(45 days)
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.
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.
This document is a Premarket Notification Summary (510(k)) for the GORE-TEX® Soft Tissue Patch, GORE-TEX® MycroMesh Biomaterial, GORE-TEX® DualMesh Biomaterial, and GORE-TEX® DualMesh Biomaterial with Holes. It focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device.
Therefore, the requested information regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for a new device's performance will not be available in this document.
Instead, the document addresses substantial equivalence based on:
- Predicate Devices: Identification of existing, legally marketed GORE-TEX® products, Davis & Geck DEXON Mesh, and Ethicon Vicryl Woven Mesh as predicates.
- Device Description: Stating that the applicant GORE surgical meshes are not being changed except for labeling. The manufacturing process and material (ePTFE) are proprietary and have a long history of use in various medical applications.
- Intended Use: The proposed devices have the same intended use (reconstruction of hernias, temporary bridging of fascial defects and soft tissue deficiencies) as the predicate devices.
- Technological Characteristics: A table comparing the applicant and predicate devices on intended use and material. It acknowledges that not all devices incorporate the same materials but argues that the extensive clinical history of the individual biomaterials, including ePTFE, indicates that material differences do not pose new safety or effectiveness questions.
- Performance Data/Clinical Experience: Refers to "Published Clinical Data" (in Attachment 5, not provided here) on GORE-TEX® ePTFE usage in temporary soft tissue deficiencies to support successful clinical performance.
Summary Absence of Requested Information:
- Acceptance Criteria and Device Performance Table: Not applicable, as this is a 510(k) summary for existing devices with labeling changes, not a performance study against specific criteria for a new device.
- Sample Size for Test Set and Data Provenance: Not applicable. No specific test set to evaluate a new device is described. The rationale relies on existing broad clinical experience.
- Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth as typically defined for diagnostic or AI devices is not relevant here.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not the subject of this 510(k) submission.
- Standalone Performance Study: Not applicable. No "algorithm only" performance is being presented.
- Type of Ground Truth Used: Not applicable in the context of a new device performance study. The "truth" here is established clinical history and biocompatibility of the materials.
- Sample Size for Training Set: Not applicable. No training set for an algorithm is discussed.
- How Ground Truth for Training Set was Established: Not applicable.
Conclusion based on the provided text:
This 510(k) submission seeks clearance based on substantial equivalence, primarily asserting that the applicant devices are unchanged and have established safety and effectiveness through extensive historical clinical use and published data (referenced in Attachment 5, which is not included). It does not present new performance data from a dedicated study with pre-defined acceptance criteria, specific test sets, or expert-adjudicated ground truth as would be expected for a novel device.
§ 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.