CORMATRIX ECM FOR VASCULAR REPAIR

{0}------------------------------------------------ CorMatrix Cardiovascular, Inc. # 510(k) Summary: K140789 # JUL 15 2014 | Company Information | | |----------------------|--------------------------------------------------| | Company Name: | CorMatrix Cardiovascular, Inc. | | Contact Name: | Bryan Brosseau | | Contact Title: | Regulatory Affairs Manager | | Address: | 1100 Old Ellis Rd. | | | Roswell, GA 30076 | | Phone: | 470-514-4036 | | Fax: | 678-680-5486 | | Date Prepared: | April 15, 2014 | | Product Information | | | Trade Name: | CorMatrix® ECM® for Vascular Repair | | Common Name: | Patch, Pledget and Intracardiac | | Classification Name: | Patch, Pledget and Intracardiac, 21 CFR 870.3470 | | | Product Code DXZ. Class II | #### Predicate Devices The CorMatrix® ECM® for Vascular Repair is substantially equivalent to the following devices: - . Synovis® Vascu-Guard® Peripheral Vascular Patch, K983602 - CorMatrix ECM for Carotid Repair, K111187 - . Cook® Biotech Surgisis® Peripheral Vascular Patch, K001785 - . CorMatrix ECM for Cardiac Tissue Repair, K063349 #### Indications for Use The CorMatrix® ECM® for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels. #### Device Description The CorMatrix ECM for Vascular Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). The device is constructed of a multilaminate (6-ply), decellularized, non-crosslinked, lyophilized ECM cut to specific shapes and sizes and terminally sterilized using Ethylene Oxide gas. The 6-ply CorMatrix ECM for Vascular Repair is derived from the same multilaminate SIS-ECM material as the CorMatrix ECM for Carotid Repair (6-ply), the Cook Biotech Surgisis Peripheral Vascular Patch (4-ply), and the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix {1}------------------------------------------------ ECM for Vascular Repair will be supplied as a 6-ply, lyophilized, sterilized sheet of SIS-ECM. The device design, construction, and configurations are identical to the FDA-cleared CorMatrix ECM for Carotid Repair (K111187). ### Non-Clinical Testing Summary All non-clinical testing performed for the CorMatrix ECM for Carotid Repair (K111187) supports the CorMatrix ECM for Vascular Repair as the device materials are identical. The criteria established for suture retention strength, probe burst strength, and tensile strength for the carotid artery application are also relevant to the expanded indications as carotid repair represents the most challenging application associated with the expanded indications. The animal testing performed for the CorMatrix ECM for Carotid Repair (K111187) demonstrates that the device performs as intended with no systemic or local adverse events. The device testing demonstrated that the device exhibited less angiographic stenosis, better tissue integration, less calcification, and greater re-endothelialization than the control device. The performance of the device when used for carotid repair in the animal model supports the use of the 4-ply ECM material for the expanded Indications for CorMatrix ECM for Vascular Repair. Bench testing performed for the CorMatrix ECM for Carotid Repair (K111187) directly supports the CorMatrix ECM for Vascular Repair. Testing included evaluation of: - · Suture Retention Strength - Probe Burst Strength � - . Tensile Strength The testing listed above demonstrates that the device will perform as intended for the proposed Indications for Use. The suture retention strength, probe burst strength, and tensile strength of the device far exceed the mechanical forces experienced in the clinical setting for all of the applications proposed in the expanded Indications for Use. The collective non-clinical data described above supports the proposed Indications for Use of the CorMatrix ECM for Vascular Repair and does not raise any new concerns of safety or effectiveness. #### Substantial Equivalence The device design, construction, and configurations are identical to the CorMatrix ECM for Carotid Repair (K111187). The proposed indications for the CorMatrix ECM for Vascular Repair are equivalent to the Indications for Use of predicate devices identified above. The Indications for Use of the CorMatrix ECM for Vascular Repair, Cook Biotech Surgisis Peripheral Vascular Patch, and the Synovis Vascu-Guard all include repair of peripheral vessels, including the carotid, renal, iliac, femoral, and tibial blood vessels. {2}------------------------------------------------ CorMatrix Cardiovascular, Inc. # CorMatrix® ECM® for Vascular Repair 510(k) Premarket Notification The differences between the Indications for Use of the CorMatrix ECM for Vascular Repair when compared to the CorMatrix ECM for Carotid Repair (K111187) include only changes to the specific vessels which may be repaired with the device. The changes are minor and do not raise any new concerns associated with safety and effectiveness. #### Conclusion The CorMatrix ECM for Vascular Repair is substantially equivalent to the predicate devices identified above. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a document or sign. Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 15, 2014 CorMatrix Cardiovascular, Inc. % Bryan Brosseau Regulatory Affairs Manager 1100 Old Ellis Road Roswell, Georgia 30076 Re: K140789 Trade/Device Name: CorMatrix® ECM® for Vascular Repair Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Made of Polypropylene, Polyethylene Terephthalate, or Polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: April 15, 2014 Received: April 16, 2014 Dear Mr. Brosseau: 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 device {4}------------------------------------------------ Page 2 - Bryan Brosseau 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. **Kenneth J. Cavanaugh -S** for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. 510(k) Number (if known) ### K140789 Device Name CorMatrix® ECM® for Vascular Repair #### Indications for Use (Describe) The CorMatrix® ECM® for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels. Type of Use (Select one or both; as applicable) X 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) Image /page/5/Picture/15 description: The image shows the name "Kenneth J. Cavanaugh - S" in a simple, sans-serif font. The name is written in black ink on a white background. There is some noise or artifacts around the middle initial and last name, possibly due to the image being a scan or a low-resolution copy. The text is horizontally aligned and appears to be part of a signature or heading.