AQUAFLO HYDROGEL WOUND DRESSING & PACKER

{0} FDA U.S. FOOD & DRUG ADMINISTRATION February 25, 2025 Sherwood Medical Company Frank J. Fucile Director of Regulatory Affairs 1915 Olive Street St. Louis, Missouri 63103-1625 Re: K952945 Trade/Device Name: AquaFlo™ Hydrogel Wound Dressing and AquaFlo™ Hydrogel Wound Packer Regulation Number: 21 CFR 878.4022 Regulation Name: Hydrogel wound dressing and burn dressing Regulatory Class: Class I Product Code: NAE Dear Frank J. Fucile: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 23, 1995. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code NAE. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, Yu- Chieh.Chiu@fda.hhs.gov. Sincerely, # Yu-chieh Chiu -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} [LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service AUG 23 1995 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Mr. Frank J. Fucile Director of Regulatory Affairs Sherwood Medical Company 1915 Olive Street St. Louis, Missouri 63103 Re: K952945 AquaFlo™ Hydrogel Wound Dressing and AquaFlo™ Hydrogel Wound Packer Regulatory Class: Unclassified Product Code: MGQ Dated: July 26, 1995 Received: July 31, 1995 Dear Mr. Fucile: We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations: 1. These devices may not be labeled for use on third degree burns. 2. These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. 3. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. 4. These devices 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 devices and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. {2} Page 2 - Mr. Frank J. Fucile If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices 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 immediately will allow you to begin marketing your devices as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and permits your devices to proceed to the market, but it does not mean that FDA approves your devices. Therefore, you may not promote or in any way represent your devices or their labeling as being approved by FDA. If you desire specific advice regarding labeling for your devices in accordance with 21 CFR Part 801, promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Ann C. Forner Jr Kimber C. Richter, M.D. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health 2 {3} ATTACHMENT #1 K950945 THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990 510(k) Summary of Safety & Effectiveness AquaFlo™ Hydrogel Wound Dressing/Packer Submitted By Sherwood Medical Co., 1915 Olive St., St. Louis, MO 63103, (314) 241-5700 Contact: Frank J. Fucile, Director of Regulatory Affairs Date Prepared: June 22, 1995 AUG 23 1995 The AquaFlo™ Hydrogel Wound Dressing/Packer is a non-classified, hydrogel wound dressing, Panel 79, Procode MGQ. The AquaFlo™ Hydrogel Wound Dressing/Packer is a sterile, polyurethane-based hydrophilic hydrogel. The gel is supported, prior to use, on a polyethylene scrim. The AquaFlo™ Hydrogel Wound Dressing/Packer provides a moist wound environment which is conducive for optimal wound healing. The dressings protect against bacterial contamination and dehydration of the wound. They readily conform to any wound configuration, absorb wound exudate and provide a cooling, pain relieving covering. The wound packer may be used to help maintain a passageway in cavities, when support of overlying tissues and protection of underlying tissues is needed. The AquaFlo™ Hydrogel Wound Dressing/Packer will be supplied in the following sizes: Dressings - 2" x 2", 4" x 4", 6" x 6", and 8" x 8"; Wound Packer - 12 inch rope. The dressings on their supporting scrim will be individually packaged between strips of polyethylene and heat sealed in foil pouches. 2" x 2" and 4" x 4" dressings will be packed 5 per intermediate carton and ten intermediates per case. 6" x 6" and 8" x 8" dressings will be packed 5 per intermediate carton and 6 intermediates per case. The Wound Packer will also be packaged between strips of polyethylene and heat sealed in foil pouches. Wound Packers will be packed 5 per intermediate carton and 6 intermediates per case. The AquaFlo™ Hydrogel Wound Dressing is substantially equivalent to four currently marketed hydrogel dressings: Clearsite Hydrogel Dressing (NDM, K914207), Nu-Gel Hydrogel Dressing (Johnson & Johnson, K932336), Elasto-gel Hydrogel Dressing (Southwest Technologies, K872165), and Vigilon Hydrogel Dressing (Bard, K820134). The AquaFlo™ Hydrogel Wound Dressing/Packer and the NDM, J&J, Southwest, and Bard dressings have undergone the following comparative testing: a) hydrogel hydration testing (measured as percent weight increase and percent increase in length) in: 1) deionized water, 2) 1% saline solution; and b) hydrogel dehydration (measured as percent weight remaining). The results of this testing indicate that the AquaFlo™ Hydrogel Wound Dressing/Packer performed equally or superior compared to the NDM, J&J, Southwest and Bard products, and raise no new issues relating to safety or efficacy. The AquaFlo™ Hydrogel Wound Dressing/Packer will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.