(27 days)
The 0.025" HyTek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.
The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for directing the catheter through a blood vessel.
The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to facilitate smoother passage.
The HyTek Guidewire is available in diameters of .014" to .025, and in lengths from 80 cm to 300 cm.
This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI-powered medical device. Instead, it is a 510(k) summary for a traditional medical device (guidewire) seeking substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table or answer the questions related to AI device performance evaluation as the provided text pertains to a conventional medical device submission. The focus of this document is on the physical characteristics and intended use of the HyTek Guidewire and its comparability to an existing device, not on the performance of a software algorithm.
§ 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.