SPECTRUM DESIGNS SPECTRAGEL

{0}------------------------------------------------ ### SUMMARY OF SAFETY AND EFFICACY OCT 26 1999 ## SPECTRUM DESIGNS SPECTRAGEL SILICONE GEL #### 1. Submitter's Data Spectrum Designs Inc. Spectrum Designs Medical 6387 B. Rose Lane Carpinteria, CA 93013 ## 2. ContactPerson Jim Dishman Phone: 805 684 7678 805 684-0497 Fax: # 3. Device Name, Classification________________________________________________________________________________________________________________________________________________ Spectrum Designs Spectragel Silicone Gel Product code: Class II 79 MDA ## 4. Identification of Substantially Equivalent Devices Spectrum Designs Medical Spectragel Applied Biomedical: Kelocote #### 5. Device Description Spectragel is used only on intact skin and is manufactured out of medical grade, biocompatible silicone material. #### 6. Indications for Use Spectrum Designs Spectragel is indicated for use in the topical management of Hypertrophic and keloid scars. Spectrum Designs Spectragel may also be used prophylactically to help retard the formation of such scars {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized image of an eagle with three lines representing its wings. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 26 1999 Mr. Jim Dishman President Spectrum Designs, Inc. 6387-B Rose Lane Carpinteria, California 93013 Re: K992522 Trade Name: Spectragel Regulatory Class: Unclassified Product Code: MDA Dated: July 26, 1999 Received: July 28, 1999 Dear Mr. Dishman: 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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. {2}------------------------------------------------ Page 2 - Mr. Jim Dishman 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 Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE Applicant: Spectrum Designs Inc. 510(k) Number : Device Name: Spectrum Designs Spectragel Indications for Use: Spectrum Designs Spectragel is indicated for use in the topical mangement of hypertrophic and keloid scars. Spectrum Designs Spectragel may also be used prophylactically to help retard the formation of such scars. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) # Concurrence of CDRH Office of Device Evaluation (ODE) Prescription use Per 21 CFR 801.109 or Over-the counter (Division Sign-Off) Division of General Restorative Devices K9932522 510(k) Number