← Product Code FRO · K990042 # SILON DUAL-DRESS (K990042) _Bio Med Sciences, Inc. · FRO · Mar 19, 1999 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K990042 ## Device Facts - **Applicant:** Bio Med Sciences, Inc. - **Product Code:** FRO - **Decision Date:** Mar 19, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use For the management of partial and full thickness wounds including the following: Second Degree Burns Skin Graft Donor Sites Autograft Sites Abrasions Lacerations Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic) Skin Tears ## Device Story Silon Dual-Dress is a dual-sided wound dressing. One side features open-celled hydrophilic foam; the other side features a perforated, non-adherent semi-occlusive film. The film allows wound exudate to wick away. The foam side provides an adhesive surface for fixation; the film side provides a non-adherent covering for sensitive wounds. The dressing is marked with biocompatible ink to identify the foam side. It is intended for clinical management of various partial and full-thickness wounds. It does not accelerate healing, nor is it a permanent dressing or artificial skin. ## Technological Characteristics Dual-sided wound dressing; one side open-celled hydrophilic foam, one side perforated semi-occlusive film. Biocompatible ink used for labeling. Non-electronic, non-implantable, passive dressing. ## Predicate Devices - Silon Transparent Wound Dressings ([K912032](/device/K912032.md), [K923150](/device/K923150.md)) - Epitec Dressing ([K971337](/device/K971337.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K990042 Image /page/0/Picture/1 description: The image shows the logo for Bio Med Sciences, Inc. The logo features the letters "BMS" in a bold, sans-serif font, with a solid black square to the left of the "B". Below the letters is the company name, "Bio Med Sciences, Inc.", in a smaller font. The logo is simple and professional, and the use of black and white gives it a clean and modern look. 101 Technology Drive ● Bethlehem. PA 18015 Phone: (610) 974-8801 FAX: (610) 974-8831 Toll Free: 1-800-25-SILON 1257-4566) http://www.silon.com XIII. 5100 SUMMARY SILON® DUAL-DRESS™ ## PRODUCT DESCRIPTION Silon® Dual-Dress™ is a single dressing with two different sides. One side consists of an open-celled hydrophilic foam. The other side consists of a non-adherent semi-occlusive film. The semi-occlusive film is perforated to allow wound exude to wick away from the wound. With the foam side of the dressing down against the wound, the product provides an adhesive surface for difficult fixation conditions. With the film side down, the dressing provides a non-adherent covering for fragile and sensitive wounds. One side of the dressing is clearly marked with the product name and the words "Foam on Other Side" printed with a biocompatible ink. ## INDICATIONS FOR USE For the management of partial and full thickness wounds including the following: - Second Degree Burns ● - Skin Graft Donor Sites - Autograft Sites � - Abrasions ● - . Lacerations - Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic) - Skin Tears Contraindications (either side down); - Third Degree Burns . ## SUBSTANTIAL FOUITALENCE Bio Med Sciences claims substantial equivalency for Silon® Dual-Dress™ to the following devices: - 1. Silon Transparent Wound Dressings (Bio Med Sciences, Inc. 510K #s K912032 & K923150) - 2. Epitec® Dressing (Rynel Ltd, Inc. 510K #K971337) {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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three overlapping, curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 9 1999 Mr. Mark E. Dillon President BioMed Sciences, Inc. 101 Technology Drive Bethlehem, Pennsylvania 18015 Re: K990042 Trade Name: Silon Dual-Dress Regulatory Class: Unclassifed Product Code: MGP Dated: January 4, 1999 Received: January 6, 1999 Dear Mr. Dillon: 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: - 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 Enclosure {3}------------------------------------------------ Page 1 of 1 K990042 510 (k) Number (if KNOHN): Silon Dual-Dress DEVICE NAME: INDICATIONS FOR USE: For the management of partial and full thickness wounds including the following: - Second Degree Burns b - Skin Graft Donor Sites . - 이 Autograft Sites - 이 Abrasions - Lacerations 1 - Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic) - Skin Tears (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-Use (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K990042 --- **Source:** [https://fda.innolitics.com/device/K990042](https://fda.innolitics.com/device/K990042) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com