CORRESTORE PATCH SYSTEM

K031586 · Somanetics Corp. · DXZ · Aug 7, 2003 · Cardiovascular

Device Facts

• Record ID: K031586
• Device Name: CORRESTORE PATCH SYSTEM
• Applicant: Somanetics Corp.
• Product Code: DXZ · Cardiovascular
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CorRestore patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.

Device Story

CorRestore Patch System is an oval tissue patch composed of glutaraldehyde-fixed bovine pericardium. It functions as an intracardiac patch for cardiac reconstruction and repair. The system includes the patch and an integral suture bolster (also fixed bovine pericardium) in an oval ring shape. It is provided as a kit, optionally including various sutures and a disposable sizer set to assist surgeons in selecting the appropriate patch size. The device is used by surgeons in a clinical setting during cardiac procedures. The patch provides a structural material for repair, and the integral bolster aids in securement. The device is substantially equivalent to the predicate CorRestore Patch System (K011487), with the only modification being the addition of a new suture supplier (Genzyme).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Glutaraldehyde-fixed bovine pericardium. Form factor: Oval patch with integral oval ring suture bolster. Accessories: Suture strips (1.4 x 16 cm) and disposable sizer set. Sterilization: Not specified, but packaging prevents liquid sterilant contact with sutures.

Indications for Use

Indicated for cardiac reconstruction and repair in patients requiring intracardiac patching.

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

• CorRestore Patch System (K011487)

Submission Summary (Full Text)

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AUG - 7 2003

## Appendix D

CorRestore™ Patch System, new suture supplier Trade Name: Intracardiac Patch or Pledget Common Name: Establishment Information: Somanetics Corporation 1653 East Maple Road Troy, MI 48083 Phone: [phone] [phone] Fax: Contact Person: Ronald A. Widman, Vice President of Medical Affairs Class II, Panel 74 DXZ Classification:

## Product Description:

The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed bovine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered.

| Without<br>Sutures | W/ Ethicon<br>Sutures | W/ Genzyme<br>Sutures | Product |
|--------------------|-----------------------|-----------------------|------------------------------|
| 1.5P2 | 1.5P2S | 1.5P2SG | 1.5 x 2 cm* CorRestore Patch |
| 2P3 | 2P3S | 2P3SG | 2 x 3 cm* CorRestore Patch |
| 3P4 | 3P4S | 3P4SG | 3 x 4 cm* CorRestore Patch |

Accessory:

CRPS

CorRestore Patch Sizer Set

## Substantial Equivalence:

The CorRestore patch is equivalent in indications for use, size, shape, material, manufacturing processes, sterilization, packaging, instructions and intended use to the predicate CorRestore Patch System, K011487. The only change is the addition of a new suture supplier, Genzyme. Sutures are packaged in the same way with labeling appropriate for their premarket notification status, the same as the predicate. The packaging prevents liquid sterilant from contacting the sutures. The CorRestore Patch is substantially equivalent to the predicate device.

0(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2003

Mr. Ronald A. Widman Vice President of Medical Affairs Samanetics Corporation 1653 East Maple Road Troy, MI 48083

Re: K031586

Trade Name: CoreRestore™ Patch System Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II (two) Product Code: DXZ Dated: May 19, 2003 Received: May 21, 2003

Dear Mr. Widman:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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

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Page 2 - Mr. Ronald A. Widman

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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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,

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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Page 1 of 1

KO31586 510(k) Number (if known) _

Device Name: CorRestore™ Patch System Processed Bovine Pericardial Patch

Indications For Use:

The CorRestore patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Oesterle

n of Cardiovascular Devices

**510(k) Number** K031586

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)