SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT

K062697 · Cook Biotech, Inc. · FTL · Oct 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062697
• Device Name: SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
• Applicant: Cook Biotech, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia and body wall defect. The device is intended for one-time use.

Device Story

SIS Hernia Repair Device (Surgisis Gold Hernia Repair Graft) is a surgical mesh used for soft tissue reinforcement. Implanted by surgeons during hernia or body wall defect repair procedures. Device provides structural support to weakened tissue. Manufactured from SIS (Small Intestinal Submucosa) material. Device is single-use and sterile.

Clinical Evidence

Bench testing only; device passed internal tests and release criteria.

Technological Characteristics

Surgical mesh composed of SIS (Small Intestinal Submucosa). Sterilized using established processes. Standalone device; no software or electronic components.

Indications for Use

Indicated for patients requiring reinforcement of soft tissue, specifically for the repair of a hernia or body wall defect. Intended for one-time use.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Submission Summary (Full Text)

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Special 510(k) Premarket Notification: SIS Hernia Repair Device

Attachment 4

K062697

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Special 510(k) Summary

| Submitted by: | Cook Biotech Incorporated<br>1425 Innovation Place<br>West Lafayette, IN 47906<br>Perry Guinn<br>VP Quality Assurance & Regulatory Affairs<br>Tel: [phone] x 4942<br>FAX: [phone]<br>September 15, 2006 | OCT 13 2006 |
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| Names of Device:<br>Trade Name: | SIS Hernia Repair Device, Surgisis  Gold Hernia Repair Graft | |
| Common/Usual Name: | Surgical mesh | |
| Proposed classification: | Surgical mesh (79FTL)<br>21 CFR 878.3300<br>Class II | |
| Performance standards: | No performance standards have been established under<br>Section 514 of the Food, Drug and Cosmetic Act applicable<br>to this device. | |

Intended use:

The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia and body wall defect. The device is intended for one-time use.

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Special 510(k) Premarket Notification: SIS Hernia Repair Device

#### Attachment 5

K06 2697
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### Summary of Substantial Equivalence:

The SIS Hernia Repair Device as described in this submission is substantially equivalent to its predicate with respect to the following characteristics:

#### Similarities:

- 1. Both have the same intended use.
- Both use the same operating principles. 2.
- Both incorporate the same basic design. 3.
- 4. Both incorporate the same materials.
- Both have the same shelf-life. 5.
- Both pass the same set of internal tests and release criteria. 6.
- 7. Both are packaged and sterilized using the same materials and processes.

#### Differences:

- 1. A process was changed that did not affect specifications or performance of the final device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the serpent entwined around a staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2006

Cook Biotech Incorporated % Mr. Perry W. Guinn Vice President, Quality Assurance & Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906

Re: K062697

Trade/Device Name: SIS Hernia Repair Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: September 14, 2006 Received: September 15, 2006

Dear Mr. Guinn:

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 mav 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

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Page 2 - Mr. Perry W. Guinn

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 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 your

Ron Natt

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K062697

## Indications for Use

510(k) Number (if known):

Device Name: SIS Hernia Repair Device

Indications For Use:

The SIS Hernia Repair Device is intended to be implanted to reinforce soft The Ole Homia Ropair Donts. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.

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) |
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*(Division Sign-Off)*

Division of General, Restorative, and Neurological Devices

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510(k) Number__LOG2697