(398 days)
For temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "STAR Temporary Wound Cover." It primarily deals with the regulatory approval process and doesn't contain information about specific acceptance criteria, study details, or device performance metrics as requested in the prompt. The letter states that the device is "substantially equivalent" to previously marketed devices, but it does not specify the quantitative performance metrics or studies used to demonstrate this equivalence.
Therefore, I cannot provide the requested information from this document. The document primarily confirms regulatory clearance based on substantial equivalence, rather than detailing a specific performance study.
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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a symbol that looks like three stylized human figures or birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 8 1999
Mr. Michael Deutsch Osteogenics, Inc. 7781 Lakeview Drive Burlington, Wisconsin 53105
Re: K983753 Trade Name: STAR Temporary Wound Cover Regulatory Class: II Product Code: FTL Dated: August 31, 1999 Received: September 2, 1999
Dear Mr. Deutsch:
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 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 requirement, as set forth in the Quality System Regulation (OS) 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. Michael Deutsch
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 vour 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) 594-4595. 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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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October 19, 1999
510(k) Number: K983753
Device Name: STAR Temporary Wound Cover
Indications For Use:
For temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary.
/ Perscription
_ Over-the-Counter
Signature
(Division Si 8%993753 ral Restorative Dev Division of 510(k) Numb
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.