(109 days)
The model MB-300 Series Upperarm Digital Blood Pressure Monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in addrio, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
Upperarm Digital Blood Pressure Monitor (Upperarm Digital Sphygmomanometer), Model MB-300 Series
The provided text is a letter from the FDA regarding a 510(k) premarket notification for an Upperarm Digital Blood Pressure Monitor. It does not contain the acceptance criteria, reported device performance, or details of a study (like sample size, ground truth, expert information, or specific study types like MRMC or standalone) to prove the device meets said criteria.
Therefore, I cannot fulfill your request for this information from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the FDA's regulatory decision, but doesn't detail the performance study data itself.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES .
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread, composed of three human profiles facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC - 4 2009
Hangzhou Hua'an Medical & Health Instruments Co., Ltd c/o Mr. Ji Bo General Manager Building 2, Baimiao Industrial Park Economic Development Zone Wuchang Hangzhou, Zhejiang 310023 P.R. CHINA
K092514 'Re:
Trade/Device Name: Upperarm Digital Blood Pressure Monitor, MB-300 Series Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: undated Received: November 12, 2009
Dear Mr. Bo:
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.
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.
{1}------------------------------------------------
Page 2 -- Mr. Ji Bo
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 (OS) 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,
W. M.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indication For Use Statement
510(k) Number (if known): 0
Device Name: Upperarm Digital Blood Pressure Monitor (Upperarm Digital Sphygmomanometer), Model MB-300 Series
Indication For Use:
The model MB-300 Series Upperarm Digital Blood Pressure Monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in addrio, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
WM
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K092514
Hua'an-MB Ver: 1/0
રીકેર
§ 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).