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 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).

AI/ML Overview

The CorMatrix® ECM® for Vascular Repair, a medical device for vascular repair, did not undergo a standalone study with acceptance criteria and reported device performance in the provided 510(k) summary. Instead, the submission relies on the substantial equivalence to previously cleared predicate devices and non-clinical testing performed for a related device, CorMatrix ECM for Carotid Repair (K111187).

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" table with corresponding "reported device performance" from a dedicated study for the CorMatrix ECM for Vascular Repair is presented in the document. The document states that the new device's performance is supported by the non-clinical testing of the predicate device (CorMatrix ECM for Carotid Repair, K111187). The performance claims are comparative to a control device in an animal study.

Test Parameter	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (from K111187 for Carotid Repair)
Suture Retention Strength	Sufficient to perform as intended in clinical setting	Exceeds mechanical forces in clinical setting
Probe Burst Strength	Sufficient to perform as intended in clinical setting	Exceeds mechanical forces in clinical setting
Tensile Strength	Sufficient to perform as intended in clinical setting	Exceeds mechanical forces in clinical setting
Angiographic Stenosis	Less than control device	Less than control device
Tissue Integration	Better than control device	Better than control device
Calcification	Less than control device	Less than control device
Re-endothelialization	Greater than control device	Greater than control device
Adverse Events (Systemic)	None	None
Adverse Events (Local)	None	None

2. Sample sized 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 explicitly stated for either bench testing or animal testing. The animal study for the CorMatrix ECM for Carotid Repair (K111187) is mentioned, but the number of animals used is not provided.
Data Provenance: Not explicitly stated. The studies were performed for a prior 510(k) submission (K111187).

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 information is not applicable as the studies described are for mechanical and biological properties in an animal model, not for diagnostic interpretation by human experts.

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

This information is not applicable.

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

This information is not applicable. The device is a physical vascular patch, not an AI-powered diagnostic tool requiring human reader studies.

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

A "standalone" study in the sense of a comprehensive performance evaluation specifically for the CorMatrix ECM for Vascular Repair was not done. Instead, the submission leveraged non-clinical testing (bench and animal) performed for its predicate device, the CorMatrix ECM for Carotid Repair (K111187). The document explicitly states: "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."

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

For the animal study:

Angiographic stenosis, tissue integration, calcification, and re-endothelialization: These would typically be determined by histological examination (pathology) and imaging (angiography) by experts in veterinary pathology or similar fields.
Adverse events: Clinical observation and potentially pathological examination.

For bench testing:

Suture Retention Strength, Probe Burst Strength, Tensile Strength: These are objective physical measurements with established testing standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."

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

This information is not applicable.

Summary

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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

Device Description

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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.

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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.

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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

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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

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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)

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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).