AQUA PATCH

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the left. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. H. Clay Wilson, P.E. Submission Correspondent Precision Converters, Inc. 10969 Shady Trail, Suite 101 Dallas, Texas 75220 DEC 18 1997 Re: K973693 Aqua Patch Regulatory Class: Unclassified Product Code: MGO Dated: November 14, 1996 Received: September 26, 1997 Dear Mr. Wilson: 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations: - This device may not be labeled for use on third degree burns. 1. - 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. - 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. - 4. This device may not be labeled as a treatment or a cure for any type of wound. The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual {1}------------------------------------------------ Page 2 - Mr. H. Clay Wilson, P.E. registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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. 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) 594-4595. 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 vours. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Indications for Use: K-97 3693 ് പ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Device Name: Aqua Patch Hydrogel Dressing Dermal ulcers, superficial wounds, 1st and 2nd degree burns, donor sites, skin tears, radiation reactions (burns), protection around tube sites. | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Prescription Use _______ (Per 21 CFR 801.109) | OR Over-The-Counter Use ✓ (Optional Format 1-2-96) | | <div align="center">____________________________</div> <div align="center">(Division Sign-Off)</div> | | | Division of General Restorative Devices | | | 510(k) Number | k973693 |