(169 days)
Durepair is indicated as a dura substitute for the repair of the dura mater.
Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.
The document describes the Durepair Dura Regeneration Matrix, a collagen implant for repairing dura mater defects. This is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
Key Takeaway: The entire submission focuses on demonstrating that a manufacturing process change for the Proposed Durepair Device does not alter its fundamental technological characteristics, material, indications for use, or safety and effectiveness compared to the Predicate Durepair Device. Therefore, the "acceptance criteria" discussed are largely related to ensuring the proposed device performs comparably to the predicate across various physical, mechanical, and biological properties.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides "Table 2 – Summary of Bench Top Testing" and "Table 3 – Summary of Biocompatibility Testing" which directly address acceptance criteria and the performance of the Proposed Durepair device.
| Test | Acceptance Criteria (Test Method Summary) | Reported Device Performance (Results for Proposed Durepair device) |
|---|---|---|
| Bench Top Testing | ||
| Sizes | Specified length/width tolerance of ± 5%. Measured with digital calipers. | All samples met the acceptance criteria. |
| Tensile Strength | Average 5 MPa minimum. Sampled from two thinnest corners. | All samples met the acceptance criteria. |
| Tensile Stiffness | Average 225 MPa maximum. Sampled from two thinnest corners. | All samples met the acceptance criteria. |
| Suture Retention Strength | Minimum of 5 N at a pull rate of 20mm/min, 3mm suture bite (polypropylene 4-0 suture). Two samples from thinnest areas. | All samples met the acceptance criteria. |
| Wet Shrink Temperature | 58° - 67° C (in-process specification) via Differential Scanning Colorimeter. | All samples met the acceptance criteria. |
| Pore Size | No visible through pores. | All samples met the acceptance criteria. |
| Hydration Rate | Time to hydrate ≤ 3 minutes using saline solution at room temperature. | All samples met the acceptance criteria. |
| Histology (Wet EBM) | No cells or cellular/nuclear debris evident. | All samples met the acceptance criteria. |
| Safety (Pyrogenicity) | Non-pyrogenic (≤ 2.15 EU/device). No bacterial endotoxins per production lot. | All samples met the acceptance criteria. |
| Bioburden | No bioburden observed in final rinse water (0 CFUs for each lot). | All samples met the acceptance criteria. |
| Biocompatibility Testing | ||
| Calcification | No calcification. Samples implanted in weanling rats for 4 weeks; explants grossly and microscopically examined. | Pass. No calcification was present. |
| Cytotoxicity | Per ISO 10993-5. Test item non-cytotoxic if no cultures show > mild reactivity (grade 2). Mouse fibroblasts to MEM elution of product. | Pass. None of the cultures showed > grade 2 reactivity. |
| Skin Sensitization Study (Saline & Cottonseed Oil Extraction) | Per ISO 10993-10. No significant dermal contact sensitization. Guinea pig maximization test. | Pass. All test animals scored a 0 and had no significant dermal contact sensitization. |
| Irritation Study, Intracutaneous Injection (Saline & Cottonseed Oil Extraction) | Per ISO 10993-10. Mean reaction scores for test articles |
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).