(41 days)
Not Found
No
The device description and intended use focus on a bioabsorbable material for staple line reinforcement. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies described are device integrity tests, not related to algorithmic performance.
No
The device aids in reinforcement during surgery and is not intended to treat or prevent a disease, nor does it affect the structure or function of the body.
No
The device is a bioabsorbable material used for reinforcing staple lines during surgery, not for diagnosing conditions.
No
The device description clearly outlines a physical, bioabsorbable material with a suture pullcord, intended for use with surgical stapling devices. It is a tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during surgical procedures to reinforce staple lines in soft tissue. This is a therapeutic or surgical support function, not a diagnostic one.
- Device Description: The description details a bioabsorbable material used with surgical staplers. This aligns with a surgical device, not a device used to test samples from the body.
- 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 focus on device integrity and equivalence to predicate devices used in surgery, not on diagnostic accuracy metrics like sensitivity or specificity.
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
SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.
Product codes
878.3300, FTL, FTM
Device Description
The 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 SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is to be used with surgical stapling devices.
The 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
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
WL Gore & Associates, Inc. performed device integrity testing to support that the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is equivalent to the predicate devices. All device integrity test results for the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material met specified requirements.
Key Metrics
Not Found
Predicate Device(s)
K001789, K014183, K013346, K926167
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.
0
SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
APR 2 1 2003
K030782/,
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | 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 |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
E-mail: mdjohnso@wlgore.com
Device Description
The 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
Image /page/0/Picture/10 description: The image shows the logo for W. L. Gore & Associates. The logo features the word "GORE" in a bold, sans-serif font, with a stylized graphic to the right that resembles a swoosh or a wing. Below the word "GORE" are two lines of smaller text, which are difficult to read due to the image's resolution, but appear to be the company's tagline or a description of their business.
1
K030782/2
510(k) Premarket Notification 510(k) Summary of Substantial Equivalence
SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
bioabsorbable glycolide and trimethylene carbonate copolymer. The SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is to be used with surgical stapling devices.
The 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
SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.
Substantially Equivalent Devices
In WL Gore & Associates' opinion, the 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 intended use.
- SEAMGUARD® Staple Line Reinforcement Material (WL Gore & . Associates, Inc., Flagstaff, AZ) - K001789
- Absorbable Foam Buttress (AFB) (J&J Corporate Biomaterials Center, a ● Division of Ethicon, Somerville, NJ) - K014183
- Resolut ADAPT® ST Regenerative Membrane (WL Gore & Associates, Inc., . Flagstaff, AZ) - K013346
- Polyviolene Braided Polyester Suture (Look, Inc., Ada, OK) K926167 .
Labeling, packaging and sterilization of the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is substantially equivalent to that of the predicate devices listed above.
Summary of Studies
WL Gore & Associates, Inc. performed device integrity testing to support that the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is equivalent to the predicate devices. All device integrity test results for the SEAMGUARD Bioabsorbable Staple Line Reinforcement Material met specified requirements.
Image /page/1/Picture/16 description: The image shows the logo for GORE. The logo has the word "GORE" in bold, italicized letters. Above the word "GORE" is a black arrow pointing to the right. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The overall design is simple and conveys a sense of health and human well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2003
Mr. Mike Johnson Regulatory Affairs W.L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86002-0500
Re: K030782
Trade/Device Name: SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 10, 2003 Received: March 11, 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 electronic 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 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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
For 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
SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
INDICATION FOR USE
510(k) Number (if known):
Device Name:
SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material
Intended Use / Indication For Use:
SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.
uriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K630782
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Image /page/4/Picture/18 description: The image contains the GORE logo on the left side. The logo is a stylized depiction of the word "GORE" with an arrow pointing to the right. To the right of the logo, the word "Confidential" is written in a simple, sans-serif font. The text is in black and appears to be a watermark or classification label.