(209 days)
The Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.
The guide wires may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
The Hi-Torque Command™ 14 ST Guide Wire (guide wire with short taper) and Hi-Torque Command™ 14 MT Guide Wire (guide wire with medium taper) have a maximum diameter of 0.0144" (0.366 mm) and are provided in 210 cm and 300 cm lengths. The distal tip of the guide wire is available as a straight tip or an angled tip, both of which are shapeable.
The provided document (K240997 Summary) outlines the premarket notification for the Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire. This document does not describe an AI/ML-enabled device. Therefore, a study demonstrating the device's performance against acceptance criteria for an AI/ML model, as requested in the prompt, is not present.
The information in the document pertains to a traditional medical device (guide wires) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and simulated use testing, and biocompatibility testing. Clinical studies were not deemed necessary.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them based on the provided text. The prompt's specific requirements (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are applicable to AI/ML device evaluations, not to the traditional medical device described in this 510(k) summary.
§ 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.