(44 days)
The Traxcess™ 14 SELECT Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
The Traxcess™ 14 SELECT Guidewire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. The core wire proximal coated section is 0.014" stainless steel wire, and the distal coated section is tapered nitinol wire, contained within a 0.012" outer diameter wire coil. The wire coil is 400 mm in length. The distal 30 mm coil section is constructed of platinum/nickel for maximum radiopacity, and the balance, 370mm of the coil is constructed of stainless steel. The distal 14 mm section of the guidewire is shapeable by the physician. The coil section of the guidewire and the distal stainless-steel section is coated with a hydrophilic coating, while the proximal stainless-steel section is coated with PTFE. The purpose of these surface coatings is to provide lubricity when the Traxcess™ 14 SELECT guidewire is passed through percutaneous catheters. A shaping mandrel, torque device, and insertion tool are included with the device.
The provided text describes the acceptance criteria and a study demonstrating that the Traxcess™ 14 SELECT Guidewire meets these criteria. However, it's important to note that this document is for a medical device (guidewire), not an AI/ML powered device. Therefore, many of the requested categories (e.g., ground truth, experts, MRMC study, training set) typically associated with AI/ML device performance evaluation are not applicable or found in this context.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench/Biocompatibility Testing) | Reported Device Performance (Result & Conclusion) |
|---|---|
| Bench Testing: | |
| Physical attributes (dimensional requirements) | Device met established dimensional specifications |
| Surface Contamination (absence of defects/contamination) | Device was free from surface defects and contamination |
| Corrosion Resistance | Device met established corrosion resistance |
| Simulated use testing (prep, introduction, tracking rating ≥ 3) | Device performed as intended under simulated use |
| Guidewire Coating adherence (maintained after advance/retract cycles) | Durability and lubricity of coating was maintained after advance/retract cycles |
| Guidewire fracture resistance (no fracture, no coating flaking) | Device met established fracture resistance specification |
| Particulate Testing (≤ 6000 particles (≥ 10 microns) and ≤ 600 particles (≥ 25 microns)) | Device has comparable particulate results to the predicate device |
| Biocompatibility Testing: | |
| Cytotoxicity (ISO 10993-5:2009) (Scores of grade 0, 1, or 2) | The test articles are non-cytotoxic (grade 0) |
| Sensitization (ISO 10993-10:2010) (Grades of |
§ 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.