GORE BIO-A FISTULA PLUG

K083266 · W. L. Gore & Associates, Inc. · FTL · Mar 27, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083266
• Device Name: GORE BIO-A FISTULA PLUG
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GORE BIO-A™ Fistula Plug device is intended for use in the reinforcement of soft tissue for repair of anorectal fistulas.

Device Story

GORE BIO-A™ Fistula Plug is a preformed, three-dimensional surgical mesh (disk with attached tubes) used for anorectal fistula repair. Composed of synthetic bioabsorbable PGA/TMC copolymer fiber, the device is implanted by a surgeon to reinforce soft tissue. It functions by initially occupying the fistula defect and eliciting a physiological tissue response; as the plug gradually degrades via hydrolytic and enzymatic pathways, it is replaced by native tissue. The device is provided sterile for single use.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by in vitro and in vivo testing.

Technological Characteristics

Material: Synthetic bioabsorbable PGA/TMC copolymer fiber. Design: Preformed three-dimensional mesh (disk with attached tubes). Mechanism: Bioabsorbable scaffold for tissue ingrowth; degrades via hydrolytic and enzymatic pathways. Sterilization: Provided sterile for single use.

Indications for Use

Indicated for the reinforcement of soft tissue for the repair of anorectal fistulas in patients requiring 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

• Gore Bioabsorbable Mesh (K033671)
• SIS Fistula Plug (K050337)

Submission Summary (Full Text)

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W. L. Gore & Associates, Inc. GORE BIO-A™ Fistula Plug Section 5. 510(k) SUMMARY

K083266
pg 1 of 2

# 510(k) SUMMARY

# Applicant:

W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21922 USA

MAR 2 7 2009

# Contact:

Barbara L. Smith Regulatory Associate

Common Name: Fistula Plug

Classification: 21CFR878.3300

Classification Name: Surgical Mesh

FDA product code: FTL

Device Class: II

#### Device Predicates:

- 1. 510(k)#: K033671 Predicate Device name: Gore Bioabsorbable Mesh Manufacturer: W. L. Gore & Associates, Inc.
- 2. 510(k) #: K050337 Predicate Device Name: SIS Fistula Plug Manufacturer: Cook Biotech Incorporated

#### Device Description:

The GORE BIO-A™ Fistula Plug is a surgical mesh supplied in a preformed threedimensional shape (disk with attached tubes) and comprised of a porous structure of synthetic bioabsorbable PGA/TMC copolymer fiber, degraded via a combination of hydrolytic and enzymatic pathways. The PGA:TMC material is bioabsorbable and has been demonstrated to be both biocompatible and non-antigenic. It is not derived from animal or human tissues. The GORE BIO-A™ Fistula Plug is a tailorable, bioabsorbable material intended to reinforce soft tissue during the phases of wound healing by initially occupying the fistula defect and at the

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K083266
pg 2 of 2

W. L. Gore & Associates, Inc. GORE BIO-A™ Fistula Plug Section 5. 510(k) SUMMARY

same time eliciting a physiological tissue response which fills the fistula defect with native tissue as the fistula plug gradually absorbs. The GORE BIO-A™ Fistula Plug is provided sterile for single use only.

# Statement of Intended Use:

The GORE BIO-A™ Fistula Plug device is intended for use in the reinforcement of soft tissue for repair of anorectal fistulas.

# Technological Characteristics:

The GORE BIO-ATM Fistula Plug device is comprised of the same material, technology and three-dimensional disk with tubes mesh design as the predicate GORE Bioabsorbable Mesh hernia plug device. The indications for use and performance of the GORE BIO-A™ Fistula Plug are substantially equivalent to the predicate Cook SIS Fistula Plug.

# Substantial Equivalence:

A variety of in vitro and in vivo tests and comparisons demonstrate that the GORE BIO-A™ Fistula Plug device is substantially equivalent in intended/indications for use, performance, materials and technology to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

CES

Public Health Service

Image /page/2/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

W.L. Gore & Associates, Inc. % Ms. Barbara L. Smith Regulatory Associate 301 Airport Road Elkton, Maryland 21922

MAR 2 7 2009

Re: K083266

Trade/Device Name: GORE BIO-A™ Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 18, 2009 Received: March 19, 2009

Dear Ms. Smith:

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 forth in the quality systems (OS) 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 - Ms. Barbara L. Smith

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 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,

L. Airm D. for

Matk . Melkerson Ditector Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K083266

# Indications for Use

510(k) Number (if known): _

Device Name:_GORE BIO-A™ Fistula Plug_

Indications for Use:

The GORE Fistula Plug device is intended for use in the reinforcement of soft tissue for the repair of anorectal fistulas.

Prescription Use (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)

Daniel Krone for mxin 3/27/09
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K083266