(320 days)
The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.
Not Found
This document is an FDA 510(k) clearance letter for the "Shelhigh Pericardial Patch (without detoxification treatment)" and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance studies, or the methodologies used to establish such criteria and conduct studies.
Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not delve into the technical details of its performance or the studies behind it.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of three stylized human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Shlomo Gabbay, M.D. Chief Scientific Officer Shelhigh, Inc. P.O. Box 884 Millburn, New Jersey 07041
SEP 2 3 1997
K964467 Re :
Shelhigh Pericardial Patch (without detoxification treatment) Regulatory Class: II Product Code: DXZ Dated: June 19, 1997 Received: June 25, 1997
Dear Dr. Gabbay:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device (without the detoxification treatment) 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 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 requlation (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 Reqister. 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 - Shlomo Gabbay, M.D.
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 leqally 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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Fatch Intracardiac 870. 3470 - DXZ II -
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K964467
Device Name: Shelhigh Pericardial Patch Patch Patch
Indications For Use: The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K964467 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
(Optional Format 1-2-96)
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).