(84 days)
SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.
SyntheCel® Dura Replacement Devices (Onlay and Substitute) are composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Replacement Devices function as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Replacement Devices are immunologically inert and have demonstrated minimal foreign body response. They are non-resorbable.
The provided text describes the SyntheCel® Dura Replacement Devices and the studies performed to demonstrate their safety and effectiveness for FDA clearance.
Here's an analysis of the acceptance criteria and the studies, based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Efficacy Endpoint) | Reported Device Performance |
|---|---|
| Absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively, confirmed by radiographic evaluation and physical examination of the surgical site. | The results of overall success analyses indicate that the SyntheCel® is non-inferior to the dura replacement control group. |
| Non-Clinical Acceptance Criteria | Reported Device Performance |
| Tensile strength comparable to predicates | SyntheCel® Dura Replacement Device performance was found to be comparable in tensile strength. |
| Burst strength comparable to predicates | SyntheCel® Dura Replacement Device performance was found to be comparable in burst strength. |
| Suture pull-out strength comparable to predicates | SyntheCel® Dura Replacement Device performance was found to be comparable in suture pull-out strength. |
| No meningitis, CSF leakage, infection, hydrocephalus, device vascularization, nor significant hemorrhage in animal study. | Results noted at necropsy show no meningitis, CSF leakage, evidence of infection, hydrocephalus, device vascularization, nor significant hemorrhage in any of the animals regardless of the implant type. |
| No evidence of a toxic leachable or local adverse effect in animal study. | SyntheCel® Dura Replacement Devices showed no evidence of a toxic leachable or local adverse effect. |
| Non-irritating, non-sensitizing, non-mutagenic, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic (Biocompatibility). | Demonstrated that the material is non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic. |
| Pyrogenicity |
§ 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).