SURGISIS BIODESIGN TISSUE GRAFT

K073391 · Cook Biotech, Inc. · FTM · Mar 21, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073391
• Device Name: SURGISIS BIODESIGN TISSUE GRAFT
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SURGISIS® Biodesign Tissue Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera. The device is intended for one-time use.

Device Story

SURGISIS® Biodesign Tissue Graft is a surgical mesh used for soft tissue reinforcement and hernia repair. Manufactured from porcine small intestinal submucosa (SIS); supplied in a dried state in a sterile double pouch. Implanted by surgeons during procedures to repair body wall defects; minimizes tissue attachment to viscera upon direct contact. Device acts as a scaffold for tissue repair. No complex electronics or software involved.

Clinical Evidence

No human clinical trials provided. Evidence consists of animal studies from published and unpublished literature demonstrating minimal tissue attachment to viscera when compared to a named predicate.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form factor: Dried, sterile, multi-size surgical mesh. Principle: Biological tissue scaffold for soft tissue reinforcement. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring reinforcement of soft tissues where weakness exists, 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.

Predicate Devices

• SURGISIS® Biodesign Tissue Graft (K062697)
• Veritas® Collagen Matrix (K062915)

Submission Summary (Full Text)

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510(k) Premarket Notification: SURGISIS® Biodesign Tissue Graft

K073391

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#### 9 510(K) SUMMARY

Submitted by:

MAR 2 1 2008

Perry W. Guinn VP Regulatory Affairs and Quality Assurance Cook Biotech Incorporated 1425 Innovation Place West Lafavette. IN 47906 [phone] November 30, 2007

### Device:

Trade Names:

Common/Usual Name: Proposed Classification Name: SURGISIS® Biodesign Tissue Graft, SIS Hernia Repair Device Surgical Mesh Surgical Mesh 21 CFR §878.3300 (79FTM) Class II

#### Intended Use:

The SURGISIS® Biodesign Tissue Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.

The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.

The device is intended for one-time use.

## Predicate Devices:

The SURGISTS® Biodesign Tissue Graft is substantially equivalent to itself (D.C. #K062697) acting as its own predicate and is substantially equivalent to Veritas® Collagen Matrix (D.C. #K062915) manufactured by Synovis Surgical Innovations.

# Device Description:

The SURGISIS® Biodesign Tissue Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a range of sizes. The device is packaged in a dried state, and is supplied sterile in a sealed double pouch system.

# Substantial Equivalence:

The SURGISIS® Biodesign Tissue Graft is similar with respect to intended use, rnaterials and technological characteristics to its predicate devices in terms of section 510(k) substantial equivalence, as shown through bench and biocompatibility testing submitted in previous cleared 510(k)s.

Company Confidential

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### Indication Testing:

A number of animal studies from published and unpublished literature were conducted specific to the subject of this submission. All studies concluded that SURGISIS® Biodesign Tissue Graft demonstrates minimal tissue attachment to the viscera when compared to a named predicate.

# Conclusions Drawn from Tests:

The SURGISIS® Biodesign Tissue Graft is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the additional intended use, which is the subject of this submission.

Company Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2008

Cook Biotech, Inc. % Mr. Perry W. Guinn VP, Quality Assurance & Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906-1000

Re: K073391

Trade/Device Name: SURGISIS® Biodesign Tessue Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 26, 2008 Received: February 27, 2008

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 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

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Page 2 - Mr. Perry W. Guinn

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 our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark M Millman

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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# Indications for Use

510(k) Number (if known):

Device Name: SURGISIS® Biodesign Tissue Graft

Indications For Use:

The SURGISIS® Biodesign Tissue Graft is intended to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.

The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.

This 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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Mark A. Melhus

Division of General, Restorative, and Neurological Devices

510(k) Number K07339/