CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR

• K Number: K063349
• Device Name: CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
• Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
• Date Cleared: 2007-02-16 ( 102 days)
• Product Code: DXZ , PRO
• Regulation Number: 870.3470
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K980431 , K051405 , K041736 , K982810 , K983602 , K040415 , K041716

Intended Use

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.

Device 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.

AI/ML Overview

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.

Regulation Number and Section

§ 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).