(51 days)
GORE-TEX® Soft Tissue Patch PLUS, GORE-TEX® DualMesh PLUS Biomaterial, GORE-TEX® MycroMesh PLUS Biomaterial, GORE-TEX® DualMesh PLUS Biomaterial with Holes
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No
The summary describes a physical implantable device made of ePTFE with antimicrobial agents, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for reconstruction of hernias and soft/tissue deficiencies, and temporary bridging of fascial defects, which are therapeutic applications.
No
The device's Intended Use states it is for "reconstruction of hernias and soft/tissue deficiencies and for the temporary bridging of fascial defects," which are surgical reparations, not diagnostic activities.
No
The device description clearly states it is made of ePTFE loaded with antimicrobial agents, indicating a physical, implantable material, 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 the reconstruction of hernias and soft/tissue deficiencies and for the temporary bridging of fascial defects. This describes a device used in vivo (within the body) for surgical repair.
- Device Description: The description details a material (ePTFE) with antimicrobial agents, designed to be implanted or used directly on tissue. This is consistent with a surgical implant or patch.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing samples taken from the human body. This device is designed for direct surgical use on the body.
N/A
Intended Use / Indications for Use
The devices are indicated for use in the reconstruction of hernias and soft/tissue deficiencies and for the temporary bridging of fascial defects.
Product codes
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Device Description
Inert, biocompatible, expanded polytetrafluoroethylene (ePTFE) loaded with the antimicrobial preservative agents silver carbonate and chlorhexidine diacetate.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
GORE-TEX® Soft Tissue Patch PLUS, GORE-TEX® DualMesh PLUS Biomaterial, GORE-TEX® MycroMesh PLUS Biomaterial, GORE-TEX® DualMesh PLUS 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
FEB - 6 1997
Premarket Notification 510(k) Summary vi.
- W.L. Gore and Associates, Inc. A. Submitter: P.O. Box 900 Flagstaff, AZ 86002-0900
Contact : R. Larry Pratt
Phone: 520-779-2771
B. Applicant Devices:
Names of Devices with Modified Labeling
GORE-TEX® Soft Tissue Patch PLUS GORE-TEX® DualMesh PLUS Biomaterial GORE-TEX® MycroMesh PLUS Biomaterial GORE-TEX® DualMesh PLUS Biomaterial with Holes
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Applicant Devices Description: C.
Inert, biocompatible, expanded polytetrafluoroethylene (ePTFE) loaded with the antimicrobial preservative agents silver carbonate and chlorhexidine diacetate. -
Indications For Use: D.
The devices are indicated for use in the reconstruction of hernias and soft/tissue deficiencies and for the temporary bridging of fascial defects. -
E. Predicate Devices:
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The following devices, loaded with antimicrobial preservative agents, are cited as substantially equivalent predicate devices concerning possible adverse reactions, materials, design, biocompatibility, mechanical strength, manufacturing, packaging, sterilization, antimicrobial activity and preservative efficacy:
GORE-TEX® Soft Tissue Patch PLUS GORE-TEX® DualMesh PLUS Biomaterial GORE-TEX® MycroMesh PLUS Biomaterial GORE-TEX® DualMesh PLUS Biomaterial with Holes
1
The following devices, without antimicrobial preservative agents, are cited as substantially equivalent predicate devices which contain the same indications for use statement :
GORE-TEX® Soft Tissue Patch GORE-TEX® DualMesh Biomaterial GORE-TEX® MycroMesh Biomaterial GORE-TEX® DualMesh Biomaterial with Holes
Technological Characteristics: F.
This Premarket Notification submission is for a modification to the indications for use for the applicant devices. The applicant devices are not being changed in any way (except for labeling) as a result of this submission's clearance. The materials, design and performance characteristics for the applicant devices have not changed from those of the predicate devices. There are no new technological characteristics due to the modification of the indications for use.
Safety and Effectiveness Conclusions: G.
This Premarket Notification concerns a modification to the indications for use for currently marketed, previously cleared surgical mesh devices. Therefore, the applicant devices are the same, and consequently, substantially equivalent to the predicate devices with regard to possible adverse reactions, materials, design, biocompatibility, preservative effectiveness, antimicrobial activity, mechanical strength, packaging, manufacturing process and sterilization process.
The applicant devices and the predicate devices have the same intended use as prostheses for permanent or temporary wound or defect support. Each of the devices perform their equivalent clinical functions by incorporating biocompatible materials to permanently or transiently bridge or support a tissue defect.
The modification of the indications for use for the applicant devices does not raise questions of safety or effectiveness that have not been previously addressed.
GORE-TEX®, MycroMesh®, DualMesh®, Soft Tissue Patch PLUS™ are trademarks of W.L. Gore and Associates, Inc.
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