(133 days)
The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.
The Viradius™ Neurowire consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The distal section of the guidewire is coated with a hydrophilic coating and the proximal portion of the device is coated with a hydrophobic coating. The guidewire is inserted into a polyethylene hoop and then placed along with a torque device into a labeled poly/tyvek pouch and ethylene oxide sterilized. The pouch, along with an Instruction for Use paper insert is placed into a labeled shipping box.
The Viradius™ Neurowire is a guidewire intended for selective placement of catheters within the neuro and peripheral vasculature. The information provided outlines the acceptance criteria and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device (NeuroScout Steerable Guidewire, K100351).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Viradius™ Neurowire are generally that the device "meets acceptance criteria" or performs comparably to the predicate device or selected competitor guidewires, or that the results are adequate/acceptable. The reported device performance indicates that all devices met these criteria for all tested parameters.
| Test / Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bond and Joint Tensile Strength | The guidewire, including all joints, must not suffer damage when subjected to tensile force. | All devices met acceptance criteria. |
| Ultimate Torque Response | The guidewire must withstand a minimum complete rotations without physical damage. | All devices met acceptance criteria. |
| Torque Response | Distal tip rotation shall be equivalent to predicate guidewire. | All devices met acceptance criteria. |
| Tip Deflection | Tip deflection force shall be comparable to selected competitor guidewires. | All devices met acceptance criteria. |
| Push Track – Anatomical Model | Force required to advance guidewire through simulated tortuous neurovascular arteries shall be comparable to predicate device. | All devices met acceptance criteria. |
| Surface Integrity | Guidewire surface shall not have any particulate visible to the naked eye under close inspection without magnification. | All devices met acceptance criteria. |
| Guidewire Diameter | The diameter was measured and met specifications (implicitly, as it passed; also noted 0.012" distal, 0.014" proximal). | All devices met acceptance criteria. |
| Guidewire Length | The length was measured and met specifications (implicitly, as it passed; also noted 205 cm / 300 cm). | All devices met acceptance criteria. |
| Catheter Compatibility | Guidewire shall be compatible with microcatheters, distal access catheters, guide catheters, and fluids. | All devices met acceptance criteria. |
| Kink Resistance | Proximal shaft shall not kink when subjected to a bend radius. | All devices met acceptance criteria. |
| Flex Test | In accordance with ISO 11070:2014 8.5 the guidewire shall not fracture, loosen, or fail in such a manner that any section of the coil is left free to stretch, a sharp, or potentially traumatic fracture surface is exposed, any part of the device becomes separated such that it would not be removable by withdrawing the device from use, or coated guidewires show flaking of the coating. | All devices met acceptance criteria. |
| Distal Fracture Test | In accordance with ISO 11070:2014 8.4 the guidewire shall not fracture, loosen, or fail in such a manner that any section of the coil is left free to stretch, a sharp, or potentially traumatic fracture surface is exposed, or any part of the device becomes separated such that it would not be removable by withdrawing the device from use. | All devices met acceptance criteria. |
| Tip Bending and Retention | After insertion through a competitive microcatheter, the bend radius shall not degrade. | All devices met acceptance criteria. |
| Device Coating Adhesion | After simulated use, the guidewire coating shall not exhibit any scratches, flaking, or generate any loose coating material. | All devices met acceptance criteria. |
| Particulate Testing | The guidewire was evaluated for particulate generation under simulated use in a representative tortuous model, with an implicit acceptance criterion of an "adequate" number and size of particulates. | Number and size of particulates generated was adequate. |
| Corrosion Test | The guidewire shall not exhibit visual corrosion when immersed in sodium chloride solution. | All devices met acceptance criteria. |
| Biocompatibility (Cytotoxicity) | Pass | Pass |
| Biocompatibility (Sensitization) | Pass | Pass |
| Biocompatibility (Intracutaneous) | Pass | Pass |
| Biocompatibility (Systemic Tox) | Pass | Pass |
| Biocompatibility (Pyrogen) | Pass | Pass |
| Biocompatibility (Hemocompat.) | Pass | Pass |
| Sterilization (SAL) | SAL of 10^-6 in accordance with ISO 11135-1:2007. | Validated. |
| Shelf Life (1 year) | Product and packaging remain functional and maintain sterility for up to one year; packaging integrity, seal strength, and device functionality met all acceptance criteria. | Met all acceptance criteria through aging studies. |
2. Sample Size and Data Provenance (Test Set)
The document does not explicitly state the sample sizes (number of units or iterations) used for each specific bench test mentioned. However, for all performance tests, it states that "All devices met acceptance criteria." This implies that a sufficient number of devices were tested to draw this conclusion based on the test methods used.
The data provenance for the test set is retrospective/bench (laboratory) data, generated from direct testing of the Viradius™ Neurowire and comparison to the predicate device or competitor guidewires. There is no indication of country of origin as it applies to clinical data, as no clinical studies were performed.
3. Number of Experts and Qualifications (Ground Truth for Test Set)
This section is not applicable. The studies described are primarily bench (laboratory) performance tests and biocompatibility testing, not studies that involve human interpretation of medical images or diagnoses requiring expert ground truth in the traditional sense. The "ground truth" for these tests is the objective physical and chemical properties and performance of the device relative to established standards or a predicate device.
4. Adjudication Method (Test Set)
This section is not applicable. As the studies were bench tests demonstrating physical performance and material safety, there was no adjudication method involving multiple human reviewers to establish a consensus or resolve discrepancies, which is typical for clinical or imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The submission explicitly states: "No clinical studies were performed as there are no change to the indications for use or the fundamental scientific technology of the device." Therefore, there is no information on the effect size of human readers improving with or without AI assistance. This device is a medical instrument, not an AI or imaging diagnostic tool.
6. Standalone (Algorithm Only) Performance
No standalone performance study was done. This device is a medical guidewire, a physical instrument, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this submission.
7. Type of Ground Truth Used
The "ground truth" for the performance testing was based on:
- Engineering/Performance Standards: Adherence to established ISO standards (e.g., ISO 11070:2014, ISO 11135-1:2007) and internal company specifications.
- Comparison to Predicate Device: Performance (e.g., torque response, push track force) comparable to the NeuroScout Steerable Guidewire (K100351).
- Objective Laboratory Measurements: Direct measurements of physical dimensions (diameter, length), visual inspection (surface integrity, corrosion), and chemical tests (biocompatibility).
- Simulated Use Models: Performance in simulated anatomical models (e.g., push track test, particulate testing in tortuous model).
8. Sample Size for the Training Set
No training set was used. This device is a physical medical instrument, not a machine learning model or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
§ 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.