(47 days)
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 hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures.
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is also intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
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.
The provided text is a 510(k) Premarket Notification for a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a study with the detailed information requested.
Therefore, the prompt's request for specific acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.
The document does mention studies, but not in the format or with the detail required by the prompt's specific questions.
Here's what can be extracted from the provided text regarding studies:
Summary of Studies Mentioned:
- Type of Study: "In vivo studies"
- Purpose: To support the modification to the "Indication for Use" for specific surgical procedures (hysterectomy, liver resection, bladder reconstruction, bronchial, cardiac, esophagus, pancreas, and spleen).
- Conclusion: These studies, along with other data and information, were deemed sufficient to support a determination of substantial equivalence to predicate devices.
Why the requested information is not available:
- Acceptance Criteria/Performance Table: The 510(k) submission process for substantial equivalence does not typically require the establishment of, or reporting against, specific performance acceptance criteria in the way a PMA (Pre-Market Approval) might. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
- Sample Sizes (Test/Training): The document generally refers to "in vivo studies" without specifying sizes, whether they were test or training sets, or their provenance.
- Expert Ground Truth/Adjudication/MRMC/Standalone: These concepts are relevant to studies involving qualitative assessments, particularly in areas like imaging diagnostics or where expert review forms the basis of "truth." This device is a physical reinforcement material, so these types of studies are not applicable in terms of its primary function. The "ground truth" for its performance would likely be physiological outcomes, not expert interpretation of an image or data.
- Type of Ground Truth: While "in vivo studies" are mentioned, the specific nature of the "ground truth" (e.g., successful staple line reinforcement, reduction in complications) is not detailed.
In conclusion, the provided text does not contain the information necessary to complete the table or answer most of the specific questions about acceptance criteria and detailed study methodology. The 510(k) process relies on demonstrating equivalence rather than comprehensive performance against predefined, quantitative criteria.
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DEC 2 2 2004
510(k) Premarket Notification
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | GORE SEAMGUARD® Bioabsorbable Staple 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: | Brandon HansenRegulatory AffairsMedical Products DivisionWL Gore & Associates, Inc.3450 West Kiltie LaneFlagstaff, AZ 86002-0500Telephone: (928) 864-3784Facsimile: (928) 864-4144E-mail: bhansen@wlgore.com |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
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GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
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.
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 hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures.
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is also intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
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 and K032865
- 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 hysterectomy, liver resection, bladder reconstruction, bronchial, cardiac, esophagus, pancreas, and spleen surgical procedures.
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Koy. in.
510(k) Premarket Notification
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
Conclusion (Statement of Equivalence)
Through data and information presented, numerous similarities support a I hrough and of substantial equivalence, and therefore market clearance of the WL determination of succeant.com Bioabsorbable Staple Line Reinforcement Material through this 510(k) Premarket Notification.
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Image /page/3/Picture/1 description: The image is a black and white emblem. The emblem is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 2004
Mr. Brandon Hansen Regulatory Affairs Medical Products Division W.L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86002
Re: K043056
K043020
Trade/Device Name: Gore Seamguard Bioresorbable Staple Line Reinforcement Material Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: November 4, 2004 Received: November 5, 2004
Dear Mr. Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowed above and have determined the device is substantially equivalent (for the indications forcherous as over and his sure) to legally marketed predicate devices marketed in interstate for tase stated in the encreases of the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The I ou mayy are so 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 Extre rate of 7 more of 1 (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.
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Page 2 - Mr. Brandon Hansen
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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 yours,
Miriam C. Provost
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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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Gore Seamgaurd Bioresorbable Staple Line Reinforce ment Device Name:__________________________________________________________________________________________________________________________________________________________________ Material
Indications 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 ass in vargent is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material 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® Bioabsorbable Staple Line Reinforcement Material is also intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_KO43056
AND/OR
Prescription Use × (Part 21 CFR 801 Subpart D) 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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.