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510(k) Data Aggregation
(500 days)
Indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
Cova™ORTHO-NERVE is a pure collagen membrane designed to be used as a barrier to allow guided healing along distinct anatomical planes. It is completely resorbable within a time frame that is compatible with healing. The membrane is obtained by standardized, controlled manufacturing processes. Cova™ORTHO-NERVE is further sterilized in double-pouches by gamma-irradiation. Cova™ORTHO-NERVE membranes are designed to be resorbable, non inflammatory and biocompatible for uses to treat peripheral nerve injuries. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™ORTHO-NERVE is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm, 30 x 40 mm and 40 x 60 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the zone to be treated.
This document describes a 510(k) premarket notification for the Cova™ORTHO-NERVE, a resorbable collagen membrane for peripheral nerve repair. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a table of acceptance criteria and reported device performance from a clinical study is not applicable in this context. The information provided relates to non-clinical data, bench tests, and animal studies to demonstrate safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission demonstrating substantial equivalence to predicate devices, specific acceptance criteria for a novel device performance claim (e.g., a specific sensitivity/specificity for an AI algorithm) are not presented in the document. Instead, the "acceptance criteria" are implied by meeting the standards for biocompatibility, physical characteristics, and safety established by the predicate devices and relevant ISO standards.
| Test Category | Acceptance Criteria (Implied by Predicate Equivalence & ISO) | Reported Device Performance (Cova™ORTHO-NERVE) |
|---|---|---|
| Biocompatibility | No cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolytic activity, mutagenicity, or clastogenicity. Absorption within a compatible timeframe. | Non-cytotoxic, No evidence of sensitization, No evidence of irritation, No mortality or systemic toxicity, No material-mediated pyrogenicity, No hemolytic activity, No evidence of mutagenicity, No evidence of clastogenicity. Absorption by 13 weeks. No inflammation observed. |
| Implantation/Performance | Protection during nerve repair, no adverse tissue reaction, no fibrous peri-nervous tissue, no systemic toxicity. | Protection during nerve repair. No fibrous peri-nervous tissue observed after 3, 60, or 90 days. No adverse tissue reaction to the implant up to 13 weeks of implantation. No systemic toxicity. |
| Viral Inactivation | Reduction of final viral load to the limit of detection. | Demonstrated "that the inactivation steps reduced down the final viral load to the limit of detection." |
| Bench Tests | Meet similar specifications as predicate devices (e.g., color, odor, feel, dimensions, suture strength, tensile strength, pH, UV spectra purity, enzymatic degradation, swelling rate, compression, kinking, endotoxin limit). | "The following tests were performed and were found to meet the similar specifications as a predicate." (Specific values not provided, but deemed acceptable) |
| Animal Study (Performance & Safety) | Ability to confer a protective environment for the repaired nerve, no fibrous peri-nervous tissue, lowered time for re-intervention. | Demonstrated "its ability to confer a protective environment for the repaired nerve." "No fibrous peri-nervous tissue was observed after 3, 60 or 90 days." "Time for re-intervention was also lowered." |
2. Sample Sizes Used for Test Set and Data Provenance
- Biocompatibility Tests: The document does not explicitly state the sample sizes for each specific biocompatibility test (e.g., how many guinea pigs for sensitization, how many mice for systemic toxicity, how many rabbits for pyrogenicity). It only indicates the types of animals used for some tests.
- Implantation/Absorption Study: Rats were used. The number of rats is not specified, but time points were 3 weeks, 30 days, and 90 days.
- Implantation (Safety and Performance) Study: Rats were used. The number of rats is not specified, but time points were 3, 30, and 90 days.
- Subchronic/Chronic Toxicity Study: Rats were used for a 13-week study. The number of rats is not specified.
- Animal Study (Performance in nerve repair): A "rat model" was used. The specific number of rats or nerves involved is not provided.
- Data Provenance: All studies (biocompatibility, implantation, animal study) appear to be preclinical (animal and in vitro) and were conducted by the manufacturer or contracted labs. The document does not specify the country of origin for the data beyond the manufacturer being in France. These are prospective non-clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes a medical device (collagen membrane) and not an AI/imaging device requiring expert-established ground truth for a test set in the conventional sense. The "ground truth" for the non-clinical studies is determined by direct measurement, observation, and histological analysis by researchers/pathologists.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the document is for a physical medical implant, not an AI or imaging diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the document is for a physical medical implant, not an AI or imaging diagnostic device. There is no "algorithm" in the context of Cova™ORTHO-NERVE.
7. Type of Ground Truth Used
The "ground truth" for the studies described relies on:
- Biochemical/Cellular Assays: For cytotoxicity, sensitization, pyrogenicity, hemolysis, genotoxicity.
- Histopathology/Microscopic Examination: For implantation studies (inflammation, tissue reaction, absorption, fibrous tissue formation around nerves).
- Direct Observation/Measurement: For physical bench tests (dimensional, tensile strength, pH, etc.).
- Viral Load Measurement: For viral inactivation studies.
- Functional Outcomes/Observation: In the animal study, the ability to confer protection and reduce re-intervention time.
8. Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of a physical medical device. The device's characteristics are inherent to its manufacturing process and material properties, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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