BOVINE PERICARDIUM PATCH

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 22, 2014 CollaFirm, LLC Dr. Surendra P. Batra Founder and Chief Executive Officer 7 Deer Park Drive, Suite M-7 Monmouth Junction, New Jersey 08852 Re: K141721 Trade/Device Name: Bovine Pericardium Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXE, OXB, PAJ Dated: November 24, 2014 Received: November 25, 2014 Dear Dr. Batra: 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Binita S. Ashar -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name Bovine Pericardium Patch #### Indications for Use (Describe) Bovine Pericardium Patch is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: Buttressing and reinforcing staple lines during lung resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy/pneumectomy/pneumectomy, pneumoreduction) and other incisions and excision of the lung and bronchus. Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric banding. Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair of hemias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Bovine Pericardium Mesh is provided below. | Device Common Name: | Surgical Mesh | | |----------------------------|-------------------------------------------------------------------------------------------------------------|--| | Device Proprietary Name: | Bovine Pericardium Patch | | | Submitter: | CollaFirm, LLC<br>7 Deer Park drive, Suite M-7<br>Monmouth Junction, NJ 08852 | | | Contact: | Surendra P. Batra, Ph. D<br>Founder & CEO, CollaFirm LLC<br>Phone: (732) 823-1051<br>surendra@collafirm.com | | | Prepared By: | Stephen P. Rhodes<br>Biologics Consulting Group, Inc. | | | Date Prepared: | June 25, 2014 | | | Classification Regulation: | 21 CFR 878.3300, Class II | | | Panel: | 79 General & Plastic Surgery | | | Product Code: | FTM, OXE, OXB, PAJ | | | Predicate Device: | Veritas® Collagen Matrix, Synovis Surgical Innovations<br>K062915 | | #### Indication for Use: Bovine Pericardium Patch is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy / pneumectomy, pneumoreduction) and other incisions and excision of the lung and bronchus. Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). {4}------------------------------------------------ # Device Description: The Bovine Pericardium Patch is intended for use as an implant to reinforce soft tissue where weakness exists. The Boyine Pericardium Patch is derived from bovine pericardium tissue. The tissue is subjected to decontamination and decellularization processing using non-toxic reagents. The resulting mesh is intended for use as a resorbable implant for soft tissue repair which subsequently remodels and is integrated in the host connective tissue. The Bovine Pericardium Patch is terminally sterilized and is available in sizes ranging from 2cm x10cm to 8cm x16cm. # Performance Data: Mechanical testing, biocompatibility testing and animal testing were conducted per the recommendations in: Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance – Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, " dated March 2, 1999." The following tests were conducted: ## Biocompatibility - In Vitro Cytotoxicity ● - Skin Sensitization ● - Intracutaneous Reactivity - Acute Systemic Toxicity ● - Genotoxicity - Muscle Implantation ● - In Vitro Hemolysis ● - Pyrogenicity ● - Subchronic Systemic Toxicity ● Bench/Laboratory Testing - Tensile Strength ● - Suture Retention Strength - Burst Force - Tear Resistance - DNA Residuals - Collagen Analysis - Viral Inactivation - Stability The biocompatibility testing showed the comparable safety profile of the Bovine Pericardium Patch and the predicate. Bench testing demonstrated that the mechanical properties of the mesh are substantially equivalent for reinforcing soft tissue. {5}------------------------------------------------ #### Substantial Equivalence: As summarized in Table 1 below, the Bovine Pericardium Patch is substantially equivalent to the predicate device with respect to design, physical shape, characteristics, basic principles of operation and intended use. | | Bovine Pericardium Patch | Veritas® Collagen Matrix | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | TBD | K062915 | | Submitter | CollaFirm | Synovis Surgical Innovations | | Classification Regulation | 21 CFR 878.3300, Class II | 21 CFR 878.3300, Class II | | Product Code | FTM, OXE, OXB, PAJ | FTM, OXE, OXB, PAJ | | Indication | Bovine Pericardium Patch is<br>intended for use as an implant for<br>the surgical repair of soft tissue<br>deficiencies, this includes but is<br>not limited to the following:<br>Buttressing and reinforcing staple<br>lines during lung resection (e.g.,<br>wedge resection, blebectomy,<br>lobectomy, bullectomy, bronchial<br>resection, segmentectomy,<br>pneumonectomy / pneumectomy,<br>pneumoreduction) and other<br>incisions and excision of the lung<br>and bronchus.<br>Reinforcement of the gastric<br>staple line during the bariatric<br>surgical procedures of gastric<br>bypass and gastric banding.<br>Abdominal and thoracic wall<br>repair, muscle flap reinforcement,<br>rectal prolapse excluding<br>rectocele, reconstruction of the<br>pelvic floor excluding<br>transvaginal organ prolapse<br>repair, and repair of hernias (e.g.,<br>diaphragmatic, femoral,<br>incisional, inguinal, lumbar,<br>paracolostomy, scrotal,<br>umbilical). | Veritas® Collagen Matrix is<br>intended for use as an implant for<br>the surgical repair of soft tissue<br>deficiencies, this includes but is<br>not limited to the following:<br>Buttressing and reinforcing staple<br>lines during lung resection (e.g.,<br>wedge resection, blebectomy,<br>lobectomy, bullectomy, bronchial<br>resection, segmentectomy,<br>pneumonectomy / pneumectomy,<br>pneumoreduction) and other<br>incisions and excision of the lung<br>and bronchus.<br>Reinforcement of the gastric<br>staple line during the bariatric<br>surgical procedures of gastric<br>bypass and gastric banding.<br>Abdominal and thoracic wall<br>repair, muscle flap reinforcement,<br>rectal prolapse excluding<br>rectocele, reconstruction of the<br>pelvic floor excluding<br>transvaginal organ prolapse<br>repair, and repair of hernias (e.g.,<br>diaphragmatic, femoral,<br>incisional, inguinal, lumbar,<br>paracolostomy, scrotal,<br>umbilical).<br>Veritas® Collagen Matrix<br>minimizes tissue attachment to the<br>device in case of direct contact | | | Bovine Pericardium Patch | Veritas® Collagen Matrix | | | | with viscera. | | Rx/OTC | Rx | Rx | | Physical Shape | Rectangular Patch | Rectangular Patch | | Available Sizes | Various sizes ranging from<br>2x8cm to 12x25cm | Various sizes ranging from<br>2x8cm to 12x25cm | | Product Description | Type I Bovine Collagen | Type I Bovine Collagen | | Animal Tissue | Bovine Pericardium | Bovine Pericardium | | Sterile | Yes (E-Beam) | Yes (E-Beam) | | Pore Size (SEM) | 1-3 μm | 1-4 μm | | Average Device Thickness | 0.55mm | 0.67mm | | Storage | 20-25°C | 20-25°C | | Handling characteristics | Flexible | Flexible | Table 1: Device Comparison Table {6}------------------------------------------------ #### Conclusion Based on the indications for use, technological characteristics and performance test results, the Bovine Pericardium Patch is substantially equivalent to the predicate.