(29 days)
The Volo 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Volo 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles, from soft to standard. The product is provided in 200cm and 300cm lengths.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The provided text is a 510(k) summary for the Volo 14 Guidewire, and it details the device's characteristics, indications for use, and a comparison to a predicate device (Aristotle 14 Guidewire). This document focuses on demonstrating substantial equivalence to an already cleared predicate device, rather than proving a device meets specific performance acceptance criteria for a novel AI/ML device.
Therefore, the information required to answer your request (acceptance criteria, study details for AI/ML device performance, sample sizes, expert ground truth establishment, MRMC studies, etc.) is not present in the provided text. The document describes functional testing for a medical device (guidewire), not the performance of an AI/ML algorithm.
The testing described in the document is for the physical and functional aspects of the guidewire, such as:
- Biocompatibility: Assessed by material equivalence to the predicate device.
- Sterilization: Confirmed by method and process equivalence to the predicate.
- Functional Testing: This includes:
- Tip Shape/Retention
- Torqueability
- Torque Strength
- Tip Flexibility
- Simulated Use Model Testing and Product Compatibility (e.g., torqueability in tortuous vasculature, lubricity, microcatheter support & tracking, compatibility with introducer, torque device, and microcatheter).
These tests are standard for a guidewire to demonstrate its physical and operational safety and efficacy, and its comparability to a predicate device. They do not involve AI/ML performance evaluation.
§ 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.