(21 days)
The VascuMetrix Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.
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This document discusses a Special 510(k) submission for the VascuMetrix Dilators, which are vessel dilators for percutaneous catheterization. The submission focuses on modifications to an existing device, the Gelbfish Vascular Dilators (K0012256).
Here's an analysis of the provided information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the VascuMetrix Dilators. Instead, the submission relies on a comparison to a predicate device and a statement of "substantial equivalence."
Acceptance Criteria (Inferred from comparison to predicate):
| Criterion | Acceptance Metric (Implied) | Reported Device Performance (VascuMetrix Dilators) |
|---|---|---|
| Shaft Lumen Size | Must accommodate guidewires ≤ 0.035" | Accommodates 0.018" and/or 0.014" guidewires |
| Tip Outer Diameter | Must be within range 2.0 mm to 7.0 mm | Ranges from 1.0 mm to 10.0 mm |
| Markings/Etchings | Device size not marked (for predicate) | Device size laser etched on the tip |
| Physical Properties | Substantially equivalent to predicate | Deemed substantially equivalent |
| Performance Characteristics | Substantially equivalent to predicate | Deemed substantially equivalent |
| Intended Use | Substantially equivalent to predicate | "To be used over a guidewire to dilate or calibrate blood vessels" (same as predicate) |
Note: The phrase "substantially equivalent" in regulatory contexts implies that the new device is as safe and effective as the predicate device, and does not raise new questions of safety and effectiveness.
2. Sample size used for the test set and the data provenance
The document does not mention any specific test set, clinical data, or sample sizes used to demonstrate the performance of the modified device. The submission appears to be based on a comparison of device specifications and intended use against a legally marketed predicate device. This is typical for a Special 510(k) for minor device modifications, where new clinical data might not be required if the changes do not significantly affect safety or effectiveness.
Therefore, there is no information on data provenance (country of origin, retrospective/prospective) as no specific study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. Since no test set or clinical study is described, there's no mention of experts establishing a ground truth. The "ground truth" in this context is the performance and safety profile of the predicate device, to which the modified device is compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for the reasons stated above (no test set 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
This information is not applicable and not provided. The device in question is a physical medical device (vascular dilators), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. As explained above, the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device submission (physical medical device with minor modifications relying on substantial equivalence), the "ground truth" is fundamentally the established safety and effectiveness profile of the predicate device as previously cleared by the FDA, along with engineering and manufacturing specifications. The FDA's determination of substantial equivalence (as stated in the letter) means they found adequate evidence (likely through bench testing, material comparisons, and engineering analysis, although not detailed here) that the modified device's performance aligns with the predicate's.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are relevant for machine learning or AI models, which is not the case for this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
In summary, the provided document describes a regulatory submission for a physical medical device based on substantial equivalence to a predicate device, focusing on changes in dimensions and markings. It does not detail specific acceptance criteria in a quantitative sense for novel testing, nor does it present any clinical study data, expert reviews, or AI-related performance metrics.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).