(170 days)
The SaluTunnel™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
The SaluTunnel Nerve Protector is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. The wall of the sheath has a longitudinal slit that allows SaluTunnel to be spread open for easy placement at the site of injury. The SaluTunnel Nerve Protector is designed to be interfaced between the nerve and its bed and, if necessary, to create a conduit for axonal growth across a nerve gap. SaluTunnel Nerve Protector is available in 2 through 10 mm inner diameter sizes. Each SaluTunnel device must be secured in place to prevent migration. Each SaluTunnel device should be chosen to be size appropriate. The device is manufactured from Salubria biomaterial. Salubria is made from a polymer (polyvinyl alcohol) and saline. Each SaluTunnel is provided sterile, hydrated in saline for presentation onto the operative field, for single use only.
Here's a breakdown of the acceptance criteria and the study information for the SaluTunnel™ Nerve Protector, based on the provided text:
Key Takeaways from the Document:
- This 510(k) submission is for the SaluTunnel™ Nerve Protector.
- The primary method for demonstrating safety and effectiveness, and thus meeting acceptance criteria, is through substantial equivalence to existing predicate devices (SaluBridge Nerve Cuff, NeuroWrap™ Nerve Protector, NeuroMend™ Collagen Nerve Wrap).
- The studies conducted are primarily non-clinical (bench-top and biocompatibility)
- The device's biocompatibility leans heavily on the SaluBridge Nerve Cuff, which is stated to be made from the exact same material and manufacturing process, differing only in a longitudinal slit.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Category | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No evidence of cytotoxicity, sensitization, irritation, mutagenicity, clastogenicity, or local/systemic toxicity. | Cytotoxicity: No evidence of cytotoxicity (for SaluBridge and aged SaluTunnel). |
| Sensitization: No evidence of sensitization. | ||
| Intracutaneous Reactivity: No evidence of irritation. | ||
| Genotoxicity (Ames): No evidence of mutagenicity. | ||
| Genotoxicity (Chromosomal Aberration): No evidence of clastogenicity. | ||
| Implantation/Chronic Toxicity: No evidence of local or systemic toxicity compared to silicone control implant. | ||
| Design Verification (Bench-Top Testing) | Device must meet all established requirements for physical and mechanical properties. | Dimensional/Visual Inspection: Met requirements. |
| Simulated Use: Met requirements. | ||
| Suture Retention Strength (SaluBridge): Met requirements. | ||
| Sterilization Validation: Met requirements. | ||
| Packaging Verification: Met requirements. | ||
| Shelf Life Determination: Met requirements. | ||
| Substantial Equivalence | Device must be substantially equivalent in function and intended use to predicate devices and satisfy safety and effectiveness requirements. | Demonstrated through detailed comparison to predicate devices (K002098, K041620, K060952) in intended use, material, design, sizes, sterilization, shelf life, and packaging. Non-clinical testing supports this. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set (Biocompatibility): Not explicitly stated in terms of number of devices or animals, but refers to ISO standard methods (MEM Elution, Kligman Maximization, Intracutaneous Injection, Ames Mutagenicity, Chromosomal Aberration Assay) and a Rat Subcutaneous Implantation Study.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are non-clinical, so geographical provenance for human data isn't applicable.
- Test Set (Design Verification): Refers to "units which were sterilized and met finished goods release requirements" and "all sizes" for dimensional/visual inspection. No specific number is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This type of information is generally not applicable for non-clinical (bench-top and biocompatibility) studies. The "ground truth" is established through adherence to standardized laboratory methods and measurements.
- For the overall substantial equivalence claim, the "ground truth" is the established safety and efficacy of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable as the studies described are non-clinical (biocompatibility and bench-top testing) and do not involve human readers/experts for adjudication in the context of diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical testing and substantial equivalence, not on human interpretive performance of an AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this device is a physical medical device (nerve protector), not a software algorithm or AI. Therefore, "standalone" performance in the context of an algorithm is not applicable.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth is established by standardized international (ISO) testing methods and comparison to known negative controls (e.g., silicone control implant in the rat study).
- Design Verification: Ground truth is established by engineering specifications, material properties, and functional requirements.
- Overall Equivalence: The primary "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a physical medical device, not an AI/machine learning algorithm that requires a "training set." The materials and manufacturing processes are established for the SaluBridge Nerve Cuff (the "parent" device).
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" in the context of an AI algorithm for this device. The properties and performance characteristics of the SaluTunnel Nerve Protector are derived from testing the device itself and leveraging the established data of its substantially equivalent predecessor, the SaluBridge Nerve Cuff.
§ 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).