(90 days)
As provided in 21 CFR 870.1340, a catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
The BD Introsyte™ products identified in this 510(k) notification are splittable, polyethylene catheter introducers. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate spring-activated needle-shielding technology. BD Introsyte introducers are available in sizes ranging from 16 to 24 gauge. BD Splittable Needle Introducers range from 16 to 24 gauge.
The provided text is a 510(k) premarket notification summary for various BD Introsyte Catheter Introducer products. It details their intended use, technological characteristics, and a conclusion of substantial equivalence to predicate devices based on nonclinical tests.
Acceptance Criteria and Device Performance
Based on the provided text, the acceptance criteria are not explicitly stated in numerical or statistical targets. Instead, the primary acceptance criterion for these modified devices (BD Introsyte™ Precision Introducer, BD Introsyte-N™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer, BD Introsyte-N™ Autoguard™ Shielded Introducer, and BD Splittable Needle Introducer) is substantial equivalence to their unmodified predicate devices. This substantial equivalence is demonstrated through nonclinical tests.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance | Study Conclusion |
|---|---|---|
| Substantial Equivalence in: | Penetration: Tested side-by-side with unmodified devices. | Data demonstrated substantial equivalence in product performance. |
| - Product Performance | Catheter Drag: Tested side-by-side with unmodified devices. | Data demonstrated substantial equivalence in product performance. |
| - Biocompatibility | Not explicitly detailed what specific biocompatibility tests were performed, but a general statement of equivalence. | Data demonstrated substantial equivalence in biocompatibility. |
The key modification highlighted is the change in lubrication systems to be "ozone friendly." The study aimed to show that this change did not adversely affect the device's performance or safety compared to the existing, legally marketed versions.
Study Details:
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Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size (number of devices or tests performed) for the side-by-side testing. It states "Side-by-side testing of modified and unmodified devices was conducted."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be entirely nonclinical (laboratory testing) rather than involving human subjects. It is retrospective in the sense that the new devices are compared to previously established devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a nonclinical study involving physical performance tests (penetration, catheter drag) and biocompatibility, not a diagnostic or clinical study requiring expert interpretation of results or establishment of ground truth in a clinical context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As a nonclinical, objective performance test, there would typically be no human adjudication process of test results in the way it's done for clinical image interpretation or diagnosis. The data would be quantitatively compared against predefined parameters.
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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 is a nonclinical study of physical medical devices (catheter introducers), not a study involving AI, human readers, or image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This study does not involve an algorithm or AI. It is a nonclinical performance evaluation of physical devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for evaluating the modified devices was the established performance and biocompatibility of the unmodified predicate devices. The tests aimed to demonstrate that the modified devices performed equivalently to these established benchmarks.
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The sample size for the training set:
- Not applicable. This is a nonclinical performance study, not a machine learning study that would involve training sets.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of nonclinical device performance evaluation.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).