GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

K032865 · W. L. Gore & Associates, Inc. · FTL · Nov 28, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032865
• Device Name: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

Device Story

Bioabsorbable membrane formed into a sleeve with a polyester braided suture pullcord; used with surgical stapling devices to reinforce staple lines during soft tissue transection or resection. Supplied in sterile pouches with Tyvek inserts for placement onto stapler cartridge and anvil jaws. Used by surgeons in clinical settings (OR) during various procedures including lung, bariatric, and gastrointestinal surgeries. Provides mechanical reinforcement to staple lines to potentially improve surgical outcomes. Material is a microporous synthetic bioabsorbable glycolide and trimethylene carbonate copolymer.

Clinical Evidence

In vivo studies were conducted to support the expanded indications for use in gastric, small bowel, mesentery, colon, and colorectal procedures.

Technological Characteristics

Microporous membrane composed of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer; includes polyester braided suture pullcord; supplied sterile in foil film laminate pouches with Tyvek inserts; form factor designed for stapler cartridge and anvil jaws.

Indications for Use

Indicated for patients undergoing surgical procedures requiring soft tissue transection or resection where staple line reinforcement is necessary, including lung resection, bariatric, gastric, small bowel, mesentery, colon, and colorectal procedures.

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® Bioabsorbable Staple Line Reinforcement Material (K030782)
• GORE-TEX® Vascular Graft (K991683)

Submission Summary (Full Text)

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GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

NOV 288 2003

K032865 page 11

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Proprietary Name: | GORE SEAMGUARD® Bioabsorbable Staple<br>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<br>Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |

### Performance Standards

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

### Device Description

The GORE 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

Image /page/0/Picture/10 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the logo, there is some smaller text that is difficult to read. The word "Confidential" is written in a simple, sans-serif font.

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K032865 pag

510(k) Premarket Notification 510(k) Summary of Substantial Equivalence GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

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 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

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

# Substantially Equivalent Devices

In WL Gore & Associates' opinion, the GORE 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 labeling.

- SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material (WL . Gore & Associates, Inc., Flagstaff, AZ) - K030782
- GORE-TEX® Vascular Graft (WL Gore & Associates, Flagstaff, AZ) -. K991683

#### Summary of Studies

In vivo studies support the modification to the "Indication for Use" of the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

# Conclusion (Statement of Equivalence)

Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the WL Gore & Associates, Inc. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material through this 510(k) Premarket Notification.

Image /page/1/Picture/15 description: The image shows the Gore logo on the left and the word "Confidential" on the right. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right above the words "Creative Technologies Worldwide" in smaller letters. The word "Confidential" is in a simple, sans-serif font and is positioned to the right of the logo. The image suggests that the document or information associated with it is confidential and related to Gore.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 28 2003

Mr. Mike Johnson Regulatory Affairs Medical Products Division WL Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86002-0500

Re: K032865

Trade/Device Name: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: September 12, 2003 Received: September 15, 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation ( 21 CT-R Part 801). please contact the Office of Compliance at (301) 594-46.59. 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/dsma/dsmamain.html

Sincerely vours,

fo Mark N. Millkerson

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

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510(k) Premarket Notification Indication For Use

K032865

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

# INDICATION FOR USE

510(k) Number (if known):

K032865

Device Name:

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material

Intended Use / Indication For Use:

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

fo Mark n Milkeran

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

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

Prescription Use OR (Per 21 CFR 801.109)

Confidential

(Optional Format 1-2-96)

Over-The-Counter Use

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