PATCH, PLEDGET AND INTRACARDIAC

K111187 · Cormatrix Cardiovascular, Inc. · DXZ · Jul 26, 2011 · Cardiovascular

Device Facts

• Record ID: K111187
• Device Name: PATCH, PLEDGET AND INTRACARDIAC
• Applicant: Cormatrix Cardiovascular, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Jul 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

CorMatrix ECM for Carotid Repair is an acellular extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). The device is processed to remove muscle layers, leaving an intact submucosa with a portion of the tunica propria. It is supplied as a multilaminate, lyophilized, sterilized sheet in various sizes. Used by surgeons during carotid endarterectomy or vascular reconstruction, the patch serves as a scaffold for tissue repair. It is applied to the carotid artery to facilitate closure and reinforce suture lines. The device provides a biological substrate for host tissue remodeling. It is terminally sterilized using Ethylene Oxide gas.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by nonclinical bench testing (suture retention, probe burst strength, tensile strength, biocompatibility, sterilization validation, packaging, and shelf-life) and animal testing evaluating safety, performance, and burst pressures of repaired vessels.

Technological Characteristics

Multilaminate, lyophilized porcine small intestinal submucosa (SIS) ECM sheet. Terminally sterilized via Ethylene Oxide gas. Dimensions: 1x10cm, 1x15cm, 2x10cm, 2x15cm. Mechanical properties include suture retention, probe burst strength, and tensile strength.

Indications for Use

Indicated for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing in patients requiring such surgical intervention.

Regulatory Classification

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.

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)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

## Contact Person:

Heather Lake Regulatory Consultant Experien Group, LLC 155-A Moffett Park Dr., Suite 210 Sunnyvale, CA 94089 U.S.A. Phone: [phone] FAX: [phone]

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

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### 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

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.

## PRODUCT 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.

### 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.

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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.

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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.

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### 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

KL

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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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:

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.

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