(157 days)
Micrus Watusi guide wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Watusi guide wire is not intended for use in the coronary arteries. The guide wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. A torque device (pin vise) in included with the guide wire to facilitate directional manipulation of the guide wire. An introducer device is included to introduce the guide wire into the catherer or hemostatic valve, and can also be used to shape the tlexible tip of the guide wire, as desired.
The Micrus guide wire consists of these major components:
- A flexible proximal shaft. .
- A distal, atraumatic, radiopaque, coiled tip. .
- A tapered core wire. .
- A hydrophilic coating covering the distal end. .
- A detachable torque device (pin vise type). .
- An insertion tool or shaping mandrel .
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter for the Micrus Watusi 0.014" Guide Wire, which establishes substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance studies with acceptance criteria as one might find in a clinical trial report.
Here's why the requested information is absent:
- Acceptance Criteria & Reported Device Performance: This type of information is typically found in design verification and validation reports or clinical study reports, which are usually proprietary and not publicly available in a 510(k) clearance letter. The clearance process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing and often without extensive human subject studies for this type of device.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): These details are specific to performance studies, often clinical or reader studies, which are not detailed in this regulatory clearance document. For a guide wire, performance is primarily assessed through bench testing (e.g., kink resistance, tensile strength, lubricity) and comparison to the predicate device's specifications.
In summary, this document is a regulatory approval letter, not a device performance study report.
§ 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.