(114 days)
The Crosstella RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Crosstella RX PTA Balloon Dilatation Catheter (Crosstella RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Crosstella RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Crosstella RX in a PTA procedure is 0.018 inches; hence, sheath introducers with a minimum diameter of 4 or 5 Fr have been deemed to be compatible with Crosstella RX. The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1500 and 2000 mm.
The Crosstella RX is provided with the following accessory device:
- . Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.
This document describes the Crosstella RX PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document focuses on the regulatory submission to the FDA (510(k) summary) and details of the device's design, indications for use, and a list of performance and biocompatibility tests conducted. While it states that the device "met all the predetermined acceptance criteria of design verification and validation," it does not provide the actual criteria or the results in a tabulated format.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, expert details for ground truth, or adjudication methods, as this information is not present in the provided text.
§ 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).