(121 days)
PROLENE Soft Polypropylene Mesh may be used for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
PROLENE Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of hernias and other fascial defects. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh. PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of 3.5 mil diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. Polypropylene material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. PROLENE Soft Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property is designed to allow adaption to various stresses encountered in the body.
Here's an analysis of the provided text regarding acceptance criteria and performance studies. It appears the document describes a 510(k) premarket notification for a surgical mesh, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing new acceptance criteria or full device performance in the same way an AI/software device would.
Based on the provided text, the device is PROLENE Soft Polypropylene Mesh and the study is focused on demonstrating substantial equivalence to a predicate device (PROLENE Soft Polypropylene Mesh, K001122), particularly for a new larger size (50 cm x 50 cm).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from testing) | Reported Device Performance (Summary) |
|---|---|---|
| Material Composition | Identical materials to predicate device | Yes, composed of knitted filaments of extruded polypropylene, identical to predicate. |
| Sterility | - EO/ECH residuals within acceptable limits (ISO 10993-7:2008) |
- Natural Product Resistance Testing & Comparative Resistance Testing met acceptance criteria
- Bioburden testing met defined acceptance criteria (ISO 11737-1)
- Sterility Assurance Level (SAL) of 10^-9 (for subject device)
- SAL of 10^-6 (for comparison with predicate) | All sterility validation tests met acceptance criteria. Achieved SAL of 10^-9. |
| Biocompatibility | - Evaluation in accordance with ISO 10993-1:2009 - Endotoxin criteria of
§ 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.