(118 days)
The Torcon NB® Advantage Catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
Torcon NB® Advantage Catheters are selective angiographic catheters manufactured with a thinwall radiopaque nylon material, having a blue hue. The nylon catheter is constructed with stainless steel braiding and a large internal diameter. These catheters are manufactured with a soft distal tip which may or may not be tapered at the distal tip and are manufactured in a variety of distal curve configurations (DAV, MPA, KMP, etc.) to facilitate selective angiography.
Torcon NB® Advantage Catheters are available in 4.1 to 7.0 French, and nominal lengths measuring 35 to 125 centimeters. The catheter tips may be tapered at the distal tip to accept a 0.035 or 0.038 inch diameter wire guides. Alternately, the subject device may have a non-tapered tip or may be manufactured with a closed distal end. The subject devices are manufactured with sideport quantities ranging from zero to twelve per device.
Torcon NB® Advantage Catheters are for use in angiographic procedures as a conduit for the delivery of contrast media to assist physicians in the diagnosis and management of occlusions or stenoses and in placement of medical devices. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the Cook Incorporated Torcon NB® Advantage Catheters, asserting its substantial equivalence to a predicate device.
Specifically, the document states:
- "Based on the risk analysis, no new performance testing was deemed warranted to support a determination of substantial equivalence to the predicate device."
- "There are no technological characteristic differences between the predicate device... and the subject device."
Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, and training set details) is not available in the provided text. The device's clearance is based on its similarity to an already cleared predicate, rather than new performance testing.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).