(552 days)
The NervAlign® 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 NervAlign® Nerve Cuff is a collagen membrane matrix derived from porcine pericardium. It is a sterile, whitish to light beige colored, freeze-dried, pre-cut, flat sheet of acellular collagen. The NervAlign® Nerve Cuff is available in three (3) different sizes: 10x10mm, 20x30mm and 30x40mm.
The collagen material that comprises the Nerve Cuff is derived from the same species as that of the predicate nerve cuff (AxoGuard Nerve Protector; K132660) manufactured by Cook Biotech Incorporated.
Like the predicate, the NervAlign® Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodelled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals.
The NervAlign® Nerve Cuff is packaged in a dried state, is for single use and provided sterile.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "NervAlign Nerve Cuff." It focuses on demonstrating the substantial equivalence of the NervAlign Nerve Cuff to a legally marketed predicate device (AxoGuard Nerve Protector; K132660).
Based on the provided document, the device (NervAlign Nerve Cuff) is not an AI/ML powered device, nor does it involve human-in-the-loop performance, or a comparative effectiveness study with human readers (MRMC). Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "Number of experts used to establish the ground truth for the test set and the qualifications of those experts", are not applicable to this specific device submission.
This submission relies on non-clinical performance testing to demonstrate substantial equivalence, rather than clinical studies involving human performance or diagnostic accuracy.
Here's the information that is applicable and can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in a numerical or pass/fail table format with specific thresholds. Instead, the "Results" column from the "Performance Data" section effectively serves as the reported device performance and implicitly demonstrates that the device met the necessary standards for its intended use and for demonstrating substantial equivalence to the predicate.
| Test | Test Method Summary | Reported Device Performance (Results) |
|---|---|---|
| Suture retention strength | A suture was placed through aged and unaged devices and the force required to pull free was measured. | Test was completed and met specification. Like predicate the device has sufficient strength for its intended use. |
| Thickness | Direct measurement of the device with micrometer when hydrated according to IFU. | Thickness measurements of device showed substantially equivalent to predicate. |
| Tensile Strength | Direct measurement of the device. Device placed between two grips and the separation force required to reach device failure was measured. | Test was completed and met specification. Like predicate device is suitable for intended use. |
| Cytotoxicity | The device was evaluated for potential cytotoxic effects using a mammalian cell line following ISO 10993-5 guidelines. | The test article extract showed no cytotoxic potential. |
| Sensitization | The device was evaluated for the potential to cause delayed dermal contact sensitization in guinea pigs based on ISO 10993-10. | Extracts of the test article showed no evidence of inducing delayed contact sensitization in the guinea pig. |
| Acute intracutaneous reactivity (Irritation) | The device was evaluated for the potential to cause irritation following intracutaneous injection in rabbits based on ISO 10993-10. | Extracts of the test article show no evidence of irritation. |
| Acute systemic toxicity | The device was evaluated for acute systemic toxicity in mice based on ISO 10993-11. | No mortality or evidence of systemic toxicity from both extracts, injected into mice. |
| Pyrogenicity | The device was evaluated for the potential to induce a pyrogenic response following intravenous injection in rabbits. Study conducted according to the United States Pharmacopeia (USP 41 - NF36, General Chapter ). | The test article met the requirements and is judged non-pyrogenic. |
| Hemolysis | The device was evaluated for hemolytic potential when in contact with blood based on ASTM F756 and requirements of ISO 10993-4. | The direct contact of the test article was slightly hemolytic. The extracts at 25, 12.5 and 6.25% were non-hemolytic. Device is suitable for intended indication. (Note: This result is presented as acceptable despite "slightly hemolytic" in direct contact, indicating agency's acceptance based on overall risk/benefit or context of use and non-hemolytic extracts). |
| Genotoxicity (AMES) | The device was evaluated for the potential to induce reverse mutations in Salmonella typhimurium and Escherichia coli tester strains per ISO 10993-3. | Extracts of the device were considered to be non-mutagenic to tester strains. |
| Genotoxicity (mouse lymphoma assay) | The device was evaluated to determine its mutagenic potential using the mouse lymphoma forward gene mutation assay per ISO 10993-3. | Test article considered non-mutagenic. |
| Endotoxin | Bacterial endotoxin testing is conducted per USP 85 and European Pharmacopoeia 2.6.14. | Device is produced and released with endotoxin level \ |
§ 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).