(30 days)
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, or with "J" end. The wires range from .014" diameter through .025" diameter and lengths from 20cm. to 360 cm. The wires may also be PTFE coated.
This document is a 510(k) summary for a medical device (guidewire) and does not describe an AI/ML device or a study involving acceptance criteria for such a device.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or multi-reader multi-case studies, as these concepts are not applicable to the provided document.
The document discusses the substantial equivalence of Galt Medical's Vascular Guidewires (Mandrel Type) to previously marketed guidewires (predicate devices) based on non-clinical tests like tensile strength and torqueability. It's a regulatory submission for a traditional medical device, not a software or AI/ML product.
§ 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.