(66 days)
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:
- A table of acceptance criteria and the reported device performance: Not present. The "performance data" mentioned refers to bench test results, not diagnostic performance.
- 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.
- 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.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, because it's not a diagnostic device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, because it's not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable (no AI model).
- 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.
§ 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).