COOK UROLOGICAL GRAFT

K090688 · Cook Biotech, Inc. · PAG · Jul 10, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090688
• Device Name: COOK UROLOGICAL GRAFT
• Applicant: Cook Biotech, Inc.
• Product Code: PAG · General, Plastic Surgery
• Decision Date: Jul 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.

Device Story

COOK Urological Graft is a bioabsorbable, extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). Supplied in a lyophilized, sterile state within a double pouch system, it is intended for surgical implantation to reinforce soft tissues in urological anatomy or provide temporary support for the kidney. The device functions as a scaffold for tissue reinforcement. It is used by surgeons in clinical settings. The graft is identical in material and technological characteristics to previously cleared SIS-based meshes, providing a biocompatible alternative for soft tissue repair.

Clinical Evidence

Substantial equivalence supported by bench, animal, biocompatibility, and clinical testing. No specific performance metrics or study results provided in the summary document.

Technological Characteristics

Bioabsorbable extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). Supplied lyophilized and sterile in a double pouch system. Class II surgical mesh (21 CFR 878.3300).

Indications for Use

Indicated for patients requiring reinforcement of soft tissues in urological anatomy, including temporary wound or solid organ support in the kidney.

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

• SURGIS Mesh (K980431)
• SURGISIS® Sling (K992159)
• Vicryl Mesh bag (K051701)

Submission Summary (Full Text)

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K090688

## 510(k) Summary

#### COOK Biotech Incorporated

JUL: 1.0 2009

## COOK® Urological Graft

Manufacturer Name:

COOK Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: [phone] FAX: [phone]

Official Contact:

Perry W. Guinn

### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations: COOK® Urological Graft Surgical Mesh Class II, 21 CFR §878.3300

' PAG

#### INTENDED USE:

The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.

#### DEVICE DESCRIPTION:

The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGIS Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

### EQUIVALENCE TO MARKETED DEVICES

The COOK Urological Graft is similar with respect to intended use, and identical with respect to materials and technological characteristics to the predicate devices in terms of section 510(k) substantial equivalence, as shown through bench, animal, biocompatibility and clinical testing.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 2 8 2012

Cook Biotech, Inc. % Mary A. Faderan, Ph.D., RAC Regulatory Specialist 1425 Innovation Place WEST LAFAYETTE IN 47906

Re: K090688 Trade/Device Name: COOK Urological Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: July 1, 2009 Received: July 2, 2009

Dear Dr. Faderan:

This letter corrects our substantially equivalent letter of July 10, 2009.

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 (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 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Rooks

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090688

# Indications for Use

510(k) Number (if known): K090688

COOK Urological Graft Device Name:_

Indication's For Use:

The COOK Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The device is supplied sterille and intended for one-time use.

Prescription Use X (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)

Daniel Krane for Nixon
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K090666