(214 days)
Collagen Dura Membrane is intended for use as a dura substitute for the repair of dura mater.
Collagen Dura Membrane is a white, nonfriable, conformable, membrane matrix consisting of highly purified collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. The product's mechanical strength allows the membrane matrix to be sutured in place. Collagen Dura Membrane is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
The Collagen Dura Membrane is a dura substitute for the repair of dura mater. The acceptance criteria and supporting study are described below, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as demonstrating "similarity to predicate device" or "not considered sensitizing," etc., in comparison to established standards and the predicate device (Durepair® Dura Regeneration Matrix).
| Test Parameter | Acceptance Criteria (Implied from comparison) | Reported Device Performance (Collagen Dura Membrane) |
|---|---|---|
| Material Properties | ||
| Dimensions | Similar to predicate device | Dimensions similar to predicate device |
| Suture Pullout Strength | Similar to predicate device | Suture strength similar to predicate device |
| Tensile Strength | Similar to predicate device | Tensile strength similar to predicate device |
| Conformability | Similar to predicate device | Conformability similar to predicate device |
| Hydrothermal Transition | Similar to predicate device | Hydrothermal transition temperature similar to predicate device. |
| Porosity/Permeability | Similar to predicate device | Permeability similar to predicate device |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic (as per ISO 10993-5) | Non-cytotoxic. |
| Sensitization | Not considered sensitizing (as per ISO 10993-10) | Not considered to be sensitizing. |
| Intracutaneous Reactivity | No erythema and no edema (as per ISO 10993-10) | No erythema and no edema from the test extract injected intracutaneously into the rabbits. |
| Acute Systemic Toxicity | No mortality or significant systemic toxicity (as per ISO 10993-11) | No mortality or evidence of significant systemic toxicity. |
| Genotoxicity | Non-mutagenic (as per ISO 10993-3) | Non-mutagenic to Salmonella typhimurium tester strains TA98, TA100, and TA1537, and to Escherichia coli strain WP2uvrA. None of the test article treatments induced substantial increases in the number of revertant colonies. Non-mutagenic (Mouse Lymphoma Assay). Levels of micronucleated cells within normal negative ranges. Non-mutagenic (In Vivo Mouse Micronucleus Assay). |
| Pyrogenicity | Non-pyrogenic (as per USP (151)) | The test article was judged as nonpyrogenic. |
| Implantation | Minimum tissue reaction up to 4 weeks, no adverse reaction (as per ISO 10993-6) | Minimum tissue reaction up to 4 weeks of implantation and no adverse tissue reaction to the host. |
| Subchronic Systemic | No evidence of systemic toxicity or adverse findings | There was no evidence of systemic toxicity or adverse findings attributed to the test article at 13 week time point. |
| Toxicity | at 13 weeks (as per ISO 10993-11) | |
| Chronic Toxicity | No evidence of systemic toxicity or adverse findings | There was no evidence of systemic toxicity or adverse findings attributed to the test article at 26 week time point. |
| at 26 weeks (as per ISO 10993-11) | ||
| Device Performance | ||
| Dura Repair & Resorption | Performance similar to predicate device | Subject device performed as well as the predicate device. |
| Resorption Profile | Verification of design criteria | Resorption profile verified design criteria. |
| Handling/Implantability | Handles as well as predicate device with typical surgical technique | Subject device handles as well as the predicate device using typical surgical technique for implantation. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical or independent evaluation using human readers. Instead, the study uses various in vitro and in vivo models for comparison to the predicate device and established standards.
- Animal Studies:
- Rabbit dural defect repair model: Used for dura repair and resorption comparison. Specific sample size not stated.
- Rat subcutaneous model: Used for resorption profile. Specific sample size not stated.
- Canine craniectomy model: Used for handling and implantability. Specific sample size not stated.
- Biocompatibility Studies: Specific animal numbers for each test (e.g., rabbits for intracutaneous reactivity, mice for systemic toxicity and micronucleus assay) are not explicitly detailed in this summary, but would have been part of the full study protocols.
- Data Provenance: The studies are non-clinical (in vitro, animal studies). The country of origin of the data is not specified but would typically be from the manufacturing or testing facilities commissioned by Collagen Matrix, Inc. All data is prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The studies performed are non-clinical, involving laboratory testing and animal models. There is no mention of human experts establishing ground truth for a "test set" in the context of diagnostic performance or clinical outcomes in the summary provided. Expert interpretation would primarily relate to pathologists or researchers evaluating animal tissues, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set
Not applicable, as there is no mention of a "test set" requiring adjudication by human readers in this non-clinical submission summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical dura substitute, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dura substitute, not an algorithm or software.
7. The type of ground truth used
The "ground truth" for the non-clinical studies was established through:
- Comparative measurements: Direct measurements of physical properties (dimensions, strength, conformity, temperature, permeability) compared to those of the predicate device.
- Standardized biological assays: Results from in vitro and in vivo biocompatibility tests were evaluated against established criteria from ISO 10993 series and USP standards (e.g., "non-cytotoxic," "not sensitizing," "no mortality or significant systemic toxicity").
- Histopathological evaluation: For implantation and animal efficacy studies, the "ground truth" would be the pathological assessment of tissue reaction, new dura formation, resorption, and overall device integration in the animal models.
- Direct observation: For handling and implantability, the "ground truth" was based on surgical observation during the canine model study.
8. The sample size for the training set
Not applicable. The device is a physical implant, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).