GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Device Description

The subject GORE® SEAMGUARD® Reinforcement device is an assembly of three components: 1) the implantable device, 2) two (2) loading carriers (for anvil & cartridge side of stapling device), and 3) a protective cover. The implantable device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: GORE® SEAMGUARD® Reinforcement (K131658)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Functional/Mechanical Performance (Substantial Equivalence to Predicate)	Bench Study: "Testing of the GORE® SEAMGUARD® Reinforcement consisted of a simulated use performance testing. The tests demonstrated the performance of the subject SEAMGUARD device is substantially equivalent to the predicate SEAMGUARD device." This implies criteria such as: effective affixation to stapler, successful delivery to implant site, structural integrity during stapling, etc. The specific numerical criteria are not detailed in this summary.
Biocompatibility	Animal Study: "biocompatibility testing in accordance with ISO 10993-1" "The results of these tests revealed the device is biocompatible for its intended use..."
In Vivo Safety and Tissue Response	Animal Study: "...in vivo safety studies. The results of these tests revealed...demonstrated no clinically relevant device-related complications, no adverse tissue response, and histological results comparable to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not explicitly state a numerical sample size for the "simulated use performance testing" (bench study) or the "in vivo safety studies" (animal study). It mentions "testing" and "studies" in plural, implying multiple tests/animals, but no specific numbers are given.
Data Provenance:
- Bench Study: Not specified, but generally performed in a laboratory setting.
- Animal Study: Animal data (in vivo). The country of origin for the studies is not specified. Both studies are prospective as they were conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the summary. The evaluations appear to be objective measurements (e.g., performance metrics in bench testing, histological analysis in animal studies) rather than interpretations requiring expert consensus on a subjective ground truth.

4. Adjudication Method for the Test Set:

Not applicable as the ground truth establishment method (if any) is not specified as requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This device is a medical implant (staple line reinforcement material), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

Not applicable. This device is a passive implant; it does not involve any algorithms or AI to be evaluated for standalone performance.

7. The Type of Ground Truth Used:

Bench Study: The "ground truth" for the simulated use performance testing would be objective measurements and observations of the device's functional characteristics (e.g., successful loading, secure attachment, integrity after stapling, comparison to predicate device performance specifications).
Animal Study: The "ground truth" for biocompatibility and in vivo safety studies would be:
- Biocompatibility: Conformance to ISO 10993-1 standards, which involve specific tests for cytotoxicity, sensitization, irritation, etc.
- In Vivo Safety: Histological analysis of tissue response (e.g., inflammation, foreign body reaction) and clinical observation of device-related complications in animal models. The comparison was made to the predicate device's expected tissue response.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, no training set is involved for this type of medical device.

Summary

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K131658 Page 1/3

W. L. Gore & Associates, Inc. GORE® SEAMGUARD® Reinforcement Section 5. 510(k) Summary

Image /page/0/Picture/2 description: The image shows the logo for GORE. The logo has the word "GORE" in bold, block letters. Above and to the right of the word is a black arrow shape. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font.

510(k) SUMMARY (Per 21CFR807.92)

510(k) Owner:

Owner/Operator: W. L. Gore & Associates, Inc. 1505 N. Fourth Street Flagstaff, AZ 86004

Regulatory Contact:

W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Barbara L. Smith Phone: 410-506-8189 Fax: 410-506-8221 E-mail: blsmith@wlgore.com

EP 0 6 2013

Date Prepared:

May 15, 2013

Device Names/Classification

Trade Name:	GORE® SEAMGUARD® Reinforcement
Common Name:	Staple line reinforcement material
Classification Name:	Mesh, Surgical, absorbable, staple linereinforcement (21CFR878.3300)
Product Code:	OXC

Predicate Device

K043056 GORE® SEAMGUARD® Bioabsorbable Staple Line . Reinforcement Material

Device Description

Gore and Designs are trademarks of W. L. Gore & Associates, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for GORE. The logo features the word "GORE" in a bold, sans-serif font, with a stylized arrow pointing to the right. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font. The logo is black and white.

W. L. Gore & Associates. Inc. GORE® SEAMGUARD® Reinforcement Section 5. 510(k) Summary

device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.

Indications for Use

GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures, GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Summary of Similarities and Difference in Technological Characteristics, Performance and Intended Use

The intended/indications for use for the subject SEAMGUARD device is identical to the predicate SEAMGUARD device. The primary difference between the subject and predicate SEAMGUARD devices is in the feature for loading and delivery of the device to the implantation site. The subject SEAMGUARD device utilizes loading carriers and an adhesive to secure the device on the stapler as an alternative to the sleeve with suture pull cord feature of the predicate SEAMGUARD device.

Performance Data / Predicate Device Comparison

Non-Clinical

Bench study: Testing of the GORE® SEAMGUARD® Reinforcement consisted of a simulated use performance testing. The tests demonstrated the performance of the subject SEAMGUARD device is substantially equivalent to the predicate SEAMGUARD device.

Animal study: Testing of the GORE® SEAMGUARD® Reinforcement device also included biocompatibility testing in accordance with ISO

Gore and Designs are trademarks of W. L. Gore & Associates, Inc.

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K131658 Page 3/3

Image /page/2/Picture/1 description: The image shows the logo for GORE. The logo is in a black box. The word "GORE" is in bold, sans-serif font. Below the word "GORE" is the text "Creative Technologies Worldwide" in a smaller font.

W. L. Gore & Associates, Inc. GORE® SEAMGUARD® Reinforcement Section 5. 510(k) Summary

10993-1 and in vivo safety studies. The results of these tests revealed the device is biocompatible for its intended use and demonstrated no clinically relevant device-related complications, no adverse tissue response, and histological results comparable to the predicate device.

Clinical: No clinical evaluations of this product have been conducted.

Conclusion

W.L. Gore & Associates concludes that the subject GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement device in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling, and performance.

Gore and Designs are trademarks of W. L. Gore & Associates, Inc.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 6, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

W.L. Gore & Associates, Incorporated % Ms. Barbara L. Smith 301 Airport Road Elkton, Maryland 21921

Re: K131658

Trade/Device Name: GORE® SEAMGUARD® Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXC Dated: August 9, 2013 Received: August 20, 2013

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Barbara L. Smith

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/deliault.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.

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 (30!) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson - S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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W. L. Gore & Associates, Inc. GORE® SEAMGUARD® Reinforcement Section 4. Indications for Use

Indications for Use

510(k) Number (if known):

Device Name: GORE® SEAMGUARD® Reinforcement

Indications For Use:

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)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131658

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.