(77 days)
Not Found
No
The device description and intended use focus on a physical, bioabsorbable material used for surgical staple line reinforcement, with no mention of software, algorithms, or data processing.
No.
The device is a staple line reinforcement material used in surgical procedures, not a therapeutic device designed to treat or cure a disease or condition.
No
The device is a bioabsorbable material used for reinforcing staple lines during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a bioabsorbable membrane and includes physical components like a sleeve, suture pullcord, and packaging. 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 is for surgical procedures to reinforce staple lines in various anatomical sites (lung, gastric, small bowel, mesentery, colon, colorectal). This is a therapeutic/surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a bioabsorbable material used with surgical staplers. It is physically implanted or applied during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are "in vivo studies" supporting the use of the device during surgical procedures, not studies evaluating diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Product codes (comma separated list FDA assigned to the subject device)
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
lung, gastric, small bowel, mesentery, colon, and colorectal
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 gastric, small bowel, mesentery, colon, and colorectal procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
NOV 288 2003
K032865 page 11
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: | Mike Johnson
Regulatory Affairs
Medical Products Division
WL Gore & Associates, Inc.
3450 West Kiltie Lane
Flagstaff, AZ 86002-0500
Telephone: (928) 864-3615
Facsimile: (928) 864-4144
E-mail: mdjohnso@wlgore.com |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
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
Image /page/0/Picture/10 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the logo, there is some smaller text that is difficult to read. The word "Confidential" is written in a simple, sans-serif font.
1
K032865 pag
510(k) Premarket Notification 510(k) Summary of Substantial Equivalence GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
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 lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
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
- 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 gastric, small bowel, mesentery, colon, and colorectal procedures.
Conclusion (Statement of Equivalence)
Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the WL Gore & Associates, Inc. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Material through this 510(k) Premarket Notification.
Image /page/1/Picture/15 description: The image shows the Gore logo on the left and the word "Confidential" on the right. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right above the words "Creative Technologies Worldwide" in smaller letters. The word "Confidential" is in a simple, sans-serif font and is positioned to the right of the logo. The image suggests that the document or information associated with it is confidential and related to Gore.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the head and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 28 2003
Mr. Mike Johnson Regulatory Affairs Medical Products Division WL Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86002-0500
Re: K032865
Trade/Device Name: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: September 12, 2003 Received: September 15, 2003
Dear Mr. Johnson:
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.
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 forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
Page 2 - Mr. Mike Johnson
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation ( 21 CT-R Part 801). please contact the Office of Compliance at (301) 594-46.59. 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 vours,
fo Mark N. Millkerson
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
4
510(k) Premarket Notification Indication For Use
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
INDICATION FOR USE
510(k) Number (if known):
Device Name:
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
Intended Use / 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 lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
fo Mark n Milkeran
ivision Sign-Off) Division of General, Restorative and Neurological Devices
" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Confidential
(Optional Format 1-2-96)
Over-The-Counter Use
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