(184 days)
Parietex™ surgical mesh; slings or pre-cut implants are intended for the repair of Inguinal and Incisional hernias, genito-urinary and rectal prolapses by promontofixation via open abdominal or laparoscopic approach. No applications other than the ones indicated are recommended.
Mesh made of Biocompatible, knitted multifibre polyester (PET). Each mesh is supplied sterile and nonpyrogenic in a single-use package.
The provided text describes a 510(k) summary for the Parietex Surgical Mesh, which is a medical device for surgical repair. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined metrics.
Here's a breakdown of the requested information based on the provided text, along with an explanation of why some points cannot be fully addressed:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria in terms of specific performance metrics with target values for this device. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of mechanical properties and reported clinical outcomes literature.
| Category | Acceptance Criteria (Not explicitly stated as such) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Similar to predicate devices (Mersilene, Prolene, Marlex) for thread resistance, tear resistance, and breaking resistance. | Thread Resistance (N): Chain: 68.5, Weft: 55.4 (Compared to Mersilene: Chain 115.2, Weft 15.5; Prolene: Chain 57, Weft 74.6; Marlex: Chain 57.2, Weft 55.8) |
| Tear Resistance (daN): Chain: 3.36, Weft: 2.78 (Compared to Mersilene: Chain 0.64, Weft 0.68; Prolene: Chain |
§ 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.