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The Phoenix Atherectomy System is in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle.

The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle. The Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold the guidewire in a fixed position relative to the Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The Phoenix Tracking Catheter models track directly over the guidewire with no tip deflection capability. The currently marketed models available for clinical use are 1.8mm, 2.2mm, and 2.4mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.

The subject 510(k) submission is proposed to introduce the following modifications:

(i) the predicate 2.2 mm X 130cm Phoenix Deflecting Catheter is being modified to add a new model with a 2.4mm distal cutter assembly to enable debulking to a larger lumen diameter. The 2.4 mm distal cutter assembly is equivalent in design to the currently marketed 2.4mm X 127cm Phoenix Deflecting Catheter.

(ii) the predicate 1.8 mm X 149cm Phoenix Tracking Catheter is being modified to add a 1.5mm tip diameter X 149cm Phoenix Tracking Catheter model to the Phoenix Catheter product family.

This document is a 510(k) premarket notification approval letter for the Phoenix Atherectomy System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets them, particularly regarding the performance of an AI-based system.

The provided text describes a medical device for atherectomy, which is a mechanical procedure to remove plaque from peripheral arteries. The "Testing Summary" section lists various engineering and functional tests (e.g., dimensional inspection, simulated use, torque tests, embolic profile test), but these are related to the physical performance and safety of the atherectomy system itself, not to the performance of an AI system for diagnostics or image analysis.

Therefore, I cannot provide the requested information from this document, as it does not pertain to an AI-based device or a study structured with acceptance criteria, ground truth, and human reader performance data as typically seen in AI/ML medical device submissions.

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