SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

K030782 · W. L. Gore & Associates, Inc. · FTM · Apr 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030782
• Device Name: SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Apr 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.

Device Story

Bioabsorbable membrane sleeve; composed of synthetic glycolide and trimethylene carbonate copolymer; includes polyester braided suture pullcord. Used with surgical stapling devices to reinforce staple lines during soft tissue transection/resection. Supplied sterile in foil pouches with Tyvek inserts for placement onto stapler cartridge and anvil jaws. Intended for use by surgeons in clinical/OR settings. Reinforcement material provides mechanical support to staple lines; reduces potential for leaks or bleeding; bioabsorbable nature allows gradual resorption by body post-procedure.

Clinical Evidence

Bench testing only. Device integrity testing performed to demonstrate equivalence to predicate devices. All test results met specified requirements.

Technological Characteristics

Microporous bioabsorbable membrane; synthetic glycolide and trimethylene carbonate copolymer; polyester braided suture pullcord; supplied sterile; form factor designed for surgical stapler cartridge and anvil jaws.

Indications for Use

Indicated for patients undergoing surgical procedures requiring soft tissue transection or resection, specifically lung resection and bariatric procedures (gastric bypass and gastric banding), where staple line reinforcement is clinically necessary.

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 (K001789)
• Absorbable Foam Buttress (AFB) (K014183)
• Resolut ADAPT® ST Regenerative Membrane (K013346)
• Polyviolene Braided Polyester Suture (K926167)

Submission Summary (Full Text)

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

SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

APR 2 1 2003

K030782/,

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Proprietary Name: | SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Staple Line Reinforcement Material |
| Classification Name: | Surgical Mesh |
| Device Classification: | Class II |
| Product Classification and Code: | 878.3300, FTL |
| Classification Panel: | General and Plastic Surgery Devices |
| Establishment Registration Number: | 2025240 |
| Contact Person: | Mike Johnson<br>Regulatory Affairs<br>Medical Products Division<br>WL Gore & Associates, Inc.<br>3450 West Kiltie Lane<br>Flagstaff, AZ 86002-0500 |
| | Telephone: [phone]<br>Facsimile: [phone] |

## Performance Standards

Performance standards do not currently exist for these devices. None established under Section 514.

E-mail: [e-mail]

## Device Description

The SEAMGUARD Bioabsorbable Staple Line Reinforcement Material consists of a bioabsorbable membrane formed into a sleeve with use of a polyester braided suture pullcord. The bioabsorbable material is comprised of a microporous structure of synthetic

Image /page/0/Picture/10 description: The image shows the logo for W. L. Gore & Associates. The logo features the word "GORE" in a bold, sans-serif font, with a stylized graphic to the right that resembles a swoosh or a wing. Below the word "GORE" are two lines of smaller text, which are difficult to read due to the image's resolution, but appear to be the company's tagline or a description of their business.

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

K030782/2

510(k) Premarket Notification 510(k) Summary of Substantial Equivalence

SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

bioabsorbable glycolide and trimethylene carbonate copolymer. The SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is to be used with surgical stapling devices.

The SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is supplied in sterile, foil film laminate pouches. Pouches contain the necessary material for the cartridge jaw and the anvil jaw of the surgical stapler. Tyvek® inserts facilitate placement of the reinforcement material onto the stapler jaws.

#### Indication for Use

SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.

## Substantially Equivalent Devices

In WL Gore & Associates' opinion, the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.

- SEAMGUARD® Staple Line Reinforcement Material (WL Gore & . Associates, Inc., Flagstaff, AZ) - K001789
- Absorbable Foam Buttress (AFB) (J&J Corporate Biomaterials Center, a ● Division of Ethicon, Somerville, NJ) - K014183
- Resolut ADAPT® ST Regenerative Membrane (WL Gore & Associates, Inc., . Flagstaff, AZ) - K013346
- Polyviolene Braided Polyester Suture (Look, Inc., Ada, OK) K926167 .

Labeling, packaging and sterilization of the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is substantially equivalent to that of the predicate devices listed above.

### Summary of Studies

WL Gore & Associates, Inc. performed device integrity testing to support that the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is equivalent to the predicate devices. All device integrity test results for the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material met specified requirements.

Image /page/1/Picture/16 description: The image shows the logo for GORE. The logo has the word "GORE" in bold, italicized letters. Above the word "GORE" is a black arrow pointing to the right. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The overall design is simple and conveys a sense of health and human well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2003

Mr. Mike Johnson Regulatory Affairs W.L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86002-0500

Re: K030782

Trade/Device Name: SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 10, 2003 Received: March 11, 2003

Dear Mr. Johnson:

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.

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

Page 2 - Mr. Mike Johnson

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

- Miriam C. Provost

For 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

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

SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

K630782

## INDICATION FOR USE

K030782

510(k) Number (if known):

Device Name:

SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

Intended Use / Indication For Use:

SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.

uriam C. Provost

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

510(k) Number K630782

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Image /page/4/Picture/18 description: The image contains the GORE logo on the left side. The logo is a stylized depiction of the word "GORE" with an arrow pointing to the right. To the right of the logo, the word "Confidential" is written in a simple, sans-serif font. The text is in black and appears to be a watermark or classification label.