(17 days)
These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
TUTOMESH® is a bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. The TUTOMESH® device consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.
The provided text is a 510(k) summary for the TUTOMESH® surgical mesh device, which is a regulatory submission to the FDA. It does not contain a study that proves the device meets specific acceptance criteria.
Instead, it asserts substantial equivalence to predicate devices based on materials, design, function, intended use, and fundamental scientific technology. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. These elements are typically found in detailed clinical trial reports or performance testing documentation, which are not part of this 510(k) summary.
The summary focuses on:
- Device Name: TUTOMESH®
- Proprietary Names: TUTOMESH®
- Common Name: Surgical Mesh
- Product Code: 79 FTL, Orthopedics Panel (later updated to FTM, MFX)
- Regulation Number: 21 CFR 878.3300
- Regulation Name: Surgical mesh
- Device Description: Bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. It is described as collagenous connective tissue with three-dimensional intertwined fibers, offering multidirectional mechanical strength and supporting replacement by new endogenous tissue.
- Intended Use: General and plastic surgery applications, including repair of pericardial structures and as a prosthesis for surgical repair of soft tissue deficiencies like gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, pelvic floor reconstruction, and various hernias.
- Substantial Equivalence Claim: The device is claimed to be substantially equivalent to predicate devices in materials, design, function, intended use, and fundamental scientific technology.
- Regulatory Decision: The FDA determined the device to be substantially equivalent, permitting it to be marketed.
§ 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.