(16 days)
The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in 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 a 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. These models are available in 1.8 mm and 2.2 mm tip diameter sizes; a 2.4 mm tip diameter size (identical in design to the currently marketed 2.4 mm Phoenix Deflecting Catheter) has been added under this 510(k). 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.
This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter 149 cm Phoenix Tracking Catheter models to improve the overall catheter pushability and internal debris maceration of the longer length catheter models and (as just noted previously) to also add a 2.4 mm tip diameter 130 cm Phoenix Tracking Catheter to the Phoenix Catheter product family. Tables 9-1 and 9-2 summarize the subject modifications relative to the predicate devices.
The provided text describes a 510(k) premarket notification for the Phoenix Atherectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria from an AI/reader study perspective.
Therefore, many of the requested categories for AI/reader study evaluation cannot be fulfilled from this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria with numerical targets. Instead, it states that the modified Phoenix Atherectomy System's performance and technological characteristics were evaluated by a series of tests to demonstrate equivalence to the predicate device. The general acceptance is that the device "meet pre-defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System with the identical intended use."
The tests performed include:
- Dimensional and Visual Inspection
- Simulated Use
- Cutter Torque / Chain Torque-to-Failure Test
- Functional Outer Shaft Torque Test
- Knob to Shaft Testing
- Catheter Drive Train Stress Test
- Cutter Stall Test
- Temperature Rise of Catheter During Simulated Use
- Kink Bend Radius Test
- Catheter Trackability in Below-the-Knee Anatomy
- Sheath Flow Rate (2.4mm X 130 cm Phoenix Catheter only)
- Sheath Compatibility (2.4mm X 130 cm Phoenix Catheter only)
The document asserts that "The results from this testing demonstrate that the performance and technological characteristics of the modified Phoenix Atherectomy System meet pre-defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System with the identical intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described appears to be bench testing and simulated use, not clinical or human-data-driven studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document does not describe an AI/reader study or the establishment of ground truth by experts in that context. The "ground truth" here would relate to the engineering specifications and performance capabilities verified through the various tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as this is not an AI/reader study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual atherectomy system, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be derived from engineering specifications, material properties, and the results of the described bench and simulated use tests. It is based on the device's physical and functional capabilities as measured against design requirements for safety and effectiveness, and comparison to the predicate device.
8. The sample size for the training set
Not applicable. There is no AI model or training set described.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set described.
§ 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).