TUTOPATCH, TUTOMESH

K081538 · Rti Biologics, Inc. · FTM · Jun 19, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081538
• Device Name: TUTOPATCH, TUTOMESH
• Applicant: Rti Biologics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 19, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Device Story

TUTOMESH is a bovine pericardium-derived 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. Used by surgeons in general and plastic surgery to support replacement by endogenous tissue; serves as a prosthesis for soft tissue repair and pericardial structure reinforcement. Fixed by surgeon during procedure; provides structural scaffold for tissue ingrowth.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material properties.

Technological Characteristics

Bovine pericardium collagenous connective tissue; processed via Tutoplast solvent dehydration; sterilized via gamma irradiation. Features three-dimensional intertwined fibers for multidirectional mechanical strength and elasticity.

Indications for Use

Indicated for patients requiring surgical repair of soft tissue deficiencies or pericardial structures in general and plastic surgery. Includes repair of gastric banding, muscle flap reinforcement, rectal/vaginal prolapse, pelvic floor reconstruction, and various hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

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)

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

K081538

**RTI | BIOLOGICS**

ADVANCING SCIENCE, SAFETY & INNOVATI

JUN 1 9 2008

## Attachment 4: 510(K) Summary

May 30, 2008

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

Proprietary Names: TUTOMESH®

Surgical Mesh Common Name:

Product Code: 79 FTL, Orthopedics Panel

Code Section: 21 CFR 878.3300

#### Substantial Equivalence:

The TUTOMESH® device is substantially equivalent to predicate devices in materials, design, function, intended use and fundamental scientific technology.

#### Description:

TUTOMESH® is a bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. The TUTOMESH® device consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.

#### Intended Use:

These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Summary of Technological Characteristics: TUTOMESH® has materials, design and function equivalent to predicate devices.

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

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 its wings forming three curved lines. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 9 2008

RTI Biologics, Inc. % Ms. Lisa Simpson Director of Regulatory Affairs 11621 Research Circle Alachua, Florida 32615

Re: K081538

Trade/Device Name: TUTOMESH® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM, MFX Dated: May 30, 2008 Received: June 2, 2008

Dear Ms. Simpson:

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 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.

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

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 N. Millman

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

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

## Attachment 2: Indications for Use

# 510(k) Number (if known): KOG1538

Device Names: TUTOMESH®

### Indications for Use:

These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Prescription Use X Over-The-Counter Use 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)

NeifRe Osde fdmxm

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K081538