Wrist Electronic Sphygmomanometer is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.

Device Description

The Wrist Electronic Sphygmomanometer is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the oscillometric technique.

The device uses the oscillometric method to determine blood pressure. This is accomplished by means of a sensitive transducer, which measures cuff pressure and minute pressure oscillations within the cuff. The first determination sequence initially pumps up to a cuff pressure of about 180-230mmHg for adults. After inflating the cuff, the Wrist Electronic Sphygmomanometer begins to deflate it at a rate of 3-6 mmHq/sec, and measures systolic, mean, and diastolic pressure. The Wrist Electronic Sphygmomanometer deflates the cuff one step each time it detects two pulsations of relatively equal amplitude ("peak matching"). The time between deflation steps depends on the frequency of these matched pulses (pulse rate of the patient). However, if the Wrist Electronic Sphygmomanometer is unable to find any pulse within several seconds, it will deflate to the process of finding two matched pulses at each step provides artifact rejection due to patient movement and greatly enhances accuracy.

The device will obtain the pressure point, which is before the maximum peak and whose amplitude of peak is 0.45 times the reference amplitude, is determined to be the systolic pressure; and the pressure point, which is after the maximum peak and whose amplitude of peak is 0.75 times the reference amplitude, is determine to be the diastolic. When the diastolic pressure has been determined, the NIBP Meter finishes deflating the cuff and updates the screen.

AI/ML Overview

The provided document describes the Wrist Electronic Sphygmomanometer (models CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358) and its substantial equivalence to a predicate device, the Med-link Wrist Digital Blood Pressure Monitor (Model: ESM101). The primary study proving the device meets acceptance criteria appears to be a performance evaluation according to the AAMI / ANSI / ISO 81060-2 standard, which is a standard for non-invasive blood pressure monitors.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document largely details equivalence to a predicate device rather than precise acceptance criteria and specific performance numbers for the subject device beyond the general range and accuracy claims. However, the performance specifications listed for the subject device can be inferred as its reported performance, and by extension, the acceptance criteria as meeting these specifications (and demonstrating equivalence to the predicate which also meets these).

Acceptance Criteria / Specification	Reported Device Performance (Subject Device)
Measuring Pressure Range	0~299mmHg
Measuring Pulse Range	40~199 times/min
Pressure Resolution	1 mmHg or 0.1kPa
Measuring Pressure Accuracy	± 3mmHg
Measuring Pulse Accuracy	±5%
Cuff Circumference	13.5-19.5 cm
Inflation and Deflation	Automatic
Measuring Method	Non-invasive Oscillometric
Patient Population	Adult
Display	LCD
Operation Temperature	+5 to +40 °C
Operation Humidity	15 to 90%
Operation Atmospheric Pressure	80 kPa~106 kPa
Transport/Storage Temperature	-25°C to +70°C
Transport/Storage Humidity	≤93%R.H.
Transport/Storage Atmospheric Pressure	70 kPa~106 kPa
Safety Standards Compliance	IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30
EMC Standards Compliance	IEC 60601-1-2
Biocompatibility Standards Compliance	ISO 10993 series

The document notes that the device "meets the requirements as safety and performance standards required," implying that its performance aligns with what is expected by relevant standards like AAMI / ANSI / ISO 81060-2.

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

The document states that "Performance according to AAMI / ANSI / ISO 81060-2 standard" was conducted. This standard typically specifies requirements for clinical validation, often involving a certain number of subjects. However, the exact sample size used for the test set (clinical validation cohort) is not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not provide this information. For a blood pressure monitor, ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a reference device, not necessarily "experts" in the context of image interpretation. The ISO 81060-2 standard outlines procedures for obtaining reference blood pressure measurements.

4. Adjudication Method for the Test Set

The document does not provide this information. For blood pressure device validation, adjudication usually refers to how discrepancies between multiple reference measurements are handled, which is part of the ISO 81060-2 methodology but not detailed here.

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

Not applicable (N/A). This device is a non-invasive blood pressure measurement system and not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

The performance evaluation according to AAMI / ANSI / ISO 81060-2 is inherently a standalone performance study of the device, as it evaluates the algorithm's accuracy in measuring blood pressure compared to a reference standard without human intervention in the measurement process (though humans apply the device and record results).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For blood pressure monitoring devices, the ground truth is established through simultaneous measurements using a validated reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer as per AAMI/ISO standards). The document states "Performance according to AAMI / ANSI / ISO 81060-2 standard," which defines how this ground truth is established.

8. The Sample Size for the Training Set

The document does not provide this information. Blood pressure monitors typically do not have a "training set" in the machine learning sense. The device's algorithm is developed based on physiological principles and validated against clinical data.

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

The document does not provide this information. As mentioned above, the concept of a "training set" with established ground truth is not typically relevant for this type of medical device in the same way it would be for an AI/ML algorithm. The underlying oscillometric algorithm is based on established scientific principles and previously collected physiological data, but not usually in a "training set" context as defined for AI.

Summary

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January 27, 2021

Shenzhen Changkun Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, 510000 China

Re: K193386

Trade/Device Name: Wrist Electronic Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 28, 2020 Received: December 31, 2020

Dear Cassie Lee:

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,

for LT 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) K193386

Device Name

Wrist Electronic Sphygmomanometer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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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Sponsor:	ShenZhen Changkun Technology CO., LTD.
Subject Device:	Wrist Electronic Sphygmomanometer, Models: CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358
Document Name:	FDA 510(k) Submission Report

510(k) Summary

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

1. Submitter's Information

510(k) Owner's Name: ShenZhen Changkun Technology CO., LTD. Establishment Registration Number: Applying Address: 801, 3 floor 4floor 5floor 7floor, B building, NO.69, zhenbi road, biling community, biling street, pingshan district, Shenzhen city, Guangdong, China Tel: +86-0755-29100487 Fax: +86-0755-23463480 Contact Person (including title): Steve Li (Manger Representative) E-mail: changkunkj@163.com

Application Correspondent:

Contact Person: Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: requlatory(@glomed-info.com

2. Subject Device Information

Type of 510(k): Traditional Common Name: Noninvasive blood pressure measurement systems Classification Name: system, measurement, blood-pressure, non-invasive Trade Name: Wrist Electronic Sphygmomanometer Model Name: CK-101, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 870.1130 Regulatory Class: 2

3. Predicate Device Information

Sponsor	Shenzhen Med-link Electronics Tech Co., Ltd.
Deviceand Model	Name	Med-link Wrist Digital Blood Pressure MonitorModel: ESM101
510(k) Number	K181154

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Sponsor:	ShenZhen Changkun Technology CO., LTD.
Subject Device:	Wrist Electronic Sphygmomanometer, Models: CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358
Document Name:	FDA 510(k) Submission Report

Product Code	DXN
RegulationNumber	870.1130
RegulationClass	II

4. Device Description

5. Intended Use / Indications for Use

6. Test Summary

Wrist Electronic Sphygmomanometer has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30 standards
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Electromagnetic compatibility test according to IEC 60601-1-6 standard
� Performance according to AAMI / ANSI / ISO 81060-2 standard
� Lithium battery report in accordance with IEC62133
� Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
� Usability test according to IEC62366 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

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Sponsor:	ShenZhen Changkun Technology CO., LTD.
Subject Device:	Wrist Electronic Sphygmomanometer, Models: CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358
Document Name:	FDA 510(k) Submission Report

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Wrist Electronic Sphygmomanometer is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Company	ShenZhen ChangkunTechnology CO., LTD.	Shenzhen Med-link Electronics TechCo., Ltd.	--
Product Name	Wrist ElectronicSphygmomanometer	Med-link Wrist Digital BloodPressure Monitor	--
Model Name	CK-101, CK-101S, CK-102S,CK-W118, CK-W132, CK-W133,CK-W135, CK-W175, CK-W176,CK-W355, CK-W356, CK-W358	ESM101	--
ClassificationName	System, Measurement, Blood-pressure, Non-invasive	System, Measurement, Blood-pressure, Non-invasive	SE
510(k) Number	Applying	K181154	--
Product Code	DXN	DXN	SE
Intended Use and Indications for Use
Intended Use /Indications forUse	Wrist ElectronicSphygmomanometer is non-invasive blood measurement ofarterial blood pressure values inadults. It is intended to measurethe diastolic, systolic bloodpressures and pulse rate throughan inflatable cuff wrappedaround the wrist. It can be usedby medical professionals or athome. The cuff circumference islimited to 13.5-19.5 cm.	Med-link Wrist Digital BloodPressure Monitor is non-invasiveblood measurement of arterial bloodpressure values in adults. It isintended to measure the diastolic,systolic blood pressures and pulserate through an inflatable cuffwrapped around the wrist. It can beused by medical professionals or athome. The cuff circumference islimited to 13.5-19.5 cm.	SE
Electrical requirement
Power Supply	For model CK-101, CK-101S,CK-102S, CK-W118, CK-W132,CK-W133, CK-W135, CK-W176: 2 x 1.5V "AAA" alkalinebatteries;For model CK-W175, CK-W355,CK-W356, CK-W358: 3.7V400mAh Li-ion Battery	DC 3.0V(2xAAA alkaline battery)	SENote 1
Performance specification
MeasurementSite	Wrist	Wrist	SE

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Sponsor:	ShenZhen Changkun Technology CO., LTD.
Subject Device:	Wrist Electronic Sphygmomanometer, Models: CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356,CK-W358
Document Name:	FDA 510(k) Submission Report

Elements ofComparison	Subject Device	Predicate Device	Verdict
Measuring	Pressure:0~299mmHg	Pressure:0~280mmHg	SE
range	Pulse 40~199 times/min	Pulse:40~199beats/minute	Note 2
Pressureresolution	1 mmHg or 0.1kPa	1 mmHg or 0.1kPa	SE
Measuring	Pressure: ± 3mmHg	Pressure: ± 3mmHg	SE
accuracy	Pulse: ±5%	Pulse: ±5%	SE
CuffCircumference	13.5-19.5 cm	13.5-19.5 cm	SE
Inflation andDeflation	Automatic	Automatic	SE
MeasuringMethod	Non-invasive Oscillometric	Non-invasive Oscillometric	SE
PatientPopulation	Adult	Adult	SE
Display	LCD	LCD	SE
Operation	Temperature: +5 to +40 °C,Humidity: 15 to 90%,Atmospheric Pressure: 80 kPa~106 kPa	Temperature: +5°C~+40°C,Humidity: 15%~85%RH	SE
condition
Transport/storage environment	Temperature: -25°C to +70°C;Humidity: ≤93%R.H.;Atmospheric Pressure: 70 kPa~106 kPa	Temperature: -20°C~+55°CHumidity: ≤95%RH, non-condensing	SE
Safety	IEC 60601-1IEC 60601-1-11IEC 80601-2-30	IEC 60601-1IEC 80601-2-30	SE
EMC	IEC 60601-1-2	IEC 60601-1-2	SE
Biocompatibility	ISO 10993 series	ISO 10993 series	SE

Comparison

Note 1:

Although the "Power Supply" of the subject device is a little different from the predicate device, they all complied with the requirements of safety standards as IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30 required. So this difference will not raise any safety or effectiveness issue.

Note 2:

Although "Measuring scope" of the subject device are a little different from the predicate devices, but the difference of subject device is very similar with the K181154, and both they meet the requirements as safety and performance standards required. So these parameters' differences will not raise any safety or effectiveness issue.

Final Conclusion:

The subject device Non-invasive Sphygmomanometer (Wrist Electronic Sphygmomanometer) (Model:CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355,

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Sponsor:	ShenZhen Changkun Technology CO., LTD.
Subject Device:	Wrist Electronic Sphygmomanometer, Models: CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358
Document Name:	FDA 510(k) Submission Report

CK-W356, CK-W358) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

8. Date of the summary prepared: December 28, 2020

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).