(28 days)
Boston Scientific ChoICE™ PT, PT Graphix™, ChoICE, Luge, and Mailman Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
Boston Scientific CholCE™ PT Magnet, PT Graphix™ Magnet, CholCE Magnet, Luge Magnet, and Mailman Magnet Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
The Boston Scientific CholCE™, Mailman™, Luge™, CholCE™ PT, and CholCE™ PT Graphix Guide Wires with ICE® Hydrophilic Coating are available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm or 300 cm. These guide wires contain a 304 stainless steel core wire. The proximal section of the core wire of all models is coated with polytetrafluoroethylene (PTFE) for lubricity. The distal end of the core wire is formed (flattened) to allow for shaping. All models are available with a shapeable Straight Tip or a preformed "J" Tip to address user preference. Varying tapers along the distal core wire and differing tip materials (spring coil or polymer) provide combinations of rail support and tip flexibility to address user requirements. The 182 cm guide wires are designed with an extension section for exchange of Over-the-Wire systems by using either the MAGNET Exchange Device or the AddWire™ Extension Wire. The 300 cm guide wires allow exchange of therapeutic devices without the use of an extension wire or exchange system.
The provided text is a 510(k) Summary for Boston Scientific guide wires. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria.
The document primarily focuses on non-clinical testing performed to demonstrate that the new guide wires are "substantially equivalent" to previously cleared predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/ML device from this document. This document pertains to a medical device approval that relies on substantial equivalence and non-clinical testing, not on an AI/ML algorithm's performance against specific acceptance criteria in the manner requested.
If you have a document for an AI/ML device submission that includes a performance study, I would be able to extract that information.
§ 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.