The Wrist Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

Device Description

The Wrist Blood Pressure Monitor, including XY-W01B, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with wrist circumference of 135-215mm through oscillometric method. The initial inflation pressure of the cuff is zero pressure. When start the cuff will be inflated and deflated. The Wrist Blood Pressure Monitor is composed of monitor unit and wrist cuff. Of which the monitor unit contains main control circuit board, air pump, deflation valve, LCD and shell. The two models XY-W01A and XY-W01B have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard, except for product appearance. The devices are powered by 2 AAA batteries. The Wrist Blood Pressure Monitor has a memory function that automatically stores 90 sets data of the latest measurements.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the Wrist Blood Pressure Monitor (models XY-W01A, XY-W01B).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard: ISO 81060-2:2018)	Reported Device Performance (Clinical Test)
Mean error for systolic pressure ≤ ±5 mmHg	Mean error within ±5 mmHg
Standard deviation for systolic pressure ≤ 8 mmHg	Standard deviation within 8 mmHg
Mean error for diastolic pressure ≤ ±5 mmHg	Mean error within ±5 mmHg
Standard deviation for diastolic pressure ≤ 8 mmHg	Standard deviation within 8 mmHg
All data not over the limits.	All data is not over the limits.

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

Sample Size: 120 subjects (53 female and 67 male)
Data Provenance: The document does not explicitly state the country of origin.
Retrospective or Prospective: Not explicitly stated, but clinical tests for device approval are typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For blood pressure monitors, the "ground truth" (reference measurements) is typically established by trained technicians using a standardized auscultatory method, not necessarily by "experts" in the sense of physicians or radiologists establishing a diagnostic truth.

4. Adjudication Method

This information is not provided in the document, as it relies on direct comparative measurements rather than expert adjudication of imaging or diagnostic results.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret images. For a blood pressure monitor, the performance is compared against a reference measurement.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The clinical test evaluated the device's accuracy in measuring blood pressure and pulse rate against a reference standard.

7. Type of Ground Truth Used

The ground truth implicitly used is reference blood pressure measurements, likely obtained through a rigorously standardized auscultatory method as per the ISO 81060-2:2018 standard.

8. Sample Size for the Training Set

This information is not provided in the document. Given that this is a hardware device with an embedded algorithm (oscillometric technique), there isn't typically a separate "training set" in the way an AI/ML model would have for image recognition. The core algorithm's parameters are likely developed through extensive engineering and testing rather than a distinct training phase on a large dataset.

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

This information is not provided. As mentioned above, the concept of a "training set ground truth" as understood in AI/ML is not directly applicable here. The device's underlying oscillometric algorithm and its parameters would have been developed and refined through engineering principles and testing against various blood pressure profiles and body types.

Summary

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February 11, 2025

Guangdong Xinyu Electronic and Technology Co., Ltd. Rita Long Manager Number 42, CuiCheng Road, Cuiheng New District Zhongshan, Guangdong 528400 China

Re: K241634

Trade/Device Name: Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 14, 2025 Received: January 14, 2025

Dear Rita Long:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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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Indications for Use

510(k) Number (if known) K241634

Device Name Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.

1. Summary Prepared Date

20 May 2024

2. Submitter's Information Sponsor

� Company Name: Guangdong Xinyu Electronic and Technology Co., Ltd.
� Address: Number 42, CuiCheng Road, Cuiheng New District Zhongshan Guangdong 528400 China
� Phone: 86-760-88818598
Contact Person (including title): Ms. Rita Long (Regulatory Manager) �
� E-mail: zcy_cg@163.com

Application Correspondent:

� Company Name: Guangdong Xinyu Electronic and Technology Co., Ltd.
� Address: Number 42, CuiCheng Road, Cuiheng New District Zhongshan Guangdong 528400 China
Phone: 86-760-88818598 �
� Contact Person (including title): Ms. Rita Long (Regulatory Manager)
� E-mail: zcy_cg@163.com

3. Subject Device Information

� Type of 510(k) submission: Traditional
Common Name: Noninvasive blood pressure measurement system �
Trade Name: Wrist Blood Pressure Monitor �
Model: XY-W01A, XY-W01B �
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive �
� Review Panel: Cardiovascular
� Product Code: DXN
� Regulation Number: 870.1130
� Regulation Class: II

4. Predicate Device Information

� 510(k) number: K231310
� Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd.
� Trade Name: Electronic Blood Pressure Monitor
� Classification Name: System, Measurement, Blood-Pressure, Non-Invasive

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K241634 Summary Guangdong Xinyu Electronic and Technology Co., Ltd.

Model: HWA11, HWA10 �
� Review Panel: Cardiovascular
� Product Code: DXN
Regulation Number: 21 CFR 870.1130 �
� Requlation Class: II

5. Device Description

The Wrist Blood Pressure Monitor is composed of monitor unit and wrist cuff. Of which the monitor unit contains main control circuit board, air pump, deflation valve, LCD and shell. The two models XY-W01A and XY-W01B have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard, except for product appearance. The devices are powered by 2 AAA batteries. The Wrist Blood Pressure Monitor has a memory function that automatically stores 90 sets data of the latest measurements.

Indications for Use 6.

7. Comparison to Predicate Device

Compare to the predicate devices, the subject device has same intended use, similar product design, same performance, same safety as the predicate device, the summarized comparison information is listed in the following table:

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K241634 Summary

Guangdong Xinyu Electronic and Technology Co., Ltd.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Manufacturer	Guangdong Xinyu Electronic andTechnology Co., Ltd.	Shenzhen Jumper MedicalEquipment Co., Ltd.K231310
510 (k) Number
Product name	Wrist Blood Pressure Monitor	Electronic Blood PressureMonitor	-
Models	XY-W01A, XY-W01B	HWA11, HWA10	-
Product Code	DXN	DXN	Same
Regulation No.	21 CFR 870.1130	21 CFR 870.1130	Same
Class	II	II	Same
Indicationfor use	The wrist Blood Pressure Monitor isintended to measure the systolic anddiastolic blood pressure as well as thepulse rate of adult person via non-invasive oscillometric technique atmedical facilities or at home. Theintended wrist circumference is 13.5-21.5 cm.	The Electronic Blood PressureMonitor is intended to measurethe systolic and diastolic bloodpressure as well as the pulserate of adult person via non-invasive oscillometric techniqueat medical facilities or at home.The intended wristcircumference is 13.5-21.5 cm.	Same
Environment ofuse	Medical Facilities /Home Use	Medical Facilities /Home Use	Same
Patientpopulation	Adult	Adult	Same
Over-The-Counter (OTC)	Yes	Yes	Same
Measurementmethod	Cuff oscillometric method	Cuff oscillometric method	Same
Wrist cuffcircumference	13.5-21.5 cm	13.5-21.5 cm	Same
Measurement range	Pressure: 0mmHg ~295mmHg(0kPa~39.33kPa)Pulse rate: 40 to 180 beats/min	Pressure:0 to 295 mmHgPulse rate: 40 to 199beats/min	DifferentNote 1
Pressure sensor	Piezo resistance sensor	Piezo resistance sensor	Same
Accuracy ofpressure	Blood Pressure: ±3mmHg	Blood Pressure: ±3mmHg	Same
Accuracy ofpulse rate	Pulse Rate: ±5% of reading	Pulse Rate: ±5% ofreading	Same
Inflation method	Automatic inflation with electric pump	Automatic inflation withelectric pump	Same
Deflation method	Automatic rapid deflation valve	Automatic rapid deflation valve	Same
Display	LCD	LCD	Same
Power source	2*AAA batteries	2*AAA batteries	Same
Operation condition	+10° C~ +40° C15% ~ 85% RH860hPa~1060hPa	5 to 40°C15 to 85% RH700 to 1060hPa	DifferentNote 2
Storage/Transportation	-20 ~ +55°C	-20 to 55°C	DifferentNote 2
Elements ofComparison	Subject Device	Predicate Device	Verdict
condition	10% ~ 93% RH500hPa~1060hPa	700 to 1060hPa
Dimensions	73(W) x 65(H) x 88(D) mm	61 (W) × 24.1(D) × 87 (H)mm	DifferentNote 3
Weight	Approx. 150g (without battery)	Approx. 111±5g (withoutbatteries)	DifferentNote 3

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K241634 Summary

Guangdong Xinyu Electronic and Technology Co., Ltd.

Note 1

The pulse rate is narrower than the predicate device, but it contains the pulse range of most of people and meets the requirements of IEC 80601-2-30. Therefore, the difference will not affect the safety and effectiveness of the subject device.

Note 2

All the differences in operation and storage/transportation condition don't affect the safety and effectiveness which is concluded after all the required testing, thus, this difference does not raise different questions of safety and effectiveness.

Note 3

Minor differences in the dimensions and weight do not impact the safety or performance of blood pressure or pulse rate measurements. Thus, the subject device is substantially equivalent to the predicate device

8. Performance Data

Non-clinical data

The Wrist Blood Pressure Monitor comply with:

IEC 60601-1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
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
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 4. IEC 60601-1-2:2014+A1:2020 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements

and tests 5. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation

and skin sensitization

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".

FDA guidance: Content of Premarket Submissions for Device Software Functions, JULY 20, 2023

Clinical test

The clinical test was conducted to verify that the proposed device met the requirements of the ISO 81060-2 : 2018 . The study population consisted of 120 subjects (53 female and 67 male) with an age range of 12 to 85 years. For systolic and diastolic pressures , the mean error shall be + 5mmHg or less , with a standard deviation of 8mmHg or less, all data is not over the limits. No adverse effect and/or complication is found in this study.

9. Conclusion

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K241634 Summary

Guangdong Xinyu Electronic and Technology Co., Ltd.

as effective as the predicated device(K231310).

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).