EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700

K082139 · Edwards Lifesciences, LLC · DXZ · Oct 23, 2008 · Cardiovascular

Device Facts

• Record ID: K082139
• Device Name: EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXZ · Cardiovascular
• Decision Date: Oct 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Edwards Bovine Pericardial Patch is intended for use as a surgical patch material for: augmenting the patient's own pericardium to assist in closure following open-heart surgery; intracardiac defects; septal defects and annulus repairs; cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; great vessel reconstruction and repairs; and suture-line buttressing.

Device Story

The Edwards Bovine Pericardial Patch is a surgical implant consisting of a 10 cm x 15 cm sheet of bovine pericardium preserved in a buffered glutaraldehyde solution. It is used by surgeons during open-heart, cardiac, and vascular procedures to augment native pericardium, repair intracardiac or septal defects, perform annulus repairs, reconstruct great vessels, or provide suture-line buttressing. The patch is tailored intraoperatively by the surgeon to fit the specific anatomical requirements of the patient. By providing a biocompatible, durable material for tissue repair and reconstruction, the device assists in achieving surgical closure and structural integrity in cardiovascular applications.

Clinical Evidence

No clinical data provided. Safety and effectiveness are established based on the well-documented clinical history of bovine pericardial patches in cardiovascular reconstruction and repair.

Technological Characteristics

Material: Glutaraldehyde-fixed bovine pericardium. Form factor: 10 cm x 15 cm rectangular sheet. Sterilization: Not specified. Energy source: None (passive implant).

Indications for Use

Indicated for patients undergoing open-heart surgery, cardiac, vascular, or great vessel reconstruction and repair, and suture-line buttressing requiring pericardial augmentation or defect closure.

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

• Edwards Bovine Pericardial Patch (K833763)
• PeriPatchTM Sheet (K040835)
• CV Peri-Guard Cardiovascular Patch (K971726)
• Glycar Pericardial Patch (K963967)
• Vascu-Guard (K942010)

Submission Summary (Full Text)

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

## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 | OCT 23 2008 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Daryl Richardson, Regulatory Affairs Associate III | |
| Date Prepared: | July 18, 2008 | |
| Trade name: | Edwards Bovine Pericardial Patch | |
| Classification<br>Name: | Intracardiac Patch or Pledget (21 CFR 870.3470, Product Code DXZ) | |
| Predicate Devices: | Edwards Bovine Pericardial Patch, K833763<br>PeriPatchTM Sheet, K040835<br>CV Peri-Guard Cardiovascular Patch, K971726<br>Glycar Pericardial Patch, K963967<br>Vascu-Guard, K942010 | |
| Device<br>Description: | The Edwards Bovine Pericardial Patch is comprised of a rectangular sheet of<br>bovine pericardium that has been preserved in a buffered glutaraldehyde solution.<br>The pericardial patch is in the form of a 10 cm x 15 cm size, and may be tailored<br>during surgery to meet the specific configuration needs of individual circumstances. | |
| Indications for<br>Use: | The Edwards Bovine Pericardial Patch is intended for use as a surgical patch<br>material for: augmenting the patient's own pericardium to assist in closure following<br>open-heart surgery; intracardiac defects; septal defects and annulus repairs;<br>cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction<br>and repairs; great vessel reconstruction and repairs; and suture-line buttressing. | |
| Comparative<br>Analysis: | The Edwards Bovine Pericardial Patch is manufactured from glutaraldehyde fixed<br>bovine pericardium; this is the same material used for the predicate devices.<br><br>The Edwards Bovine Pericardial Patch is considered to be similar to the predicates because:<br>Same raw material Same intended medical use Operates using the same fundamental scientific technology Similar shape Similar processing method Similar sterilization method Similar packaging and labeling | |
| Functional/Safety<br>Testing: | The safety and effectiveness of bovine pericardial patches for reconstruction and<br>repair is well established. Pericardial patches have been proven to be effective in<br>achieving the desired result and well tolerated by the host tissue. | |
| Conclusion: | The Edwards Bovine Pericardial Patch is substantially equivalent to the predicate devices. | |

## Appendix B – Page 1 of 1

PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without the written permission from Edwards Lifesciences, LLC.

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

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 23 2008

Edwards Lifesciences LLC c/o Mr. Daryl Richardson Regulatory Affairs Heart Valve Therapy One Edwards Way Irvine, CA 92614

Re: K082139

Edwards Bowine Pericardial Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II Product Code: DXZ Dated: July 28, 2008 Received: July 29, 2008

Dear Mr. Richardson:

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.

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

Page 2 - Mr. Daryl Richardson

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dma R. bohner

Bram D. Zuckerman, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use Statement

510(k) Number (if known): KO82139

Device Name: Edwards Bovine Pericardial Patch

Indications for Use:

The pericardial patch is intended for use as a surgical patch material for: augmenting the patient's own pericardium to assist in closure following openheart surgery; intracardiac defects; septal defects and annulus repairs; cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; great vessel reconstruction and repairs; and suture-line buttressing.

Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

Duna R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko82139

Page 1 of 1

ાન ની

Appendix A - Page 1 of 1

PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without the written permission from Edwards Lifesciences, LLC.