PROCOLL

{0}------------------------------------------------ K 120339 page 1/1 Page 10 of 224 JUN 2 1 2012 ﺔ ترته Midlands Innovation and Research Centre Dublin Road. Athlone, Co. Westmeath, Ireland Tel: + 353 (0)90 6486834 Fax: + 353 (0)90 6486835 www.innocoll-pharma.com # 510(k) Summary # Date Prepared: Submitter: 24th January 2012 Innocoll Pharmaceuticals, Midland Innovation and Research Centre, Dublin Road, Athlone, Co. Westmeath, Ireland. Submission Correspondent: Aaron Wyse Director of Requlatory Affairs Tel: +353 (0) 9066 90661 Fax: +353 (0) 9066 34895 Proprietary Name: Procoll Common Name: Collagen matrix ### Device Classification: Product Code: Classification Name: Regulatory Class: KGN Wound Dressing, Collagen Unclassified # Statement of Substantial Equivalence: Procoll is substantially equivalent in materials of construction to Collagen Sponge (K092805). Procoll is produced using the same materials and processes as Collagen Sponge. {1}------------------------------------------------ K 120339 page 2/2 Page 11 of 224 # Intended Use: Procoll may be used for the management of full and partial thickness wounds including: - Diabetic ulcers . - . Venous ulcers - Pressure ulcers . - Ulcers caused by mixed vascular etiologies � - Abrasions . - . Traumatic wounds - 1st and 2nd degree burns . - Dehisced surgical wounds . - Exuding wounds . ### Description: Procoll is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Procoll is supplied sterile and non-pyrogenic, in various sizes, and for single use only. #### Biocompatibility and testing: Evaluation of the biocompatibility of Procoll was completed in line with the requirements of ISO 10993 -1: 2009. There are no new biocompatibility issues arising with the use of Procoll; 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. #### Conclusion: Procoll is substantially equivalent to the predicate devices 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 & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002 SUN. 2 1 2012 Innonoll Pharmaceuticals LTD. % Mr. Aaron Wyse Director of Regulatory Affairs Midlands Research and Innovation Centre, Dublin Road Athlone, Ireland EI Re: K120339 Trade/Device Name: Procoll Regulatory Class: Unclassified Product Code: KGN Dated: June 12, 2012 Received: June 15, 2012 # 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 {3}------------------------------------------------ # Page 2 - Mr. Aaron Wyse 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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/Industry/default.htm. Sincerely yours, FOR Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Statement of Indications for Use 510(k) Number (if known): K120339 Device Name: Procoll Indications For Use: Procoll may be used for the management of full and partial thickness wounds including: - Diabetic ulcers . - Venous ulcers - Pressure ulcers - Ulcers caused by mixed vascular etiologies - Abrasions - Traumatic wounds - 1st and 2nd degree burns - Dehisced surgical wounds - Exuding wounds Prescription Use (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) Daniel Kane ku MAXIM (Division Sign-Off) Division of Surgical. Orthapedie, and Restorative Devices 510(k) Number K120339 Concurrence of CDRH, Office of Device Evaluation (ODE) Procoll 510k Indications for Use 4 - 1