(29 days)
The Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures.
The Insertion Tool is a sterile accessory device indicated to facilitate the introduction of a guidewire into the lumen of a guiding catheter, without damage to the guidewire's distal tip.
It is designed to accommodate guidewires with diameters from 0.010" to 0.018" and is composed of a rigid funnel known as the hub which is attached to a stainless steel hypotube. The interior of the hub is designed to allow a guidewire with multiple bends at the distal tip to be directed easily into the smaller diameter stainless steel hypotube.
This document is a 510(k) summary for an "Insertion Tool" and does not relate to an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human-in-the-loop performance, and training/test set specifics for an AI/ML model is not applicable and cannot be extracted from the provided text.
The document describes a medical device, its intended use, and comparison to predicate devices, focusing on design verification and validation through bench tests. There is no mention of AI/ML algorithms or their performance in this submission.
§ 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.