(15 days)
The FoxCross 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 FoxCross 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 guide wire 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.
The provided text describes a 510(k) submission for the Abbott Vascular FoxCross PTA Catheter, asserting its substantial equivalence to a predicate device, the FoxPlus PTA Catheter. This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, the submission focuses on demonstrating substantial equivalence based on technological characteristics and in vitro bench tests, analyses, and biocompatibility data compared to a previously cleared device. It does not present a clinical study with performance metrics or acceptance criteria for a new device's efficacy or safety.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent in the provided text.
Here's a breakdown of why each specific point cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not available. The document states "Summary of Substantial Equivalence: The FoxCross PTA Catheter...is substantially equivalent to the FoxPlus PTA Catheter...as demonstrated by the results of the in vitro bench tests, analyses, and biocompatibility data." No specific criteria or performance values are given.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. The testing mentioned is "in vitro bench tests," which typically refers to laboratory testing, not human subject data. Therefore, details like data provenance or sample size of a test set are not applicable in the context of clinical data.
- 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, as there's no clinical test set or ground truth established by experts mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set or adjudication process is mentioned.
- 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 a PTA catheter, a physical medical device, not an AI software or a device that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth is established or discussed.
- The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. There is no mention of a "training set" or ground truth for it.
In summary, the provided documentation is a 510(k) summary for a physical medical device, focusing on substantial equivalence to a predicate device via bench testing. It does not provide the type of performance study details requested for AI or diagnostic devices.
§ 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).