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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.

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The Fox sv 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 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, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (maximum 0.018"). The balloon material expands to a known diameter at specific pressures.

The provided text describes a 510(k) summary for the Fox™ sv PTA Catheter, asserting its substantial equivalence to predicate devices. It focuses on in vitro bench tests and biocompatibility testing to demonstrate safety and effectiveness.

However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, reported device performance (beyond general safety and effectiveness), details about a study that proves it meets these criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The 510(k) summary primarily addresses:

• Device Identification: Submitter, trade name, common name, classification details.
• Predicate Devices: Identifies K062843 (Fox sv PTA Catheter) and K942094 (Cordis® SAVVY® PTA Dilatation Catheter).
• Device Description: Standard over-the-wire PTA catheter with a double lumen and balloon.
• Intended Use: Dilatation of lesions in various arteries and arteriovenous dialysis fistulae.
• Technological Characteristics Comparison: Notes that the subject device is identical to the predicate Fox sv PTA Catheter except for an extended catheter length (150cm from 135cm). It also compares favorably to the Cordis® SAVVY® PTA Catheter across multiple characteristics.
• Summary of Substantial Equivalence: States that "The results of the in vitro bench tests and analyses and biocompatibility testing demonstrate the safety and effectiveness of the Fox sv PTA Catheter subject device."

Therefore, based solely on the provided text, the requested details about acceptance criteria and a specific study proving device performance are not available.

Ask a specific question about this device

The Fox SV 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 delivery or expansion 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, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon material expands to a known diameter at specific pressure.

Sorry, but this document does not contain the information required to answer your question. The document is a 510(k) summary for a medical device (Fox SV PTA Catheter) and focuses on regulatory approval and substantial equivalence to a predicate device. It does not include details about acceptance criteria, study methodologies, or performance data in the way you've outlined.

The provided document describes:

• The device trade name, classification, and regulation number.
• The intended use and device description.
• A statement of substantial equivalence based on non-clinical testing.
• FDA communication regarding the 510(k) premarket notification.

It lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• Types of ground truth used (e.g., pathology, outcomes data).
• Training set sample sizes or how training set ground truth was established.

Ask a specific question about this device

The Fox SV 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 delivery or expansion 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, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon material expands to a known diameter at specific pressure.

The provided document, a 510(k) summary for the Fox SV PTA Catheter, does not contain information on acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document states: "The Fox SV PTA Catheter is substantially equivalent to the predicate device. Substantial equivalence was confirmed through non-clinical testing."

This indicates that the primary method for demonstrating safety and effectiveness for this 510(k) submission was a comparison to a legally marketed predicate device (Fox Plus PTA Catheter K040954) through non-clinical testing, rather than a clinical study with defined acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on demonstrating substantial equivalence, device description, and intended use as per 510(k) requirements, not on detailed performance study results against specific acceptance criteria.

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