(137 days)
The Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and intended for one-time use.
The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate Nerve Cuff (K031069), also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in clamshell container inside a sealed double pouch system.
The document describes the acceptance criteria and study results for the Cook Biotech Incorporated Nerve Cuff (K132660). The submission focuses on demonstrating substantial equivalence to a predicate device (Surgisis Nerve Cuff, K031069) through bench, biocompatibility, and animal studies.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative "acceptance criteria" for each test in the way you might find in an AI/software device submission. Instead, it demonstrates performance by showing that the Nerve Cuff is "substantially equivalent" to its predicate device or meets specific qualitative standards.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Ultimate tensile strength | Comparable to predicate (Surgisis Nerve Cuff) | "The tensile strength was comparable to Surgisis Nerve Cuff predicate." "the Nerve Cuff has sufficient tensile... strength for its application." |
| Suture retention strength | Comparable to predicate (Surgisis Nerve Cuff) | "The suture retention strength was comparable to the Surgisis Nerve Cuff." "the Nerve Cuff has sufficient... suture retention strength for its application." | |
| Compression and rebound testing | Applicable results from predicate (as material/configuration are identical) | "Compression and rebound testing was performed on the predicate Surgisis Nerve Cuff. Since the Nerve Cuff is identical in material and configuration to the Surgisis Nerve Cuff, the results are applicable to the subject device's intended use." | |
| Hydration testing | Devices within specified thickness range upon hydration | "Re-hydrated devices were compared to non-hydrated controls. Devices were within the specified thickness range upon hydration." | |
| Biocompatibility | Genotoxicity (Mouse micronucleus assay) | Non-mutagenic | "results indicate that the test article is non-mutagenic in this system." |
| Genotoxicity (Mouse lymphoma assay) | Non-mutagenic | "results show that the test article extracts were well within the limits defined for a negative response and the test article is considered non-mutagenic in this assay." | |
| Direct contact in vitro hemolysis | Non-hemolytic (Hemolytic index ≤ 5%) | "Under conditions of the study, the mean hemolytic index of the test article was 2%." | |
| Cytotoxicity | Non-cytotoxic (no evidence of cell lysis/toxicity, |
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).