434

4 Device Descriptions

5 Intended Use/ Indications for Use

The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals and home environments by using a non-invasive oscillometric technique with a single upper arm cuff (22-36 cm).

The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings.

6 SE Comparison

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Product: Digital Blood Pressure Monitor

Version: A/0

Characteristics	Subject device	Predicate device (K091434)	Remark
DeviceName	Digital Blood Pressure Monitor	Truly Automatic Arm BloodPressure Monitor DB series	NA
DeviceModel	WBP101, WBP102, WBP103,WBP104, WBP105, WBP106,WBP107.	DB21, DB22, DB23, DB31,DB32, DB61M, DB62M, DB63M,DB71M	NA
Manufacturer	WEONY (SHENZHEN)TECHNOLOGY CO., LTD.	Truly Instrument Limited	NA
IntendedUse/Indicationfor Use	The subject device intended tomeasure the diastolic, systolicblood pressures and pulse rateof an adult individual inhospitals and homeenvironments by using a non-invasive oscillometrictechnique with a single upperarm cuff (22-36 cm).The device detects theappearance of irregular heartbeats during measurementand gives a warning signalwith readings.	Truly Automatic Arm BloodPressure Monitor DB series,Models DB21, DB22, DB23,DB31, DB32, DB61M, DB62M,DB63M, DB71M are a seriesdevice intended to measure thesystolic and diastolic bloodpressure and pulse rate of anadult individual, by using a non-invasive technique in which aninflatable cuff is wrapped aroundthe upper arm.The devices features includeirregular pulse rhythm detectionduring measurement, anddisplay a warning signal with thereading once the irregularheartbeat is detected.	SE
IntendedPopulation	adult	adult	same
IntendedAnatomicalsite	upper arm	upper arm	same
Prescription& OTC	OTC	OTC	same
WorkingPrinciple	Oscillometric method	Oscillometric method	same
Pressurization Source	Automatic internal pump	Automatic internal pump	same
InternalPowersupply	4pcs "AA" alkaline Batteries	4- size "AA" alkaline Batteries	same
MemoryFunction	2 × 90 memories (SYS, DIA,Pulse)	DB21: 2×60; DB22: 2×50;DB23: 4×99; DB31: 2×60;DB32: 1×99; DB61M:4×99; DB62M: 4×99;DB63M: 4×99; DB71M:4×99	SE
Cuff Size	220mm~360mm	220mm~340mm	SimilarNote01
Measuringrange	Pressure: 0 to 299 mmHg (in 1mmHg increment);Pulse: 40 to 180 beat/minute	Pressure: (20mmHg~280mmHg)Pulse rate range (40-195)	SimilarNote02

Table 1. Substantial Equivalence Comparison

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WEONY (SHENZHEN) TECHNOLOGY CO., LTD

Product: Digital Blood Pressure Monitor

Version: A/0

Measuringresolution	1 mmHg	1 mmHg	same
Accuracy	Pressure: ±3mmHg; Pulse:±5%	Pressure: ±3mmHg; Pulse ±5%.	same
DisplayType	LCD digital display	LCD digital display	same
Cuffattachmentmethod	By plastic host connected tomonitor	By plastic host connected tomonitor	same
IrregularHeartbeatDetection	The subject devices have theIHB function.	DB22, DB23, DB61M, DB62M,DB63M, DB71M have the IHBfeature.	same
OperatingEnvironment	10~40℃,	10~40℃,	same
	15%~90%RH	15%~90%RH
Materials	Patient contact materials of thecuff have been tested inaccordance with ISO 10993tested in accordance withaccordance with ISO 10993and FDA guidance	Patient contact materials of thecuff have been tested inaccordance with ISO 10993tested in accordance withaccordance with ISO 10993 andFDA guidance	Same

Note01: The subject devices have the larger arm circumference than predicate device, but the subject devices have been tested by ISO81060-2.

Note02: The subject device has a different measuring range of pressure and pulse from the predicate device, but the subject devices have been validated all the full claimed range.

The subject device is as same as predicate device in Working Principle. Intended patient population, intended application site, measuring accuracy. Only their Cuff size, measuring ranges are a little bit different (refer to Note01 to Note 02) which had been validated. Als, the differences would not raise any safety or effectiveness issue based on tests in this submission.

Thus, the subject device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US.

7 Brief discussions of the non-clinical tests

The subject device conforms to the following guidances and standards:

Non-Invasive Blood Pressure (NIBP) Monitor Guidance や
IEC 60601-1:2005+A1:2012: Medical Electrical Equipment Part 1: General や Requirements for Basic Safety and Essential Performance;
IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General や Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
IEC 60601-1-11: 2010 Medical Electrical Equipment Part 1-11: General ゃ Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems

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Used in The Home Healthcare Environment;

ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices Part 5: ゃ Tests for In Vitro cytotoxicity;
や ISO 10993-10: 2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
ゃ IEC 80601-2-30: 2013 Medical electrical equipment - Part 2-30: Particular Requirements for the Basic Safety and Essential Performance of Automated Non-invasive Sphygmomanometers

8 Brief discussions of clinical tests

ISO 81060-2:2018 Non-invasive sphygmomanometers Part 2: Clinical ゃ validation of automated measurement type;
In this clinical investigation, 85 patients (47 males and 38 females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect.

The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.

9 Other information (such as required by FDA guidance)

No other information.

11 Conclusions

The subject device:

Digital Blood Pressure monitor manufactured by WEONY (SHENZHEN) TECHNOLOGY CO., LTD. is respectively substantially equivalent to the predicate device Arm Blood Pressure Monitor manufactured by Truly Instrument Limited (K091434).

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).