(45 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML.
Yes
The device is indicated for use in the reconstruction of hernias and other soft tissue deficiencies, which directly addresses a health condition or body function.
No
The device description indicates it is a surgical mesh for reconstruction, not for identifying or diagnosing a medical condition.
No
The device description clearly states it is a surgical mesh constructed from physical materials (expanded polytetrafluorethylene fibers), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "reconstruction of hernias and other soft tissue deficiencies." This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The device is a "flat nonabsorbable surgical mesh constructed from monofilament expanded polytetrafluorethylene (PTFE) fibers." This describes a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the GORE INFINIT Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.
Product codes
FTL
Device Description
GORE INFINIT Mesh is a flat nonabsorbable surgical mesh constructed from monofilament expanded polytetrafluorethylene (PTFE) fibers. The fibers are warp knitted into a textile pattern with bi-axial stretch that allows the material to comply with native tissue. The warp knit pattern also allows the mesh to be custom tailored without unraveling of the edges. The mesh is knitted with a pore size that allows appropriate tissue integration without negatively affecting abdominal wall compliance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The GORE INFINIT Mesh device has performance characteristics comparable to the PROLENETM Soft Mesh predicate device based on bench testing and in accordance with those characteristics specified in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh". Nonclinical laboratory (animal) testing and clinical performance data were not evaluated as part of this application.
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.
0
K08 1069 page 1/3
W. L. Gore & Associates, Inc. GORE INFINIT Mesh Section 5. 510(k) SUMMARY
510(k) SUMMARY
MAY 30 2008
Owner/Operator:
W. L. Gore & Associates, Inc 555 Paper Mill Road Newark, Delaware 19711 USA Owner/Operator #: 9925013
Submission Contacts:
Michael J. Titus Regulatory Affairs Associate W.L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21922 USA Phone: 410-506-8125 Fax: 410-506-8221 Email: mtitus@wlgore.com
Submission Date:
April 14, 2008
Device Name:
Proprietary Name: GORE INFINIT Mesh Common Name: INFINIT Mesh Classification Name: Surgical Mesh Product Code: FTL Class: II
Substantial Equivalence:
Predicate devices
-
- Product Name: GORE DUALMESH® Biomaterial 510k #: K992189 Manufacturer: W.L. Gore & Associates, Inc.
1
K081069 page 2/3
W. L. Gore & Associates, Inc. GORE INFINIT Mesh Section 5. 510(k) SUMMARY
-
- Product Name: Prolene™ Soft (Polypropylene) Mesh 510k #: K001122 Manufacturer: ETHICON, Inc.
The GORE INFINIT Mesh is comprised of the same base material (PTFE) as the predicate device, GORE DUALMESH® Biomaterial, and has the same intended use. The GORE INFINIT Mesh is different from the other predicate device, the PROLENE™ Soft Mesh, in that the PROLENE™ Soft Mesh device is made of polypropylene. The GORE INFINIT Mesh also has the same general intended use as the PROLENETM Soft Mesh. Differences between the devices do not raise any significant issues of safety or effectiveness.
- Product Name: Prolene™ Soft (Polypropylene) Mesh 510k #: K001122 Manufacturer: ETHICON, Inc.
Intended Use:
GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.
Device Description
GORE INFINIT Mesh is a flat nonabsorbable surgical mesh constructed from monofilament expanded polytetrafluorethylene (PTFE) fibers. The fibers are warp knitted into a textile pattern with bi-axial stretch that allows the material to comply with native tissue. The warp knit pattern also allows the mesh to be custom tailored without unraveling of the edges. The mesh is knitted with a pore size that allows appropriate tissue integration without negatively affecting abdominal wall compliance.
Materials
GORE INFINIT Mesh is made from expanded polytetrafluorethylene (PTFE) fibers. This material is the same as that used in the predicate device, GORE DUALMESH® Biomaterial, and has a significant history of safe and efficacious use as implantable material. There are no other materials in the implanted device.
2
K081069 page 3/3
W. L. Gore & Associates, Inc. GORE INFINIT Mesh Section 5. 510(k) SUMMARY
Performance
The GORE INFINIT Mesh device has performance characteristics comparable to the PROLENETM Soft Mesh predicate device based on bench testing and in accordance with those characteristics specified in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh". Nonclinical laboratory (animal) testing and clinical performance data were not evaluated as part of this application.
Conclusions
Based on the information provided herein, we conclude that the GORE INFINIT Mesh device is substantially equivalent to its predicates in terms of design, intended use, principle of operation and performance attributes.
Difference between the predicates and the GORE INFINIT Mesh do not raise any significant issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2008
W.L. Gore & Associates, Inc. % Mr. Michael J. Titus Regulatory Affairs Associate 301 Airport Road Elkton, Maryland 21922-1408
Re: K081069
Trade/Device Name: GORE INFINIT Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2008 Received: April 15, 2008
Dear Mr. 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. 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.
4
Page 2 – Mr. Michael J. Titus
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milken
Mark N. Melkerson 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):
Device Name: GORE INFINIT Mesh
Indications For Use:
GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | 1081069 |
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