← Product Code KGN · K103648 # COLLAGEN POWDER (K103648) _Innocoll Pharmaceuticals, Ltd. · KGN · Sep 14, 2011 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K103648 ## Device Facts - **Applicant:** Innocoll Pharmaceuticals, Ltd. - **Product Code:** KGN - **Decision Date:** Sep 14, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Collagen Powder may be used for the management of wounds such as: Diabetic ulcers Venous ulcers Pressure ulcers Ulcers caused by mixed vascular etiologies Full-thickness & partial thickness wounds Abrasions Traumatic wounds 1st and 2nd degree burns Dehisced surgical wounds Exuding wounds ## Device Story Collagen Powder is a sterile, single-use collagen matrix in powder form for wound management. It is applied topically to various wound types to assist in management. The device is manufactured from Type I collagen, which is not denatured during processing. It is intended for use by healthcare professionals in clinical settings. The device benefits patients by providing a collagen-based dressing for wound care. Viral inactivation validation ensures the absence of pathogenic organisms. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993-1. Biochemical characterization confirmed Type I collagen. Viral inactivation validation assessment performed. Particle size analysis conducted on finished product. ## Technological Characteristics Collagen matrix in powder form; predominantly Type I collagen; sterile; single-use. Biocompatibility per ISO 10993-1. Viral inactivation validated. Particle size range verified. ## Predicate Devices - Collagen Sponge ([K092805](/device/K092805.md)) - Collatek Powder ([K012990](/device/K012990.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}------------------------------------------------ K103648 12 SEP 1 4 2011 Innocoll Pharmaceuticals Midlands Innovation and Research Centre Dublin Road, Athlone, Co. Westmeath, Ireland Tel: + 353 (0)90 6486834 Fax: + 353 (0)90 6486835 www.innoooll-pharma.com # 510(k) Summary Date Prepared: Submitter: September 13" 2011 Innocoll Pharmaceuticals, Midland Innovation and Research Centre, Dublin Road, Athlone, Co. Westmeath Ireland. | Submission Correspondent: | Aaron Wyse | |---------------------------|--------------------------------| | | Director of Regulatory Affairs | | | Tel: +353 (0) 87 0520845 | | | Fax: +353 (0) 9066 34895 | Proprietary Name: Collagen Powder Common Name: Topical Wound Dressing ## Device Classification: Product Code: Classification Name: Regulatory Class: KGN Dressing Wound Collagen Unclassified #### Statement of Substantial Equivalence: Collagen Powder is substantially equivalent in materials of construction and intended use to Collagen Sponge (K092805) and Collatek Powder (K012990). Collagen Powder has been evaluated for its biocompatibility which meets requirements and is therefore substantially equivalent to the predicates delineated in this submission. Collagen Powder is manufactured from the same ingredients used for the manufacture of Collagen Sponge (K092805). Collagen Powder 510k 510k Summary 5 - 1 {1}------------------------------------------------ K103648 2/7 # Intended Use: Collagen Powder may be used for the management of wounds such as: - Diabetic ulcers o - o Venous ulcers - Pressure ulcers o - Ulcers caused by mixed vascular etiologies o - Full-thickness & partial thickness wounds O - Abrasions o - Traumatic wounds o - 1st and 2nd degree burns O - o Dehisced surgical wounds - o Exuding wounds ## Description: Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only. #### Biocompatibility and Testing: Evaluation of the biocompatibility of Collagen Powder was completed in line with the requirements of ISO 10993 -1: 2009. There are no new biocompatibility issues arising with the use of Collagen Powder; the materials of construction for Collagen Powder match Collagen Sponge (K092805). Biochemical characterization of the collagen used to manufacture Collagen Powder was undertaken which characterized the collagen as being predominantly Type I collagen which is not denatured during the collagen rendering process. Viral inactivation validation assessment was conducted on the collagen which demonstrates that the collagen material post processing can be assumed not to contain any pathogenic organisms. Particle size analysis was conducted on the finished product which verified a particle size range for Collagen Powder. #### Conclusion: Collagen Powder is substantially equivalent to the predicate devices delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807. Collagen Powder 510k 510k Summary 5 - 2 {2}------------------------------------------------ Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Innocoll Pharmaceuticals. Ltd. % Mr. Aaron Wyse Directory of Regulatory Affairs Midlands Innovation & Research Centre, Dublin Road Athione, Co. Westmeath Ireland - Re: K103648 Trade/Device Name: Collagen Powder Regulatory Class: Unclassified Product Code: KGN Dated: September 1, 2011 Received: September 6, 2011 SEP 1 4 201 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {3}------------------------------------------------ Page 2 - Mr. Aaron Wyse CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go io http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/det/ault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm. DESIGN TOURNAMENT PARTICIPANTS Sincerely yours, Mark A. Milken Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K103 648 # Statement of Indications for Use 510(k) Number (if known): Device Name: Collagen Powder Indications For Use: Collagen Powder may be used for the management of wounds such as: - Diabetic ulcers o - 0 Venous ulcers - Pressure ulcers 0 - Ulcers caused by mixed vascular etiologies 0 - Full- & partial thickness wounds 0 - Abrasions ಂ - Traumatic wounds 0 - 1st and 2nd degree burns O - Dehisced surgical wounds 0 - Exuding wounds O 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) R (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number Collagen Powder 510k Indications for Use 4 - 1 --- **Source:** [https://fda.innolitics.com/device/K103648](https://fda.innolitics.com/device/K103648) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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