(47 days)
Not Found
No
The device description and intended use focus on a bioabsorbable material for staple line reinforcement, with no mention of AI or ML capabilities.
No.
The device is described as a bioabsorbable material for reinforcing staple lines during surgery, not for treating a disease or condition.
No
The device is a bioabsorbable material used for reinforcing staple lines during various surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a bioabsorbable membrane formed into a sleeve, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is a surgical implant used during surgical procedures to reinforce staple and suture lines in various soft tissues and organs. It is a physical material implanted in the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. Its function is purely mechanical reinforcement during surgery.
Therefore, the GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material falls under the category of a surgical device or implant, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hysterectomy, lung, liver, bladder, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, spleen, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 Hansen |
| Regulatory Affairs | |
| Medical Products Division | |
| WL Gore & Associates, Inc. | |
| 3450 West Kiltie Lane | |
| Flagstaff, AZ 86002-0500 | |
| Telephone: (928) 864-3784 | |
| Facsimile: (928) 864-4144 | |
| E-mail: bhansen@wlgore.com |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
1
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.
2
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.
3
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.
4
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
5
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 ____________________________________________________________________________________________________________________________________________________________________