(99 days)
The Spartan Center Wire™ is indicated for general intravascular use in the peripheral vasculature. It can be deployed into the vessel to facilitate the selective placement of diagnostic or therapeutic catheters.
The device is not intended for use in the coronary or neuro vasculature.
The Spartan Center Wire™ is a stabilizing exchange wire designed for temporary assistance in catheter exchange. The device is comprised of a tubular mesh tip attached to a pusher wire of adequate length to accommodate the exchanging of catheters commonly used for access, stabilization, or aspiration. The pusher wire diameter is 0.015" (0.38 mm) with length 350 cm to allow for the exchange of therapeutic devices without the use of extension wires or other exchange devices. The distal end is a permanently attached self-expanding mesh that is deployed out of an introducer sheath and into the vessel where it conforms to the vessel wall. There are 3 distal radiopaque markers and 1 proximal radiopaque marker visible under fluoroscopy. The deployed and stable mesh ensures that the wire is not displaced from the desired position and can be advantageously utilized in multiple exchanges or re-positioning of catheters. The Spartan Center Wire™ is offered in 2 available sizes to accommodate common vascular sizing. There is a 4 mm diameter basket with 15 mm useable length and a 6 mm basket with 30 mm useable length. Both sizes are compatible with catheters that have a minimum I.D. of 0.027".
The provided text describes the performance data for the Spartan Center Wire™ medical device, primarily focusing on bench testing, biocompatibility, sterilization, pyrogenicity, shelf life, and animal studies. However, it does not contain information about acceptance criteria or studies related to an AI/ML-driven device's performance in a diagnostic context, MRMC studies, or multi-reader studies. The device in question is a physical catheter guidewire, not a medical AI software.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance of an AI/ML device from the provided text. The prompt asks for details that are not present in the document.
The document explicitly states: "No clinical testing was conducted." and "No torque device is needed or supplied with the Spartan Center Wire™." This reinforces that the evaluation is for a physical device, not an AI/ML software.
§ 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.