(25 days)
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.
The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:
- 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool)
- 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool)
- 0.035'' Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
- Safe-Cross Console with Display and Footswitch .
The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR inout on the console to allow the medical practitioner to visualize structures within the wessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.
The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.
The provided text describes a 510(k) submission for a medical device modification (Safe-Cross® RF TO Crossing System). This document is primarily focused on demonstrating substantial equivalence to a predicate device through biocompatibility, bench, and animal testing.
It does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
The submission is for a modification to a catheter guide wire, which is a physical medical device, not an AI/ML system. Therefore, the questions related to AI/ML device performance metrics, sample sizes for AI/ML models, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this document.
The document discusses "performance requirements of the device specifications" and "intravascular performance requirements in an animal model," but these are general statements about the device's physical function and safety, not specific quantitative acceptance criteria for an AI/ML algorithm.
Without the requested information from the provided text, I cannot complete the table or answer the specific questions about AI/ML device acceptance criteria and study details.
§ 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.