(86 days)
Conform Sheeting is indicated for use in the management of keloid and hypertrophic Scars. Conform Sheeting may also be used prophylactically to help retard the formation of such scars.
Not Found
This document is an FDA 510(k) clearance letter for a medical device called "Conform Sheeting, Model IGEL." It is a regulatory document addressing the substantial equivalence of the device to legally marketed predicate devices.
This document DOES NOT contain information about acceptance criteria, device performance specifications, study details (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the request.
The letter is focused on the regulatory approval process and states that the device is substantially equivalent for its intended use, which is in the management and prevention of keloid and hypertrophic scars. It does not provide any technical performance data or a study description of the kind requested.
Therefore, I cannot fulfill the request using only the provided text.
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Public Health Service
OCT 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Meade RA/OA Manager Implantech Associates, Inc. 2064 Eastman Avenue, Unit 101 Ventura, California 93003
Re: K012419
Trade/Device Name: Conform Sheeting, Model IGEL Regulatory Class: Unclassified Product Code: MDA Dated: July 24, 2001 Received: July 30, 2001
Dear Mr. Meade:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Stephen Meade
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, us
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: Implantech Associates, Inc.
510(k) Number (if known): K012419
Device Name: Conform Sheeting
Indications For Use:
Conform Sheeting is indicated for use in the management of keloid and hypertrophic Scars. Conform Sheeting may also be used prophylactically to help retard the formation of such scars.
(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
Over-the-Counter
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Exhibit II, Page 1 of 1
OR
510(k) Number K012419
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.