COVAMAX RESORBABLE COLLAGEN MEMBRANE

{0}------------------------------------------------ AUG 2 6 2011 biom'up ADVANCED BIOMATERIALS # 5. 510(k) Summary, Cova™MAX Resorbable Collagen Membrane for Guided Tissue and Bone Regeneration | Submitter's name and address: | Biom'Up S.A.<br>8, Allee Irene Joliot-Curie<br>69800, Saint-Priest,<br>France | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Valerie Centis, R&D Project Manager and<br>Regulatory Affairs | | | Biom'up S.A.<br>8, Allee Irene Joliot-Curie<br>69800, Saint-Priest, France<br>Phone: +33 (0)4 86 57 36 10<br>Fax: +33 (0)4 37 69 00 84<br>Email: regulatory.affairs@biomup.com | | Date Summary was prepared: | October 18th 2010 | | Trade/Proprietary Name: | Cova™MAX | | Common/Usual Name: | Resorbable Membrane for Guided Tissue and Bone<br>Regeneration | | Classification Name: | Barrier, Animal Source, Dental | | Product Code: | NPL | | Regulation Number: | 21 CFR 872.3930 | | Device Classification: | Class II | | Predicate Devices | BIO-GIDE® (K042197)<br>Ossix™ Plus (K053260) | ## Device Description Cova™MAX is a resorbable acellular membrane for guided tissue and bone regeneration in dental applications. Cova™MAX membranes are manufactured using a standardized, controlled process. Each Cova™MAX membrane is fabricated solely from Type I collagen extracted from veterinary certified pig tendon. Porcine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial quantities. It is packaged in a double package and sterilized by gamma irradiation. ਟ-1 , ال {1}------------------------------------------------  ADVANCED BIOMATERIALS Cova™MAX membranes serve as a barrier to guide the healing process between anatomic plans of tissues. It has been designed in accordance with the accepted principles or guided bone regeneration (GBR) as a wound healing material post surgery. They are designed to be resorbable, non inflammatory and biocompatible for uses in clinical periodontics. The Cova™MAX membrane is completely resorbable within a timeframe compatible with the healing process. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™MAX is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm and 30 x 40 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the periodontal defect or zone to be treated. #### Intended Use Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in: -Simultaneous use of GBR-membrane (Guided Bone Regeneration) and implants; -Augmentation around implants placed in immediate extraction sockets; -Augmentation around implants placed in delayed extraction sockets; -Localized ridge augmentation for later implantation; -Alveolar ridge reconstruction for prosthetic treatment; -Filling of bone defects after root resection, cystectomy and removal of retained teeth; -Guided bone regeneration in dehiscence defects; -Guided tissue regeneration procedures in periodontal and recession defects. ### Basis for Substantial Equivalence The intended use, product design, composition, physical structure and target population of Cova™MAX resorbable collagen membranes are substantially equivalent to the FDA cleared and legally marketed predicate devices BIO-GIDE® (K042197) and Ossix™Plus (K053260). Similarities are presented in Table 1. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for "biom'up ADVANCED BIOMATERIALS". The logo has the word "biom'up" in bold, black letters, with the "up" portion slightly raised. Above the word is a graphic of several curved lines that are filled with small, vertical black lines. Below the word is the phrase "ADVANCED BIOMATERIALS" in smaller, black letters. | Medical Device Name | Cova™MAX | BIO-GIDE® | Ossix™Plus | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Origin | Porcine | Porcine | Porcine | | Intended use | Used for guided tissue regeneration<br>procedures in periodontal defects<br>to enhance regeneration of the periodontal<br>apparatus | Used for guided tissue regeneration<br>procedures in periodontal defects<br>to enhance regeneration of the periodontal<br>apparatus | Used for guided tissue regeneration<br>procedures in periodontal defects<br>to enhance regeneration of the periodontal<br>apparatus | | Device characteristics | Membrane-like<br>Easy to manipulate<br>Flexible<br>Implantable<br>Wettable<br>Smooth | Membrane-like<br>Easy to manipulate<br>Flexible<br>Implantable<br>Wettable<br>Smooth | Membrane-like<br>Easy to manipulate<br>Flexible<br>Implantable<br>Wettable<br>Smooth | | Biocompatibility | Established | Established | Established | | Non pyrogenic | Yes | Yes | n/a | | Resorbable | Yes | Yes | Yes | | Suturable | Yes | Yes | Yes | | Reusable | Single-use device | Single-use device | Single-use device | | Shelf-Life | 18 months | 36 months | 36 months | | Sterilisation Method | Gamma irradiation | Gamma irradiation | Gamma irradiation | | Packaging | Double-peel packages | Double-peel packages | Double-peel packages | Table 1. Cova™MAX and its predicates summarized comparison chart. Any differences in technological characteristics between the Cova™MAX and the predicate devices do not raise any new issues of safety or efficacy. The performance and safety of the material used was evaluated. The collective results have demonstrated that the Cova™MAX is substantially equivalent to the respective predicate devices with regard to safety and efficacy. ## Safety Biocompatibility studies have demonstrated Cova™MAX to be: non-cytotoxic, nonpyrogenic, non-irritating, and non-sensitizing. The following studies were conducted: - a) Cytotoxicity - b) Dermal Sensitization/irritation - c) Acute Systemic Toxicity - d) Acute Intracutaneous Reactivity - e) Genotoxicity - f) Mutagenecity - g) Pyrogenecity - h) Implantation/Absorption - i) Sub-Chronic/Chronic Toxicity - Hemolysis ﻤﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ The Cova™MAX Resorbable Collagen Membrane for Guided Tissue and Bone Regeneration manufacturing process complies with the United States Food and Drug Administration and European Standards for animal tissue sourcing and viral inactivation. {3}------------------------------------------------ K103087 biom'up ADVANCED BIOMATERIALS # Summary of Effectiveness Data # Animal Data Guided Bone Regeneration in periodontics has been proven from animal model studies. That is, during the surgery, a barrier membrane is placed over the wound to prevent contact of connective tissue with the bony surface. Thereby, bone cells can grow into the defect site to fill the space. A comprehensive literature research showed that numerous materials, including the predicates, have been studied for this use in various animal models. The animal data provided evidence that using equivalent membranes as Cova™MAX as a barrier to aid in wound healing has been verified using resorbable membranes is a valid approach. ### Clinical Data Results from human studies from the literature are consistent with animal studies. Similar to animal studies, resorbable membranes such as Cova™MAX are effective as a barrier to aid in wound healing its use fully accepted in the clinical practice of periodontics. It should be noted that the 13-week resorption claim is an estimate from a rat implantation study which was similar to predicate animal studies. An estimation for clinical resorption will need to be made by the clinician based on the known resorption times (6 and 8 months) of similar devices: Bio-Gide® and Ossix™Plus and on experience. # Conclusion Cova™MAX Resorbable Collagen Membrane for Guided Tissue and Bone Regeneration is substantially equivalent to its predicate devices: BIO-GIDE® and Ossix™Plus. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three curved lines or strokes, possibly representing human figures or abstract shapes. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Valerie Centis R&D Manager and Regulatory Affairs Biom'Up SA 8. Allee Irene Joliot-Curie 69800, Saint-Priest France AUG 2 6 2011 Re: K103087 Trade/Device Name: Cova™MAX Resorbable Membrane for Guided Tissue and Bone Regeneration Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: August 23, 2011 Received: August 24, 2011 Dear Ms. Centis: 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. {5}------------------------------------------------ Page 2 - Ms. Centis 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); 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.fda.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 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, Susan Kunze Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # k103087 # Indications for Use 510(k) Number (if known): Device Name: Cova™MAX Resorbable Membrane for Guided Tissue and Bone Regeneration Indications for Use: Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in: -Simultaneous use of GBR-membrane (Guided Bone Regeneration) and implants; -Augmentation around implants placed in immediate extraction sockets; -Augmentation around implants placed in delayed extraction sockets; -Localized ridge augmentation for later implantation; -Alveolar ridge reconstruction for prosthetic treatment; -Filling of bone defects after root resection, cystectomy and removal of retained teeth; -Guided bone regeneration in dehiscence defects; -Guided tissue regeneration procedures in periodontal and recession defects. Prescription Use _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) Susan Punroe (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K100897 Page 1 of 1