The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches (22 cm to 42 cm). The device is intended for indoor use.

Device Description

The Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual 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".

When using the device, users will be able to monitor their blood pressure and their pulse rate. The device will give metrics about heart health:

Systolic blood pressure
Diastolic blood pressure
Pulse rate

The device should be placed on the left upper arm during all the measurement duration. The measurement lasts between 30 seconds and 3 minutes depending on the selected mode by the user. The measurement can be longer if the user selects the triple measurement mode (three blood pressure measurements in a row to give an average).

Users will get an instant feedback after the measurement thanks to a LED matrix located on the tube part of the device.

WPM05 (BPM Connect)
The device synchronizes with Withings application and Withings server via Bluetooth or Wi-Fi connectivity.

WPM06 (BPM Connect Pro)
The device synchronizes with third-party applications by cellular, Wi-Fi or Bluetooth connectivity. On the mobile application, users have access to their historic and more contents around each metrics.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Blood Pressure Monitor (K223374), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily refers to the relevant standards and states that the device meets them. It doesn't present a specific table of numerical acceptance criteria alongside the device's numerical performance for all parameters. However, it does highlight the performance specific to blood pressure and pulse measurement.

Acceptance Criteria (Standard Reference)	Reported Device Performance
Blood Pressure Measurement Accuracy
ISO 80601-2-30: 2017 & ISO 81060-2: 2018 (Mean error and SD of differences for SBP and DBP)	Not over the limits of ISO 81060-2: 2018
Blood Pressure Measurement Range
IEC 80601-2-30 (Range for subject device)	0mmHg ~ 285mmHg
Predicate Device (for comparison)	0mmHg ~ 299mmHg
Blood Pressure Measurement Accuracy (Specific to device)	Within ±3mmHg (0.4kPa) or 2% of reading
Pulse Measurement Range
Subject Device (via IEC 80601-2-30 demonstration)	40-180 beat/minute
Predicate Device (for comparison)	40-199 beat/minute
Pulse Measurement Accuracy	±5% of reading
Biocompatibility
ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)	Passed (Biocompatibility evaluation conducted)
Electrical Safety
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11	Demonstrated safety and performance
Wireless Coexistence
ANSI C63.27: 2017, AAMI TIR69: 2017	Testing conducted

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

Sample Size for Test Set (Clinical Data): 135 qualified healthy adult subjects.
Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer's location in China, it is highly probable the clinical study was conducted there. The study appears to be prospective as it involves "qualified healthy adult subjects" being tested.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth in the clinical validation study. For ISO 81060-2 adherence, typically a specific protocol involving independent, trained observers (often physicians or technicians certified in blood pressure measurement) taking reference measurements with a validated mercury sphygmomanometer or auscultatory method is followed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method. In the context of ISO 81060-2 clinical validation, ground truth is established through a standardized reference measurement method (e.g., auscultation by trained observers), and discrepancies are usually handled by comparing the device readings to these established reference readings. It's not a consensus-based adjudication in the same way an imaging study might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for interpretative devices (e.g., AI for radiology) where human readers are making diagnoses. This device is a measurement device (blood pressure monitor), and its accuracy is validated against established reference measurement methods, not through human reader interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The clinical data section explicitly states: "The device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard specifically evaluates the accuracy of the automated device (algorithm only) against a reference standard.

7. Type of Ground Truth Used

Clinical Ground Truth (Reference Standard Measurement): The ground truth was established through a standardized clinical reference measurement method, as prescribed by ISO 81060-2. This typically involves simultaneous or near-simultaneous measurements by trained observers using a validated reference sphygmomanometer (e.g., mercury or calibrated oscillometric device for reference) with the test device.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. While the device uses an "Oscillometric method" which is a "well-known technique in the market," the specific neural network or machine learning component that would require a distinct training set is not detailed. The oscillometric method itself relies on empirically derived algorithms and signal processing, often refined with large datasets, but these are usually part of the initial engineering and development, not explicitly detailed as a 'training set' in the 510(k) summary for such a device.

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

Since the document does not mention a distinct "training set" or explicit machine learning model in the context of the submission, it does not provide information on how the ground truth for a training set was established. The oscillometric method generally works by analyzing oscillations in cuff pressure during deflation to determine systolic, diastolic, and mean arterial pressure using proprietary algorithms derived from physiological principles and extensive validation studies over time.

Summary

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June 30, 2023

Guangdong Transtek Medical Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K223374

Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 7, 2022 Received: November 4, 2022

Dear Kevin 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. 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 mediation-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.

Robert T. Kazmierski -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223374

Device Name Blood Pressure Monitor

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

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2021/07/16

1. Submission sponsor

Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Jerry Fan Title: RA Manager E-mail: jialong.fan(@transtekcorp.com

Submission correspondent 2.

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067

Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160

Trade/Device Name	Blood Pressure Monitor
Model	WPM05 and WPM06
Common Name	Automatic Blood Pressure Monitor
Regulatory Class	Class II
Product Code	DXN
Submission type	Traditional 510(K)

Subject Device Information 3.

Predicate Device 4.

Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.

Device name: Blood Pressure Monitor, LS-802-GS

510(K) Number: K202891

5. Device Description

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blood pressure and calculating pulse rate, which is a well-known technique in the market called the "Oscillometric method".

When using the device, users will be able to monitor their blood pressure and their pulse rate. The device will give metrics about heart health:

Systolic blood pressure
Diastolic blood pressure
Pulse rate

Users will get an instant feedback after the measurement thanks to a LED matrix located on the tube part of the device.

WPM05 (BPM Connect)

The device synchronizes with Withings application and Withings server via Bluetooth or Wi-Fi connectivity.

WPM06 (BPM Connect Pro)

The device synchronizes with third-party applications by cellular, Wi-Fi or Bluetooth connectivity. On the mobile application, users have access to their historic and more contents around each metrics.

6. Intended use & Indication for use

Features	Subject DeviceWPM05, WPM06	Predicate Device K202891LS802-GS	Remark
Applicant	Guangdong Transtek MedicalElectronics Co., Ltd.	Guangdong Transtek MedicalElectronics Co., Ltd.	/
ClassificationRegulation	21CRF 870.1130	21CRF 870.1130	Same
Classification andCode	Class II,DXN	Class II,DXN	Same
Commonname	Automatic Arm Blood PressureMonitor	Automatic Arm Blood PressureMonitor	Same
Intended use	The device is a digital monitorintended for use in measuring	The Transtek Blood PressureMonitor is digital monitors	Different (1)
Features	Subject DeviceWPM05, WPM06	Predicate Device K202891LS802-GS	Remark
	blood pressure and pulse rate.The device is intended to beused in a human adultpopulation with an armcircumference of 9 inches to 17inches (22 cm to 42 cm). Thedevice is intended for indooruse.	intended for use in measuringblood pressure and heartbeat ratewith arm circumference rangingfrom 22cm to 45cm (about 8¾"-17½")It is intended for adult indooruse only.








PatientPopulations	Adults	Adults	Same
Principle	Oscillometric method	Oscillometric method	Same
Target population	Adult	Adult	Same
Anatomical sites	Upper Arm	Upper Arm	Same
Where used(hospital, home,ambulance, etc.)	Home	Home	Same
Energy used and /or delivered	5V rechargeable Li-Polymerbattery	4 * 1.5V AA Battery,or by a DC 6V adapter	Different (2)
Human factors	Blood pressure	Blood pressure	Same
Performance	Measuring systolic and diastolicblood pressure and pulse rate ofadult individual	Measuring systolic and diastolicblood pressure and pulse rate ofadult individual, Includingirregular pulse rhythm detection	Same
Biocompatibility	Cuff, according to ISO-10993	Cuff, according to ISO-10993	Same
Compatibility withthe environmentand other devices	Operation Environment:5℃~ 40℃, up to 90%RH,Atmospheric: 86KPa~106KPa.Storage Environment:-20℃~~60℃, up to 95%RH.Atmospheric: 86KPa~~106KPa.	Operation Environment:5℃~40℃,15%~~90%RH,Atmospheric: 70KPa~~106KPa.Storage Environment:-20℃~60℃, ≤93%RH.	Different (3)
Electrical safety	According to IEC60601-1-2According to IEC60601-1	According to IEC60601-1-2According to IEC60601-1	Same
Blood PressureMeasurement	0mmHg ~ 285mmHg,within ±3mmHg (0.4kPa) or2% of reading	0mmHg ~ 299mmHg,within ±3mmHg (0.4kPa)	Different (4)
Pulsemeasurement	40-180 beat/minute, ±5% ofreading	40-199 beat/minute, ±5% ofreading	Different (5)
Cuff Deflation	Automatic deflation	Automatic deflation	Same
Features	Subject DeviceWPM05, WPM06	Predicate Device K202891LS802-GS	Remark
Wireless	WPM05: Bluetooth and Wi-FiWPM06: Bluetooth, Wi-Fi andCellular	LTE	Different(6)

Comparison to the Predicate Device 7.

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Justification of difference:

Different (1): The substantial difference of the intended use is the arm circumference ranging. The subject device is within the range of the predicate device. The subject device was validated according to ISO 80601-2-30 and ISO 81060-2. The performance data can demonstrate this difference does not raise different questions of safety and effectiveness.

Different (2): The battery is different. The IEC 60601-1 test report can demonstrate that the subject device can maintain the safety and performance with the battery. Thus, this difference does not raise different questions of safety and effectiveness.

Different (3): Compared with the predicate device reguires less strict operation and storage environment. The IEC 60601-1-11 test report can demonstrate that the subject device can maintain the safety and performance within the operation and storage environment. Thus, this difference does not raise different questions of safety and effectiveness.

Different (4) (5): The blood pressure measurement range and accuracy are different. The pulse rate measurement range and accuracy are different. The IEC 80601-2-30 can demonstrate that the subject device can maintain the safety and performance within the measurement range. Thus, the difference does not raise different questions of safety and effectiveness.

Different (6): The wireless module is different. However, the wireless function is same. The monitor can transmit the measurement result through wireless and display the measurement on the mobile application. Thus, this difference does not raise different questions of safety and effectiveness.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:

. Cytotoxicity
Sensitization .
Irritation .

The subject device is considered surface contacting for a duration of exceed 24 hours but not exceed 30 days.

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Non-clinical data

The device has been tested according to the following standards:

IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Basic Safety . and essential performance
IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 80601-2-30: Medical electrical equipment Particular requirements for the basic safety and . essential performance of automated non-invasive sphygmomanometers.
IEC 60601-1-11: 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
FDA Guidance for Non-Automated Sphygmomanometer. .

Wireless testing:

ANSI C63.27: 2017: American National Stand for Evaluation of Wireless Coexistence. .
. AAMI TIR69: 2017 Risk management of radio-frequency wireless coexistence for medical devices and systems.
Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food . and Drug Administration Staff (August 14, 2013)

Clinical data

The device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study population consisted of 135 qualified healthy adult subjects. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.

9. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent 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).