(34 days)
The A&D Medical LifeSource UA-779PC & UA-779T are designed to be used by end users who are eighteen (18) years and older at home and doctor/nuse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC &UA-779T uses the oscillometric method to conduct the measurement.
Digital Blood Pressure Monitors
The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report detailing acceptance criteria and performance data. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available within this document.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to legally marketed predicate devices..." This indicates that the device's clearance is based on its substantial equivalence to existing devices, rather than a detailed clinical study with the specified metrics.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies.
- Results of standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "Indications for Use" section (Image 2) merely describes the intended use of the device: "to be used by end users who are eighteen (18) years and older at home and doctor/nurse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC & UA-779T uses the oscillometric method to conduct the measurement." This is not a performance metric or acceptance criterion.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 1999
A&D Engineering, Inc. c/o Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
кадзава Re : A&D Medical, Models UA-779PC, UA-779T Requlatory Class: II (two) Product Code: DXN November 15, 1999 Dated: Received: November 16, 1999
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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.). You may, thereforc, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 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.
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Page 2 - Mr. Robert Mosenkis
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) 594-4648. 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,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ___ Kココラ888
Device Name: A&D Medical LifeSource UA-779PC & UA-779T Digital Blood Pressure Monitors
Indications for Use:
The A&D Medical LifeSource UA-779PC & UA-779T are designed to be used by end users who are eighteen (18) years and older at home and doctor/nuse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC &UA-779T uses the oscillometric method to conduct the measurement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use QI Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ ×
(Optional Format 1-2-96)
Dele K. Looper le
Division Sign-Off
Ivision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _ K993888
NIBP510(k) docs
§ 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).