(210 days)
The IVT 0.014" Railwire™ is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
The IVT 0.014" Railwire™ is constructed from a stainless steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible. The core is nominally 0.0136" in diameter. The coil, approximately 1.2 * in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. Both the core and coil are single continuous pieces that are secured together at two points. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder. This design provides both unibody integrity and flexibility. The IVT Railwire™ will be manufactured in various lengths ranging from 100 to 300 cms. All Railwire™s will receive a final parylene (polypara-xylyene) coating prior to packaging and sterilization. Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the Railwire™ allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.
This document describes a medical device, the IVT 0.014" Railwire™, a guidewire. It does not contain information about studies related to AI/ML device performance, acceptance criteria, or ground truth establishment as it predates modern AI/ML medical device evaluations. The request for information such as "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are all related to the evaluation of AI/ML-driven devices.
Therefore, since the provided text describes a physical medical device (a guidewire) and not an AI/ML-driven device, the requested information (acceptance criteria, study details, expert involvement, and ground truth for AI/ML evaluation) is not applicable or available within the given document.
The document discusses:
- Device Description: Construction materials (stainless steel, gold alloy coil), dimensions, coating (parylene), and mechanism of steering.
- Intended Use: To facilitate navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
- Substantial Equivalence: Comparison to predicate guidewire devices (IVT 0.014" Guidewire, IVT 0.014" Peripheral Guidewire, Cook Family of Guidewires) based on intended use, materials, design, technical characteristics, labeling, biocompatibility, and physical performance testing.
It concludes that the device is safe, effective, and substantially equivalent to similar marketed devices based on these traditional medical device evaluation standards.
§ 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.