NORMLGEL 0.9% ISOTONIC SALINE GEL

{0}------------------------------------------------ *K984368 ### 510(k) SUMMARY | Applicant: | Mölnlycke Health Care<br>500 Baldwin Tower<br>Eddystone, PA 19022 | |-------------------------------------|------------------------------------------------------------------------------| | Proprietary Name: | Normlgel® 0.9% Isotonic Saline Gel | | Contact Person: | Miguel A. Negron, Manager, Regulatory Affairs & Quality<br>Tel. 610-499-3383 | | Substantially<br>Equivalent Device: | Normlgel® Protective Wound Gel | Normlgel® 0.9% Isotonic Saline Gel is a sterile sodium chloride solution in amorphus gel form. Normlgel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Normigel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Normlgel® 0.9% Isotonic Saline Gel represents a new formulation of our own currently marketed Normlgel Protective Wound Gel product. This new formulation provides a higher viscosity. Normlgel® 0.9% Isotonic Saline Gel is provided in 5 gm and 15 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling. The biocompatibility of Normlgel have been determined when tested in accordance with the ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. FEB 2 2 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Miguel A. Negron Manager, Regulatory Affairs and Quality Molnlycke Health Care 500 Baldwin Tower Eddystone. PA 19022 Re: K984368 Trade Name: Normlgel 0.9% Isotonic Saline Gel Regulatory Class: Unclassified Product Code: MGQ Dated: December 4, 1998 Received: December 7, 1998 Dear Mr. Negron: 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. - This device may not be labeled as a treatment or a cure for any type of wound. 4. 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}------------------------------------------------ ### Page 2 - Mr. Miguel A. Negron 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 tollfree number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html. Sincerely yours, Neil K.P. Ogden for 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 {3}------------------------------------------------ #### Indications for Use Statement Section 8: # PREMARKET NOTIFICATION # INDICATIONS FOR USE STATEMENT 510(k) Number: K984368 Mölnlycke Health Care Device Name: Normigel® 0.9% Isotonic Saline Gel Indications for Use: Normlyel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODF.) TKV (Division Sign-Off) Division of General Restorative Devices 510(k) Number _ Prescription Use (Per 21 CFR 801.109) Or Over-The-Counter Use