The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5cm to 21.5cm in home and hospital facilities by using a non-invasive oscillometric technique. The device detects the appearance of irregular heartbeats 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 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. 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 wrist circumference approximately between 135 and 215 mm, includes the inflatable bladder and PU shell. All models of the wrist 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 two AAA alkaline batteries or adatpter.

The device has irregular 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

This document describes the FDA 510(k) clearance for the Digital Blood Pressure Monitor WBP Series (K231542) by Weony (Shenzhen) Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to predicate devices, particularly regarding performance and accuracy.

Here is an analysis of the requested information based on the provided text:

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

The primary acceptance criteria for blood pressure monitors is typically defined by the ISO 81060-2 standard for clinical validation of automated measurement type. This standard specifies limits for the difference between the device's measurements and reference measurements. The document states the device was tested against this standard and the results show the accuracy is "within acceptable scope specified in ISO 81060-2."

While the document references the standard for acceptance, it does not provide a specific table of numerical acceptance criteria alongside the actual reported device performance (e.g., mean difference and standard deviation). However, the "SE Comparison" table includes:

Characteristic	Acceptance Criteria (Implied by Predicates)	Reported Performance (Subject Device)
Accuracy (Pressure)	±3mmHg or 2% of reading (Predicate K131742) / ±3mmHg (Predicate K210671)	±3mmHg
Accuracy (Pulse)	±5% (Both Predicates)	±5%
Measuring Range (Pressure)	0 to 299 mmHg (Both Predicates)	0 to 299 mmHg
Measuring Range (Pulse)	40 to 180 beat/minute (Both Predicates)	40 to 180 beat/minute
Measuring Resolution	1 mmHg (Both Predicates)	1 mmHg

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

Sample Size for Test Set: 85 patients (41 males and 44 females)
Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Weony (Shenzhen) Technology Co., Ltd. in China, and the study was likely conducted in China. The study was a prospective clinical validation as it involved patients participating in a new study.

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

The document states that a "manual Mercury Sphygmomanometer was used as a reference device" for ground truth. It does not mention the number of experts or their qualifications for establishing this ground truth. Typically, for such studies, trained clinical personnel (e.g., doctors, nurses) would perform the manual measurements.

4. Adjudication method for the test set

The document does not describe any specific adjudication method for the test set. The ground truth was established by direct comparison to a manual mercury sphygmomanometer.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not conducted. This refers to studies where multiple human readers assess cases with and without AI assistance. The device is a direct measurement device (blood pressure monitor), not an AI-assisted diagnostic imaging tool.

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

Yes, the primary clinical validation described is a standalone performance study. The device, as an automated non-invasive sphygmomanometer, inherently performs its measurements and calculations without human intervention in the core measurement process. The study validates the device's accuracy against a gold standard (manual mercury sphygmomanometer).

7. The type of ground truth used

The ground truth used was reference measurements from a manual Mercury Sphygmomanometer.

8. The sample size for the training set

The document does not specify a separate "training set" sample size. For medical devices like blood pressure monitors, the validation typically involves extensive bench testing and a clinical validation study (as described) rather than a machine learning "training set" in the conventional AI sense. If there was any internal algorithm development or calibration, the data used for that is not detailed.

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

As there's no explicitly mentioned "training set" in the AI sense, this information is not applicable. The device's underlying "algorithm" is the oscillometric method, which is a well-established physiological principle, not a machine learning model that requires a distinct, labeled training dataset from scratch. The performance is validated through the clinical study against a gold standard.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 7, 2023

Weony (Shenzhen) Technology Co., Ltd. Lucy Yan Consultant 401, the 6th building, Changfeng Industrial Zone Dongkeng Community, Fenghuang Street, Guangmi Shenzhen, GuangDong 518132 China

Re: K231542

Trade/Device Name: Digital Blood Pressure Monitor WBP Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 18, 2023 Received: May 30, 2023

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.

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

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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,

Stephen C. Browning -S

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) K231542

Device Name Digital Blood Pressure Monitor WBP Series

Indications for Use (Describe)

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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510(k) Summary K231542

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

1 Administrative Information

Submission Date	May. 18, 2023
Manufacturerinformation	Submitter's Name: WEONY (SHENZHEN) TECHNOLOGYCO., LTD.Address: 401, the 6th building, Changfeng Industrial Zone,Dongkeng Community, Fenghuang Street, GuangmingDistrict, Shenzhen, 518132, PR. China.
	Contact person: Autumn LiuTEL: 86-755-86057437E-Mail: autumn.liu@weony-sz.com
SubmissionCorrespondent	Contact person: Ms Lucy.YanE-Mail: Lucy.yan@aivikon.comAddress: 401, the 6th building, Changfeng Industrial Zone,Dongkeng Community, Fenghuang Street, GuangmingDistrict, Shenzhen, 518132, PR. China.
Establishmentregistration number	NA

2 Device Information

Common name ofthe device	System, Measurement, Blood-Pressure, Non-Invasive
Trade name of thedevice	Digital Blood Pressure Monitor WBP Series
Type/Model of thedevice	WBP203, WBP204, WBP205, WBP206Classification panel: Cardiovascular
Classificationinformation	Classification name: System, Measurement, Blood-Pressure, Non-Invasive
	Regulation Number: 870.1130
	Device Class: II

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		Product Code: DXN
typesubmission	of	510(k)
		Traditional

3 Predicate Device Information

Primary predicate device:

Sponsor:	Omron Healthcare, Inc.
Device:	Model HEM-6131
510(K) Number:	K131742

Reference predicated device :

Sponsor:	WEONY (SHENZHEN) TECHNOLOGY CO., LTD.
Device:	WBP101, WBP102, WBP103, WBP104,WBP105, WBP106, WBP107.
510(K) Number:	K210671

4 Device Descriptions

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5 Intended Use/ Indications for Use

6 SE Comparison

Characteristics	Subject device	Primary Predicate device (K131742)	Reference Predicate device(K210671)	Remark
Device Name	Digital Blood Pressure Monitor WBPSeries	Model HEM-6131	Digital Blood Pressure Monitor	NA
Device Model	WBP203, WBP204, WBP205,WBP206,	HEM-6131	WBP101, WBP102, WBP103,WBP104, WBP105, WBP106,WBP107.	NA
Manufacturer	WEONY (SHENZHEN)TECHNOLOGY CO., LTD.	Omron Healthcare, Inc.	WEONY (SHENZHEN)TECHNOLOGY CO., LTD.	NA
Intended Use/Indication forUse	The device is a digital monitorintended for use in measuring bloodpressure and pulse rate in adultpatient population with wristcircumference ranging from 13.5cm to21.5cm in home and hospital facilitiesby using a non-invasive oscillometrictechnique. The device detects theappearance of irregular heartbeatsduring measurement and gives awarning signal with readings.	The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult patient population withwrist circumference ranging from 5 1/4inches to 8 1/2 inches (13.5 cm to 21.5cm).The device detects the appearance ofirregular heartbeats during measurement and gives awarning signal with readings.	The subject device intended tomeasure the diastolic, systolic bloodpressures and pulse rate of an adultindividual in hospitals and homeenvironments by using a non-invasive oscillometric technique witha single upper arm cuff (22-36 cm).The device detects the appearanceof irregular heart beats duringmeasurement and gives a warningsignal with readings.	SE
IntendedPopulation	adult	adult	adult	Same
Environment ofUSE	Home	Home	Home	Same
IntendedAnatomical site	Wrist	Wrist	upper arm	Same asK131742
Prescription &OTC	ОТС	ОТС	ОТС	Same
PatientConnection	Yes via Cuff	Yes via Cuff	Yes via Cuff	Same
WorkingPrinciple	Oscillometric method	Oscillometric method	Oscillometric method	Same
Pressuresensor	Piezo resistance sensor	Piezo resistance sensor	Piezo resistance sensor	Same
PressurizationSource	Automatic internal pump	Automatic internal pump for inflationAutomatic internal valve for deflation	Automatic internal pump	Same
Internal Powersupply	2pcs "AAA" alkaline Batteries	2 pcs "AAA" alkaline Batteries	4pcs "AA" alkaline Batteries	Same asK131742
MemoryFunction	2 × 90 memories (SYS, DIA, Pulse)	60 measurements	2 × 90 memories (SYS, DIA, Pulse)	Same asK231288
Cuff Size	13.5 cm to 21.5 cm	13.5 cm to 21.5 cm	220mm~360mm	Same asK131742

Table 1. Substantial Equivalence Comparison

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WEONY (SHENZHEN) TECHNOLOGY CO., LTD

Measuringrange	Pressure: 0 to 299 mmHg (in 1 mmHgincrement);	Pressure: 0 to 299 mmHg (in 1 mmHgincrement);	Pressure: 0 to 299 mmHg (in 1mmHg increment);	Same
	Pulse: 40 to 180 beat/minute	Pulse: 40 to 180 beat/minute	Pulse: 40 to 180 beat/minute
Measuringresolution	1 mmHg	1 mmHg	1 mmHg	Same
Accuracy	Pressure: ±3mmHg; Pulse: ±5%	Pressure: ±3mmHg or 2% of reading;Pulse ±5%.	Pressure: ±3mmHg; Pulse: ±5%	Same
Display Type	LCD digital display	LCD digital display	LCD digital display	Same
IrregularHeartbeatDetection	Yes	Yes	Yes	same
OperatingCondition	10~40℃,	10~40℃,	10~40℃,	DifferentNote01;Same asK231288
	15%~85%RH	15%~85%RH	15%~90%RH
StorageCondition	-20~55℃,	-20~60℃,	-20~55°C,	DifferentNote02:Same asK231288
	10%~95%RH	10%~95%RH	10%~95%RH
Dimension	L78mmW65mmH66mm	78(W)60(D)21(H)mm	L140mmW116mmH55mm	SE
Weight	Approx. 81.5g(batteries not included)	Approximately 101g	Approx. 265.5g(batteries notincluded)	SE
Materials	Patient contact materials of the cuffhave been tested in accordance withISO 10993 tested in accordance withaccordance with ISO 10993 and FDAguidance	Patient contact materials of the cuff havebeen tested in accordance with ISO10993 tested in accordance withaccordance with ISO 10993 and FDAguidance	Patient contact materials of the cuffhave been tested in accordance withISO 10993 tested in accordancewith accordance with ISO 10993 andFDA guidance	Same

Product: Digital Blood Pressure Monitor WBP Series

Note01 &02: The subject devices have different environment conditions of operation and storage from predicate device, but the subject devices have been tested by IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30 and ISO81060-2.

The subject device is as same as predicate device in Working Principle, intended patient population, intended application site, measuring accuracy. Only their environment conditions 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 [807.92(b)(1)]:

The subject device conforms to the following guidances and standards:

や Non-Invasive Blood Pressure (NIBP) Monitor Guidance
IEC 60601-1:2005+A1:2012+A2:2020: Medical Electrical Equipment Part 1: ゃ

General Requirements for Basic Safety and Essential Performance;

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� IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
IEC 60601-1-11: 2015 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;
ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices Part 5: � Tests for In Vitro cvtotoxicity:
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for ゃ irritation and skin sensitization;
IEC 80601-2-30: 2018 Medical electrical equipment Part 2-30: Particular � Requirements for the Basic Safety and Essential Performance of Automated Non-invasive Sphygmomanometers

The nonclinical, bench testing included:

· Performance verification testing including Static Pressure accuracy, Static Leakage and Dynamic Pressure accuracy to confirm acceptable performance of device features and functions

• Cleaning verification testing to confirm device retains its performance when cuff is cleaned with household detergents (70% alcohol) as may be required in home use environment

• Product life verification testing to confirm device retains its performance when the device was used to measure blood pressure for at least 2 years as may be required in home use environment

· Irregular heart beat testing against the reference predicate WBP101 device (K210671)

Other nonclinical safety testing included:

· Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
· Evaluation of relevant electrical safety, electromagnetic compatibility and electrostatic discharge requirements per IEC60601 and 80601 requirements
Software verification and validation

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of WBP203 SERIES meet the established specifications necessary for consistent performance during its

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intended use. In addition, the collective bench testing demonstrates that WBP203 SERIES does not raise different questions of safety or effectiveness for measurement of blood pressure and pulse in a home use environment when compared to the predicates.

8 Brief discussions of clinical tests [807.92(b)(2)]:

ISO 81060-2:2018 Non-invasive sphygmomanometers Part 2: Clinical ゃ validation of automated measurement type;
In this clinical investigation, 85 patients (41 males and 44 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 primary predicate device Blood Pressure Monitor manufactured by Omron Healthcare, Inc. (K131742) and the reference predicate device Digital Blood Pressure Monitor manufactured by WEONY (SHENZHEN) TECHNOLOGY CO., LTD. (K210671).

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).