(74 days)
Not Found
No
The description focuses on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML.
Yes
The device is used for the reconstruction of hernias and soft tissue deficiencies, which directly addresses a disease or condition.
No
This device is a surgical mesh prosthesis used for reconstruction of hernias and soft tissue deficiencies. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an "implantable surgical mesh prosthesis" made of "expanded polytetrafluoroethylene (ePTFE)" in a "flat sheet configuration," indicating a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "implantable surgical mesh prosthesis indicated for the reconstruction of hernias and soft tissue deficiencies." This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The description of the material (ePTFE with antimicrobial agents) and its configuration (flat sheet with macropores) aligns with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for physical repair.
N/A
Intended Use / Indications for Use
An implantable surgical mesh prosthesis indicated for the reconstruction of hernias and soft tissue deficiencies.
Product codes
Not Found
Device Description
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with antimicrobial preservative agents in a flat sheet configuration of various length and width dimensions. Macropores are placed in the device in order to optimize rapid tissue fixation.
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 applicant device has been shown via bench testing to have mechanical strength values substantially equivalent to the mechanical strength values of the predicate devices.
Combining clinical features from each of the previously cleared predicate devices into GORE-TEX® DualMesh PLUS Biomaterial with Holes does not compromise the safety or effectiveness of the applicant device. The manufacturing of macropores into the predicate GORE-TEX® DualMesh PLUS Biomaterial does not raise new types of safety or effectiveness questions. The descriptive and mechanical strength information contained within this Premarket Notification document are precise enough to demonstrate the substantial equivalency of GORE-TEX® DualMesh PLUS Biomaterial with Holes.
Key Metrics
| Applicant Device | ||
|---|---|---|
| Suture Pull-Out Force (kg/5 pins) | Mean | Std Dev |
| Low Rate | 7.7 | 0.5 |
| High Rate | 8.2 | 0.7 |
| Tensile Force to Break (kg/0.5") | 8.3 | 0.3 |
Predicate Device(s)
GORE-TEX® DualMesh PLUS Biomaterial and GORE-TEX® DualMesh Biomaterial with Holes
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
VI. Premarket Notification 510(k) Summary
A. Submitted By: W.L. Gore & Associates, Inc. P.O. Box 900 Flagstaff, AZ 86002-0900
Contact : R. Larry Pratt Regulatory Affairs
Phone: 520-779-2771 520-779-3480 Fax:
- B. Device Name: GORE-TEX® DualMesh PLUS Biomaterial with Holes
- C. Applicant Device Description:
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with antimicrobial preservative agents in a flat sheet configuration of various length and width dimensions. Macropores are placed in the device in order to optimize rapid tissue fixation.
-
D. Indications For Use:
An implantable surgical mesh prosthesis indicated for the reconstruction of hernias and soft tissue deficiencies. -
E. Predicate Devices:
Gore's surgical mesh products, GORE-TEX® DualMesh PLUS Biomaterial and GORE-TEX® DualMesh Biomaterial with Holes, are cited as predicate devices which have been found to be substantially equivalent through the premarket notification process. -
F . Technological Characteristics:
The applicant device integrates the clinically successful attributes of GORE-TEX® DualMesh PLUS Biomaterial and GORE-TEX® DualMesh Biomaterial with Holes into a single device through the manufacture of macropores into GORE-TEX® DualMesh PLUS Biomaterial.
1
The applicant device is manufactured using the same inert, biocompatible ePTFE material as the predicate devices. The antimicrobial preservative agents loaded into the applicant device are the same, and are loaded in the same amounts, as for the previously cleared GORE-TEX® DualMesh PLUS Biomaterial. The macropores manufactured into the applicant device have the same dimensions and are created using the same process as the macropores in the previously cleared GORE-TEX® DualMesh Biomaterial with Holes.
Mechanical strength values of the applicant device are substantially equivalent to the mechanical strength values of the predicate devices and are sufficient for its indicated uses .
| Applicant Device | ||
|---|---|---|
| Suture Pull-Out Force | ||
| (kg/5 pins) | Mean | Std Dev |
| Low Rate | 7.7 | 0.5 |
| High Rate | 8.2 | 0.7 |
| Tensile Force to Break | ||
| (kg/0.5") | 8.3 | 0.3 |
G. Safety and Effectiveness Conclusions:
The applicant device is indicated for use in clinical applications which have previously been cleared for the predicate devices.
The applicant device is manufactured of the same inert, biocompatible expanded PTFE and the same antimicrobial preservative agents as the previously cleared GORE-TEX® DualMesh PLUS Biomaterial.
Macropores are created in the applicant device utilizing the same manufacturing process and technology as used for creating macropores in the previously cleared GORE-TEX® DualMesh Biomaterial with Holes.
The packaging materials and process used for the applicant device do not differ from those used for the predicate devices. The applicant device is sterilized using the same sterilization methods and utilizes the same poststerilization release criteria as the predicate devices.
2
The applicant device has been shown via bench testing to have mechanical strength values substantially equivalent to the mechanical strength values of the predicate devices.
Combining clinical features from each of the previously cleared predicate devices into GORE-TEX® DualMesh PLUS Biomaterial with Holes does not compromise the safety or effectiveness of the applicant device. The manufacturing of macropores into the predicate GORE-TEX® DualMesh PLUS Biomaterial does not raise new types of safety or effectiveness questions. The descriptive and mechanical strength information contained within this Premarket Notification document are precise enough to demonstrate the substantial equivalency of GORE-TEX® DualMesh PLUS Biomaterial with Holes.
GORE-TEX and DualMesh are trademarks of W.L. Gore & Associates.