(238 days)
The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.
This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.
Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)
| Test Attribute | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensional Verification | All defined guidewire dimensions are within the specified tolerances. | Pass |
| Visual Inspection | The guidewire shall be free of visual defects when removed from packaging. | Pass |
| Torqueability | The guidewire shall transmit rotation from the proximal end to the distal tip to allow users to select branches of the vasculature and reach the target location. | Pass |
| Torque Strength | Device shall not fail under expected torsional input when distal end is unable to move/rotate. | Pass |
| Tip Flexibility | Tip of guidewire shall not cause vessel damage; defined by ability to buckle to reduce contact pressure and prevent perforation. | Pass |
| Tensile Strength and Tip Pull | Guidewire shall withstand tensile forces expected in clinical use without breaking. | Pass |
| Kink Resistance | Guidewire shall be able to traverse through clinically relevant bends without kinking. | Pass |
| Coating Integrity | Coating shall remain intact during clinical use. | Pass |
| Coating Lubricity | Coating shall be lubricious to reduce frictional forces for navigation. | Pass |
| Particulate Evaluation | Guidewire shall not generate particles at a level greater than the range generated by the predicate. | Pass |
| Corrosion Resistance | Guidewire shall not corrode from time of manufacture through its shelf life. | Pass |
| Radiopacity | Opacity to x-ray shall allow physicians to visualize guidewire under fluoroscopy. | Pass |
| Simulated Use | Guidewire must be able to reach anatomical locations and deliver catheters and other interventional devices used in common neurovascular procedures. | Pass |
| Cytotoxicity | Test article extracts must yield grade 2 or lower. | Pass, Noncytotoxic |
| Sensitization | Overall pattern, intensity, duration, character of reactions compared to control conditions. | Pass, Nonsensitizer |
| Irritation or Intracutaneous Reactivity | Difference between test extract mean score and corresponding control mean score ≤1. | Pass, Nonirritating |
| Acute Systemic Toxicity | None of the animals treated with test article extracts must show significantly greater biological reactivity than control-treated animals. | Pass, Non-toxic (acute systemic) |
| Material Mediated Pyrogenicity | Test article extract must yield |
§ 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.