← Product Code FRO · K990891 # DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING (K990891) _Dermaphylyx, Inc. · FRO · May 27, 1999 · SU · SN_ **Canonical URL:** https://fda.innolitics.com/device/K990891 ## Device Facts - **Applicant:** Dermaphylyx, Inc. - **Product Code:** FRO - **Decision Date:** May 27, 1999 - **Decision:** SN - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU ## Intended Use Dermaphylyx Hydrocolloid Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds. The following Indications are for Prescription Use or under the direction of a health care professional: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters ## Device Story Dermaphylyx Hydrocolloid Wound Dressing is a self-adhesive, semi-occlusive, absorptive dressing. Construction consists of a hydrocolloid adhesive wound contact layer and a polyurethane film/foam outer layer. Device acts as a physical barrier against exogenous water and dirt while maintaining breathability. Used in professional clinical settings or by patients for OTC care of minor wounds. Applied topically to manage wound exudate and protect the wound site. Does not accelerate healing, treat, or cure wounds; not for third-degree burns or long-term permanent use. ## Clinical Evidence bench testing only ## Technological Characteristics Materials: Hydrocolloid adhesive contact layer, polyurethane film/foam backing. Principle: Semi-occlusive, absorptive barrier. Form factor: Self-adhesive dressing. Connectivity: None. Sterilization: Not specified. ## Predicate Devices - SpyroColloid® Wound Dressings (Innovative Technologies US, Inc.) ## 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}------------------------------------------------ ## 510(k) Dermaphylyx Hydrocolloid Wound Dressing Dermaphylyx, Inc. # K 990891 ## 510(k) Summary | Proprietary Name: | Dermaphylyx Hydrocolloid Wound Dressing | |----------------------|-------------------------------------------------------------------------------------------------------------------| | Common Name: | Dressing | | Classification: | Unclassified | | Submitter's Details: | Dermaphylyx, Inc.
78-E, Olympia Avenue,
Woburn, MA 01801-2057
Tel: (781) 933-4772
Fax: (781) 933-3933 | #### Description: - T Dermaphylyx Hydrocolloid Wound Dressings are sclf-adhesive, semi-occlusive and absorptive. The wound contact surface is composed of a hydrocolloid adhesive. A second layer consists of a polyurcthane film/foam. The product provides a barrier to exogenous water and dirt while maintaining breathability. Dermaphylyx Hydrocolloid Wound Dressings are intended for use in the management of partial and fitle thickness wounds in both a professional and OTC environment. They may be used on the following wounds: > Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites Over the Counter applications include abrasions, minor cuts, minor lacerations, as well as minor burns and blisters. Dermaplylyx Hydrocolloid Wound Dressings are substantially equivalent to SpyroColloid® Wound Dressings (Innovative Technologies US, Inc.). These devices are sclf-adhesive polyurethane Hydrocolloid Wound Dressings, which provide a degree breathability. They are intended for use in the management of a wide variety of wounds. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 7 1993 Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106 West 75th Lane Arvada, Colorado 80005-5306 Re: K990891 Trade Name: Hydrocolloid Wound Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: March 12, 1999 Received: March 17, 1999 Dear Dr. Reed: We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your section 970(x) notificants. It is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, use stated in the cherosule) to actions al 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 (the Act). " Tou may, unerelore, masseric Act (Act) and the following limitations: - This device may not be labeled for use on third degree burns. 1. - This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization. - This device may not be labeled as a long-term, permanent, or no-change dressing, or గా 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, I he general controls provisions of the practices, labeling, and prohibitions against misbranding and adulteration. {2}------------------------------------------------ Page 2 -- Andrew M. Reed, Ph.D. If your device is classified (see above) into either class II (Special Controls) or class III n major If your device is classified (see above) mo such additional controls. Existing major (Premarket Approval) it may be subject to such attincolde of Federal Regulations (CFR), regulations affecting your device can be found in the Code of Federal Regulations (CFR regulations affecting your device can be found in the Courses on and many and and and and Title 21, Parts 800 to 895. A substaintially courrely and Devices: General GMP with the Good Manufacturing Practices (GMP) for Medical Devices: the Food with the Good Manufacturing Fractices (GMP) Prochic GMP inspections, the Food and regulation (21 CFR Part 820) and that, through periodic GMP inspections, the G regulation (21 CFR Part 820) and that, through periodic Crim Interprocemply with the GMP Drug Administration (FDA) will verify such assumptions. Failure to comply with the GM Drug Administration (FDA) Will Venty Such assuming a FDA may publish further regulation may result in regulatory action. In addition Please note: this response announcements concerning your device in the Federal Register Please note: this response announcements concerning your device in the received any obligation you might have to your premarket notification submission for for accesses under the Flectronic Product to your premarket notifications subthsslor for devices under the Llectronic Product under sections 531 through 542 of the Art for devices under the Llectronic Product or sect under sections 551 tiffough 5 the Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) The states and and and and and security as for hetartial courvalence of your device to This letter will allow you to begin matketing your activelence of your device to a premarket notification. The FDA finaling of substitation for vour device and thus, per premarket notification. The FDA miding of substantial equilation 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 Press and the support of the liness of admines), plansa contact the Office of If you desire specific advice for your uevice on varies), please contact the Office of and additionally 809.10 for in vitro successions of the forcessions on the promotion an and additionally 809.10 for in villy diagnolice are contributions on the promotion and Compliance at (301) 594-4595. Additionally, 161 questions of Compliance at (301) 594-4639. advertising of your device, please contact the Office of Compliance to premarket advertising of your device, piease connect the over reserved to preference to premarket. Also, please note the regulation entitled, "Misformation on your responsibilities Also, please note the regulation onlines, "Information on your responsibilities under the notification" (21 CFR 807.97). Online of Small Manufacturers Assistance at its toll-free Act may be obtained from the Division of Small Manufacturers Assistance at its toll-f Act may be obtained from also =443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 510(k) Dermaphylyx Hydrocolloid Wound Dressing Dermaphylyx, Inc. Page 1 of 1 ### PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT 510(k) Number: વ્વવહિવા K Dermaphylyx, Inc. Dermaphylyx Hydrocolloid Wound Dressing Device Name: Indications for Use: Dermaphylyx Hydrocolloid Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds. The following Indications are for Prescription Use or under the direction of a health care professional: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and laccrations Donor sites The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ A (Per 21 CFR 801.109) OR Over-The-Counter Use X (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices: 510(k) Number K94089/ --- **Source:** [https://fda.innolitics.com/device/K990891](https://fda.innolitics.com/device/K990891) **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. 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