(385 days)
The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Femoral Artery Vascular Pad". This type of document is a regulatory approval for a physical medical device, not a software AI/ML device.
Therefore, the requested information about acceptance criteria, study details, ground truth, and AI/ML specific details (like multi-reader multi-case studies, standalone performance, training sets, etc.) is not applicable to this document.
The document primarily states that the device is substantially equivalent to legally marketed predicate devices for providing pressure hemostasis after femoral catheterization procedures. It does not contain any performance data, clinical study details, or acceptance criteria in the format typically used for AI/ML device evaluations.
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Rockville MD 20857
DEC I I 1997
Mr. Delbert R. Rice RMDS, Inc. 1208 SE 104th Avenue Vancouver, Washington 98664-4740
Re : K964663 Femoral Artery Vascular Pad - Model Number PAD2 Regulatory Class: II (two) Product Code: DXC Dated: September 7, 1997 September 16, 1997 Received:
Dear Mr. Rice:
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, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory 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 requlations.
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This letter will allow you to beqin 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, 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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Indications for Use Statement: 18
510(k) Number (if known):_
Device Name: FAVP: Femoral Artery Vascular Pad
Indications For Use:
The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓ | OR | Over-The-Counter Use |
|---|---|---|
| -------------------------------------------------------------------- | ---- | ----------------------------------------------------------------------- |
| (Optional Format 1-2-96) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Research | |
| and Neurologic Devices |
| 510(k) Number | K964663 |
|---|---|
| --------------- | --------- |
RMDS, Inc. * Delbert L. Rice * 1208 SE 104th Avenue * Vancouver * WA * 98664-4740 1-360-256-8623 * 1-360-256-8623 FAX A892058.DOC
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).