(29 days)
The Fox sv PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries.
This catheter is not intended for the expansion or delivery of stents.
The Fox sv 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 and is accessed via the side leg port. The balloon material expands to a known diameter at specific pressure. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. 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 Abbott Vascular Fox sv PTA Catheter. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and in vitro bench tests, analyses, and biocompatibility data.
The provided text does not contain information on acceptance criteria or a study that proves the device meets specific performance metrics in terms of clinical effectiveness or accuracy (as one would expect for an AI/CADe device).
Instead, this submission is for a medical device (a PTA catheter) that underwent an engineering-based evaluation for substantial equivalence, not a performance study comparing diagnostic accuracy or clinical outcomes.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to diagnostic or clinical efficacy, nor details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The information provided relates to a traditional medical device submission, focusing on:
- Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the Fox sv PTA Catheter (a line extension) is substantially equivalent to previously cleared predicate devices (Fox sv PTA Catheter and Fox Cross PTA Catheter) based on technological characteristics and non-clinical data.
- Technological Characteristics Comparison: The submission states that the subject device is "identical in technological characteristics to the Fox sv PTA Catheter" and "substantially equivalent to the FoxCross PTA catheter with similar balloon diameters and lengths."
- Non-Clinical Data: The summary mentions "in vitro bench tests, analyses and biocompatibility data" as evidence for substantial equivalence. However, specific acceptance criteria and results from these tests are not detailed in the provided text.
If this were a submission for an AI/CADe device and the information was available, it would typically include a detailed performance study addressing the requested points.
§ 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).