Bluetooth blood pressure monitor

K161530 · Shenzhen Kingyield Technology Co., Ltd. · DXN · Mar 31, 2017 · Cardiovascular

Device Facts

• Record ID: K161530
• Device Name: Bluetooth blood pressure monitor
• Applicant: Shenzhen Kingyield Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 31, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

BW-BW1 Bluetooth Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and heart rate from the wrist using the oscillometric method, the measured data is transferred to a smart phone for the patient record archiving and/or measured data analysis purpose. The device is intended for use in only adult population, not applied to the other populations such as neonatal baby. It can not be used while the wrist (arm) has bleeding or wound the blood flowing from the wound in pressurizing.

Device Story

Wrist-worn oscillometric blood pressure monitor; measures systolic/diastolic pressure and heart rate. Device uses cuff inflation/deflation to detect arterial pressure oscillations. Data transmitted via Bluetooth to smartphone for archiving and analysis. Intended for adult patient self-use in home or clinical settings. Provides digital display of vital signs; enables longitudinal tracking of cardiovascular data via mobile application. Benefits include convenient, non-invasive monitoring of blood pressure trends.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to predicate device specifications.

Technological Characteristics

Wrist-worn oscillometric blood pressure monitor. Connectivity: Bluetooth for data transfer to smartphone. Power: Battery-operated. Software: Embedded firmware for signal processing and data transmission. Sterilization: Not applicable (non-sterile).

Indications for Use

Indicated for adult patients for non-invasive measurement of systolic/diastolic blood pressure and heart rate via wrist oscillometry. Contraindicated for neonates and patients with bleeding or wounds on the wrist/arm.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2017

Shenzhen Kingyield Technology Co., Ltd. % Field Fu, Consultant Shenzhen Joyantech Consulting Co., Ltd. 2032#. International Mavor Communication Center. Shizhou Zhong Road 55#, Na Shenzhen, Guangdong 518100 CHINA

Re: K161530

Trade/Device Name: BW-BW1 Bluetooth 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 31, 2017 Received: March 3, 2017

Dear Field Fu:

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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Minde Jellman
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)

K161530

Device Name

BW-BW1 Bluetooth Blood Pressure Monitor

Indications for Use (Describe)

BW-BW1 Bluetooth Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and heart rate from the wrist using the oscillometric method, the measured data is transferred to a smart phone for the patient record archiving and/or measured data analysis purpose.

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

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

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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