REGENSIS PERICARDIAL PATCH

K051405 · Cormatrix Cardiovascular, Inc. · DXZ · Aug 31, 2005 · Cardiovascular

Device Facts

• Record ID: K051405
• Device Name: REGENSIS PERICARDIAL PATCH
• Applicant: Cormatrix Cardiovascular, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Aug 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.

Device Story

CorMatrix Pericardial Patch is a porcine small intestinal submucosa-derived sheet used for pericardial reconstruction and repair. Device is provided in varying dimensions. It is intended for use by surgeons in clinical settings. The patch serves as a scaffold for tissue repair. Safety and efficacy were established through bench and animal testing.

Clinical Evidence

No clinical data. Evidence consists of bench testing and animal testing to support safety and efficacy.

Technological Characteristics

Material: Porcine small intestinal submucosa. Form factor: Sheets of varying dimensions. Class II device.

Indications for Use

Indicated for the reconstruction and repair of the pericardium 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

• Cook Biotech, Inc., SurgiSIS (K980431)
• TEI Biosciences, Inc., TISSUEMEND (K020455)
• W.L. Gore & Associates, Inc., Preclude Pericardial Membrane (K012098)
• PM Devices, Inc., Peripatch Sheet (K031948)

Submission Summary (Full Text)

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# AUG 3 1 2005

## 510(k) SUMMARY

# 510(k) Notification K051405

#### GENERAL INFORMATION

#### Applicant:

CorMatrix Cardiovascular, Inc. 919 Waverly Road Tallahassee, FL 32312 Phone: [phone] FAX:

### Contact Person:

Ms. Punam Gollamudi Regulatory Project Manager Experien Group, LLC 155 Moffett Park Drive, Suite A-101 Sunnyvale, CA 94089 Phone: [phone] FAX: [phone] Email: [e-mail]

### Date Prepared:

July 18, 2005

DEVICE INFORMATION

#### Trade/Proprietary Name:

CorMatrix Pericardial Patch

# Common/Classification Name/Product Code:

Product Code: DXZ Device Classification Name: Patch, Pericardial

# Device Classification:

Class II

## PREDICATE DEVICES

- Cook Biotech, Inc., SurgiSIS (K980431) .
- TEI Biosciences, Inc., TISSUEMEND (K020455) .
- W.L. Gore & Associates, Inc., Preclude Pericardial Membrane (K012098) ◆
- PM Devices, Inc., Peripatch Sheet (K031948) .

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KOSI40S 0.222

## INTENDED USE

INTENDED USE
The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.

# PRODUCT DESCRIPTION

PRODUCT DESCRIPTION
The CorMatrix Pericardial Patch is manufactured from porcine small intestinal i he Conviatiix refleardial is manufactures are a seets with varying dimensions.

## SUBSTANTIAL EQUIVALENCE

SUBSTANTIAL EQUIPALENCE
The proposed indications for the CorMatrix Pericardial Patch are substantially The proposed indications for use of the predicate devices. Any differences in the equivalent to the midications for ass or ass of the prices do not raise any new issues of safety or technological characterishes between the actives substantially equivalent to the predicate devices.

# TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

I ESTING IN SUITORY OF DOBS INFERRActeristics between the CorMatrix Pericardial Patch and the predicate devices do not raise any new issues of safety or efficacy. The and the predicate devices do not raise any hased in the CorMatrix Pericardial Patch was performance and satery of the bro material as onimal testing. The collective evaluated infough oxlonstre block.ppMatrix Pericardial Patch is substantially equivalent to the respective predicate devices with regard to safety and efficacy.

#### SUMMARY

SUMMANT
The CorMatrix Pericardial Patch is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

FEB 23 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CorMatrix Cardiovascular, Inc. c/o Ms. Punam Gollamudi Regulatory Consultant 919 Waverly Road Tallahassee, FL 32312

Re: K051405

CorMatrix Pericardial Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II (two) Product Code: 74 DXZ Dated: July 18, 2005 Received: July 19, 2005

Dear Ms. Gollamudi:

This letter corrects our substantially equivalent letter of August 31, 2005.

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 (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 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

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#### Page 2 - Ms. Punam Gollamudi

CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to continue 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna D. Vachner

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): K051405

Device Name:_CorMatrix Pericardial Patch

Indications For Use: The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Jackson

(Division Sign-Off) Casion of Cardiovascular Devices

510(k) Number_1605 1405

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