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The Viatrac 14 Plus Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arties) or for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

The Viatrac 14 Plus Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of the single lumen and dual lumen tubing. One lumen is used for the inflation of the balloon with a contrast medium. The second lumen in the distal shaft permits the use of a guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated.

The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length at a specific pressure.

On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral, or renal guiding catheter. An additional marker is located at the guidewire exit notch and aids in locating the guidewire exit notch.

This document is a 510(k) summary for the Viatrac 14 Plus Peripheral Dilatation Catheter, not a clinical study report for an AI/ML medical device. Therefore, the information required for acceptance criteria and study details for an AI system is not present in this document.

The 510(k) summary states that the changes to the device are minimal (a change in resin material source for an inner member material) and do not alter its technological characteristics, design, or manufacturing process. The device's substantial equivalence to the predicate device is demonstrated through:

• Biocompatibility assessment: in accordance with ISO 10993 series of standards (Cytotoxicity, Sensitization, Hemocompatibility, Pyrogenicity).
• Functional testing: (Catheter bend integrity, Inner member lumen collapse, Catheter tensile integrity, Tip tensile).

Since this is a filing for a physical medical device (a catheter) with a minor material change, and not an AI/ML-based device, the concepts of "acceptance criteria for an AI model," "test set and data provenance," "experts for ground truth," "adjudication methods," "MRMC studies," "standalone algorithm performance," "training set," and "ground truth establishment for training set" are not applicable.

Therefore, I cannot provide the requested table and study details regarding AI/ML device performance based on the provided text. The document describes a traditional medical device submission focused on material changes and physical performance, not on the performance of a diagnostic AI algorithm.

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The VIATRACTM 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal shaft has a tapered stainless steel mandrel, which provides support and flexibility to the shaft and is attached at the proximal end.

The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the catheter has a single arm adaptor that provides access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.

The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is available with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm, with lengths of 15, 20, 30, and 40 mm and in catheter lengths of 80 cm and 135 cm.

On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral or renal guiding catheter. An additional marker is located at the guide wire exit notch and aids in locating the guide wire exit notch.

The provided text describes a medical device, the VIATRAC™ 14 PLUS Peripheral Dilatation Catheter, and its 510(k) submission for substantial equivalence. It does not present a study with acceptance criteria and reported device performance in the way a diagnostic AI device would.

Instead, this document is a regulatory submission for a physical medical device (a catheter) and focuses on demonstrating its substantial equivalence to a predicate device based on its design, materials, technological characteristics, and intended use.

Here's why the provided information does not directly answer your detailed request for AI device study criteria:

• Type of Device: The device is a physical catheter, not an AI/software as a medical device (SaMD).
• Assessment Method: Its safety and effectiveness are established through in vitro bench tests and analyses, not clinical trials with human readers or standalone algorithm performance.
• Regulatory Pathway: The 510(k) process for this type of device demonstrates substantial equivalence, not necessarily meeting pre-defined diagnostic performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of your specific questions are not applicable to the content provided:

1. A table of acceptance criteria and the reported device performance: Not present. The "performance data" mentioned refers to bench test results, not diagnostic performance.
2. Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic performance. Any "test set" would refer to physical units of the catheter undergoing bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic "ground truth" to establish for a dilatation catheter.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, because it's not a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, because it's not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

Summary of Device Performance (as per document, relevant to a physical device):

The document states:
"The safety and effectiveness of the VIATRAC™ 14 PLUS Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses."

It also asserts "Technological Characteristics: Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices."

In conclusion, this document describes a traditional medical device (catheter) and its regulatory approval process, which is fundamentally different from the performance evaluation of an AI-powered diagnostic device.

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