(30 days)
Parietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.
Parietene™ macroporous mesh is designed for extraperitoneal mesh placement only, for the repair of abdominal wall hernias by laparoscopic or open approach.
Parietene™ macroporous mesh is a non-absorbable synthetic surgical mesh made of two-dimensional (2D) monofilament polypropylene knitted textile.
Parietene™ macroporous mesh is offered in square flat sheet version (50cm x 50cm).
The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The macroporous textile provides strength required to withstand biomechanical stresses throughout the healing period, while allowing for tissue ingrowth. As the textile integrates, host tissue ingrowth is intended to provide strength to the repair.
The detailed composition listed below refers to the estimated maximum amount of each material and substance to which a patient can be exposed when 1 unit of the largest size of Parietene™ macroporous mesh is implanted (i.e. PPM5050). This amount could be less if the mesh is trimmed by the practitioner prior to implantation.
Mesh composition: monofilament polypropylene yarn (up to 11.5 g)
This FDA 510(k) clearance letter is for a surgical mesh (Parietene™ Macroporous Mesh, PPM5050), not an AI-powered diagnostic device. Therefore, the requested information regarding AI device acceptance criteria, study methodologies (MRMC, standalone performance), expert ground truth establishment, training sets, and data provenance is not applicable to this document.
The document discusses the substantial equivalence of the new mesh size (50cm x 50cm) to previously cleared predicate devices based on:
- Performance testing: In-vitro (bench) tests for trocar compatibility, bursting strength, deflection, uniaxial tensile maximum force and elongation, and tear strength.
- Biocompatibility evaluation.
- Sterilization validation.
- Literature and MAUDE database review of predicate and reference devices.
There is no mention of an AI algorithm, human readers, or image interpretation in this clearance.
§ 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.