The CorMatrix® ECM® for Carotid Repair is intended for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing.

Device Description

The CorMatrix ECM for Carotid Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). SIS is developed from a select layer of tissue that is recovered from porcine small intestine. During processing, the inner and outer muscle layers of the material are removed, leaving an intact submucosa with a portion of the tunica propria layer attached to the outer surface. Following processing, the remaining acellular ECM material is cut to specific shapes and sizes, lyophilized, and terminally sterilized using Ethylene Oxide gas. The CorMatrix ECM for Carotid Repair is derived from the same SIS-ECM material as CorMatrix's two commercially available products, the CorMatrix ECM for Pericardial Closure and the CorMatrix ECM for Cardiac Tissue Repair. The CorMatrix ECM for Carotid Repair will be supplied as a multilaminate, Iyophilized, sterilized sheet of SIS-ECM. The CorMatrix ECM will be provided in four sizes: 1x10cm, 1x15cm, 2x10cm and 2x15cm sheets.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the CorMatrix ECM for Carotid Repair. Based on the provided text, there is no acceptance criteria or study of an AI/ML powered device. This document describes the "substantial equivalence" of a biologic patch material to predicate devices. Therefore, a table of acceptance criteria and device performance for an AI/ML powered device, an MRMC study, or a standalone study are not applicable and cannot be extracted from this text.

Here's an analysis of what is provided, framed in terms of the closest relevant aspects, and explicitly stating where information requested is not present for an AI/ML device:

Analysis of CorMatrix® ECM® for Carotid Repair

This document describes a 510(k) premarket notification for a medical device. The device is a patch material for vascular reconstruction and repair of the carotid artery, derived from porcine small intestinal submucosa. The submission focuses on demonstrating "substantial equivalence" to existing predicate devices through nonclinical bench and animal testing. This is not an AI/ML powered device.

Therefore, most of the requested information related to AI/ML device acceptance criteria, study design, and ground truth establishment (especially for AI models) is not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: This device is a biologic patch material, not an AI/ML algorithm. The "acceptance criteria" here refer to performance specifications for the physical properties of the patch, not diagnostic accuracy metrics typically associated with AI/ML.

Acceptance Criterion (Nonclinical Test)	Reported Device Performance
Suture retention strength	Meets established specifications (Specific values not provided)
Probe burst strength	Meets established specifications (Specific values not provided)
Tensile strength	Meets established specifications (Specific values not provided)
Biocompatibility	Meets established specifications (Specific results not provided)
Sterilization validation	Meets established specifications (Specific results not provided)
Packaging and shelf-life	Meets established specifications (Specific results not provided)
Animal testing (Safety & Performance)	Performance, as well as burst pressures of repaired vessels at various time points (Specific results not provided)

Disclaimer: The document explicitly states that the collective results "demonstrate that the CorMatrix ECM for Carotid Repair meets the established specifications necessary for consistent performance for its intended use" and "does not raise new questions of safety or efficacy." However, specific numerical acceptance thresholds and the exact measured performance values are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable in the context of an AI/ML test set. The testing involved nonclinical bench tests and animal studies. Specific "sample sizes" for these tests (e.g., number of patches tested for suture retention, number of animals in the in vivo study) are not provided in this summary.
Data provenance: Not applicable in the context of human clinical data for an AI/ML device. The testing was nonclinical (bench and animal). The country of origin for the animals or bench test materials is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the ground truth here refers to the physical and biological properties of a material, established through standardized testing procedures, not expert interpretation of diagnostic images or data for an AI/ML algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of bench and animal testing described. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in interpreting data, which is not the nature of the testing performed for this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a surgical patch, not an AI/ML diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone study was not done. This concept is only relevant for AI/ML algorithms, which this device is not.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established through standard nonclinical testing methodologies (e.g., ASTM standards for material strength, biocompatibility assays, in vivo animal model observations for biological response and vessel burst pressure). It is based on objective measurements and observations from these tests.

8. The sample size for the training set

Not applicable. This is a hardware/biologic device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth generation process.

Summary

{0}------------------------------------------------

CORMATRIX CARDIOVASCULAR, INC.

CORMATRIX® EC 510(k) Premarket Not.

JUL 26 2011

SECTION 5

510(k) SUMMARY (CONT.)

510(k) Notification K

GENERAL INFORMATION

Applicant:

CorMatrix Cardiovascular, Inc. 155-A Moffett Park Dr., Suite 240 Sunnyvale, CA 94089-1330 U.S.A. Phone: 408-734-2628 FAX: 408-734-2629

Contact Person:

Heather Lake Regulatory Consultant Experien Group, LLC 155-A Moffett Park Dr., Suite 210 Sunnyvale, CA 94089 U.S.A. Phone: 408-400-0856 FAX: 408-400-0865

Date Prepared: April 26, 2011

DEVICE INFORMATION

Classification:

21 CFR§870.3470, Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluroethylene

Product Code:

DXZ

Trade Name:

CorMatrix® ECM® for Carotid Repair

Generic/Common Name:

Patch, Pledget and Intracardiac

{1}------------------------------------------------

SECTION 5 510(k) SUMMARY (CONT.).

PREDICATE DEVICES

CorMatrix® ECM® for Cardiac Tissue Repair (K063349) .
Cook® Biotech Surgisis® Peripheral Vascular Patch (K001785) .
Bio-Vascular/Synovis® Vascu-Guard® Peripheral Vascular Patch (K983602) ●
Carbomedics Vascutek Thin Wall Carotid Patch (K963611) .

INTENDED USE

PRODUCT DESCRIPTION

The CorMatrix ECM for Carotid Repair is derived from the same SIS-ECM material as CorMatrix's two commercially available products, the CorMatrix ECM for Pericardial Closure and the CorMatrix ECM for Cardiac Tissue Repair. The CorMatrix ECM for Carotid Repair will be supplied as a multilaminate, Iyophilized, sterilized sheet of SIS-ECM. The CorMatrix ECM will be provided in four sizes: 1x10cm, 1x15cm, 2x10cm and 2x15cm sheets.

SUBSTANTIAL EQUIVALENCE

The indications for use for the CorMatrix ECM for Carotid Repair are substantially equivalent to the indications for use for 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 ECM for Carotid Repair is substantially equivalent to the predicate devices.

{2}------------------------------------------------

6111187

SECTION 5 510(k) SUMMARY (CONT.)

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench and animal testing was conducted on the CorMatrix ECM for Carotid Repair to support a determination of substantial equivalence to the predicate devices.

Nonclinical Testing Summary:

The nonclinical testing assessed the following aspects of the device:

Suture retention strength .
Probe burst strength .
Tensile strength .
Biocompatibility .
Sterilization validation .
Packaging and shelf-life .

Animal testing examined the safety and performance, as well as burst pressures of repaired vessels at various time points. The collective results of the nonclinical testing demonstrate that the CorMatrix ECM for Carotid Repair meets the established specifications necessary for consistent performance for its intended use. The collective nonclinical testing demonstrates that the CorMatrix ECM for Carotid Repair does not raise new questions of safety or efficacy for carotid artery repair.

SUMMARY

The CorMatrix ECM for Carotid Repair is substantially equivalent to the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

CorMatrix Cardiovascular, Inc. c/o Kit Cariquitan 155 Moffett Park Dr., Suite 210 Sunnyvale, CA 94089

JUL 26 2011

Re: K111187

Trade/Device Name: CorMatrix® ECM® for Carotid 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 26, 2011 Received: April 27, 2011

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 (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 offecting 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.

{4}------------------------------------------------

Page 2 - Mr. Kit Cariquitan

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.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

CORMATRIX CARDIOVASCULAR, INC.

CORMATRIX® ECM® FOR CAROTID REPAIR 510(k).PREMARKET NOTIFICATION

SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K ( | | | 8-7

Device Name: CorMatrix® ECM® for Carotid Repair

Indications For Use:

Prescription Use X (21 CFR Part 801 Subpart D)

And/Oi

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

ion Slan-Off) ion of Cardiovascular Devices

510(k) Number K111187

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).