← Product Code KGN · K061746 # COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID (K061746) _Innocoll Pharmaceuticals · KGN · Oct 2, 2006 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K061746 ## Device Facts - **Applicant:** Innocoll Pharmaceuticals - **Product Code:** KGN - **Decision Date:** Oct 2, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use CollaGUARD may be used for the management of wounds such as: - Pressure ulcers - Venous stasis ulcers - Diabetic ulcers - First and second degree burns - Partial and full thickness wounds - Superficial injuries ## Device Story CollaGUARD is a clear collagen matrix film for topical wound management. It is supplied sterile for single-use. The device functions as a physical dressing to support wound healing phases. It is intended for clinical or home use as a topical application. The healthcare provider applies the dressing directly to the wound site to facilitate management of various wound types, including ulcers and burns. ## Clinical Evidence No clinical data provided. Biocompatibility testing performed per ISO 10993-1:2003 requirements; device passed all tests. ## Technological Characteristics Clear collagen matrix film. Biocompatible per ISO 10993-1:2003. Sterile, single-use. No electronic components or software. ## Predicate Devices - Collagen Topical Wound Dressing ([K040558](/device/K040558.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word "Innocoll" in a bold, sans-serif font. The word is underlined with a thick, black line. Below the line, the word "Pharmaceuticals" is written in a smaller, sans-serif font. OCT - 2 2006 pass 1 g 2 IDA Business & Technology Park Garrycaltie, Athlone Co. Westmeath, Ireland Tel: +353 (0)90 6486834 Fax: +353 (0)90 6486835 www.innocoll-pharma.com # 510(k) Summary - 1. Date Prepared: August 15, 2005 2. Submitter Innocoll Pharmaceuticals IDA Business and Technology Park Garrycastle Athlone Co. Westmeath Ireland. Tel: +353 (0) 9064 86834 Fax: +353 (0) 9064 86835 Submission Correspondent: Aaron Wyse Director of Quality and Regulatory Affairs - CollaGUARD™ 3. Proprietary Name: - 4. Common Name: Topical Wound Dressing - 5. Device Classification: Product Code: KMF Classification Name: Dressing Wound Collagen Regulatory Class: Unclassified #### 6. Statement of Substantial Equivalence: CollaGUARD™ is substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc. {1}------------------------------------------------ K061746 Page 5 - 2 #### 7. Intended Use CollaGUARD may be used for the management of wounds such as: - · Pressure ulcers - Venous stasis ulcers - · Diabetic ulcers - · First and second degree burns - · Partial and full thickness wounds - · Superficial injuries ### 8. Description CollaGUARD™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only. #### 9. Biocompatibility CollaGUARD's biocompatibility testing has been completed against the requirements of ISO 10993 -1:2003. CollaGUARD has passed the requirements of all tests and has been shown to be a biocompatible topical wound dressing. #### 10.Conclusion CollaGUARD™ is a member of a family of collagen products distributed by Innocoll Pharmaceuticals. The collagen products have an extensive and established history of safety and effectiveness. Collagen has a primary role in all phases of wound healing making it an effective agent for managing wound treatment. CollaGUARD™ is substantially equivalent to the predicate device delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings, and a wavy line representing its legs. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Innocoll Pharmaceuticals % Mr. Aaron Wyse Director of Quality and Regulatory Affairs IDA Business and Technology Park. Garrycastle, Athlone Co. Westmeath, Ireland OCT - 2 2006 Re: K061746 Trade/Device Name: CollaGuard Regulation Name: Collagen Dressing Regulatory Class: Unclassified Product Code: KGN Dated: August 15, 2006 Received: August 31, 2006 Dear Mr. Wyse: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Aaron Wyse This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. > Sincerely yours. Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: CollaGUARD Indications For Use: #### Indications: CollaGUARD may be used for the management of wounds such as: - Pressure ulcers . - . Venous stasis ulcers - . Diabetic ulcers - First and second degree burns . - Partial and full thickness wounds . - Superficial injuries . Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|-----------------------------------| | | (Division Sign-Off) | | | Division of General, Restorative, | | | and Neurological Devices | | 510(k) Number | LC6-1746 | --- **Source:** [https://fda.innolitics.com/device/K061746](https://fda.innolitics.com/device/K061746) **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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