(78 days)
The Bard Ventralex Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard Ventralex Patch (REF 0010301) is also intended to repair soft tissue deficiencies including deficiencies caused by trocars.
The proposed Ventralex Patch is a self-expanding, three layer device. Two layers consist of polypropylene mesh. The top layer of polypropylene mesh forms a positioning strap and pocket. The purpose of the strap and pocket is to facilitate placement, positioning and fixation of the device. After the device has been properly placed and attached, the positioning strap must be removed and properly discarded. The monofilament PET polymer "ring" is captured between the two layers of polypropylene mesh and adds stability to the device enabling greater simplicity and assurance in the proper placement. The third layer of the device is a single laver of expanded polytetrafluoroethylene (ePTFE) that is attached to the polypropylene mesh with an interlocking PTFE stitch pattern. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer.
The provided text describes a 510(k) summary for the "Small Bard Ventralex Patch," a medical device intended for hernia repair and soft tissue deficiencies. This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting a study with acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.
Therefore, the requested information, such as specific acceptance criteria for device performance, a study proving these criteria are met, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.
The document details the device's description, its intended use, and its similarities to a predicate device (Bard Ventralex Hernia Patch K021736) to show substantial equivalence. The FDA letter confirms the substantial equivalence determination, allowing the device to be marketed.
In summary:
- Acceptance Criteria and Reported Device Performance: Not applicable/not provided in this type of regulatory document. The "performance" is primarily established by substantial equivalence to the predicate device.
- Sample size for the test set and data provenance: No test set or associated study is presented.
- Number of experts used to establish ground truth: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable (this is a physical medical device, not an algorithm).
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.