(266 days)
The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.
The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle. The distal tip of the MRWire is marked with discrete ring markers for MRI visibility and comes in different configurations such as straight and angled. Additionally, the Pebax® tip extrusion, contains BaSO4 for X-Ray visibility.
Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).
The provided document is a 510(k) summary for the MRWire Guide Wire. It details the device, its intended use, and a comparison with a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI algorithm or human readers for diagnostic performance. Therefore, many of the requested fields, particularly those related to AI model evaluation, ground truth establishment, expert consensus, and MRMC studies, cannot be directly addressed from this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests, implying certain acceptance criteria were met for each, but it does not quantitatively define these criteria or provide specific numerical results for each test. Instead, it offers a qualitative statement of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Proximal shaft stiffness meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Bend strength meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Tensile Strength meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Torque Strength meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Torqueability meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Tip Flexibility meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Catheter Compatibility meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Dimensional Verification meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| Biocompatibility meets standard | Testing confirmed performance is substantially equivalent to predicate device. |
| MR Compatibility (see detailed conditions below) | MR Conditional: Safely scanned in a 1.5 or 3.0 T MR system with specific gradient and SAR limits. Max temperature rise |
§ 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.