(535 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and basic data storage/display features, with no mention of AI/ML algorithms for data analysis or interpretation.
No.
The device measures blood pressure and pulse rate, which are diagnostic indicators, but it does not treat or directly alleviate a medical condition, which is the primary function of a therapeutic device.
Yes
The device is intended to measure systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status, aiding in the identification or monitoring of medical conditions. This falls under the definition of a diagnostic device.
No
The device description explicitly details hardware components like a battery, inflatable cuff, and mechanisms for inflation and deflation, indicating it is a physical device with integrated software, not a software-only 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.
- Device Function: The Wrist Type Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the wrist. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the body, not to analyze biological samples.
Therefore, this device falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home.
The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.
Product codes
DXN
Device Description
The proposed device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor.
The Wrist Type Blood Pressure Monitor can automatically complete the inflation, deflation and measurement of systolic and diastolic blood pressure as well as the pulse rate of adult person. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data;
User can set the time as year, month, day, hour and minute;
User can enable or disable the function of voice broadcast about measurement result;
User can select the unit of the measurement: mmHg or KPa;
The device has the data storage function for data reviewing, including the data of systolic pressure. diastolic pressure, pulse rate and measurement time.
The device has low power indicator to indicate the states of low batteries power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
adult person
Intended User / Care Setting
It can be used at medical facilities 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)
The clinical trials for YK-BPW1 were performed according to ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2013 within the +/-5mmHg.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
+/-3 mmHg (BP Accuracy)
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 9, 2018
Xuzhou Yongkang Electronic Science Technology Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. LiYuan Town, TongZhou District, Beijing, 101121 China
Re: K162616
Trade/Device Name: Wrist Type Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: January 21, 2018 Received: January 25, 2018
Dear Ray Wang:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willemsen
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Wrist Type Blood Pressure Monitor
Indications for Use (Describe)
The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home.
The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Tab #3 510(k) Summary
This 510(k) Summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K162616
-
- Date of Preparation
01/21/2018
- Date of Preparation
-
Sponsor 2.
Xuzhou Yongkang Electronic Science Technology Co., Ltd
4F Building C8, 40 Jingshan Road, Econonic and Technolgical Development Zone, Xuzhou, Jiangsu, China Establishment Registration Number: Not yet registered or the Number Contact Person: YanLi Li Position: General Manager Tel: 86-516- 87892766-631 Fax:86- 516-87892766 -606 Email: lyl(@yonker.cn
- Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe Technology Service Co., Ltd.
5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: Wrist Type Blood Pressure Monitor Common Name: Blood Pressure Monitor Model(s): YK-BPW1
Regulatory Information:
Classification Name: System, measurement, blood-pressure, non-invasive; Classification: II; Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;
Indication For Use Statement:
The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home. The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.
Device Description 5.
The proposed device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor.
The Wrist Type Blood Pressure Monitor can automatically complete the inflation, deflation and measurement of systolic and diastolic blood pressure as well as the pulse rate of adult person. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data;
User can set the time as year, month, day, hour and minute;
User can enable or disable the function of voice broadcast about measurement result;
User can select the unit of the measurement: mmHg or KPa;
The device has the data storage function for data reviewing, including the data of systolic pressure. diastolic pressure, pulse rate and measurement time.
The device has low power indicator to indicate the states of low batteries power.
5
-
- Identification of Predicate Device
Predicate #
- Identification of Predicate Device
510(k) Number: K131569
Product Name: PG 800A Series Electronic Blood Pressure Monitor Manufacturer: Shenzhen Pango Electronic Co., Ltd.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
ISO 80601-2-30:2013, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
- Clinical Test Conclusion
The clinical trials for YK-BPW1 were performed according to ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
- Clinical Test Conclusion
There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2013 within the ±5mmHg.
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9. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device
K131569 | Remark |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | DXN | DXN | SE |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870. 1130 | SE |
| Class | 2 | 2 | SE |
| Intended Use | The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home. The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm. | The PG-800A Series Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. | SE |
| Application Site | Wrist | Wrist | SE |
| Patient
Population | Adult | Adult | SE |
| Measurements
Item | SYS,DYS,Pulse | SYS,DYS,Pulse | SE |
| Principle | Oscillometric | Oscillometric | SE |
| Main
Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries | SE |
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| ITEM | Proposed Device | Predicate Device
K131569 | Remark |
|-------------------------|-----------------------------------------------------------------|------------------------------------------------|----------|
| BP Range | 20-280 mmHg | 30-280 mmHg | SE |
| BP Accuracy | $ \pm $ 3 mmHg | $ \pm $ 3 mmHg | SE |
| PR Range | 40-199 | 40-199 bpm | SE |
| Operation
Condition | 5-40 °C
15%-80% RH
50kPa105kPa | 5-40 °C105kPa | -20-55 °C
30%-80% RH
Atmosphere Pressure | SE |
| Storage Condition | -20-55 °C
$ \le $ 90% RH
50kPa
10%-90% RH
Atmosphere Pressure | SE |
| Data Storage | SYS, DIA, PR, Measurement Time, No. | SYS, DIA, PR, Measurement Time, No. | SE |
| Performance
Standard | Comply with ISO 80601-2-30 | Comply with AAMI SP10 | SE |
| Cuff Size | 310 x 75 mm | 30.8 cm (length) x 8 cm (width) | Analysis |
| Power Supply | 2 x AAA | Two AAA or LR03 Batteries | SE |
| Voltage | 3V | 3V | SE |
Table 2 Performance Comparison
Analysis
The proposed device is substantially equivalent to the predicate device. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
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| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K131569 | |||
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Label and | |||
| Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory | |
| Requirements | SE | ||
| Level of Concern | |||
| of the Software | Moderate | Moderate | SE |
Table 3Safety Comparison
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.