TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358

K091142 · Rti Biologics, Inc. · FTM · Aug 31, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091142
• Device Name: TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
• Applicant: Rti Biologics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Aug 31, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for implantation to repair, reinforce and/or supplement soft tissue. This device is indicated for use in general and plastic surgery applications. This device is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include but are not limited to: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including but not limited to diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Device Story

Bovine pericardium surgical mesh; processed via Tutoplast solvent dehydration and gamma irradiation. Device consists of collagenous connective tissue with three-dimensional intertwined fibers; provides multidirectional mechanical strength and elasticity; supports replacement by endogenous tissue. Intended for implantation by surgeons in general and plastic surgery settings to repair or reinforce soft tissue deficiencies. No electronic or software components.

Technological Characteristics

Bovine pericardium; processed via Tutoplast solvent dehydration and gamma irradiation. Collagenous connective tissue with three-dimensional intertwined fibers. Multidirectional mechanical strength and elasticity.

Indications for Use

Indicated for patients requiring soft tissue repair, reinforcement, or supplementation in general and plastic surgery, including pericardial structure repair and soft tissue deficiencies such as abdominal/thoracic wall defects, gastric banding, muscle flap reinforcement, prolapse, pelvic floor reconstruction, and various hernias.

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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ADVANCING SCIENCE, SAFETY & INNOVATION

# Attachment 6: 510(K) Summary

AUG 31 2009

| Submitted by: | Lisa Simpson |
|---------------|---------------------------|
| | RTI Biologics, Inc. |
| | 11621 Research Circle |
| | Alachua, FL 32615 |
| | Phone: [phone] x4326 |
| | Fax: [phone] |

TUTOMESH®, TUTOPATCH® Proprietary Names:

Common Name: Surgical Mesh

FTM, General & Plastic Surgery Panel Product Code:

Code Section: 21 CFR 878.3300

### Substantial Equivalence:

The proposed devices are substantially equivalent to predicate devices in materials, design, function, intended use and fundamental scientific technology.

## Description:

These are borne pericardium surgical mesh devices processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. These devices consist of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, they have multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retain the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.

#### Intended Use:

This device is intended for implantation to repair, reinforce and/or supplement soft tissue.

This device is indicated for use in general and plastic surgery applications. This device is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include but are not limited to: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including but not limited to diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

#### Summary of Technological Characteristics:

The proposed device has materials, design and function equivalent to predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

2009 SEP 9

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

RTI Biologics, Inc. % Mr. Travis Arola Regulatory Affairs Manager 11621 Research Circle, P.O. Box 2650 Alachua, Florida 32616

Re: K091142

Trade/Device Name: TUTOPATCH®, and TUTOMESH® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 31, 2009 Received: August 31, 2009

Dear Ms. Simpson:

This letter corrects our substantially equivalent letter of August 31, 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 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 (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.

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Page 2 - Mr. Travis Arola

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" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Saubare Buchner

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

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# Attachment 3: Indications for Use

510(k) Number (if known):

Device Names: TUTOPATCH® TUTOMESH®

Indications for Use:

This device is intended for implantation to repair, reinforce and/or supplement soft tissue.

Prescription Use Over-The-Counter Use ਮ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Daniel Kranbu mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number: K091142