DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize fascial structures of the abdominal wall. DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is a polypropylene mesh, knitted from non absorbable, bio-stable, polypropylene monofilament fiber. DynaMesh-PP is supplied as a sterile, flexible, flat sheet of material. DynaMesh-PP is intended for use during hernia surgery, where the flat sheet can be cut to size, based on patient specific anatomical requirements. FEG Textiltechnik's DynaMesh-PP will be available in two mesh densities, standard and light, and a variety of sizes. The FEG Textiltechnik DynaMesh-PP will be packaged double-packed in two transparent plastic bags: - the inner transparent bag contains the device only - the outer transparent bag contains the inner bag and four adhesive labels for patient records. The product label will be on the outer bag, which is then protected by a cardboard box. The product has a stated shelf-life of 3 years which is supported by real-time testing.
The provided text does not describe acceptance criteria for a medical device or a study proving that the device meets those criteria. Instead, it is a 510(k) summary for a surgical mesh (DynaMesh-PP) seeking substantial equivalence to predicate devices.
The document focuses on comparing the DynaMesh-PP to existing legally marketed polypropylene meshes based on design, materials, manufacturing processes, and physical properties. It does not detail specific performance acceptance criteria or a study designed to demonstrate the device meets such criteria.
The tables provided (pages 3 and 4 of the submission) show a technological comparison to predicate devices, listing various physical features and their measured values for both the subject device (DynaMesh-PP) and the predicate device (Sofradim Parietene Mesh). These are presented to demonstrate similarity, not necessarily to meet pre-defined acceptance criteria for performance in a clinical or simulated-use context.
Therefore, I cannot populate the requested table or answer the questions as the information is not present in the provided text. The document is a regulatory submission for substantial equivalence based on comparison to existing devices, not a report on acceptance criteria and performance from an independent study.
§ 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.