(85 days)
The HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
The HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coaling to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
The provided text is a 510(k) summary for a medical device called the "HD Guide Catheter." This document describes the device and claims substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria in the manner of an AI/ML device validation.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission for this specific device. The device is a physical, mechanical catheter, not a software or AI-based diagnostic tool that would typically have acceptance criteria presented in terms of sensitivity, specificity, or human performance metrics.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Anticipated - Not Explicitly Stated in Document) | Reported Device Performance (Implied from "Testing Summary") |
|---|---|
| Device performs as designed (e.g., proper dimensions, material integrity, steerability, lubricity) | "The results of verification and validation conducted on the HD Guide Catheter demonstrate that it performs as designed..." |
| Suitable for intended use (facilitating insertion/guidance of other catheters, diagnostic angiography) | "...is suitable for its intended use..." |
| Substantially equivalent to predicate device (K080583) without new safety/effectiveness issues | "...and is substantially equivalent to the predicate device." |
Explanation: The document does not list specific numerical acceptance criteria (e.g., bend radius, tensile strength values) or corresponding performance metrics. Instead, it makes a general statement that "The results of verification and validation conducted on the HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device." This is typical for a 510(k) summary for a Class II medical device, where detailed test reports are submitted to the FDA but not necessarily included in the public-facing summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "Testing Summary" and "results of verification and validation," implying laboratory or bench testing, but no human subject or clinical study details are provided.
- Data Provenance: Not applicable, as this refers to a physical device's characteristics, not patient data.
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. This device is a physical catheter, not a diagnostic or AI-driven interpretative tool that requires expert-established ground truth. Validation would involve engineering and materials testing by qualified personnel, not medical experts establishing a "ground truth" for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which are not described for this device's validation.
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 a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for a physical device like this would be its engineering specifications, material properties, and performance under simulated use conditions.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI/ML model.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).