(130 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 AtheroMed 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 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. An optional Wire Support Clip can also be used to clip a guidewire torque device in a fixed position relative to the Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System. There are three different models of the Phoenix Catheter. Two Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8mm and 2.2mm tip diameter sizes. A third, 2.4mm tip diameter model has a Catheter tip design that can be deflected and rotated by the user so that the cutter can eccentrically debulk to a larger diameter than the Catheter's 2.4mm distal cutter. The controls for deflection and rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All three Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260cm or greater) guidewires, and all use the same Phoenix Handle. This 510(k) includes modifications to the cutter and distal assembly of the 1.8mm and 2.2mm tip diameter Phoenix Catheter models, as well as modifications to the Catheter and proximal chassis design, to further optimize the device design and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate device. Additionally, the Phoenix Guidewire has been added as a compatible guidewire in the product labeling.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the acceptance criteria implicitly through the various tests conducted and the conclusion that the device "meet defined design requirements" and "performs in a manner equivalent to the predicate Phoenix Atherectomy System." Since this is a 510(k) submission for modifications to an already cleared device, the primary acceptance criterion is substantial equivalence to the predicate device.
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Overall Equivalence to Predicate Device | Modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System with identical intended use. |
| Dimensional and Visual Inspection | Met defined design requirements. |
| Simulated Use Performance | Met defined design requirements. |
| Comparative Predicate Testing in Simulated Lesion | Met defined design requirements. |
| Cutter Torque Chain Torque-to-Failure Test | Met defined design requirements. |
| Functional Outer Shaft Torque Test | Met defined design requirements. |
| Knob to Shaft Testing | Met defined design requirements. |
| Catheter Drive Train Stress Test | Met defined design requirements. |
| Cutter Stall Test | Met defined design requirements. |
| Temperature Rise of Catheter During Simulated Use | Met defined design requirements. |
| Corrosion Test | Met defined design requirements. |
| Kink Bend Radius Test | Met defined design requirements. |
| Guidewire Compatibility | Met defined design requirements. |
| Sheath Compatibility | Met defined design requirements. |
| Sheath Flow Rate | Met defined design requirements. |
| Catheter Trackability in Below-the-Knee Anatomy | Met defined design requirements. |
| Shelf Life | Met defined design requirements. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolysis, Prothrombin Time Assay, Partial Thromboplastin Time Assay, In Vitro Platelet Aggregation Assay, Complement Activation, Pyrogenicity) | Met defined design requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test. It mentions "Comparative Predicate Testing in Simulated Lesion," implying a test set was used, but the size or characteristics of the "simulated lesion" are not detailed.
The data provenance is from laboratory testing and simulations ("Simulated Use," "Comparative Predicate Testing in Simulated Lesion," "Temperature Rise of Catheter During Simulated Use," "Catheter Trackability in Below-the-Knee Anatomy"). No information is provided about patient data, animal studies, or specific geographic origins. Given the tests listed, the data is likely prospective in nature, as tests were performed specifically to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are primarily engineering and bench-top performance evaluations, rather than clinical studies requiring expert interpretation of patient data.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The evaluations are based on objective engineering measurements and laboratory results, not on subjective interpretations from multiple readers requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. This document describes a 510(k) submission for an atherectomy system, which is a surgical tool, and the testing focuses on its physical and performance characteristics, not on diagnostic accuracy or interpretation by human readers. Therefore, the concept of "improving human readers with AI vs without AI assistance" is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this device. The Phoenix Atherectomy System is a physical medical device (catheter-based system), not an AI algorithm. Its performance is intrinsically tied to human operation during a medical procedure.
7. The Type of Ground Truth Used
The "ground truth" for the various tests appears to be defined by engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, in "Cutter Torque Chain Torque-to-Failure Test" or "Kink Bend Radius Test," the ground truth would be the pre-defined acceptable limits of torque or bend radius. For "Biocompatibility," the ground truth is established by relevant ISO standards or guidelines for material safety.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are typically used for machine learning or AI models. This document describes the evaluation of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set in the context of this device's evaluation, this question is not applicable.
§ 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).