(418 days)
Not Found
No
The description details a standard oscillometric blood pressure measurement technique with fixed algorithms for determining systolic and diastolic pressure based on amplitude ratios. There is no mention of adaptive learning, training data, or AI/ML terminology.
No.
The device is intended for non-invasive measurement of blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
A diagnostic device is used to detect, diagnose, or monitor a medical condition. This device measures blood pressure and pulse rate, which are vital signs used by medical professionals and individuals at home to monitor cardiovascular health and detect potential abnormalities.
No
The device description explicitly details hardware components like an inflatable cuff, battery, and transducer, and the performance studies include electrical safety, electromagnetic compatibility, and biocompatibility testing, all indicative of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The Wrist Electronic Sphygmomanometer measures blood pressure and pulse rate by applying a cuff to the wrist and using the oscillometric technique. This is a non-invasive measurement performed on the body.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens.
Therefore, the device's function and method of operation clearly fall outside the scope of in vitro diagnostics.
N/A
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.
Product codes
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
adults
Intended User / Care Setting
medical professionals or at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pressure: ± 3mmHg
Pulse: ±5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
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)
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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 | ||
and Model | Name | Med-link Wrist Digital Blood Pressure Monitor |
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 | |
Number | 870.1130 |
Regulation | |
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
Comparison | Subject Device | Predicate Device | Verdict |
---|---|---|---|
Company | ShenZhen Changkun | ||
Technology CO., LTD. | Shenzhen Med-link Electronics Tech | ||
Co., Ltd. | -- | ||
Product Name | Wrist Electronic | ||
Sphygmomanometer | Med-link Wrist Digital Blood | ||
Pressure 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 | -- | |
Classification | |||
Name | 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 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. | Med-link Wrist Digital Blood | ||
Pressure Monitor 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. | 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" alkaline | |||
batteries; | |||
For model CK-W175, CK-W355, | |||
CK-W356, CK-W358: 3.7V | |||
400mAh Li-ion Battery | DC 3.0V(2xAAA alkaline battery) | SE | |
Note 1 | |||
Performance specification | |||
Measurement | |||
Site | Wrist | Wrist | SE |
6
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 of
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 | |||
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 | |||
Circumference | 13.5-19.5 cm | 13.5-19.5 cm | SE |
Inflation and | |||
Deflation | Automatic | Automatic | SE |
Measuring | |||
Method | Non-invasive Oscillometric | Non-invasive Oscillometric | SE |
Patient | |||
Population | 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/stora | |||
ge environment | Temperature: -25°C to +70°C; | ||
Humidity: ≤93%R.H.; | |||
Atmospheric Pressure: 70 kPa~106 kPa | Temperature: -20°C~+55°C | ||
Humidity: ≤95%RH, non-condensing | SE | ||
Safety | IEC 60601-1 | ||
IEC 60601-1-11 | |||
IEC 80601-2-30 | IEC 60601-1 | ||
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.