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 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 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.

AI/ML Overview

Attached is an analysis of the provided text regarding the GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material.

Acceptance Criteria and Device Performance:

The provided document (K032865) does not explicitly list quantitative acceptance criteria in a table format alongside specific device performance metrics in the way one would typically expect for a software or AI/ML device. This is a 510(k) premarket notification for a medical device (surgical mesh), not an AI/ML diagnostic tool. Therefore, the "acceptance criteria" here refer to the demonstration of substantial equivalence to a predicate device, as required for 510(k) clearance, rather than performance against predetermined statistical thresholds for accuracy, sensitivity, or specificity.

The document states: "Performance standards do not currently exist for these devices. None established under Section 514." This confirms that there are no formal performance standards or acceptance criteria defined by a recognized body for this type of device at the time of clearance.

The study presented is an in vivo study demonstrating the expansion of the device's "Indication for Use" statement, concluding that the device is substantially equivalent to existing predicate devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) process):

Acceptance Criterion (Inferred for 510(k) clearance)	Reported Device Performance (as demonstrated by 'in vivo' studies)
Substantial Equivalence to Predicate Devices:	"numerous similarities support a determination of substantial equivalence" to SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material (K030782) and GORE-TEX® Vascular Graft (K991683).
Safety & Effectiveness for Expanded Indications:	In vivo studies support the modification to the "Indication for Use" for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures. The device is deemed safe and effective for these uses, consistent with the predicates.

Study Information (as applicable to a medical device 510(k) rather than AI/ML):

Sample size used for the test set and the data provenance:
- The document mentions "In vivo studies" but does not specify the sample size (e.g., number of animals or human subjects) used in these studies.
- Data provenance: Not explicitly stated, but "In vivo studies" typically refer to animal studies or potentially human clinical data. Given the context of a 510(k) for a material, it's highly likely to be animal studies focusing on biocompatibility, integrity, and performance in relevant anatomical locations. It is retrospective as it is a premarket notification, referencing studies already completed. Geographic origin is not stated, but given WL Gore & Associates is based in Flagstaff, AZ, USA, it's likely U.S.-based or conducted under applicable U.S. regulatory standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) for a medical device material. "Ground truth" as understood in AI/ML (e.g., expert consensus on images) is not a concept applied here. Device performance is assessed through material properties, in vivo biological response, and mechanical integrity, which are evaluated by engineers, pathologists, and surgeons/veterinarians involved in the in vivo studies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant for this type of medical device clearance.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This type of study design is specifically for evaluating the impact of AI on human reader performance, which doesn't apply to a bioabsorbable staple line reinforcement material.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in vivo studies, the "ground truth" would be established through direct observation during surgery, histological/pathological examination of tissue samples, and potentially necropsy results for animal models. Clinical outcomes data (e.g., incidence of leakage, bleeding, healing rates) would also contribute to the understanding of device performance in a functional context.
The sample size for the training set:
- Not applicable. This refers to AI/ML model training data. For a physical device, prior research, and manufacturing/testing data inform its design and expected performance, but there isn't a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable. As above, this is for AI/ML models. For this device, in vitro material testing, initial animal studies, and engineering principles guide the device development and manufacturing processes.

Summary

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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 StapleLine 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 JohnsonRegulatory AffairsMedical Products DivisionWL Gore & Associates, Inc.3450 West Kiltie LaneFlagstaff, AZ 86002-0500Telephone: (928) 864-3615Facsimile: (928) 864-4144E-mail: mdjohnso@wlgore.com

Performance Standards

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

Device Description

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

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the head and wings.

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 (800) 638-2041 or (301) 443-6597 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:

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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Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.