(69 days)
For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
These Freeway™ and Railrunner™ Guidewires are composed of two primary components: A PTFE coated stainless steel steerable core body, and a radiopaque platinum alloy distal coil. The coil is secured in its location by solder, which is attached to the core. The coil is attached to the core at the distal end, proximal end of the coil, and at a midpoint section (intermediate ioint). The product is offered with a shapeable straight tip or in a pre-shaped configuration. The Guidewires are optionally coated with MDX (silicone) over the distal tip and hydrophilic coating over portions of the distal tip of the Guidewire. The Guidewires are bound by the following parameters: Outside Diameter: .014", Lengths: 175cm - 300 cm, Tips: Straight or shaped, Flexibility: FREEWAY - 3 and 6 gm and RAILRUNNER - 9 and 12 gm distal loads.
No AI device assessment was conducted in the provided document. The submission is for Freeway™ and Railrunner™ Guidewires, which are physical medical devices (guidewires) and not an AI/ML software. Therefore, the requested information about acceptance criteria, study details, and AI performance metrics is not applicable based on the given text.
The document discusses non-clinical testing to demonstrate equivalence to predicate devices, biocompatibility testing, and conformance with design control procedures and quality systems, but these do not involve AI performance evaluation.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.