(26 days)
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.
The modified GORE® SEAMGUARD® Reinforcement possesses the same indications for use and fundamental scientific technology as the predicate GORE® SEAMGUARD® Reinforcement. The implantable device and loading carriers of the predicate GORE® SEAMGUARD® Reinforcement are being modified to permit the reinforcement material to be loaded onto the stapler and attach via adhesive-coated tabs that wrap around the side/back of the cartridge/anvil jaws of a surgical stapling device, in lieu of attaching a fully-coated device surface to the top surfaces of the cartridge/anvil jaws, to minimize the impact of the surface topography of surgical staplers in establishing compatible device fit. The implantable materials of the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement are the same bioabsorbable PGA:TMC. Both utilize the same bioabsorbable PLA:TMC adhesive to secure the device onto the jaws of a surgical stapler.
This document is a 510(k) premarket notification for a medical device (GORE® SEAMGUARD® Reinforcement), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details (sample sizes, ground truth, expert opinions, MRMC studies, standalone performance, training sets), and adjudication methods for an AI/ML device is not applicable here.
The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria using AI/ML methodology.
Here's what can be extracted from the document regarding the device's evaluation, framed in the context of the prompt's request, but clearly indicating the differences:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a list of specific, quantifiable acceptance criteria with corresponding numerical performance metrics as would be expected for an AI/ML device. Instead, the "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to a predicate device through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Deployment reliability under simulated use conditions. | "The tests demonstrated the performance of the modified GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Reinforcement device." (This broadly implies the modified device performed similarly well in deployment reliability as the predicate, meeting its established functional standards). |
| Substantial Equivalence (overall) in terms of: - Indications for Use - Design - Materials - Biocompatibility - Packaging - Sterilization - Labeling - Performance | "W.L. Gore & Associates concludes that the modified GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Reinforcement device in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling, and performance." (This is the overarching conclusion, indicating that all aspects were deemed sufficiently similar to the predicate.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated with a numerical value. The document mentions "deployment reliability testing under simulated use conditions," which implies testing on a sample of devices, but the number of devices or trials is not provided.
- Data Provenance: The "Pre-Clinical: Bench study" implies testing performed in a laboratory setting, likely within the manufacturer's facilities. It is a prospective test specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This type of information is typically relevant for studies involving human interpretation (e.g., radiology images). The testing described here is a bench study evaluating mechanical/functional performance, which does not involve "ground truth" established by experts in the context of a diagnostic interpretation.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a bench test for mechanical/functional performance (deployment reliability), no adjudication method (like 2+1 or 3+1 for expert discrepancies) is described or relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is for evaluating human reader performance, often with AI assistance (e.g., radiologists interpreting images). This device is a surgical reinforcement material, and its evaluation did not involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The "bench study" is analogous to a standalone functional test for the physical device.
7. The Type of Ground Truth Used:
- For the "deployment reliability testing," the "ground truth" would be the successful or unsuccessful deployment of the device as per pre-defined functional specifications, measured by objective metrics in a simulated environment. It is based on engineering specifications and direct observation of device function rather than expert consensus, pathology, or outcomes data in a diagnostic sense.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. There is no training set for this device.
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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
W.L. Gore and Associates Incorporated Ms. Barbara L. Smith, RAC Regulatory Associate 301 Airport Road, P.O. Box 1408 Elkton, Maryland 21921
Re: K150551
Trade/Device Name: GORE® SEAMGUARD® Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXC Dated: March 10, 2015 Received: March 12, 2015
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
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150551
Device Name
GORE® SEAMGUARD® Reinforcement
Indications for Use (Describe)
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 hysterectory, 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.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1of 2
510(k) Submitter
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Barbara L. Smith Phone: 410-506-8189 Fax: 410-506-8221 E-mail: blsmith@wlgore.com
Date Prepared
March 30, 2015
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
- . GORE® SEAMGUARD® Reinforcement K131658
Device Description
The modified GORE® SEAMGUARD® Reinforcement possesses the same indications for use and fundamental scientific technology as the predicate GORE® SEAMGUARD® Reinforcement. The implantable device and loading carriers of the predicate GORE® SEAMGUARD® Reinforcement are being modified to permit the reinforcement material to be loaded onto the stapler and attach via adhesive-coated tabs that wrap around the side/back of the cartridge/anvil jaws of a surgical stapling device, in lieu of attaching a fully-coated device surface to the top surfaces of the cartridge/anvil jaws, to minimize the impact of the surface topography of surgical staplers in establishing compatible device fit. The implantable materials of the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement are the same bioabsorbable PGA:TMC. Both utilize
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Section 5 - 510(k) Summary
the same bioabsorbable PLA:TMC adhesive to secure the device onto the iaws of a surqical stapler.
Indications for Use
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.
Summary of Similarities and Differences in Technological Characteristics
The indications for use for the modified GORE® SEAMGUARD® Reinforcement device is identical to the predicate GORE® SEAMGUARD® Reinforcement device. Both the modified and predicate GORE® SEAMGUARD® Reinforcement devices utilize loading carriers to load the implantable device and the same adhesive to secure the device onto the cartridge/anvil jaws of a compatible stapler. Both devices are comprised of the same bioabsorbable materials. The primary difference between the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement devices is the addition of adhesive-coated tabs for the modified device to permit attachment to a different location on a surgical stapler and a corresponding modification to the geometry of the loading carriers to facilitate attachment of the modified device.
Performance Data / Predicate Device Comparison
Pre-Clinical:
Bench study - Design verification testing of the modified GORE® SEAMGUARD® Reinforcement device consisted of deployment reliability testing under simulated use conditions and same/similar acceptance criteria. The tests demonstrated the performance of the modified GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Reinforcement device.
In Vivo (Animal study): No new animal studies were required to demonstrate substantial equivalence of the modified GORE® SEAMGUARD® Reinforcement device to the PREDICATE Seamguard. The animal studies conducted for the predicate GORE® SEAMGUARD® Reinforcement are applicable to the modified GORE® SEAMGUARD® Reinforcement device.
Clinical: No clinical evaluations of this product have been conducted.
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Conclusion
W.L. Gore & Associates concludes that the modified GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Reinforcement device in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling, and performance.
§ 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.