(26 days)
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No
The document describes a surgical staple line reinforcement device and its modifications. There is no mention of AI or ML in the intended use, device description, or performance studies. The modifications relate to the physical attachment mechanism of the reinforcement material to the stapler.
No.
The device is described as a reinforcement for staple lines in surgical procedures to minimize impact of staple line bleeding and other complications, which is a structural or supportive function rather than an active therapeutic intervention.
No
This device is a surgical reinforcement material used during stapling procedures, not a device that diagnoses medical conditions.
No
The device description clearly states it is an "implantable device" and describes physical modifications to the material and how it attaches to a surgical stapler, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in surgical procedures for reinforcement of staple lines in various soft tissues and organs. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details an implantable device used with a surgical stapler. This further confirms its use within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body during surgery.
N/A
Intended Use / 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.
Product codes
OXC
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 the same bioabsorbable PLA:TMC adhesive to secure the device onto the jaws of a surgical stapler.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Soft tissue, hysterectomy, lung, liver, bladder, bronchus, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, spleen, left atrial appendage
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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. 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. No clinical evaluations of this product have been conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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 line |
| reinforcement (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.