(29 days)
The Phoenix® Atherectomy System is 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 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 multiple models of the Phoenix Catheter. The smaller Phoenix 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. 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 Phoenix Catheter models to increase the overall working length from 130 cm to 149 cm and thereby create two new longer-length models within the Phoenix Catheter product family.
The provided document is a 510(k) premarket notification for a medical device (Phoenix® Atherectomy System). These notifications primarily aim to demonstrate substantial equivalence to a predicate device, rather than providing extensive details on novel acceptance criteria and study designs typically found in regulatory submissions for new devices or software.
Based on the provided text, the device is an updated version of an existing device (the only change being an increased working length of the catheter). Therefore, the "acceptance criteria" discussed relate to demonstrating that the modified device performs equivalently to the predicate device, not to establishing new performance benchmarks for a novel device or AI algorithm. The study described is a series of engineering and performance tests rather than a clinical trial or a study assessing human reader performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense, nor does it provide quantitative performance metrics for each. Instead, it states that the testing "demonstrate[s] that the performance and technological characteristics of the modified Phoenix Atherectomy System meet defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System."
The technological characteristics of the modified device are compared to the predicate device in Table 9-1. The "acceptance" is implied by the "Identical" assessment for most characteristics, and the successful completion of the listed tests.
| Technological Characteristic | Predicate Phoenix Atherectomy System (K140944) - 130 cm length | Modified Phoenix Atherectomy System (Subject Device) - 149 cm length | Implied Acceptance Criteria (Demonstrate Equivalence to Predicate) | Reported Device Performance (Result of Testing) |
|---|---|---|---|---|
| Rotational Speed | 10,000-12,000 RPM | Identical | Achieve 10,000-12,000 RPM | Identical |
| Guidewire Exchange | Over-the-wire | Identical | Maintain over-the-wire exchange capability | Identical |
| Guidewire Compatibility | 0.014" | Identical | Compatible with 0.014" guidewire | Identical |
| Sheath Compatibility | 5F - 6F | Identical | Compatible with 5F - 6F sheath | Identical |
| Catheter Working Length | 130 cm | 149 cm | Achieve 149 cm working length | 149 cm |
| Catheter Torque Shaft | Multi-Strand Stainless Steel (SS) | Identical | Maintain Multi-Strand SS torque shaft | Identical |
| Catheter Outer Shaft | Stainless Steel Outer Shaft and Teflon sheath | Identical | Maintain SS Outer Shaft and Teflon sheath | Identical |
| Catheter Shaft Diameter | 1.7mm | Identical | Maintain 1.7mm shaft diameter | Identical |
| Distal Cutter Flute Maximum Diameter | 1.8mm (FG1847) / 2.2mm (FG1984) | Identical (FG2160) / Identical (FG2162) | Maintain 1.8mm/2.2mm distal cutter flute max diameter | Identical |
| Tip Diameter and Crossing Profile | 1.8mm (FG1847) / 2.2mm (FG1984) | Identical (FG2160) / Identical (FG2162) | Maintain 1.8mm/2.2mm tip diameter and crossing profile | Identical |
| Cutting Tip Port | Single exit port conveys excised debris from inner guidewire lumen into Distal Cutting Flute channel | Identical | Maintain single exit port design and debris conveyance | Identical |
| Second Stage Maceration within Housing | Yes | Identical | Maintain second stage maceration | Identical |
| Cutter Housing Coating | No Coating | Identical | Maintain no coating on cutter housing | Identical |
| Distal Tip Assembly Coating | Coated | Identical | Maintain coating on distal tip assembly | Identical |
| Minimum Vessel Size for Device Use | 2.5mm (FG1847) / 3.0mm (FG1984) | Identical (FG2160) / Identical (FG2162) | Maintain minimum vessel size for use | Identical |
| Debris Collection & Removal | Continuous collection and removal of excised debris by mechanical conveyance | Identical | Maintain continuous debris collection and removal | Identical |
| Steering (Directional) mechanism | Rotation of knob on handle steers distal tip and cutter by torqueing catheter shaft | Identical | Maintain existing steering mechanism | Identical |
| Catheter Coating | No | Identical | Maintain no catheter coating | Identical |
| Sterilization | Ethylene Oxide | Identical | Maintain Ethylene Oxide sterilization | Identical |
| Single-use only | Yes | Identical | Maintain single-use only design | Identical |
The "study" that proves the device meets these criteria consists of the following tests:
- 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
- Guidewire Compatibility
- Catheter Trackability in Below-the-Knee Anatomy
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient outcomes. The testing described is bench testing and simulated use. Therefore, there is no information on a sample size of patients or data provenance (country of origin, retrospective/prospective). The "samples" would be the catheters themselves used in the engineering tests.
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)
Not applicable. This is not a study involving expert review of medical images or patient data to establish ground truth. The "ground truth" for these engineering tests would be the established design specifications and performance characteristics of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not a study requiring expert adjudication of clinical outcomes or interpretations.
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. This is a premarket notification for a mechanical atherectomy system, not an AI software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a premarket notification for a mechanical atherectomy system, not an AI software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the equivalence demonstration is the established performance and specifications of the legally marketed predicate device (K140944 Phoenix Atherectomy System). The objective of the testing was to show that the modified device's performance, despite an increased length, did not deviate in a way that would alter its safety or effectiveness compared to the predicate.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would involve a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that would involve a "training set."
§ 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).