Bluetooth blood pressure monitor

K182018 · Shenzhen Kingyield Technology Co., Ltd. · DXN · Oct 6, 2018 · Cardiovascular

Device Facts

• Record ID: K182018
• Device Name: Bluetooth blood pressure monitor
• Applicant: Shenzhen Kingyield Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 6, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.

Device Story

Bluetooth Blood Pressure Monitor (BPW1) is a wrist-worn, fully automatic, non-invasive oscillometric device for adult blood pressure and heart rate monitoring. It uses an air pump for inflation and an automatic valve for pressure release. The device detects irregular heartbeats (IHB), defined as rhythm variation ≥25% from average. It features a rechargeable Li-ion battery, LCD display, and Bluetooth 4.0 connectivity for integration with a mobile medical application (MMA). Users operate the device via a START/STOP button on the unit or the mobile app. The device provides readings and IHB symbols to the user, facilitating home-based health monitoring. It is intended for adult use only; contraindicated for patients with wrist wounds.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2013. The device met all requirements for automated non-invasive sphygmomanometers. No animal testing conducted. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30, and biocompatibility standards (ISO 10993-1, -5, -10).

Technological Characteristics

Oscillometric measurement; wrist-worn form factor; zinc alloy case/ABS buttons; Li-ion rechargeable battery. Connectivity: Bluetooth 4.0. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, ISO 81060-2, ISO 10993 series, FCC Part 15. Software includes IHB detection algorithm.

Indications for Use

Indicated for adult patients requiring non-invasive blood pressure (systolic/diastolic) and heart rate measurement via wrist-worn oscillometric monitoring. Contraindicated for neonatal populations and patients with wrist/arm wounds or bleeding.

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

• BP210 Wrist Blood Pressure Monitor (K112042)

Submission Summary (Full Text)

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October 6, 2018

Shenzhen Kingyield Technology Co., Ltd. Dacheng Gong General Manager Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District Shenzhen, 518000 Cn

Re: K182018

Trade/Device Name: Bluetooth Blood Pressure Monitor, BPW1 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 5, 2018 Received: September 6, 2018

Dear Dacheng Gong:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 comprehensive regulatory information about medical devices and radiation-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,

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12 19200300 100 1 1=130040

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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## Indications for Use

510(k) Number (if known) K182018

Device Name Bluetooth Blood Pressure Monitor, BPW1

#### Indications for Use (Describe)

This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heasurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm.

| 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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# 510(k) Summary

Date the summary was prepared: September/05/2018

#### I. Administrative Information

## 1.1 Submitter/Owner

Name: Shenzhen Kingyield Technology Co., Ltd.

Address: Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Facility registration number: 3007420856

#### 1.2 Contact person

Authorized Contact Person: Dacheng Gong Position: General Manager Address: Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District, Shenzhen, 518103, China Tel: [phone] Fax: [phone] Email: [e-mail]

#### II. MODIFIED DEVICE

Device type by its common name: Bluetooth Blood Pressure Monitor, BPW1 Regulation Number: 21CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II Panel: Cardiovascular Product Code: DXN

#### III. PREDICATE/UNMODIFIED DEVICE

Device Name: BP210 Wrist Blood Pressure Monitor Common/Usual Name: Wrist Blood Pressure Monitor BP210 510(k) Number: K112042 510(k) submitter/holder: Shenzhen Kingyield Technology Co., Ltd.

## IV. MODIFIED DEVICE DESCRIPTION

Bluetooth Blood Pressure Monitor, BPW1 is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method, including irregular heartbeats (IHB) from the wrist.

The device is powered by a rechargeable Lithium battery.

The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement.

The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0.

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An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.

## V. INDICATIONS FOR USE

This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading.

The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.

It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

The wrist circumference is limited to 13.5cm - 21.5cm.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE/UNMODIFIED DEVICE

| Comparison<br>item | Predicate/unmodified<br>device | Modified device | Explanation of the<br>differences |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The trade name | BP210 Wrist Blood<br>Pressure Monitor | Bluetooth blood pressure<br>monitor, BPW1 | |
| 510(k) Number | K112042 | | |
| Applicant | Shenzhen Kingyield<br>technology Co., Ltd. | Shenzhen Kingyield<br>technology Co., Ltd. | Identical |
| Recommended<br>classification<br>regulation | 21CFR 870.1130,<br>Noninvasive Blood<br>Pressure Measurement<br>System | 21CFR 870.1130,<br>Noninvasive Blood Pressure<br>Measurement System | Identical |
| Regulatory<br>Class | II | II | Identical |
| Panel | Cardiovascular | Cardiovascular | Identical |
| Product Code | DXN | DXN | Identical |
| Intended use | BP210 Wrist Blood<br>Pressure Monitor is<br>intended to be used to<br>measure blood pressure<br>(systolic and diastolic)<br>and heart rate from the<br>wrist by using the<br>oscillometric method.<br>The device is intended | This blood pressure monitor is<br>intended to be used to measure<br>blood pressure (systolic and<br>diastolic) and heart rate from<br>the wrist by using the<br>oscillometric method. The<br>device detects the appearance<br>of irregular heartbeats during<br>measurement and gives a | Identical<br>though the wording is<br>adjusted |
| | | | |
| | population, not applied<br>to the other populations<br>such as neonatal baby.<br>It can't be used while<br>the wrist (arm) has<br>bleeding or wound to<br>avoid the blood flowing<br>from the wound in<br>pressurizing.<br>The wrist circumference<br>is limited to 13.5cm -<br>21.5cm. | The device is intended for<br>using in only adult population,<br>not applied to the other<br>populations such as neonatal<br>baby. It can't be used while the<br>wrist (arm) has bleeding or<br>wound to avoid the blood<br>flowing from the wound in<br>pressurizing. The wrist<br>circumference is limited to<br>13.5cm - 21.5cm. | |
| Measuring<br>principle | Oscillometric method | Oscillometric method | Identical |
| Measuring<br>range | Cuff pressure: 0~299<br>mmHg Pulse : 40~180<br>beat/min | Cuff pressure: 0~299 mmHg<br>Pulse : 40~180 beat/min | Identical |
| Max cuff<br>pressure | 300mmHg | 300mmHg | Identical |
| Accuracy | Static Pressure: ± 3mmHg<br>Pulse: ± 5% reading value | Static Pressure: ± 3mmHg<br>Pulse: ± 5% reading value | Identical |
| Inflation | By air pump | By air pump | Identical |
| Deflation | Not Apply | Not apply | Identical |
| Pressure release | By automatic valve | By automatic valve | Identical |
| Dimensional<br>Specifications | Body: 77*62*34<br>Body with cuff: 77*62*84 | Body: 41*47*17.7<br>Body with bladder &<br>wristband: 270.12*41*17.7 | Equivalent<br>The changes are tested<br>according to the<br>requirements of the<br>standards IEC 60601-1, IEC<br>60601-1-2, IEC 62133, EN<br>1060-3,<br>IEC 80601-2-30,<br>60601-1-11, EN 300 328,<br>EN 301 489-1, EN 301<br>489-17, FCC 47 CFR Part<br>15, Subpart B & FCC 47<br>CFR Part 15 Subpart C, IEC<br>62366-1, IEC 60601-1-6,<br>and ISO81060-2.<br>The changes in dimensional<br>specifications are |
| | | | |
| Bladder and<br>Cuff | Cuff containing bladder | Bladder + wristband | documented; do not affect<br>the intended use or the<br>fundamental scientific<br>technology.<br><br>Equivalent<br>The changes are tested<br>according to the<br>requirements IS081060-<br>2:2013, ISO 10993-1, ISO<br>10993-5, and ISO 10993-10.<br><br>The changes in the<br>specifications are<br>documented; do not affect<br>the intended use or the<br>fundamental scientific<br>technology. |
| Event marking | By pressing the<br>START/STOP button | By pressing the<br>START/STOP button;<br>By click "START/STOP" on<br>APP | Equivalent<br>The change in the<br>specification is documented,<br>the cybersecurity risk has<br>been considered and the<br>overall residual risk is<br>acceptable.<br>The change does not affect<br>the intended use or the<br>fundamental scientific<br>technology. |
| | By pressing the MEM<br>button | By pressing the MEM button | Equivalent |
| Display | Device LCD | Device LCD;<br>LCD on collateral device<br>while connecting | Equivalent<br>The changes of the user<br>interface are documented,<br>do not affect the intended<br>use or the fundamental<br>scientific technology.. |
| Operating<br>Temp. &<br>humidity | Temp.: 10~40°C<br>Humidity: 15~90%RH<br>(noncondensing )<br>Atmospheric:<br>105kPa~80kPa | Temp.: 10~40°C Humidity:<br>15~90%RH (noncondensing )<br>Atmospheric: 106kPa~80kPa | Equivalent<br>The environmental<br>conditions changes are<br>tested according to the<br>requirements of the<br>standards IEC 60601-2-30 |
| | | | |
| Storage Temp.<br>& humidity | Temp.: -20~55°C<br>Humidity: 10~90%RH<br>(noncondensing ) | Temp.: -20~55°C Humidity:<br>0~95%RH (noncondensing ) | Equivalent<br>The environmental<br>conditions changes are<br>tested according to the<br>requirements of the<br>standards IEC 80601-2-30<br>and IEC 60601-1-11. These<br>changes do not affect the<br>intended use. |
| Communication | USB cable---<br>The memory data can be<br>transferred to the PC by<br>connecting the device with<br>the PC via USB cable | Bluetooth | Equivalent<br>The changes are tested<br>according to the<br>requirements of the<br>standards IEC 80601-2-30<br>and 60601-1-11.<br><br>The changes in the<br>specifications are<br>documented; do not affect<br>the intended use or the<br>fundamental scientific<br>technology. |
| IHB function | IHB function | IHB function | Identical |
| Memory<br>function | 90*2 | 30 | Equivalent<br>The change in the<br>specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. |
| Automatic<br>power-off | In 2 minutes | No automatic power-off<br>function, adding clock<br>function instead. | Equivalent<br>The change in the<br>specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. |
| Clock function | No clock | Yes | Equivalent |
| Material | PC and ABS for the case<br>and plastic foil for the<br>labels of the device.<br>Biocompatible materials<br>are used for the applied<br>parts (Cuff containing<br>bladder). | Zinc alloy for the case of the<br>device and ABS for Button.<br>Biocompatible materials are<br>used for the applied parts<br>(Bladder + wristband). | specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. |
| Energy source | AAA alkaline battery x 2<br>pcs | Li-ion Rechargeable battery<br>with 250 charging cycles | Equivalent<br>The change in the<br>specification is documented<br>and tested, does not affect<br>the intended use or the<br>fundamental scientific<br>technology. |
| Sterilization | Not applicable | Not applicable | Identical |
| Expiration date | Not applicable | The rechargeable battery<br>installed in the device will<br>self-discharge | Equivalent<br>Instruction Manual is<br>revised to add "The device's<br>battery should be recharged<br>periodically, even during<br>storage since the<br>rechargeable battery<br>installed in the device will<br>self-discharge, leading to an<br>unacceptably low voltage,<br>thus damaging the battery."<br>The change in the<br>specification is documented,<br>does not affect the intended<br>use or the fundamental<br>scientific technology. |
| Accessories | Instruction manual | Instruction manual which is<br>revised according to the<br>changes made | Equivalent<br>The change in the<br>specification is documented,<br>does not affect the intended<br>use or the fundamental<br>scientific technology. |
| | Soft rule | Equivalent | |
| | | The adding of the soft rule<br>that increases the measuring<br>accuracy of the device is<br>documented | |
| BP-management software<br>on Personal Computer | A mobile medical app on<br>Android | Equivalent<br>The change in the<br>specification is documented,<br>the cybersecurity risk has<br>been considered and the<br>overall residual risk is<br>acceptable.<br>The change does not affect<br>the intended use or the<br>fundamental scientific<br>technology. | |

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## VII.PERFORMANCE DATA

## VII.I Performance Testing - Bench

Testing information demonstrating safety and effectiveness of the intended environment of use is supported by testing that was conducted.

The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices.

The following National and International Standards were utilized for testing the subject device.

#### a. EMC Test:

- IEC 60601-1-2: 2014

General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests

## b. Safety Test:

-IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

-IEC 60601-1-11:2015, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance - Collateral Standard: Requirements for medical electrical systems used in the home healthcare Environment

-IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications

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### c. Reliability Test:

-IEC 80601-2-30:2009+A1:2013 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers, 2013

-EN 1060-3: 1995+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

### d. Radio Frequency Wireless Test:

-EN 300 328 V2.1.1, Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU

-Draft EN 301 489-1 V2.2.0, ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU

-Draft EN 301 489-17 V3.2.0, ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU

### e. FCC Test:

-FCC 47 CFR Part 15, Subpart B -FCC 47 CFR Part 15, Subpart C -FCC 47 CFR Part 1.1307 -FCC 47 CFR Part 2.1093

#### f. Biocompatibility Test:

-ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process

-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

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Bluetooth Blood Pressure Monitor, BPW1 tested met all relevant requirements of the aforementioned tests. The evaluation of these results present no new issues related to safety or effectiveness of the testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices.

The test methods used are the same as those submitted in the original submission.

VII-II Performance Testing – Animal N/A

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# VII-III Performance Testing - Clinical

## Clinical Validation:

- ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type

The device has achieved the requirements of ISO18060-2:2013.

## VII-IV Cybersecurity Risk Management

- FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014)
- FDA Post Market Management of Cybersecurity in Medical Devices (2016)

The overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan.

#### VIII. SUBSTANTIAL EQUIVALENCE CONCLUSION

The modified device has been found to be substantially equivalent to the predicate/unmodified device. Differences between the modified device and the predicate/unmodified device do not raise new questions of safety or effectiveness.