(5 days)
The Boston Scientific Talon Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the iliac, femoral, ilio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Talon Balloon Dilatation Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guidewire. The device is designed to be placed over guidewires which have outer diameters of 0.018" or smaller. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings. The device is offered in two lengths of 90 cm and 135 cm. The shaft tapers proximally from 4.0 Fr to a distal 3.4 Fr.
A non-compliant balloon is bonded to the distal tip of the catheter, which inflates to a known diameter and length at a specific pressure. The balloon is offered in diameters of 4.0 mm, 5.0 mm, 6.0 mm, and 7.0 mm and is available in lengths of 15 mm, 20 mm and 40 mm. The balloon is designed to exhibit controlled compliance, high rated burst pressure, and safe failure modes (longitudinal tearing).
Two radiopaque markerbands are located under the effective dilatation area of the balloon, one at the proximal transition area and the other at the distal transition area. These markerbands enable accurate positioning of the balloon in the stenosis.
Proximally the balloon lumen ends in a female luer fitting for attachment of a manometer and inflation device.
Each catheter is shipped with a wing-folding tool in place over the balloon. It is designed to protect the balloon and to hold it tightly during shipping and prior to use.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a training set.
The document is a 510(k) summary for the Boston Scientific Talon Balloon Dilatation Catheter, which primarily focuses on establishing substantial equivalence to a predicate device (K000798). The summary states that the materials and design are equivalent and the only change is the addition of a warning to the Directions for Use. It describes the device, its intended use, and confirms its classification and regulatory status.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study.
§ 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).