SIS PLASTIC SURGERY MATRIX

K034039 · Cook Biotech, Inc. · FTM · Feb 18, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K034039
• Device Name: SIS PLASTIC SURGERY MATRIX
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Feb 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Device Story

SIS Plastic Surgery Matrix; porcine small intestinal submucosa (SIS) graft; strand configuration; lyophilized; sterile; single-use. Implanted by surgeons during plastic and reconstructive procedures to reinforce soft tissue weaknesses. Provides mechanical support for tissue repair. Biocompatibility, viral inactivation, and mechanical testing (tensile/suture retention) confirm suitability.

Clinical Evidence

Bench testing only. Includes biocompatibility, viral inactivation, and mechanical testing (tensile strength and suture retention strength). No clinical data presented.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form: Lyophilized strand configuration. Sterilization: Sterile. Energy source: None. Connectivity: None.

Indications for Use

Indicated for patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery where soft tissue weakness exists.

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 Soft Tissue Graft (K980431)
• Permacol (K013625)
• Advanta PTFE Facial Implant (K992991)

Submission Summary (Full Text)

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## 9. 510(K) SUMMARY

Mark Bleyer, President Submitted By: Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 [phone] February 04, 2004

## Names of Device:

SIS Plastic Surgery Matrix Trade Name: Surgical Mesh Common/Usual Name: Proposed classification name: Surgical Mesh 21 CFR 878.3300 (FTM) Class II

### Intended Use:

The SIS Plastic Surgery Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

## Predicate Devices:

The SIS Plastic Surgery Matrix is similar to predicate devices, including the SURGISIS® Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated, Permacol (K013625) manufactured by Tissue Science Laboratories, PLC, and Advanta PTFE Facial Implant (K992991) manufactured by Atrium Medical Corporation.

#### Device Description:

The SIS Plastic Surgery Matrix is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a strand configuration. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

#### Substantial Equivalence:

The SIS Plastic Surgery Matrix is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through in vitro and biocompatibility testing.

# Discussion of Tests and Test Results:

The material comprising the SIS Plastic Surgery Matrix was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and tensile strength and suture retention strength to be sufficient.

### Conclusions Drawn from the Tests:

Outcomes from the evaluation of the SIS Plastic Surgery Matrix provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

Mr. Mark Bleyer President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, Indiana 47906

Re: K034039

Trade/Device Name: SIS Plastic Surgery Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: December 24, 2003 Received: December 29, 2003

Dear Mr. Blever:

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.

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Page 2 - Mr. Mark Bleyer

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/dsma/dsmamain.html

Sincerely yours.

iriam C. Provost

(Celia M. Witten, Ph.D., M.D. 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: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The SIS Plastic Surgery Matrix is for implantation to relnforce soft THS CO T laste Cargory mists in patients requiring soft tissue repair or relnforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K034039