(379 days)
DuraGen™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.
DuraGen™ Dural Graft Matrix is an absorbable implant for repair of dura mater. DuraGen [M is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. DuraGen™ is manufactured from bovine achilles tendon, which is classified by European Standards as Class IV material, no detectable infectivity for Bovine Spongiform Encephalopathy (BSE). The bovine tendon is known to be one of the purest sources of Type I Collagen that is commercially available. The collagen used to manufacture DuraGen™ is currently used in the manufacture of an artificial skin, absorbable hemostatic sponges, and absorbable wound dressings. The manufacturing process for DuraGen134 meets the United States Food and Drug Administration's Guidance document and European Standards for animal tissue sourcing, handling and inactivation of BSE. This process involves a treatment with sodium hydroxide that is a recognized method of inactivation of Spongiform Encephalopathy (SE). The bovine tendon is only obtained from facilities in the United States of America that have been inspected by the United States Department of Agriculture (USDA). Bovine Spongiform Encephalopathy (BSE) is not known to exist in the United States of America, therefore, the United States of America is considered by the European Union as a low risk country for bovine sourced materials. A viral inactivation study for the DuraGen™ manufacturing process was conducted by an independent certified laboratory. In this study, the sodium hydroxide treatment was evaluated for its ability to inactivate the following viral strains: I luman Immunodeficiency Virus Type I (HIV), Bovine Viral Diarrhea (BVD), Infectious Bovine Rhinotracheitis (IBR), Parainfluenza Virus Type 3 (P13). Vesicular Stomatitis (VSV). For these viruses, the sodium hydroxide treatment reduced the viral titer to non-detectable levels.
The provided text is a 510(k) Premarket Notification Summary for the Integra LifeSciences Corporation DuraGen™ Dural Graft Matrix. This document focuses on demonstrating substantial equivalence to existing devices rather than meeting specific performance acceptance criteria for a new, novel device. As such, the information you've requested regarding acceptance criteria, a study proving device meeting criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.
Specifically:
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Acceptance Criteria and Reported Device Performance: This information is not explicitly stated as "acceptance criteria" in the traditional sense of a new device coming to market. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety/effectiveness data. The "Clinical Studies" section notes that the device "performed safely and effectively as a dura substitute" based on clinical evaluations, but no numerical performance metrics or acceptance thresholds are given. The "TABLE 1: Substantial Equivalence Comparison Chart" compares technical characteristics (materials, absorption time, non-pyrogenic status) to predicate devices, but these are characteristics, not performance metrics against acceptance criteria.
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Sample Size for Test Set and Data Provenance:
- The "Clinical Studies" section mentions "Clinical evaluations involving more than 1,000 patients." It also states, "biopsies of the collagen implant were available from 100 patients for macroscopic and histological examination." It is unclear if these 1,000+ patients constitute the "test set" for the primary clinical evaluation or a broader set of patients where the collagen sponge was used.
- The provenance of the data (country of origin, retrospective/prospective) is not specified.
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Number of Experts and Qualifications: This information is not provided.
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Adjudication Method: Not provided.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or described. This type of study is more common for diagnostic imaging AI devices, whereas DuraGen™ is a surgical implant.
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Standalone Performance Study: Not described in the context of an "algorithm only" performance. The clinical studies described involved human evaluation of the device's performance in patients.
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Type of Ground Truth Used:
- For the clinical study, the text states "biopsies of the collagen implant were available from 100 patients for macroscopic and histological examination." This suggests histology/pathology was used to assess outcomes like graft encapsulation, neomembrane formation, delayed hemorrhage, or foreign body reactions.
- The "Clinical evaluations" also likely relied on clinical outcomes data (e.g., integrity of the dura repair, complications).
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Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set in that context. The "training" in this case refers to prior experience with the material in other products. The manufacturing process does undergo viral inactivation studies, but this is a process validation, not a training set.
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How Ground Truth for Training Set Was Established: Not applicable.
Summary of available information formatted as requested (with caveats):
| Feature | DuraGen™ Dural Graft Matrix | Acceptance Criteria (Not applicable/Not explicitly defined in this submission format) |
|---|---|---|
| Performance in Clinical Use | Safely and effectively as a dura substitute (subjective clinical evaluation) | |
| Incidences of graft encapsulation | None (in 100 biopsies) | |
| Incidences of neomembrane formation | None (in 100 biopsies) | |
| Incidences of delayed hemorrhage | None (in 100 biopsies) | |
| Incidences of foreign body reactions | None (in 100 biopsies) | |
| Biocompatibility | Noncytotoxic, nonpyrogenic, nonmutagenic, nonsensitizing, absorbed with no cellular or allergic responses | |
| Viral Inactivation (Sodium Hydroxide Treatment Effect) | Reduced viral titer to non-detectable levels for HIV, BVD, IBR, PI3, VSV |
Study Information:
- Study Proving Device Meets Criteria: A "long-term clinical study" and "clinical evaluations involving more than 1,000 patients" were conducted.
- Sample Size (Test Set):
- "More than 1,000 patients" for general clinical evaluations.
- "100 patients" had biopsies available for macroscopic and histological examination.
- Data Provenance: Not specified (country, retrospective/prospective).
- Number of Experts for Ground Truth: Not specified.
- Qualifications of Experts: Not specified.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance Study: No (not applicable in the AI context).
- Type of Ground Truth Used: Clinical outcomes and macroscopic/histological examination of biopsies (pathology).
- Sample Size for Training Set: Not applicable (physical device).
- How Ground Truth for Training Set was Established: Not applicable.
§ 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).