Wrist Type Blood Pressure Monitor

K162616 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · DXN · Mar 9, 2018 · Cardiovascular

Device Facts

• Record ID: K162616
• Device Name: Wrist Type Blood Pressure Monitor
• Applicant: Xuzhou Yongkang Electronic Science Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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.

Device Story

Battery-driven automatic non-invasive blood pressure monitor; uses oscillometric technique via inflatable wrist cuff. Device automatically manages inflation, deflation, and measurement of systolic/diastolic blood pressure and pulse rate. Features include user ID settings for data storage, time/date configuration, optional voice broadcast of results, unit selection (mmHg/KPa), and low battery indicator. Used in medical facilities or home environments by adults. Healthcare providers or patients review stored data (systolic/diastolic pressure, pulse rate, measurement time) to monitor cardiovascular status. Benefits include convenient, automated blood pressure tracking.

Clinical Evidence

Clinical trial performed per ISO 81060-2:2013 with 150 subjects. Auscultation using a calibrated mercurial sphygmomanometer served as the gold standard control. Results demonstrated accuracy within ±5 mmHg, meeting ISO 81060-2:2013 requirements.

Technological Characteristics

Battery-powered (2x AAA, 3V) automated oscillometric sphygmomanometer. Components: LCD, keypad, inflatable cuff (310x75mm), MCU, pump. Connectivity: None. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). Safety/EMC: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-30. Software level of concern: Moderate.

Indications for Use

Indicated for adult patients requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via oscillometric wrist cuff. Intended for use in medical facilities or home settings. Wrist circumference must be 13.5 - 19.5 cm.

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

• PG 800A Series Electronic Blood Pressure Monitor (K131569)

Submission Summary (Full Text)

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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);

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

K162616

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) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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

- 1. Date of Preparation
01/21/2018

- 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: [phone]-631 Fax:[phone] -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: [phone] Fax: [phone] Email: [e-mail]

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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.

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- 6. Identification of Predicate Device
Predicate #

510(k) Number: K131569

Product Name: PG 800A Series Electronic Blood Pressure Monitor Manufacturer: Shenzhen Pango Electronic Co., Ltd.

- 7. 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:

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.

- 8. 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.

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<br>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<br>Population | Adult | Adult | SE |
| Measurements<br>Item | SYS,DYS,Pulse | SYS,DYS,Pulse | SE |
| Principle | Oscillometric | Oscillometric | SE |
| Main<br>Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries | SE |

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| ITEM | Proposed Device | Predicate Device<br>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<br>Condition | 5-40 °C<br>15%-80% RH<br>50kPa~105kPa | 5-40 °C<br>30%-80% RH<br>Atmosphere Pressure | SE |
| Storage Condition | -20-55 °C<br>$ \le $ 90% RH<br>50kPa~105kPa | -20-55 °C<br>10%-90% RH<br>Atmosphere Pressure | SE |
| Data Storage | SYS, DIA, PR, Measurement Time, No. | SYS, DIA, PR, Measurement Time, No. | SE |
| Performance<br>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<br>Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory<br>Requirements | SE |
| Level of Concern<br>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.