(122 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 arteries, and carotid arties) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
The Viatrac 14 PLUS Pcripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen in the distal shaft permits the use of a guide wire 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 guide wire exit notch and aids in locating the guide wire exit notch.
The design of this catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
This is a 510(k) premarket notification for a medical device (Viatrac® 14 PLUS Peripheral Dilatation Catheter), not an AI/ML powered device, therefore the request portions are not applicable.
The document describes a catheter used for dilatation in peripheral vasculature and for post-dilatation of stents. The substantial equivalence was demonstrated through in vitro bench tests and retrospective analyses of clinical studies comparing it to previously cleared predicate devices. The submission indicates no changes to technological characteristics, materials, biocompatibility, performance, sterilization, or packaging. The core of the submission is to align the device's indications for use more closely with clinical use.
Therefore, the information for acceptance criteria, study details, expert involvement, and ground truth establishment, which are common for AI/ML device evaluations, are not found in this document.
§ 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).