CORRESTORE PATCH SYSTEM by SOMANETICS CORP.

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.

AI/ML Overview

This submission is a 510(k) premarket notification for the CorRestore™ Patch System. The device is an intracardiac patch made from glutaraldehyde-fixed bovine pericardium. The purpose of this submission is to introduce a new suture supplier, Genzyme, for the sutures packaged with the CorRestore™ Patch System.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a 510(k) submission for a change in suture supplier for an existing device. It does not involve performance criteria for the device itself or a study to demonstrate such performance against specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to the predicate device despite the change in suture supplier.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No new performance testing was conducted that would require a test set. The submission states, "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."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No new clinical or performance study was conducted that would require expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a medical implant, not a software algorithm.

7. Type of Ground Truth Used

Not applicable. No new ground truth was established as no new performance study was conducted. The ground for substantial equivalence rests on the comparison to the existing predicate device.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device requiring a training set.

Summary of the Study and Acceptance Criteria:

The "study" in this context is the 510(k) submission process itself, where the manufacturer demonstrates that the modified device (CorRestore™ Patch System with Genzyme sutures) is substantially equivalent to a legally marketed predicate device (CorRestore™ Patch System with previous sutures, K011487).

Acceptance Criteria for Substantial Equivalence (Implicit in 510(k) Process):

The device must meet the following criteria (as implied by the 510(k) summary):

Same Indications For Use: The CorRestore™ Patch with Genzyme sutures is intended for the same use as the predicate device: "as an intracardiac patch for cardiac reconstruction and repair."
Same Technological Characteristics, OR Different Technological Characteristics with Evidence of Safety and Effectiveness: The submission explicitly states "The only change is the addition of a new suture supplier, Genzyme." It then argues that the new sutures are packaged in the same way with appropriate labeling, and the packaging prevents liquid sterilant from contacting the sutures. This implies that the change in suture supplier does not alter the fundamental safety or effectiveness of the CorRestore™ Patch itself. The sutures themselves would have their own pre-market notification (510k) status.

Reported Device Performance (in the context of this submission):

The "performance" demonstrated is that the device, with the new suture supplier, maintains substantial equivalence to the predicate device. This is primarily a regulatory and manufacturing assessment, not a performance study in the traditional sense of clinical outcomes or diagnostic accuracy.

The key statement is: "The CorRestore™ Patch is substantially equivalent to the predicate device." This assertion, accepted by the FDA in their approval letter (K031586), serves as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence under this 510(k). The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification...and have determined the device is substantially equivalent...to legally marketed predicate devices."

Summary

{0}------------------------------------------------

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: (248) 689-3050 (248) 689-4272 Fax: Contact Person: Ronald A. Widman, Vice President of Medical Affairs Class II, Panel 74 DXZ Classification:

Product Description:

WithoutSutures	W/ EthiconSutures	W/ GenzymeSutures	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

{1}------------------------------------------------

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

{2}------------------------------------------------

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597, 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

{3}------------------------------------------------

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)

Over-The-Counter Use

(Optional Format 1-2-96)

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).