(18 days)
The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
Meditech ABPM-05 Ambulatory Blood Pressure Monitor
The provided text is a 510(k) clearance letter from the FDA for the Meditech ABPM-05 Ambulatory Blood Pressure Monitor. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance results, sample sizes for testing or training, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The letter focuses on regulatory clearance based on substantial equivalence, not on detailed study results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2007
Meditech Kft. c/o Mr. Benny Arazy Arazy Group - Medical Device Consultants Industrial Park 13 M.P. Misgav 201870 Mizpe Aviv ISRAEL
Re: K071960
Trade/Device Name: Meditech Ambulatory Blood Pressure Monitor, Model ABPM-05 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 17, 2007 Received: July 17, 2007
Dear Mr. Arazy:
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 such 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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Pagc 2 - Mr. Benny Arazy
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmimmoa 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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Attachment 2
Indications for Use Statement
510(k) Number
Device Name Meditech ABPM-05 Ambulatory Blood Pressure Monitor
Indications for The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software.
The -device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Bhumlema
of Cardlovascular Devices 510(k) Number
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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).