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510(k) Data Aggregation
(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 <151>). | 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 <2.15EU/device. |
| Subacute Systemic Toxicity & Local effects of Implantation | The device was surgically implanted in the subcutaneous tissue of rats for 4 weeks to evaluate its potential systemic toxicity and local tissue response. | The device showed no evidence of systemic toxicity. Device appeared as a well-integrated scaffold with remodelling responses. Microscopically the test article demonstrated minimal reaction to the tissue. |
| Sub-chronic Systemic Toxicity & Local effects of implantation | The device was surgically implanted in the subcutaneous tissue of rats for 8 and 13 weeks to evaluate potential systemic toxicity after 13 weeks and local tissue responses after 8 and 13 weeks. | On subcutaneous implantation the device showed no evidence of systemic toxicity after 13 weeks. Microscopically the test article demonstrated minimal tissue reaction compared to control. Device was bioresorbing at 13 weeks as expected. |
| 6-Month Nerve Wrap Study in New-Zealand White Rabbits | The device was surgically implanted around the sciatic nerve of rabbits for 1, 2 & 6 months. The effects and compatibility of the wrapping material on the nerve and surrounding tissues were assessed. | The device was well tolerated with no device related clinical signs, changes in body weight, food consumption, neurological parameters, NCV, clinical pathology, or organ weights up to 6 months post-implantation. No adverse macroscopic or microscopic changes in the nerve and surrounding tissues were observed. No device related axonal degeneration was observed. |
| Rat transected sciatic nerve model | The device was surgically implanted around the transected sciatic nerve of the rat and compared to nerves wrapped with marketed predicate control material. Data were collected at 1, 4 and 13 weeks. Local tissue responses and device degradation were evaluated, and motor and sensory neurological assessments were conducted. | At all time points the changes observed in the nerve were similar between device and predicate control material and were typical of changes in a nerve after transection. At all time points the device was considered to elicit no or minimal reaction in comparison to the predicate control. The reactivity scores for device and predicate control decreased at later time points indicating healing. The device was markedly or completely degraded at 13 weeks, compared with the control device which was not degraded. Neuromas were not observed in any animal. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact numerical sample sizes (e.g., number of devices, number of animals) for each test. Instead, it describes the type of animal models used:
- Guinea pigs for Sensitization.
- Rabbits for Acute Intracutaneous Reactivity and Pyrogenicity.
- Mice for Acute Systemic Toxicity.
- Rats for Subacute Systemic Toxicity & Local effects of Implantation and Sub-chronic Systemic Toxicity & Local effects of Implantation.
- New-Zealand White Rabbits for 6-Month Nerve Wrap Study.
- Rats for Rat transected sciatic nerve model.
The document focuses on the results rather than the specific numbers of subjects/samples per test.
- Data Provenance: The document does not explicitly state the country of origin for the data generation. The company, ReNerve Ltd, is listed with an address in North Melbourne, Victoria, Australia. The studies are non-clinical (animal and lab-based physico-chemical) retrospective in nature, meaning they were conducted prior to this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This submission is based on non-clinical performance testing for substantial equivalence, not a diagnostic or prognostic performance study that would require human expert-established ground truth. The "ground truth" for these tests comes from established biological/chemical/physical assay standards (e.g., ISO 10993 guidelines, USP, ASTM).
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, this is a non-clinical performance study, not a study where human readers would be assessing or adjudicating results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size for human readers.
- No, a MRMC comparative effectiveness study was not done. This is a non-AI, non-diagnostic medical device. The study evaluates the physical, chemical, and biological compatibility of the device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used.
- For physical and chemical tests: Ground truth is established by the specified test methods and industry standards (e.g., ISO standards, USP, ASTM, internal specifications). For example, "Test was completed and met specification."
- For biological compatibility (biocompatibility) and animal studies: Ground truth is established by the observed biological responses and histological findings in the tested animals, compared against established safety profiles and often against a control or predicate material (as seen in the rat sciatic nerve model comparing to predicate control material). The interpretation of these observations is made by trained personnel in the field (e.g., toxicologists, pathologists).
8. The sample size for the training set.
- Not Applicable. This is not an AI/ML device that requires a training set. The "test set" in this context refers to the samples/animals used for the non-clinical performance testing.
9. How the ground truth for the training set was established.
- Not Applicable. As per point 8, there is no "training set."
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