Arm Electronic Sphygmomanometer is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.

Device Description

The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.

The proposed devices are intended to be used in medical facilities or at home and provided non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for an "Arm Electronic Sphygmomanometer" and demonstrates its substantial equivalence to a predicate device. This type of submission relies on showing equivalency to an already cleared device, rather than proving novel effectiveness through significant clinical studies.

Therefore, the document explicitly does not include the detailed clinical study information requested for an AI/ML powered medical device, such as:

A complex table of acceptance criteria and reported device performance derived from a clinical trial.
Sample sizes for test sets in a clinical trial context.
Details about expert adjudication or multi-reader multi-case (MRMC) studies.
Information on training set sizes or ground truth establishment relevant to AI/ML.

The device in question is a standard non-invasive blood pressure measurement system, not an AI-powered device. Its performance is evaluated against established electrical, electromagnetic, biocompatibility, and performance standards for such devices.

Here's an analysis of what is provided, framed in the context of device acceptance, while acknowledging that it's for a traditional medical device, not an AI one:

Acceptance Criteria and Device Performance (Based on Standards Compliance, not AI-specific metrics):

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
Electrical Safety (IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30)	Complies with all referenced electrical safety standards.
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	Complies with IEC 60601-1-2 for EMC.
Performance Accuracy (AAMI / ANSI / ISO 81060-2)	Complies with AAMI / ANSI / ISO 81060-2 for blood pressure measurement accuracy: - Pressure: ±3mmHg - Pulse: ±5%
Biocompatibility (ISO 10993-5, ISO 10993-10)	Complies with ISO 10993-5 and ISO 10993-10 for biocompatibility.
Usability (IEC 62366)	Complies with IEC 62366 for usability.
Software Verification & Validation (FDA Guidance)	Complies with FDA guidance for software V&V.
Lithium Battery Safety (IEC 62133)	Complies with IEC 62133 (if applicable model).
Intended Use / Indications for Use	Substantially Equivalent to predicate device. Measures diastolic/systolic BP and pulse rate in adults via oscillometric technique. Cuff circumference 22-32cm. Use in hospital or home.
Measuring Range (Pressure)	0mmHg~299 mmHg
Measuring Range (Pulse)	40 bpm~199 bpm
Pressure Resolution	1 mmHg or 0.1kPa
Cuff Circumference	22~32cm
Operation Condition	Temperature: +5 to +40 °C, Humidity: 15 to 90%, Atmospheric Pressure: 80-106 kPa
Transport/Storage Environment	Temperature: -25°C to +70°C, Humidity: ≤93%R.H., Atmospheric Pressure: 70-106 kPa

Study Details (as per the provided document):

Sample Size and Data Provenance:
- The document mentions "lab bench testing" and compliance with international standards (e.g., ISO 81060-2 for blood pressure performance, IEC 60601 series for safety/EMC).
- For blood pressure measurement devices, ISO 81060-2 typically requires a specific number of subjects for clinical validation (often at least 85 subjects with specific demographic and blood pressure range distributions). However, the document does not explicitly state the sample size or provenance (country/retrospective/prospective) of the data used for the ISO 81060-2 performance evaluation. It only states compliance.
- This is a 510(k) submission, so the primary "study" is a comparison to a predicate device, not a de novo clinical trial. The performance data would have been generated to show compliance with the standards referenced in the submission.
Number of Experts and Qualifications for Ground Truth:
- Not applicable in the context of this traditional medical device submission. Ground truth for blood pressure measurement performance is typically established by simultaneous readings from a calibrated mercury sphygmomanometer (or an equivalent reference device) by trained observers, as specified in standards like ISO 81060-2. There isn't an "expert consensus" process like for imaging AI.
Adjudication Method:
- Not applicable as this is not an AI/ML device requiring human expert adjudication.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done, as this is a standalone blood pressure measurement device, not an AI assistance tool for human readers.
Standalone Performance:
- Yes, the performance tests (e.g., per AAMI / ANSI / ISO 81060-2) evaluate the standalone performance of the algorithm/device in measuring blood pressure and pulse rate. The accuracy criteria (±3mmHg for pressure, ±5% for pulse) are direct measurements of the device's capability.
Type of Ground Truth Used:
- For blood pressure accuracy, the ground truth is typically established by simultaneous measurements from a reference standard method (e.g., auscultation with a calibrated mercury sphygmomanometer) conducted by trained observers, as described in blood pressure measurement standards like ISO 81060-2. This is direct physiological measurement, not expert consensus or pathology in the sense of diagnostic imaging.
Sample Size for Training Set:
- Not applicable. This is not an AI/ML device that requires a "training set." The device is based on established oscillometric principles and hardware.
How Ground Truth for Training Set was Established:
- Not applicable for the same reason as above.

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: K193387

Trade/Device Name: Arm Electronic Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 27, 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) K193387

Device Name Arm Electronic Sphygmomanometer

Indications for Use (Describe)

Arm Electronic Sphygmomanometer is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.

Type of Use (Select one or both, as applicable)

☑ Own-The-Counter Use (21 CFR 201.66)
☐ Prescription Use (Part 201 CFR 201 Subpart D)

__ 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:	Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-A155
Device:	A156, CK-A158, CK-A168
Document:	FDA 510(k) Submission Report
Name:

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 6floor 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: regulatory@glomed-info.com

2. Subject Device Information

Type of 510(k): Traditional Common Name: Non-invasive blood pressure measurement systems Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Trade Name:Arm Electronic Sphygmomanometer Model Name: CK-A120, CK-A136, CK-A138, CK-A155, CK-A156, CK-A156, CK-A158, CK-A168 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 870.1130 Regulatory Class: 2

3. Predicate Device Information

Sponsor	Shenzhen BSX Technology Electronics Co., Ltd.
Device Nameand Model	Arm-type Electronic Blood Pressure MonitorModel: BSX516, BSX523, BSX525, BSX583, BSX593, BSX595
510(k) Number	K183058
Product Code	DXN

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ShenZhen Chanqkun Technoloqy CO., LTD. Sponsor: Subject Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-Device: A156. CK-A158.CK-A168 Document FDA 510(k) Submission Report Name:

RegulationNumber	870.1130
RegulationClass	II

4. Device Description

The proposed devices are intended to be used in medical facilities or at home and provided non-sterile.

5. Intended Use / Indications for Use

6. Test Summary

Arm 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"

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Arm 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 1	Remark
Elements ofComparison	Subject Device	Predicate Device 1	Remark
Company	ShenZhen Changkun TechnologyCO., LTD.	Shenzhen BSX TechnologyElectronics Co., Ltd.	--
Product Name	Arm ElectronicSphygmomanometer	Arm-type Electronic Blood PressureMonitor	--
Model Name	CK-A120, CK-A136, CK-A138, CK-A139, CK-A155, CK-A156, CK-A158,CK-A168	BSX516, BSX523,BSX525, BSX583, BSX593 andBSX595	--
ClassificationName	systems,measurement,bloodpressure, Non-invasive	systems,measurement,bloodpressure, Non-invasive	SE
510(k) Number	Applying	K183058	--
Product Code	DXN	DXN	SE
	Intended Use and Indications for Use
Intended Use /Indications forUse	Arm ElectronicSphygmomanometer is a non-invasive blood pressuremeasurement system intended tomeasure the diastolic and systolicblood pressures and pulse rate ofan adult individual by using a non-invasive oscillometric technique inwhich an inflatable CUFF iswrapped around the arm of whichthe circumference includes 22cm~32 cm. It is intended to beused in hospital environment or athome.	The blood pressure monitor is anon-invasive blood pressuremeasurement system intended tomeasure the diastolic and systolicblood pressures and pulse rate ofan adult individual by using a non-invasive oscillometric technique inwhich an inflatable CUFF iswrapped around the arm of whichthe circumference includes 22cm~32 cm. It is intended to be usedin hospital environment or at home.	SE
Electrical requirement
Power Supply	4x1.5V AA Alkaline Battery (CK-A138, CK-A139)4x1.5V AAA Alkaline Battery (CK-A120, CK-A136)3.7V 400mAh Li-ion Battery (CK-A155, CK-A156, CK-A158, CK-A168)	4x1.5V AAA Alkaline Battery(BSX516, BSX525, BSX583,BSX593 and BSX595)3.7V 400mAh Li-ion Battery(BSX523)	SENote 1
Performance specification
Measurement Site	Upper Arm	Upper Arm	SE
Measuring range	Pressure: 0mmHg~~299 mmHg:Pulse: 40 bpm~~199 bpm	Pressure: 0mmHg~299 mmHgPulse: 40 bpm ~180 bpm	SENote
Pressureresolution	1 mmHg or 0.1kPa	1 mmHg or 0.1kPa	SE
Measuringaccuracy	Pressure: ± 3mmHgPulse: ±5%	Pressure: ± 3mmHgPulse: ±5%	SE
CuffCircumference	22~32cm	22~32cm	SE
Inflation and	Automatic	Automatic	SE
Elements ofComparison	Subject Device	Predicate Device 1	Remark
Deflation			SE
MeasuringMethod	Non-invasive Oscillometric	Non-invasive Oscillometric	SE
Patient Population	Adult	Adult	SE
Display	LCD	LCD	SE
Operationcondition	Temperature: +5 to +40 °C,Humidity: 15 to 90%Atmospheric Pressure: 80 kPa~106 kPa	Temperature: +5 to +40 °C,Humidity: 15 to 85%Atmospheric Pressure: 80 kPa~106 kPa	SENote 2
Transport/storageenvironment	Temperature: -25°C to +70°C,Humidity: ≤93%R.H.Atmospheric Pressure: 70 kPa~106 kPa	Temperature: -20°C to +55 °C,Humidity: 10 to 93%Atmospheric Pressure: 70 kPa~106 kPa	SENote 2
Safety	IEC 60601-1IEC 60601-1-11IEC 80601-2-30	IEC 60601-1IEC 60601-1-11IEC 80601-2-30	SE
EMC	IEC 60601-1-2	IEC 60601-1-2	SE
Biocompatibility	ISO 10993	ISO 10993	SE

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Sponsor: ShenZhen Changkun Technology CO., LTD. Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-Subject Device: A156, CK-A158,CK-A168 Document FDA 510(k) Submission Report Name:

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ShenZhen Chanqkun Technoloqy CO., LTD. Sponsor: Subject Arm Electronic Sphygmomanometer, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-Device: A156, CK-A158,CK-A168 FDA 510(k) Submission Report Document Name:

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", "Operation condition" and "Transport/storage environment" of the subject device are a little different from the predicate devices, but the difference of subject device is very similar with the K183058. So these parameters' differences will not raise any safety or effectiveness issue.

Final Conclusion :

The subject device Non-invasive Sphygmomanometer (Arm Electronic Sphygmomanometer) (Model: CK-A120, CK-A136, CK-A138, CK-A139, CK-A155, CK-A158, CK-A168) 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 K183058.

8. Date of the summary prepared: December 27, 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).