SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG

K082682 · Cook Biotech, Inc. · FTM · Feb 27, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082682
• Device Name: SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.

Device Story

The SURGISIS® Biodesign™ Enterocutaneous Fistula Plug is a surgical mesh device used for the repair of enterocutaneous fistulas. It is manufactured from porcine small intestinal submucosa (SIS) and features a tapered configuration with a flange designed to improve retention and fistula blockage. The device is supplied in a lyophilized (freeze-dried) state within a sterile double pouch system. It is intended for use by surgeons in a clinical setting to reinforce soft tissue during fistula repair procedures. The device functions as a scaffold for tissue reconstruction, providing mechanical support to the site of the fistula to facilitate healing.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, viral inactivation testing, and mechanical testing to demonstrate that the modified device maintains appropriate characteristics for soft tissue reconstruction and is equivalent to the predicate.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form factor: Tapered configuration with a flange. State: Lyophilized (freeze-dried). Sterilization: Sterile. The device is a passive surgical mesh implant; no software, electronics, or energy sources are utilized.

Indications for Use

Indicated for implantation to reinforce soft tissue for the repair of enterocutaneous fistulas in patients requiring such surgical intervention.

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

• SIS Fistula Plug (K050337)

Submission Summary (Full Text)

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

Special 510(k) Submission, SURGISIS® Biodesign™ Enterocutaneous Fistula Plug September 8, 2008

Page 4

1872

## FEB 2 7 2009

**510(k) SUMMARY**

Submitted By:

Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 [phone] September 12, 2006

K082682

Name of Device:

SURGISIS® Biodesign™ Enterocutaneous Fistula Plug Trade Name: Common/Usual Name: Surgical Mesh Proposed classification name: Surgical Mesh

> 21 CFR 878.3300 (FTM) Class II

#### Predicate Device:

The predicate device is the original SIS Fistula Plug (510(k) No. K050337), cleared for marketing by the Food and Drug Administration on March 9, 2005.

### Device Description:

The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a flange to provide increased retention of the plug and improved blockage of the fistula. The device is packaged in a lyophilized (freeze-dried) state, and supplied sterile in a sealed double pouch system.

#### Substantial Equivalence:

The modified SIS Fistula Plug is similar with respect to intended use, materials and technological characteristics to the original, unmodified SIS Fistula Plug as shown through an analysis of risk factors, bench testing and biocompatibility testing.

#### Discussion of Tests and Test Results:

The materials comprising the modified SIS Fistula Plug have been subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the

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

K082682 pg 2of2

device to be biocompatible, adequately disinfected, and with appropriate mechanical characteristics.

### Conclusions Drawn from the Tests:

Outcomes from the evaluation of the modified SIS Fistula Plug provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to the predicate device in terms of intended use and technological characteristics.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 27 2009

Cook Biotech. Inc. % Med Institute, Inc. Mr. Perry W. Guinn VP, QA/RA 1425 Innovation Place West Lafayette, Indiana 47906

Re: K082682

Trade/Device Name: SURGIS® Biodesign™ Enterocutaneous Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 18, 2009 Received: February 19, 2009

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 Fed-ral 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

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

#### Page 2 - Mr. Perry W. Guinn

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.

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 Syrems 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 vours.

Milton R. Ogden

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

Enclosure

{4}------------------------------------------------

#### Indications for Use

82682

510(k) Number (if known):

Device Name:

SURGISIS® Biodesign™ Enterocutaneous Fistula Plug

Indications for Use:

The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.

Prescription Use XX

AND/OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CRF 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>DK</i> for <i>MYM</i> 2/22/2009 |
|---------------------|------------------------------------|
| (Division Sign-Off) | |

Division of General, Restorative, and Neurological Devices

**510(k) Number** K082682

Page 1 of