(9 days)
The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (diastolic & systolic) and pulse rate in adult patients with arm circumferences from 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
Not Found
This document is an FDA 510(k) clearance letter for A&D Engineering Inc.'s Digital Blood Pressure Monitors. Unfortunately, the provided text does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It refers to "indications for use" and "general controls provisions of the Act," but does not elaborate on the specific performance metrics or studies used to validate the device's accuracy or effectiveness.
Therefore, I cannot provide the requested information from the given input. To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which typically includes the performance data and study details.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2001
A & D Engineering Inc. c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K010828
Trade Name: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP Regulatory Class: II (two) Product Code: DXN Dated: March 19, 2001 Received: March 20, 2001
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energismere to regarly maxical Device Amendments, or to devices that prior to rid) 20, 1978, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Sourisions 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. Robert Mosenkis
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Hypt Rhodes
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP Digital Blood Pressure Monitors
Indications for Use:
The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to The A&D Mcdroal Dirocodice 11:2 & systolic) and pulse rate in adult patients with arm measure brood probare (shares 1 inches (13.0 cm) to 17.7 inches (45.0 cm).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyat Qude
Division Of Cardiovascular & Respiratory Devices
510(k) Number K010828
Prescription Use
Or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X
(Optional Format 1-2-96)
§ 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).