(45 days)
K 830889, K 810428
Not Found
No
The summary describes a surgical mesh made of PTFE with a specific microstructure. There is no mention of AI, ML, image processing, or any computational analysis of data. The focus is on the material properties and established clinical performance.
Yes
The device is used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies, which are therapeutic interventions.
No
The device is a surgical mesh intended for the reconstruction of hernias and temporary bridging of fascial defects, which are therapeutic and structural functions, not diagnostic.
No
The device description explicitly states it is a surgical mesh made of PTFE, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies." This describes a surgical implant used directly in the body for structural support and repair.
- Device Description: The description details a surgical mesh made of PTFE (ePTFE) and its physical structure. It discusses its use as an implant in various surgical applications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples, while this device is an implant used inside the body.
N/A
Intended Use / Indications for Use
The applicant devices are intended to be used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies.
Product codes
Not Found
Device Description
The applicant GORE surgical meshes are not being changed in any way (except for labeling) as a result of this submission's clearance. The proprietary manufacturing process that GORE's surgical meshes undergo creates a pattern of solid nodes of PTFE interconnected by a · latticework of PTFE fibrils. The staggering of these nodes and fibrils and the pattern of these structures produces a microstructure which determines the degree and celerity with which tissue attachment occurs. More than 4,000,000 implants of GORE-TEX ePTFE Medical Products in vascular, cardiac, dural and a broad variety of general surgery applications during the past two decades have established a substantial body of knowledge and experience relating to the biocompatibility and performance of ePTFE. A selected bibliography is provided in Attachment 5.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Davis & Geck DEXON Mesh K 830889, Ethicon Vicryl Woven Mesh K 810428
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
OCT 25 1996
Premarket Notification Summary
-
W. L. Gore and Associates, Inc. Applicant: 1. 3750 W. Kiltie Lane Flagstaff, AZ 86002 Phone: 520-779-2771
Contact: John W. Nicholson, Associate Date of Preparation: 09/06/96 -
GORE-TEX® Soft Tissue Patch a) Applicant Devices: 2. GORE-TEX® MycroMesh Biomaterial GORE-TEX® DualMesh Biomaterial GORE-TEX® DualMesh Biomaterial with Holes
- Surgical Mesh b) Common Name:
- c) Classification Name: Surgical Mesh
3. Predicate Devices:
GORE cites the following as substantially equivalent predicate devices:
GORE-TEX® Soft Tissue Patch GORE-TEX® MycroMesh Biomaterial GORE-TEX® DualMesh Biomaterial GORE-TEX® DualMesh Biomaterial with Holes Davis & Geck DEXON Mesh K 830889 Ethicon Vicryl Woven Mesh K 810428
4. Device Description:
The applicant GORE surgical meshes are not being changed in any way (except for labeling) as a result of this submission's clearance. The proprietary manufacturing process that GORE's surgical meshes undergo creates a pattern of solid nodes of PTFE interconnected by a · latticework of PTFE fibrils. The staggering of these nodes and fibrils and the pattern of these structures produces a microstructure which determines the degree and celerity with which tissue attachment occurs. More than 4,000,000 implants of GORE-TEX ePTFE Medical Products in vascular, cardiac, dural and a broad variety of general surgery applications during the past two decades have established a substantial body of knowledge and experience relating to the biocompatibility and performance of ePTFE. A selected bibliography is provided in Attachment 5.
1
ട. Intended Use:
The applicant devices are intended to be used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies.
Technological Characteristics: 6.
The Table below presents some of the basic comparative characteristics of the applicant device and its cited predicate devices.
| GORE-TEX® Soft Tissue
Patch | For the reconstruction of hernias and
soft tissue deficiencies and for the
temporary bridging of fascial defects,
such as omphaloceles | ePTFE | FTL |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----|
| GORE-TEX®
MycroMesh Biomaterial | For the reconstruction of hernias and
soft tissue deficiencies and for the
temporary bridging of fascial defects,
such as omphaloceles | ePTFE | FTL |
| GORE-TEX® DualMesh
Biomaterial | For the reconstruction of hernias and
soft tissue deficiencies and for the
temporary bridging of fascial defects,
such as omphaloceles | ePTFE | FTL |
| GORE-TEX® DualMesh
Biomaterial with Holes | For the reconstruction of hernias and
soft tissue deficiencies and for the
temporary bridging of fascial defects,
such as omphaloceles | ePTFE | FTL |
| Davis & Geck DEXON
Mesh | For use when temporary wound
support is required | Polyglycolic
Acid | FTM |
| Ethicon VICRYL Woven
Mesh | For use as a buttress to provide
temporary support during the healing
process | Polyglactin 910 | FTL |
The applicant and predicate devices have the same intended use as prostheses for temporary wound or defect support and are classified as surgical meshes. They achieve their equivalent clinical functions by incorporating biocompatible materials to transiently bridge or support a tissue defect. Although not all these devices incorporate the same technological characteristics (i.e.materials), however, the fact that these biomaterials individually have extensive and successful clinical histories indicate that this change of material type does not · pose new safety or effectiveness questions. The performance data or clinical experience with GORE-TEX® ePTFE usage in temporary soft tissue deficiencies presented above (Published Clinical Data) describes the successful clinical performance of the devices in a variety of populations. These factors combined provide the basis for a substantial equivalency determination when comparing the applicant devices with their cited predicates.