Wrist Electronic Sphygmomanometer

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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. 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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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 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. | | |---------------------|----------------------------------------------|----------------------------------------------------------------| | Device<br>and Model | Name | Med-link Wrist Digital Blood Pressure Monitor<br>Model: ESM101 | | 510(k) Number | K181154 | | {4}------------------------------------------------ | 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" {5}------------------------------------------------ | 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 | {6}------------------------------------------------ | 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, {7}------------------------------------------------ | 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