(157 days)
The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, pulmonary, or renal vasculature.
Phoenix Atherectomy Plus System:
When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2.4mm Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.
The Phoenix 2.4mm Atherectomy Plus System comprises the currently cleared Phoenix 2.4mm Deflecting Atherectomy System (K172386) and a new Phoenix Aspiration Pump. which when used in conjunction with each other are designed for removal of thrombus from vessels of the peripheral arterial vasculature.
The Phoenix 2.4mm Deflecting Atherectomy System and the Phoenix Aspiration Pump are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The Phoenix 2.4mm Deflecting Atherectomy System comprises the Phoenix 2.4mm Deflecting Atherectomy Catheter and the Phoenix Atherectomy Handle with Wire Support Clip.
The Phoenix Catheter is an over-the-wire (OTW), multi-lumen Catheter with a cutter at the distal tip that continuously captures and clears debulked (excised) material 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 incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectorny Catheter at its specified rotational speed, and is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Phoenix 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. The Phoenix Catheter is compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires.
For the purpose of this 510(k), the design of the Phoenix 2.4mm Deflecting Atherectomy System remains unchanged.
The Phoenix Aspiration Pump connects to the disposal outlet of the Phoenix Catheter via the pump's aspiration tubing. The exit end of the aspiration tubing is connected to a waste disposal bag to collect aspirated material. A 60 ml syringe is provided as part of the Aspiration Pump Assembly to assist in priming the pump aspiration tubing and purging the aspiration system of air. The Aspiration Pump is battery-operated and is operated by an ON/OFF switch. It serves as a vacuum source for the Aspiration System for aspirating the thrombus from the target vessel out of the Phoenix Catheter via the pump aspiration tubing and into the disposal bag. The Aspiration Pump is non-patient contacting.
The provided text is a 510(k) summary for the Phoenix 2.4mm Atherectomy Plus System. It describes the device, its intended use, and a comparison to predicate and reference devices, as well as a summary of testing performed to demonstrate substantial equivalence. However, it does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm-driven device performance study.
The document describes the device as a mechanical atherectomy system with an aspiration pump for removing thrombus, which is a physical device, not an AI or algorithm. The "Testing Summary" section lists various engineering and preclinical tests (e.g., visual inspection, vacuum and leak test, flow rate test, system simulated use test, preclinical animal testing), which are typical for medical devices of this nature. There is no mention of an algorithm, AI, or any data-driven performance study comparing human readers with and without AI assistance, or standalone algorithm performance, or ground truth establishment based on expert consensus for image analysis.
Therefore, I cannot provide the requested information from the given text. The text does not detail an AI/algorithm-driven study with acceptance criteria.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).