(102 days)
The CorMatrix® Patch for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair (i.e., arterial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.
The CorMatrix Patch for Cardiac Tissue Repair is manufactured from porcine small intestinal submucosa (SIS) and is supplied in four (4)-ply sheets with varying dimensions.
This 510(k) premarket notification for the CorMatrix Patch for Cardiac Tissue Repair does not describe a study involving an AI/ML device. Instead, it pertains to a medical device made from porcine small intestinal submucosa (SIS) intended for cardiac tissue repair.
Therefore, many of the requested criteria, such as "acceptance criteria and the reported device performance" in the context of an AI/ML algorithm, or details about training sets, test sets, and expert adjudication, are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: The CorMatrix Patch for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue repair (e.g., atrial septal defect (ASD), ventricular septal defect (VSD)) and suture-line buttressing.
- Product Description: It is manufactured from porcine small intestinal submucosa (SIS) and supplied in four (4)-ply sheets.
- Predicate Devices: Several existing cardiac patches and surgical meshes are listed as predicate devices.
- Testing: The document states that "The performance and safety of the SIS material used in the CorMatrix Patch for Cardiac Tissue Repair was evaluated through extensive biocompatibility, bench and animal testing." The collective results are said to have demonstrated substantial equivalence regarding safety and efficacy. However, specific details of these tests, including acceptance criteria and reported performance metrics (like those one would expect for an AI algorithm - e.g., sensitivity, specificity, AUC), are not provided in this summary.
Therefore, I cannot fulfill the request to provide the acceptance criteria and study details as they would apply to an AI/ML device, as this document is not about an AI/ML device. The document explicitly states it's about a physical medical device and its substantial equivalence to other physical medical devices.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of the 510(k) premarket notification for the CorMatrix Patch for Cardiac Tissue Repair is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
510(k) SUMMARY
FEB 16 2007
510(k) Notification K063349
GENERAL INFORMATION
Applicant:
CorMatrix Cardiovascular, Inc. 155 Moffett Park Dr., Suite A-240 Sunnyvale, CA 94089-1330 Phone: (408) 734-2628 (408) 734-2629 FAX:
Contact Person:
Kit Cariquitan Regulatory Consultant Experien Group, LLC 155 Moffett Park Drive, Suite A-101 Sunnyvale, CA 94089 Phone: 408-400-0856 (x112) FAX: 408-400-0865 Email: kitc@experiengroup.com
Date Prepared: January 16, 2007
DEVICE INFORMATION
Trade/Proprietary Name: CorMatrix Patch for Cardiac Tissue Repair
Common/Classification Name/Product Code:
Product Code: DXZ Device Classification Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene Regulation Number: 21CFR§870.3470
Device Classification: Class II
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PREDICATE DEVICES
- . Cook Biotech, Inc., SurgiSIS Surgical Mesh (K980431)
- CorMatrix Cardiovascular, Inc., CorMatrix Patch for Pericardial Closure . (K051405)
- Peritec Biosciences LTD, PFA Vascular Patch (K041736) .
- Shelhigh, Shelhigh No-React VASCUPATCH (K982810) ●
- Bio-Vascular, Inc., CV Peri-Guard Cardiovascular Patch (K983602) .
- Synovis Surgical Innovations, Peri-Strips Staple Line Reinforcement (K040415) ●
- Boston Scientific Corp., PTFE Felts and Pledgets (K041716) .
INTENDED USE
The CorMatrix Patch for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue repair (i.e., atrial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.
PRODUCT DESCRIPTION
The CorMatrix Patch for Cardiac Tissue Repair is manufactured from porcine small intestinal submucosa (SIS) and is supplied in four (4)-ply sheets with varying dimensions.
SUBSTANTIAL EQUIVALENCE
The proposed indications for use for the CorMatrix Patch for Cardiac Tissue Repair are substantially equivalent to the indications for use of the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the CorMatrix Patch for Cardiac Tissue Repair is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Any differences in technological characteristics between the CorMatrix Patch for Cardiac Tissue Repair and the predicate devices do not raise any new issues of safety or efficacy. The performance and safety of the SIS material used in the CorMatrix Patch for Cardiac Tissue Repair was evaluated through extensive biocompatibility, bench and animal testing. The collective results have demonstrated that the CorMatrix Patch for Cardiac Tissue Repair is substantially equivalent to the respective predicate devices with regard to safety and efficacy.
SUMMARY
The CorMatrix Patch for Cardiac Tissue Repair is substantially equivalent to the predicate devices.
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Public Health Service
Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Experien Group c/o Mr. Kit Cariquitan, Regulatory Consultant 155 Moffett Park Drive Suite A-101 Sunnyvale, CA 94089
FEB 16 2007
Re: K063349
Trade/Device Name: CorMatrix Patch for Cardiac Tissue Repair Regulation Number: v21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II (two) Product Code: DXZ Dated: January 16, 2007 Received: January 17, 2007
Dear Mr. Cariquitan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality
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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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063349
Device Name: CorMatrix Patch for Cardiac Tissue Repair
The CorMatrix® Patch for Cardiac Tissue Repair is indicated for use as an Indications For Use: intracardiac patch or pledget for tissue repair (i.e., arterial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision of Cardiova
510(k) Numbe
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§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).