(70 days)
Cordis Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
The catheters included in this submission are single lumen catheters with a radiopaque body and tip.
The provided text is a 510(k) premarket notification for a modification to angiography catheters. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies or acceptance criteria for a new, innovative device with a novel performance profile. Therefore, much of the requested information regarding acceptance criteria, specific study design elements, and performance metrics is not available in the provided document.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission is for a modification to an existing device, and the focus is on a statement of substantial equivalence to predicate devices rather than establishing new performance criteria. There are no specific quantitative acceptance criteria or performance results reported in the text.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission references "biocompatibility tests" but does not detail a specific test set, sample size, or the provenance of any data. The claim of substantial equivalence implies that the modified device would perform similarly to the predicate devices, which were already deemed safe and effective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Since there's no mention of a clinical or specific performance study with a test set that requires ground truth establishment by experts, this detail is absent.
4. Adjudication Method for the Test Set
This information is not provided in the document. As there's no mention of a test set requiring adjudication, this detail is not relevant to the content.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done or at least not reported in this document. This submission is for a device modification and relies on substantial equivalence to predicate devices, not on demonstrating improved human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This document describes a physical medical device (angiography catheters), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
This is not applicable in the context of this 510(k) submission. The document doesn't describe a study requiring an independent "ground truth" to evaluate the device's diagnostic or analytical performance. Safety and effectiveness are inferred through substantial equivalence and biocompatibility.
8. Sample Size for the Training Set
This information is not provided and is not applicable. Since this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the same reasons as above.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).