(90 days)
Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)
Precisa-N is a sphygmomanometer
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a blood pressure cuff (Precisa-N). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.
However, this document does not contain any information about:
- Acceptance criteria or reported device performance in a table.
- Details of a study (sample size, data provenance, number/qualifications of experts, adjudication method).
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Standalone performance (algorithm-only).
- Type of ground truth used.
- Training set size or how its ground truth was established.
Therefore, I cannot fulfill your request based on the provided text.
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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 a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Patricia Riester-Freudenmann Rudolf Riester GmbH & CO. KG P.O. Box 35 Bruckstraße 31 D-72417 Junqinqen, Germany
SEP 2 4 1997
K972379 Re: Precisa-N Requlatory Class: Class II (Two) Product Code: DXQ Dated: June 13, 1997 Received: June 26, 1997
Dear Ms. Riester-Freudenmann:
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 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, 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, labelinq, 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 Requlations, 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 requlation 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 - Ms. Patricia Riester-Freudenmann
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" (21 CFR 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/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DX6 II - Blood Pressure Cuff
of 1 Page 1 __
510(k) Number (if known):_K972379
Device Name:__Precisa-N
Indications For Use:
Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sete L. Semple le
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 97 23 79 510(k) Number _
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use /
(Optional Format 1-2-96)
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).