FLEXIGEL-G HYDROGEL WOUND DRESSING

{0}------------------------------------------------ Innovative Technologies Ltd K 98009 7 FlexiGel-G Hydrogel Wound Dressing MAR - 4 1998 Safety & Effectiveness Summary: Classification Name: Common / Usual Name: Contact: Prepared: KMF Liquid Bandage Hydrogel Wound Dressing Priscilla Whitehead Cox, Director of Regulatory Affairs Thursday, January 8, 1998 FlexiGel-G Amorphous Hydrogel Wound Dressing, is a clear, non-adherent, amorphous gel provided as a sterile, primary wound dressing. FlexiGel-G Amorphous Hydrogel Wound Dressing encourages natural debridement through autolysis by gently rehydrating necrotic tissue and is intended to provide a moist healing environment ideally suited for the management of partial to full thickness wounds. FlexiGel-G Amorphous Hydrogel Wound Dressing is supplied sterile in single use pouches or tubes. The packaged product will be steam sterilised in accordance with Sterilisation Of Health Care Products -Requirements For Validation and Routine Control - Industrial Moist Heat Sterilisation, ANSI / AAMI / ISO11134 - 993. Qualification will be based on the overkill method with a sterility assurance level of 10-6. Biocompatibility testing including cytotoxicity, haemolysis, acute systemic toxicity, skin irritation and sensitisation has been successfully completed per ISO/Tripartite guidelines. FlexiGel-G Amorphous Hydrogel Wound Dressing is similar in design, composition and function to Intrasite™ Gel manufactured by Smith & Nephew. | Characteristics | Innovative Technologies | Smith & Nephew | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Composition | Guar gum, borax, propylene<br>glycol, water | CMC, propylene glycol, water | | Colour | Clear | Clear | | Indications For Use | Partial to full thickness<br>wounds eg: arterial, diabetic,<br>pressure and venous ulcers,<br>1st & 2nd degree burns,<br>trauma wounds and dermal<br>lesions | Shallow and deep open wounds<br>eg: pressure sores, leg ulcers,<br>surgical and malignant wounds,<br>partial thickness burns, scalds,<br>lacerations and grazes. | | Fluid Donation | 0.22 g/g | 0.18 g/g | | Fluid Absorption | -0.4 g/g | 0.31 g/g | | Packaging | Foil pouch / poly tube | Polyethylene bulb applicator | ## COMPARATIVE FEATURES Innovative Technologies I to -G Hydrogel Wound O Image /page/0/Picture/16 description: The image shows a circular logo with text and a geometric shape inside. The text "REGISTERED FIRM" is arranged around the top half of the circle, and the letters "FM" are visible at the bottom, followed by the number "34786". Inside the circle is an inverted triangle or diamond shape. The logo appears to be a certification or registration mark. ISO 9001 EN 46001 Tarvin Sands Complex Tarvin. Cheshire. CH3 8JF U.K. Tel: 44 (0) 1829 741515 Fax: 44 (0) 1829 740456 510(k) Notification Road Three, Winsford Industrial Estate, Winsford, Cheshire CW7 3PD U.K. Tel: 44 (0) 1606 86 3500 Fax: 44 (0) 1606 86 3600 Registered in England 2666957 Head Office {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 4 1998 Ms. Priscilla Whitehead Cox Director, Quality Assurance/Regulatory Affairs Innovative Technologies, Limited Road Three, Winsford Industrial Estate Winsford Cheshire CW7 3PD U.K. Re: K980097 Trade Name: Flexigel-G Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGO Dated: January 8, 1998 Received: January 12, 1998 Dear Ms. Cox: 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 enclosures) 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: - 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). 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}------------------------------------------------ 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 yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {3}------------------------------------------------ 510(k) Number (if known): K980097 Revised: February 19, 1998 Device name: ElexiGel-G™ Hydrogel Wound Dressing (Prescription) Judications For Use: FlexiGcl-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.: - · Pressure Ulcers - · Venous Stasis Ulcers - · Diabetic Ulcers - · 1* and 2nd Degree Burns - · Surgical Wounds - · Trauma Wounds - · Dermal Lesions (Cuts, abrasions, etc) ## (I'LEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODF) (Division Sign-Off) Division of General Restorative Devices | 510(k) Number | K980097 | |---------------|---------| |---------------|---------| | Prescription Use<br>(Per 21 CFR 801.109) | OR Over The Counter Use | |------------------------------------------|-------------------------| |------------------------------------------|-------------------------| (Optional Format 1-2-96) {4}------------------------------------------------ ( Optional Format 1-2-96) 510(k) Number (if known): K980097 February 19, 1998 Device name: FlexiGel-G13d Hydrogel Wound Dressing (OTC) ## Indications For Use: FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as: - · Superficial cuts - · Abrasions - · Lacerations - Minor scalds - Minor bums . - Minor skin irritations ## (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTTIER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | K980097 | | Prescription Use<br>(Per 21 CFR 801.109) | OR Over The Counter Use | |------------------------------------------|-------------------------| |------------------------------------------|-------------------------| ( Optional Format 1-2-96)