(24 days)
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.
§ 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).