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510(k) Data Aggregation
(153 days)
The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
The Busse Epidural Catheter is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.
The provided document is a 510(k) summary for the Busse Epidural Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria for device performance in the way a clinical trial or algorithm performance study would. Instead, it details biocompatibility testing for the materials used in the catheter.
Here's an breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| L929 Men Elution Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Kligman Maximization Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Intracutaneous Injection Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Systemic Injection Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Salmonella Typhimurium; and Escherichia Coli Reverse Mutation Assay | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Hemolysis - Rabbit Blood | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| 14 Day Repeat Dose Intravenous Toxicity Study (Sub - Chronic) | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Intramuscular Implantation Test - ISO | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
Note: The document states "These materials have met the testing requirements and were found to be acceptable for the intended use" for all listed tests, implying that meeting the standard for each test constitutes the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This document describes biocompatibility testing of materials, not a test set of data for an AI/algorithm. Therefore, concepts like sample size for a test set, and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The tests listed are laboratory-based assessments of material interaction with biological systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. Ground truth, in the context of expert review, is not relevant for the biocompatibility tests described. These tests have established scientific methods and pass/fail criteria.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods are typically used when there's subjective interpretation, like in a clinical image review. Biocompatibility tests have objective results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This document is for a physical medical device (epidural catheter), not an AI/algorithm where human reader performance would be evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an AI/algorithm device, so standalone performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the biocompatibility tests is the established scientific methodology and criteria for each specific test (e.g., cell viability in L929, skin reaction scores in Kligman, hemolytic index in rabbit blood). Pathology would be relevant if the study involved tissue analysis from implantation, which is part of the Intramuscular Implantation Test. Outcomes data is not mentioned in these specific tests.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there's no training set, this question is not relevant.
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