(142 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The letter confirms that the device, Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35, is substantially equivalent to legally marketed predicate devices. This determination is based on a review of the manufacturer's 510(k) submission, which would have included performance data, but that data is not present in this regulatory correspondence.
To answer your request, I would need access to the actual 510(k) submission or a separate study report for the Sejoy BP-35 device. The current document only provides:
- Device Name: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35
- Intended Use: Measure blood pressure (systolic and diastolic) and pulse rate.
- Regulatory Class: Class II
- Product Code: DXN
Without the actual performance data and study details, I cannot fill out the requested table or address the specific points about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 19, 2014
Sejoy Electronics & Instruments Co., Ltd. Mr. Ren Yunhua, General Manager Building 2, No.202, Zhenzhong Road, West Lake Economy &. Technology Zone Hangzhou, Zhejiang CHINA 310030
Re: K141755
Trade/Device Names: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: November 20, 2014
Dear Mr. Ren:
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.
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Page 2 – Mr. Ren Yunhua
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Melissa A. Torres -S
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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世佳电子有限公司 Sejoy Electronics & Instruments Co., Ltd.
Indications for Use
510(k) Number (if known):
Blood Pressure Monitors BP-35 Device Name:
Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use √ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).