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510(k) Data Aggregation
(238 days)
Collagen Dural Regeneration Matrix
Collagen Dural Regeneration Matrix is intended for use as a dura substitute for the repair of dura mater.
Collagen Dural Regeneration Matrix is a white, non-friable, resorbable and biocompatible type I collagen matrix made from purified bovine Achilles tendon. Collagen Dural Regeneration Matrix is a porous, sponge-like collagen matrix with one smooth surface that conforms to the contours of the defect site. It is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
This document is a 510(k) premarket notification for a medical device called "Collagen Dural Regeneration Matrix." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the information provided is geared towards comparing the new device to an existing one.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for performance in a quantitative manner as one might find for a diagnostic device. Instead, it demonstrates substantial equivalence by comparing various parameters of the new device to its predicate. The "results" in the tables below effectively serve as the device performance against the implicit acceptance criteria of being "similar to predicate device" or "adequate."
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (Collagen Dural Regeneration Matrix) |
|---|---|---|
| General Characteristics (from Section 6) | ||
| Indications for Use | Same as predicate | Intended for use as a dura substitute for the repair of dura mater. |
| Collagen Source | Bovine Achilles tendon | Bovine Achilles tendon |
| Form | Porous Collagen Matrix | Porous Collagen Matrix |
| Color | White to off-white | White to off-white |
| Physical Integrity | Non-friable | Non-friable |
| Sizes | Variety of sizes | Variety of sizes |
| Conformability | Conformable | Conformable |
| Biocompatibility | Biocompatible | Biocompatible |
| In Vivo Stability | Gradual resorption | Gradual resorption |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use/Reuse | Single use only | Single use only |
| Packaging | Double blister | Double blister |
| In Vitro Characterization (from Section 7) | ||
| Dimensions | Similar to predicate | Dimensions similar to predicate device |
| pH | Similar to predicate | pH similar to predicate device |
| Tensile strength | Similar to predicate | Tensile strength similar to predicate device |
| Conformability | Similar to predicate | Conformability similar to predicate device |
| Hydrothermal transition temperature | Similar to predicate | Hydrothermal transition temperature similar to predicate device. |
| Liquid Permeability | Minimally permeable; similar to predicate | Minimally permeable; similar to predicate |
| Burst strength | Adequate for cerebrospinal fluid (CSF) pressure | Adequate for cerebrospinal fluid (CSF) pressure |
| Biocompatibility (from Section 7) | ||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Sensitization | No sensitization response | No sensitization response |
| Intracutaneous Reactivity | No erythema and no edema (for polar extract); No to very slight erythema or edema (for non-polar extract) | Met criteria |
| Acute Systemic Toxicity | No mortality or evidence of systemic toxicity | No mortality or evidence of systemic toxicity |
| Genotoxicity (Bacterial Reverse Mutagenic) | Non-mutagenic | Non-mutagenic to Salmonella typhimurium and Escherichia coli |
| Genotoxicity (Mouse Lymphoma Assay) | Non-mutagenic | Non-mutagenic (no two-fold or greater increase in mean mutant frequency) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Muscle Implantation | Not significant macroscopic reaction; Non-irritant (microscopically vs. control); Slight irritant (microscopically vs. negative control) | Achieved |
| Subchronic Toxicity | No evidence of systemic toxicity or adverse findings | No evidence of systemic toxicity or adverse findings attributed to the test article when compared with the predicate control. |
| Chronic Toxicity | No evidence of systemic toxicity or adverse findings | No evidence of systemic toxicity or adverse findings attributed to the test article; non-irritant when compared to the predicate control at 26 weeks. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) premarket notification in the way it would be for an AI/diagnostic device.
- Test Set: The "test set" here refers to the actual Collagen Dural Regeneration Matrix devices and components subjected to various in vitro and in vivo tests. The exact number of samples used for each bench test is not specified in the summary, but it would typically involve replicates to ensure statistical validity.
- Data Provenance:
- In Vitro Characterization: Laboratory internal testing data.
- Biocompatibility: Laboratory testing following ISO standards.
- Animal Efficacy Study: Conducted using a rabbit model.
- Retrospective/Prospective: The testing described is prospective, in that samples of the new device were specifically manufactured and tested for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable for a device like a dural regeneration matrix. Ground truth for its performance is established through physical, chemical, and biological testing as outlined in the tables, rather than expert interpretation of images or clinical data.
- For the animal study, the assessment of dura repair and resorption would typically be conducted by veterinary pathologists or qualified researchers. No specific number or qualifications are given in this summary.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth is established through objective laboratory and animal testing, not human readers or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that analyze images or data for human interpretation, often involving AI. The Collagen Dural Regeneration Matrix is a physical implant, not a diagnostic tool incorporating AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This is not an AI device.
7. The Type of Ground Truth Used
The ground truth for the device's performance and safety was established through:
- Physical and Chemical Properties: Measured quantitatively (e.g., pH, tensile strength, burst strength, dimensions, permeability, hydrothermal transition temperature) and qualitatively (e.g., conformability, color, physical integrity).
- Biocompatibility Endpoints: Based on standardized in vitro and in vivo assays (e.g., cytotoxicity, sensitization, systemic toxicity, genotoxicity, pyrogenicity, implantation responses).
- Animal Study Outcomes: Observation and assessment of dura repair and resorption in a rabbit model.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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