(173 days)
The intended use of the Pressure Products Pressure Pad is to temporarily occlude the femoral artery when used in conjunction with the appropriate femoral artery clamp.
Not Found
I am sorry, but based on the provided document, I cannot extract the acceptance criteria and the details of a study proving device performance. The document is an FDA letter regarding a 510(k) premarket notification for "Pressure Pads" and primarily discusses the device's substantial equivalence to a predicate device and regulatory compliance. It does not contain information about:
- Acceptance criteria or device performance data.
- Sample sizes for test or training sets.
- Details about expert involvement (number, qualifications, adjudication methods).
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used.
The letter confirms the device's classification and allows it to be marketed, but does not delve into the technical study results or validation parameters.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three figures in profile facing right, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 JUL
Mr. James Barley Requlatory Affairs Pressure Products 30423 Miraleste Drive Rancho Palos Verdes, CA 90275
K980087 Re: Trade Name: Pressure Products Pressure Pads, Models P100, P110, P120, P130 and P200 Requlatory Class: II Product Code: DXC Dated: April 15, 1998 Received: April 17, 1998
Dear Mr. Barley:
・
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, 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 (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 response to your premarket notification submission does not affect any
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Paqe 2 - Mr. James Barley
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) 594-4618. 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 requlation 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K980087
Device Name: Pressure Pads
Indications for Use:
The intended use of the Pressure Products Pressure Pad is to temporarily occlude the femoral artery when used in conjunction with the appropriate femoral artery clamp.
Ture A. M.
(Division Sign-Off) Division of Cardiovascular Respiratory, and Neurological Devices 2460089 510(k) Number
(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)
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OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).