SURGISIS RVP RECTO-VAGINAL FISTULA PLUG

K062729 · Cook Biotech, Inc. · FTM · Oct 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062729
• Device Name: SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified SIS Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal fistulas. The device is supplied sterile and is intended for one-time use.

Device Story

Modified SIS Fistula Plug is a surgical mesh device used for soft tissue reinforcement in recto-vaginal fistula repair. Manufactured from porcine small intestinal submucosa (SIS), the device features a tapered configuration with an integrated button to enhance retention and fistula blockage. Supplied in a lyophilized, sterile, single-use format. Intended for surgical implantation by clinicians. The device functions as a scaffold for tissue repair; it does not involve electronic inputs, software, or automated processing.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, viral inactivation testing, and mechanical testing to demonstrate that the modified device meets performance requirements and is equivalent to the predicate.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form factor: Tapered configuration with retention button. Sterilization: Sterile (double pouch system). Mechanical: Designed for soft tissue reinforcement.

Indications for Use

Indicated for implantation to reinforce soft tissue for repair of recto-vaginal fistulas.

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)

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Special 510(k) Submission Modifications to SIS Fistula Plug Cook Biotech Incorporated September 12, 2006

OCT 10 2006

6.2729

## 510(k) SUMMARY

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

#### Name of Device:

| Trade Name: | SURGISIS® RVPTM Recto-Vaginal Fistula Plug |
|-------------------------------|--------------------------------------------|
| 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 button 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.

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Special 510(k) Submission Modifications to SIS Fistula Plug Cook Biotech Incorporated September 12, 2006

page 2 82
KOB2729

# 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 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2006

Cook Biotech, Inc. % MED Institute, Inc. Mr. Daniel J. Dillon Regulatory Scientist 1400 Cumberland Avenue West Lafayette, Indiana 47906

Re: K062729

Trade/Device Name: Modified SIS Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 12, 2006 Received: September 13, 2006

Dear Mr. Dillon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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. Daniel J. Dillon

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/industry/support/index.html.

Sincerely yours,

Barbarestuehm

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

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Special 510(k) Submission Modifications to SIS Fistula Plug Cook Biotech Incorporated September 12, 2006

Indications for Use

510(k) Number (if known):

K06 2729

Device Name:

Modified SIS Fistula Plug

Indications for Use:

The modified SIS Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal fistulas. The device is supplied sterile and is intended for one-time use.

Prescription Use XX

AND/OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

ND, OR

(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)

Oarben Bneem

(Division Signalit Division of G rat, Restorative, and Neurological Devices

510(k) Number

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