(26 days)
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.
The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.
This document is a 510(k) summary for the Fox™ Plus PTA Catheter. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. It typically does not involve clinical studies designed to prove performance against specific acceptance criteria in the way that novel devices might. Instead, the focus is on demonstrating equivalence to an existing, legally marketed device.
Therefore, many of the requested elements of your query are not applicable to a 510(k) submission for substantial equivalence based on identical technological characteristics and aging tests.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device: The subject device must be identical in technological characteristics to the predicate device. | The Fox™ Plus PTA Catheter subject device is identical in technological characteristics to the Fox Plus PTA Catheter predicate device. |
| Aging Test Results: The device must demonstrate substantial equivalence to the predicate device based on aging tests. | The results of the aging tests demonstrate that the Fox Plus PTA Catheter subject device is substantially equivalent to the predicate device. |
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 applicable/not provided. The document primarily relies on demonstrating identical technological characteristics and aging test results, not a clinical test set in the traditional sense.
- Data provenance: Not applicable/not provided.
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 for a clinical test set is not established in this type of submission. The "ground truth" here is the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical test set requiring adjudication.
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 a medical catheter, not an AI-powered diagnostic device. No MRMC study was conducted.
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)
- The "ground truth" in this context is the safety and efficacy profile of the previously cleared predicate device, to which the subject device is deemed substantially equivalent. The substantial equivalence is demonstrated through identical technical characteristics and performance in non-clinical tests (like aging tests).
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).