Wrist Electronic Sphygmomanometer

K193386 · Shenzhen Changkun Technology Co., Ltd. · DXN · Jan 27, 2021 · Cardiovascular

Device Facts

• Record ID: K193386
• Device Name: Wrist Electronic Sphygmomanometer
• Applicant: Shenzhen Changkun Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

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 Story

Battery-powered automatic wrist-worn sphygmomanometer; uses oscillometric technique to measure systolic/diastolic blood pressure and pulse rate. Device inflates cuff to 180-230mmHg; deflates at 3-6 mmHg/sec. Transducer measures cuff pressure and minute oscillations. Algorithm detects pulsations; performs peak matching to reject artifacts from patient movement. Systolic pressure identified at 0.45x reference amplitude (pre-peak); diastolic at 0.75x reference amplitude (post-peak). Results displayed on LCD. Used by clinicians or patients at home for blood pressure monitoring; aids in hypertension management and cardiovascular health assessment.

Clinical Evidence

Bench testing only. Evaluated per IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), AAMI/ANSI/ISO 81060-2 (performance), IEC 62133 (battery), and ISO 10993-5/10 (biocompatibility). Software verified and validated per FDA guidance.

Technological Characteristics

Oscillometric non-invasive blood pressure measurement. Powered by 2x AAA alkaline batteries or 3.7V 400mAh Li-ion battery. Wrist-worn form factor with LCD. Cuff circumference 13.5-19.5 cm. Pressure range 0-299 mmHg; pulse range 40-199 bpm. Accuracy: ±3 mmHg (pressure), ±5% (pulse). Biocompatible materials per ISO 10993.

Indications for Use

Indicated for non-invasive measurement of arterial blood pressure (systolic/diastolic) and pulse rate in adults. Cuff circumference 13.5-19.5 cm. Suitable for use by medical professionals or home users.

Regulatory Classification

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.

Predicate Devices

• Med-link Wrist Digital Blood Pressure Monitor (K181154)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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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| 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: [phone] Fax: [phone] Contact Person (including title): Steve Li (Manger Representative) E-mail: [e-mail]

### 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: [phone] 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. | |
|---------------------|----------------------------------------------|----------------------------------------------------------------|
| Device<br>and Model | Name | Med-link Wrist Digital Blood Pressure Monitor<br>Model: 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 |
|----------------------|----------|
| Regulation<br>Number | 870.1130 |
| Regulation<br>Class | II |

### 4. 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.

# 5. Intended Use / Indications for Use

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.

#### 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 of<br>Comparison | Subject Device | Predicate Device | Verdict |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company | ShenZhen Changkun<br>Technology CO., LTD. | Shenzhen Med-link Electronics Tech<br>Co., Ltd. | -- |
| Product Name | Wrist Electronic<br>Sphygmomanometer | Med-link Wrist Digital Blood<br>Pressure Monitor | -- |
| Model Name | CK-101, CK-101S, CK-102S,<br>CK-W118, CK-W132, CK-W133,<br>CK-W135, CK-W175, CK-W176,<br>CK-W355, CK-W356, CK-W358 | ESM101 | -- |
| Classification<br>Name | System, Measurement, Blood-<br>pressure, Non-invasive | System, Measurement, Blood-<br>pressure, Non-invasive | SE |
| 510(k) Number | Applying | K181154 | -- |
| Product Code | DXN | DXN | SE |
| Intended Use and Indications for Use | | | |
| Intended Use /<br>Indications for<br>Use | Wrist Electronic<br>Sphygmomanometer is non-<br>invasive blood measurement of<br>arterial blood pressure values in<br>adults. It is intended to measure<br>the diastolic, systolic blood<br>pressures and pulse rate through<br>an inflatable cuff wrapped<br>around the wrist. It can be used<br>by medical professionals or at<br>home. The cuff circumference is<br>limited to 13.5-19.5 cm. | Med-link Wrist Digital Blood<br>Pressure Monitor is non-invasive<br>blood measurement of arterial blood<br>pressure values in adults. It is<br>intended to measure the diastolic,<br>systolic blood pressures and pulse<br>rate through an inflatable cuff<br>wrapped around the wrist. It can be<br>used by medical professionals or at<br>home. The cuff circumference is<br>limited to 13.5-19.5 cm. | SE |
| Electrical requirement | | | |
| Power Supply | For model CK-101, CK-101S,<br>CK-102S, CK-W118, CK-W132,<br>CK-W133, CK-W135, CK-<br>W176: 2 x 1.5V "AAA" alkaline<br>batteries;<br>For model CK-W175, CK-W355,<br>CK-W356, CK-W358: 3.7V<br>400mAh Li-ion Battery | DC 3.0V(2xAAA alkaline battery) | SE<br>Note 1 |
| Performance specification | | | |
| Measurement<br>Site | 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-<br>W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356,<br>CK-W358 |
| Document Name: | FDA 510(k) Submission Report |

| Elements of<br>Comparison | 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 |
| Pressure<br>resolution | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | SE |
| Measuring | Pressure: ± 3mmHg | Pressure: ± 3mmHg | SE |
| accuracy | Pulse: ±5% | Pulse: ±5% | SE |
| Cuff<br>Circumference | 13.5-19.5 cm | 13.5-19.5 cm | SE |
| Inflation and<br>Deflation | Automatic | Automatic | SE |
| Measuring<br>Method | Non-invasive Oscillometric | Non-invasive Oscillometric | SE |
| Patient<br>Population | Adult | Adult | SE |
| Display | LCD | LCD | SE |
| Operation | Temperature: +5 to +40 °C,<br>Humidity: 15 to 90%,<br>Atmospheric Pressure: 80 kPa~106 kPa | Temperature: +5°C~+40°C,<br>Humidity: 15%~85%RH | SE |
| condition | | | |
| Transport/stora<br>ge environment | Temperature: -25°C to +70°C;<br>Humidity: ≤93%R.H.;<br>Atmospheric Pressure: 70 kPa~106 kPa | Temperature: -20°C~+55°C<br>Humidity: ≤95%RH, non-condensing | SE |
| Safety | IEC 60601-1<br>IEC 60601-1-11<br>IEC 80601-2-30 | IEC 60601-1<br>IEC 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