(21 days)
The GORE SEAMGUARD Staple Line Reinforcement Material for Circular Staplers is indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.
The GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material for circular staplers consists of a bioabsorbable membrane comprosed 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 SFAMGUARD® Bioabsorbable Staple Line Reinforcement Material is supplied in sterile polyethylene terphthalate / polyethylenc pouches. These pouches contain the necessary material for the cartridge jaw and the anvil jaw of the surgical stapler.
The provided text is a Premarket Notification 510(k) Summary for the GORE SEAMGUARD® Staple Line Reinforcement Material. This type of document is filed with the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.
It's important to understand that a 510(k) submission primarily focuses on substantial equivalence to an existing device, rather than proving that the device "meets acceptance criteria" in the way one might describe the performance of software or diagnostic AI. The "acceptance criteria" here largely revolve around demonstrating that the new device performs at least as well as and is chemically and physically equivalent to its predicate.
Therefore, many of the specific questions about acceptance criteria, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training sets – which are typical for AI/software device evaluation – are not applicable to this type of medical device submission. This submission is for a material (staple line reinforcement) and not a software or AI device.
However, I can extract the relevant information from the provided text in the spirit of your request:
1. A table of acceptance criteria and the reported device performance
For a material device like the GORE SEAMGUARD®, "acceptance criteria" are generally understood as demonstrating equivalence to the predicate device in terms of design, materials, and functional attributes. The document does not specify quantitative performance metrics as "acceptance criteria" in a table format, but rather relies on a general statement of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate in design, intended use, mode of operation, and performance attributes. | "A variety of tests, assessments, and comparisons demonstrate that the SEAMGUARD® Staple Line Reinforcement Material for Circular Staplers is substantially equivalent to its predicate in terms of composition, design, intended use, mode of operation and performance attributes." (K043056) |
| Chemical Composition | Made of "bioabsorbable membrane composed of a microporous structure of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer." (Matches predicate) |
| Physical Form/Function | "Reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures" when used with surgical stapling devices. (Matches predicate's intended use) |
| Sterility | Supplied in "sterile polyethylene terphthalate / polyethylene pouches." (Matches predicate) |
2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes for any "test set" or data provenance (e.g., country of origin, retrospective/prospective). Substantial equivalence for this type of device is typically established through a combination of engineering tests (e.g., material testing, mechanical strength), biocompatibility testing, and comparison of design features, rather than a clinical "test set" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a material device, not a diagnostic or AI device that relies on expert ground truth for performance evaluation in a "test set."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. See point 3.
5. 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 is a physical medical device, not an AI or software device. No MRMC study was mentioned or would be relevant.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. See point 3. The "ground truth" for a device like this would be established through established engineering standards for material properties, biocompatibility, and functional performance in relevant models or in vitro tests. Clinical outcomes would be observed over time post-market, but aren't typically part of the 510(k) "ground truth" for demonstrating substantial equivalence.
8. The sample size for the training set
Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not Applicable. See point 8.
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053200 1/2
DEC 7 2005
Premarket Notification 510(k) Summary
Applicant:
W.L. Gore and Associates Inc. 3250 W. Kiltic Lane Flagstaff, AZ 86001
Contact:
Michael E. Ivey
Date Prepared:
November 15, 2005
Trade or Proprietary Name:
SEAMGUARD® Staple Line Reinforccment Material
Common or Usual Name:
Staple Line Reinforcement Matcrial
Classification
21 CFR 878.3300, FTL
Device Predicate:
SEAMGUARD® Staple Line Reinforcement Material - K043056
Device Description:
The GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material for circular staplers consists of a bioabsorbable membrane comprosed 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 SFAMGUARD® Bioabsorbable Staple Line Reinforcement Material is supplied in sterile polyethylene terphthalate / polyethylenc pouches. These pouches contain the necessary material for the cartridge jaw and the anvil jaw of the surgical stapler.
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Statement of Intended Use:
Indicated for use in surgical procedures in which a soft tissue anastomosis with staple linc reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.
Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the SEAMGUARD* Staple Line Reinforcement Material for Circular Staplers is substantially equivalent to its predicate in terms of composition, design, intended use, mode of operation and performance attributes.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in all capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 7 2005
Michael Ivey Regulatory Affairs Medical Products Division W.L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86003-2400
Re: K053200
K033200
Trade/Device Name: GORE SEAMGUARD® Staple Line Reinforcement Material for Circular Staplers Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: November 15, 2005 Received: November 16, 2005
Dear Mr. Ivey:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(t) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Desine Amendments for use stated in the encrosure) to regary manced promoted provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edical Federal Food. Drug commerce prior to May 20, 1970, the chassified in accordance with Federal Food, Drug, devices that have been reclassified in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. and Cosment Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of Y ou may, meretore, market the dovice, basject to annual registration, listing of
general controls provisions of the Act include requirements for annual registmenting ond general controls provisions of the Feet mendes required.
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 If your device is classified controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affective may be subject to such adultional controlis. Little 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, star be found in the Code of Pouchal 2015erning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination doss not mean Please be advised that FDA s issuation of a cases in the requirements of the Act
that FDA has made a determination that your device complies with other requirements of the Ac that FDA has made a decemmanon this Jour assert by other Federal agencies. You must a or any Federal statutes and regulations daminities or registration and listing (21
comply with all the Act's requirements, including, but not limited to: registraments as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setting CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quanty systems (QD) regalizers (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Michael Ivey
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin manieting of substantial equivalence of your device to a legally premaired notheation: "The Pro Pro mailing sitication 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 If you desire specific advice 101-your 2001) 276-0115. Also, please note the regulation entitled, Contact the Orition of Computers on (21CFR Part 807.97). You may obtain Misoraning Uy reference to premainsmonibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
farbay Buellmp
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053200
Device Name: GORE SEAMGUARD® Staple Line Reinforcement Material
for Circular Staplers
Indications for Use:
The GORE SEAMGUARD Staple Line Reinforcement Material for Circular Staplers is indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hase Buehum
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K053200
§ 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.