(137 days)
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
The Impress® Angiographic Catheters with hydrophilic coating are single lumen catheters offered in 4F and 5F sizes and 40cm to 125cm. The outer surface of the distal segment of the catheter shaft is coated with a hydrophilic coating.
The provided text pertains to a 510(k) premarket notification for a medical device, specifically the Impress® Angiographic Catheter with Hydrophilic Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with a statistical analysis plan typically associated with novel AI devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, ground truth types) are not applicable to this document. The submission relies on comparative testing to existing, legally marketed devices.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list a table of "acceptance criteria" against numerical performance metrics for the device, as would be expected for an AI/diagnostic device. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy | Met acceptance criteria |
| Substantial Equivalence to Predicate Devices | Demonstrated based on indications for use, design, safety, and performance testing. |
The "performance tests" mentioned are likely a series of engineering and biocompatibility tests (e.g., burst pressure, tensile strength, lubricity for the hydrophilic coating) to ensure the device meets its design specifications and operates safely, as opposed to a diagnostic accuracy study. The document emphasizes substantial equivalence to existing predicate devices (Impress® Angiographic Catheter K053171 and Radifocus® Glidecath™ K915414).
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. This is a medical device registration (510(k)) for an angiographic catheter, not a diagnostic AI device requiring a clinical test set with patient data. The "tests" refer to device-specific engineering and biological compatibility evaluations.
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. Ground truth establishment by experts is relevant for diagnostic performance studies, which are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies when establishing ground truth from multiple expert interpretations, which is not described in this 510(k) submission.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as relevant to diagnostic accuracy is not discussed. The "truth" here would refer to the device meeting its engineering specifications and being biologically safe and compatible.
8. The sample size for the training set
Not applicable. Training sets are relevant for AI algorithms.
9. How the ground truth for the training set was established
Not applicable. Training sets and their ground truth are relevant for AI algorithms.
§ 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).