FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This submission, K960975 for the Cordis 4F Infiniti Angiographic Catheter, is a Premarket Notification 510(k). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving device performance against detailed acceptance criteria through a clinical study in the way a PMA (Premarket Approval) submission would.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable to this 510(k) submission.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. A 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific, pre-defined quantitative performance acceptance criteria through a clinical trial in the same way a PMA would. The submission states, "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." The "performance" described is in comparison to predicate devices, focusing on design, construction, indication, and general performance characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The submission does not describe a clinical study with a "test set" in the context of diagnostic performance or efficacy. It refers to "appropriate biocompatibility tests," but these are typically bench tests or animal studies, not human clinical trials with specific "test sets" for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No human clinical study involving experts establishing ground truth for a diagnostic test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No human clinical study 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

Not Applicable. This device is an angiographic catheter, a physical medical device for delivering contrast medium, not an AI-powered diagnostic system. MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No diagnostic performance study requiring "ground truth" is described in this 510(k) summary. The submission focuses on the safety and functional characteristics of the catheter.

8. The sample size for the training set

Not Applicable. As this is not an AI/algorithm-based device, there is no concept of a "training set."

9. How the ground truth for the training set was established

Not Applicable. As this is not an AI/algorithm-based device, there is no concept of "ground truth for a training set."

Summary of what is provided in the 510(k) summary:

The provided text focuses on demonstrating substantial equivalence for the Cordis 4F Infiniti Angiographic Catheter to its predicate devices (Cordis 4F Nylex Angiographic Catheter and Cordis Paragon Angiographic Catheter) by highlighting similarities in:

Design: 4F diameter with braided proximal shaft and radiopaque tip.
Construction: Implied to be similar to predicate devices.
Indication for Use: "delivery of radiopaque contrast medium to selected sites in the vascular system" (identical to predicate).
Performance Characteristics: Assumed to be similar to functionally equivalent predicate devices.
Biocompatibility: "All appropriate biocompatibility tests were successfully performed on the materials used." This is a crucial safety aspect, but specific criteria or the detailed results of these tests are not included in this summary.

The "study" referenced implicitly in a 510(k) is the comparison to predicate devices and any non-clinical testing (like biocompatibility, as mentioned) to ensure safety and performance are equivalent. It is not a clinical study designed to establish quantitative acceptance criteria for diagnostic accuracy or efficacy.

Summary

Regulation Number and Section

§ 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).