CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR

K063349 · Cormatrix Cardiovascular, Inc. · DXZ · Feb 16, 2007 · Cardiovascular

Device Facts

• Record ID: K063349
• Device Name: CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
• Applicant: Cormatrix Cardiovascular, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Feb 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CorMatrix Patch for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue repair (i.e., atrial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.

Device Story

CorMatrix Patch for Cardiac Tissue Repair is a surgical implant used for intracardiac tissue repair and suture-line buttressing. Device consists of 4-ply porcine small intestinal submucosa (SIS) sheets. Used by surgeons in clinical settings to repair cardiac defects like ASD and VSD. SIS material acts as a scaffold for tissue repair. Device is implanted during cardiac surgery; provides structural support and facilitates tissue healing. Benefits include biocompatible repair material for cardiac applications.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility, bench testing, and animal testing to support safety and efficacy of the porcine SIS material.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form factor: 4-ply sheets of varying dimensions. Intended for surgical implantation.

Indications for Use

Indicated for patients requiring intracardiac tissue repair, including atrial septal defect (ASD) and ventricular septal defect (VSD) repair, and suture-line buttressing.

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 Surgical Mesh (K980431)
• CorMatrix Cardiovascular, Inc., CorMatrix Patch for Pericardial Closure (K051405)
• Peritec Biosciences LTD, PFA Vascular Patch (K041736)
• Shelhigh, Shelhigh No-React VASCUPATCH (K982810)
• Bio-Vascular, Inc., CV Peri-Guard Cardiovascular Patch (K983602)
• Synovis Surgical Innovations, Peri-Strips Staple Line Reinforcement (K040415)
• Boston Scientific Corp., PTFE Felts and Pledgets (K041716)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K063349

This summary of the 510(k) premarket notification for the CorMatrix Patch for Cardiac Tissue Repair is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

# 510(k) SUMMARY

FEB 16 2007

# 510(k) Notification K063349

#### GENERAL INFORMATION

# Applicant:

CorMatrix Cardiovascular, Inc. 155 Moffett Park Dr., Suite A-240 Sunnyvale, CA 94089-1330 Phone: [phone] [phone] FAX:

# Contact Person:

Kit Cariquitan Regulatory Consultant Experien Group, LLC 155 Moffett Park Drive, Suite A-101 Sunnyvale, CA 94089 Phone: [phone] (x112) FAX: [phone] Email: [e-mail]

Date Prepared: January 16, 2007

## DEVICE INFORMATION

Trade/Proprietary Name: CorMatrix Patch for Cardiac Tissue Repair

## Common/Classification Name/Product Code:

Product Code: DXZ Device Classification Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene Regulation Number: 21CFR§870.3470

Device Classification: Class II

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## PREDICATE DEVICES

- . Cook Biotech, Inc., SurgiSIS Surgical Mesh (K980431)
- CorMatrix Cardiovascular, Inc., CorMatrix Patch for Pericardial Closure . (K051405)
- Peritec Biosciences LTD, PFA Vascular Patch (K041736) .
- Shelhigh, Shelhigh No-React VASCUPATCH (K982810) ●
- Bio-Vascular, Inc., CV Peri-Guard Cardiovascular Patch (K983602) .
- Synovis Surgical Innovations, Peri-Strips Staple Line Reinforcement (K040415) ●
- Boston Scientific Corp., PTFE Felts and Pledgets (K041716) .

#### INTENDED USE

The CorMatrix Patch for Cardiac Tissue Repair is intended for use as an intracardiac patch or pledget for tissue repair (i.e., atrial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.

#### PRODUCT 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.

# SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the CorMatrix Patch for Cardiac Tissue Repair are substantially equivalent to the indications for use of 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 Patch for Cardiac Tissue Repair is substantially equivalent to the predicate devices.

# TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Any differences in technological characteristics between the CorMatrix Patch for Cardiac Tissue Repair and the predicate devices do not raise any new issues of safety or efficacy. 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 have demonstrated that the CorMatrix Patch for Cardiac Tissue Repair is substantially equivalent to the respective predicate devices with regard to safety and efficacy.

# SUMMARY

The CorMatrix Patch for Cardiac Tissue Repair is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Experien Group c/o Mr. Kit Cariquitan, Regulatory Consultant 155 Moffett Park Drive Suite A-101 Sunnyvale, CA 94089

FEB 16 2007

Re: K063349

Trade/Device Name: CorMatrix Patch for Cardiac Tissue Repair Regulation Number: v21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II (two) Product Code: DXZ Dated: January 16, 2007 Received: January 17, 2007

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) 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality

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Page 2 - Mr. Kit Cariquitan

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 begin 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/industry/support/index.html.

Sincerely yours,

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): K063349

Device Name: CorMatrix Patch for Cardiac Tissue Repair

The CorMatrix® Patch for Cardiac Tissue Repair is indicated for use as an Indications For Use: intracardiac patch or pledget for tissue repair (i.e., arterial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision of Cardiova

510(k) Numbe

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