(133 days)
This device is intended for implantation to repair, reinforce and/or supplement soft tissue. This device is indicated for use in general and plastic surgery applications. This device is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include but are not limited to: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including but not limited to diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
These are borne pericardium surgical mesh devices processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. These devices consist of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, they have multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retain the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.
This document focuses on the 510(k) summary for RTI Biologics, Inc.'s TUTOMESH® and TUTOPATCH® surgical mesh devices. The provided text is a regulatory filing asserting substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through performance data.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including details like sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, cannot be extracted from this document, as it does not contain such a study.
The document primarily states:
- Substantial Equivalence: The proposed devices are substantially equivalent to predicate devices in materials, design, function, intended use, and fundamental scientific technology.
- Description: These are bovine pericardium surgical mesh devices, processed with the Tutoplast® solvent dehydration process and gamma irradiation, consisting of collagenous connective tissue with multidirectional fibers.
- Intended Use: Implantation to repair, reinforce, and/or supplement soft tissue in general and plastic surgery applications, including various types of hernia repair and reconstruction.
- Summary of Technological Characteristics: The proposed device has materials, design, and function equivalent to predicate devices.
The FDA's letter confirms their review and determination of substantial equivalence based on the provided information, allowing the device to be marketed. This regulatory process focuses on comparing a new device to existing legally marketed predicate devices, rather than requiring extensive clinical trials to establish new performance metrics against predefined acceptance criteria for novel technologies.
§ 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.