(38 days)
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects
Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.
This document describes the premarket notification (510(k)) for the Herniamesh Relimesh, a surgical mesh intended for the reconstruction of soft tissue deficiencies. The device's acceptance criteria and the study proving it meets these criteria are established through a comparison to legally marketed predicate devices, Composite Mesh (C.R. Bard Inc.) and Hermesh 7 (Herniamesh Srl).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Relimesh device are based on demonstrating substantial equivalence to predicate devices through functional and material characteristic comparisons. The specific acceptance criteria are that the Relimesh device's performance characteristics (suture retention, burst strength, tensile strength) are comparable to or better than the predicate devices, and that its material properties and intended use are similar. The reported device performance is shown in the table below:
| Characteristic | Acceptance Criteria (inferred by predicate) | Relimesh Performance | Predicate 1: Hermesh 7 (K070625) Performance | Predicate 2: Composite Mesh (K971745) Performance |
|---|---|---|---|---|
| Material/Design | Monofilament Polypropylene & ePTFE | Polypropylene & ePTFE | 100% Polypropylene | Polypropylene & ePTFE |
| Mesh Weight (g/sq. m) | Within historical range of predicates | 78 ± 6% | 19 | 214 |
| Filament Diameter (μ) | Within historical range of predicates | 120 | 80 | 160 |
| Thickness Mesh (mm) | Within historical range of predicates | 0.5 ± 10% | 0.27 mm | 1.5 mm |
| % Porosity | Within historical range of predicates | 86.8 | 91.9 | 83 |
| Suture Retention (N) | Comparable to or better than predicates | 24.60 | 8.75 | 26 ± 7.56 |
| Burst Strength (Kpa) | Comparable to or better than predicates | 378 | 359 | 1316 ± 3.8 |
| Tensile Strength (N/cm) | Comparable to or better than predicates | 24 ± 6 | 17.7 | N/A |
| Biocompatibility | Compliant with ISO 10993 | Compliant | - | - |
| Sterility | SAL 10^-6, EtO Residual |
§ 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.