GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

K053200 · W. L. Gore & Associates, Inc. · FTL · Dec 7, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K053200
• Device Name: GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.

Device Story

Bioabsorbable membrane composed of synthetic glycolide and trimethylene carbonate copolymer; designed for use with surgical circular stapling devices. Material applied to cartridge and anvil jaws of stapler to reinforce staple lines during soft tissue anastomosis. Used in clinical settings (OR) by surgeons during bariatric, colon, colorectal, gastric, and small bowel procedures. Provides mechanical reinforcement to staple lines; bioabsorbable nature allows material to be absorbed by body over time. Benefits include potential reduction in staple line leaks or bleeding.

Clinical Evidence

Bench testing only.

Technological Characteristics

Microporous bioabsorbable membrane; material: synthetic glycolide and trimethylene carbonate copolymer. Supplied sterile in polyethylene terephthalate/polyethylene pouches. Form factor: configured for circular stapler cartridge and anvil jaws.

Indications for Use

Indicated for patients undergoing bariatric, colon, colorectal, gastric, or small bowel surgical procedures requiring soft tissue anastomosis with staple line reinforcement.

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

• SEAMGUARD® Staple Line Reinforcement Material (K043056)

Submission Summary (Full Text)

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

053200 1/2

#### DEC 7 2005

## Premarket Notification 510(k) Summary

### Applicant:

W.L. Gore and Associates Inc. 3250 W. Kiltic Lane Flagstaff, AZ 86001

### Contact:

Michael E. Ivey

#### Date Prepared:

November 15, 2005

#### Trade or Proprietary Name:

SEAMGUARD® Staple Line Reinforccment Material

#### Common or Usual Name:

Staple Line Reinforcement Matcrial

#### Classification

21 CFR 878.3300, FTL

#### Device Predicate:

SEAMGUARD® Staple Line Reinforcement Material - K043056

#### Device Description:

The GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material for circular staplers consists of a bioabsorbable membrane comprosed of a microporous structure of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer. The GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is to be used with surgical stapling devices.

The GORE SFAMGUARD® Bioabsorbable Staple Line Reinforcement Material is supplied in sterile polyethylene terphthalate / polyethylenc pouches. These pouches contain the necessary material for the cartridge jaw and the anvil jaw of the surgical stapler.

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

## Statement of Intended Use:

Indicated for use in surgical procedures in which a soft tissue anastomosis with staple linc reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.

## Substantial Equivalence:

A variety of tests, assessments, and comparisons demonstrate that the SEAMGUARD* Staple Line Reinforcement Material for Circular Staplers is substantially equivalent to its predicate in terms of composition, design, intended use, mode of operation and performance attributes.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in all capital letters. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 7 2005

Michael Ivey Regulatory Affairs Medical Products Division W.L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86003-2400

Re: K053200

K033200
Trade/Device Name: GORE SEAMGUARD® Staple Line Reinforcement Material for Circular Staplers Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: November 15, 2005 Received: November 16, 2005

Dear Mr. Ivey:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(t) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Desine Amendments for use stated in the encrosure) to regary manced promoted provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edical Federal Food. Drug commerce prior to May 20, 1970, the chassified in accordance with Federal Food, Drug, devices that have been reclassified in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. and Cosment Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of Y ou may, meretore, market the dovice, basject to annual registration, listing of
general controls provisions of the Act include requirements for annual registmenting ond general controls provisions of the Feet mendes required.
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 If your device is classified controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affective may be subject to such adultional controlis. Little 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, star be found in the Code of Pouchal 2015erning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination doss not mean Please be advised that FDA s issuation of a cases in the requirements of the Act
that FDA has made a determination that your device complies with other requirements of the Ac that FDA has made a decemmanon this Jour assert by other Federal agencies. You must a or any Federal statutes and regulations daminities or registration and listing (21
comply with all the Act's requirements, including, but not limited to: registraments as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setting CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quanty systems (QD) regalizers (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

#### Page 2-Michael Ivey

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin manieting of substantial equivalence of your device to a legally premaired notheation: "The Pro Pro mailing sitication 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 If you desire specific advice 101-your 2001) 276-0115. Also, please note the regulation entitled, Contact the Orition of Computers on (21CFR Part 807.97). You may obtain Misoraning Uy reference to premainsmonibilities under the Act from the Division of Small other general information on your response 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,

farbay Buellmp

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

Enclosure

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

# Indications for Use

510(k) Number (if known): K053200

Device Name: GORE SEAMGUARD® Staple Line Reinforcement Material

for Circular Staplers

Indications for Use:

The GORE SEAMGUARD Staple Line Reinforcement Material for Circular Staplers is indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hase Buehum

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

**510(k) Number** K053200