(29 days)
No
The document describes a physical medical device (staple line reinforcement) and its modifications, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a reinforcement material for staple lines during surgical procedures, not as a device intended to treat or cure a disease or condition.
No
This device is a bioabsorbable material used for reinforcing staple lines during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product, a bioabsorbable staple line reinforcement material, with specific geometries and materials. It is a hardware device used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in surgical procedures for reinforcing staple and suture lines in various soft tissues and organs. This is a surgical implant/accessory, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a bioabsorbable material used for surgical reinforcement, designed to fit surgical staplers. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is purely mechanical and supportive during surgery.
N/A
Intended Use / Indications for Use
GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. It can be used for reinforcement of staple lines during hysterectomy, lung resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. It is also intended to be used for remforcement of suture lines and staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Product codes
OXC
Device Description
The subject of this 510(k) pre-market notification is a modification to the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Configured for Endoscopic Surgical Staplers (EBSG, also referred to as the predicate) to include altered bioabsorbable sheet geometries, tailored lattice stitching, and inner dimension geometry for both the cartridge and anvil devices. The cartridge and anvil devices were specifically designed to fit the geometry of the Intuitive SureForm 60™ mm staplers (K173721 cleared July 5, 2018) Black, Green and Blue cartridge reloads. GORE® SEAMGUARD® Reinforcement Bioabsorbable Staple Line Reinforcement Configured for Intuitive Surgical® Robotic Endoscopic Surgical Staplers (EBSG-R, also referred to as the modified device) possesses the same fundamental scientific technology as the predicate. No other physical modifications were made to the predicate device, and the implantable materials of the modified device and predicate are the same synthetic bioabsorbable poly (glycolide: trimethylene carbonate) copolymer (PGA:TMC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hysterectomy, lung, bladder, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, spleen, cardiac (left atrial appendage)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Pre-Clinical: Bench study: Design verification testing of the modified device consisted of deployment reliability testing under simulated use conditions and same/similar acceptance criteria. The tests demonstrated the performance of the modified device. EBSG-R, is substantially equivalent to the predicate, EBSG.
In Vivo (Animal study): No changes were made to device function, technology or component materials, and no indications were added, therefore, no new animal studies were needed to demonstrate substantial equivalence of the EBSG-R device to the predicate EBSG device.
Clinical: No clinical evaluations were required to support this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
August 17, 2018
W. L. Gore & Associates, Inc. Michael J. Titus, Ph.D. Regulatory Affairs Associate 301 Airport Road Elkton, Maryland 21922
Re: K181940
Trade/Device Name: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXC Dated: July 17, 2018 Received: July 19, 2018
Dear Dr. Titus:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K181940
Device Name
GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Indications for Use (Describe)
GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. It can be used for reinforcement of staple lines during hysterectomy, lung resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. It is also intended to be used for remforcement of suture lines and 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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Section 6 - 510(k) Summary [21 CFR 807.92]
510(k) Submitter
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Michael J. Titus, Ph.D.
Date Prepared
July 30, 2018
Device Names/Classification
GORE® SEAMGUARD® Bioabsorbable Staple Line Device Name: Reinforcement Common Name: Staple Line Reinforcement Material Classification Name: Surgical mesh Classification: 21CFR 878.3300 Product Code: OXC
Predicate Devices
K043056 GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Device Description
The subject of this 510(k) pre-market notification is a modification to the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Configured for Endoscopic Surgical Staplers (EBSG, also referred to as the predicate) to include altered bioabsorbable sheet geometries, tailored lattice stitching, and inner dimension geometry for both the cartridge and anvil devices. The cartridge and anvil devices were specifically designed to fit the geometry of the Intuitive SureForm 60™ mm staplers (K173721 cleared July 5, 2018) Black, Green and Blue cartridge reloads. GORE® SEAMGUARD® Reinforcement Bioabsorbable Staple Line Reinforcement Configured for Intuitive Surgical® Robotic Endoscopic Surgical Staplers (EBSG-R, also referred to as the modified device) possesses the same fundamental scientific technology as the predicate. No other physical modifications were made to the predicate device, and the implantable materials of the modified device and predicate are the same synthetic bioabsorbable poly (glycolide: trimethylene carbonate) copolymer (PGA:TMC).
Indications for Use
GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection with staple line reinforcement is needed. It can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. It 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.
Differences in Technological Characteristics
There are no technological differences between the modified device and the predicate device.
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Summary of Performance Testing
Pre-Clinical
Bench study: Design verification testing of the modified device consisted of deployment reliability testing under simulated use conditions and same/similar acceptance criteria. The tests demonstrated the performance of the modified device. EBSG-R, is substantially equivalent to the predicate, EBSG.
In Vivo (Animal study): No changes were made to device function, technology or component materials, and no indications were added, therefore, no new animal studies were needed to demonstrate substantial equivalence of the EBSG-R device to the predicate EBSG device. Clinical
No clinical evaluations were required to support this submission.
Conclusion
Based on the information contained within this 510(k) premarket notification, W. L. Gore & Associates, Inc. concludes that the subject device GORE® SEAMGUARD® Reinforcement Bioabsorbable Staple Line Reinforcement Configured for Intuitive Surgical® Robotic Endoscopic Surgical Staplers is substantially equivalent to the predicate device in terms of indications for use, contraindications, construct, materials, biocompatibility, sterilization, and performance.