INTRASITE

{0} **U.S. FOOD & DRUG** ADMINISTRATION February 25, 2025 Smith & Nephew United, Inc. Jim Irvin Vice President of Quality Assurance and Regulatory Affairs 11775 Starkey Road P.O. Box 1970 Largo, Florida 34649-1970 Re: K942748 Trade/Device Name: Intrasite™ Gel Conformable Dressing Regulation Number: 21 CFR 878.4022 Regulation Name: Hydrogel wound dressing and burn dressing Regulatory Class: Class I Product Code: NAE Dear Jim Irvin: 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 June 29, 1994. 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 JUN 29 1994 Food and Drug Administration 1390 Piccard Drive Rockville MD 20850 Mr. Jim Irvin Vice President of Quality Assurance and Regulatory Affairs Smith & Nephew United, Inc. 11775 Starkey Road P.O. Box 1970 Largo, Florida 34649-1970 Re: K942748 IntraSite™ Gel Conformable Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: June 7, 1994 Received: June 10, 1994 Dear Mr. Irvin: 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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. 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: 1. This device may not be labeled for use on third degree burns. 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). {2} Page 2 - Mr. Jim Irvin The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and 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. 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 the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations. This letter immediately will allow you to begin marketing your device as described. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice on the labeling for your device please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-326) 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, for Paul R. Beninger, M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health 2 {3} K942748 JUN 9 1994 ## 510 (k) SUMMARY ### INTRASITE* GEL IntraSite* Gel Conformable Dressing, as subject of this submission, is a clear aqueous hydrogel, containing approximately 3% of a modified carboxymethyl cellulose (CMC) and 20% propylene glycol. The modified CMC provides the product with its absorption and rheological properties, whereas the inclusion of propylene glycol reduces drying. As an aqueous hydrogel, IntraSite* Gel is formulated to be used throughout the wound healing process, promoting rehydration of black necrotic tissue, absorbing excess exudate (including slough) and maintaining a moist wound environment conducive to granulation and re-epithelialisation. Propylene glycol is added to the formulation as a humectant, so as to prevent the product drying out during clinical usage. The propylene glycol content of both the proposed and predicate formulations is 20%. The predicate and proposed product differ in that the predicate is expressed from the foil packette directly into the wound and covered with a dressing. IntraSite* Gel Conformable is impregnated gel on/in a non-woven substrate which "carrys" the gel to the wound. Products of this nature have been used to provide moist wound healing environments to "wound care professionals" for years. Attached is information on various equivalent gel products. This product is equivalent in consistency and use. DSK7\510k\sec.4