(185 days)
Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
The Medtronic GTX Guidewire are steerable guide wires available in a variety of stiffnesses with available hydrophilic and hydrophobic coatings, which allow for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature. The Medtronic Vascular GTX Guidewire consists of a corewire covered with spring coils and terminated in a hemispherical tip, which impart various characteristics to the distal tip of the wire, such as tip stiffness. Wire coatings provide sufficient lubricity to reach and cross target lesions. Markers on the proximal portion of the corewire aid in gauging guide wire position relative to the guiding catheter tip.
The provided text is a 510(k) summary for a medical device (GTX Guidewire). It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
Specifically, the "Summary of Nonclinical Data" states: "The Medtronic GTX Gudiewire has successfully passed all verification testing." However, it does not detail what those verification tests were, what their acceptance criteria were, or what the reported performance was.
Furthermore, the "Summary of Clinical Data" explicitly states: "No clinical investigation has been performed for this device." This means there is no human-in-the-loop study, standalone algorithm study, or MRMC study described.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document focuses on regulatory submission and substantial equivalence to predicate devices, not on the detailed performance characteristics against specific acceptance criteria.
§ 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.