(302 days)
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.
Not Found
This document is a 510(k) premarket notification for the BW-BW1 Bluetooth Blood Pressure Monitor. It primarily consists of regulatory correspondence and an "Indications for Use" statement, and does not contain the detailed study information needed to answer the request.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them, because this document does not include that data. This document only states that the device is "substantially equivalent" to predicate devices, which is part of the regulatory approval process but doesn't detail performance studies.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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§ 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).