(73 days)
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
The line extensions for Brite Tip® Catheter Sheath Introducer System is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.
This appears to be a 510(k) premarket notification for a medical device (Cordis Brite Tip® Catheter Sheath Introducer System), and the provided text primarily focuses on regulatory information, intended use, and substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-based devices or studies requiring performance data.
The document states:
- "Performance standards have not been established by the FDA under section 514 of the Food, Drug and and Cosmetic Act." This indicates there are no pre-defined FDA performance standards this device needs to meet.
- The re-submission (K974448) is a "Modification" (K971608) and a "line extension." This suggests that the substantial equivalence is based on the previously cleared device, and the modifications are likely minor enough not to require new significant performance studies.
- "All materials used in the line extensions for Cordis Brite Tip® Catheter Sheath Introducer System had been successfully tested on previously concurred devices. Since all appropriate biocompatibility tests were previously performed on these materials, testing was not repeated." This further emphasizes reliance on previous testing.
- "The modified Cordis Brite Tip® Catheter Sheath Introducer System is similar in design, constructions, indication for use, and performance characteristics to other commercially available sheath introducers." This is the core argument for substantial equivalence, implying that its performance is implicitly accepted because it's similar to already cleared devices.
Therefore, many of the requested fields cannot be filled from the provided text as they relate to performance studies, which are not detailed here.
Here's the breakdown based on the provided text, indicating where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. The document focuses on substantial equivalence to a predicate device rather than specific performance metrics or acceptance criteria for a new study. | The device is deemed "substantially equivalent" to the predicate device (Brite Tip® Catheter Sheath Introducer System, K971608) in design, construction, indication for use, and performance characteristics. No specific performance data are reported. |
Regarding the study proving the device meets acceptance criteria:
The provided document does not describe a specific study designed to prove the device meets acceptance criteria in the way one would for a novel AI/ML device or a device requiring new clinical performance data. Instead, the substantial equivalence relies on:
- Similarity to a predicate device: The modified device is stated to be similar in design, construction, indication for use, and performance characteristics to the already cleared predicate device (K971608).
- Prior testing of materials: Biocompatibility tests were previously performed on the materials used in the line extensions and successfully cleared, so no new biocompatibility testing was repeated for this submission.
Therefore, the following points address what can be inferred or what is explicitly not present in the provided text:
- 2. Sample size used for the test set and the data provenance: Not applicable/Not provided. No new test set is described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No new test set requiring expert-established ground truth is described.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. No new test set requiring adjudication is described.
- 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: No. This is not an AI/ML device, and no MRMC study is mentioned.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI/ML device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. No new ground truth establishment is described. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device and its materials.
- 8. The sample size for the training set: Not applicable/Not provided. This is not an AI/ML device; no training set described.
- 9. How the ground truth for the training set was established: Not applicable/Not provided. This is not an AI/ML device; no training set described.
§ 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).