(129 days)
The TurboHawk® Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk is indicated for use in conjunction with the SpiderFX® Embolic Protection Device in the treatment of severely calcified lesions. The TurboHawk is NOT intended for use in coronary, carotid, iliac or renal vasculature.
The TurboHawk® Peripheral Plaque Excision System (TurboHawk Catheter and ev3 Cutter Driver) is designed for the treatment of de novo and restenotic calcified and noncalcified atherosclerotic lesions located in native peripheral arteries. When used in complex, hard, calcified lesions, the TurboHawk should be paired with the SpiderFX® Embolic Protection Device to mitigate any risk of distal embolization that may be generated by the breakdown of heavily calcified plaque. The TurboHawk Catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a small cutting assembly comprised of a rotating inner cutter contained within a tubular housing. The proximal end of the TurboHawk Catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the ev3 Cutter Driver. The ev3 Cutter Driver is a handheld, disposable, battery-driven unit which powers the system.
The TurboHawk Peripheral Plaque Excision System has two switches: 1) the ev3 Cutter Driver main power switch and 2) the TurboHawk Catheter thumb switch. The ev3 Cutter Driver main power switch supplies power to the device when turned ON. The TurboHawk Catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the ON position. With the cutter engaged, the TurboHawk Catheter is slowly advanced across the lesion, shaving occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the TurboHawk Catheter thumb switch distally deactivating the drive shaft and disengaging the cutter. The TurboHawk Catheter thumb switch is fully advanced distally to the OFF position in order to pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.
The TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, polyimide, tecothane, pebax, nylon, delrin, PTFE, tungsten carbide, titanium, platinum/iridium, ABS, PVC, silicone, polypropylene and hydrophilic coating.
The provided text describes the 510(k) summary for the TurboHawk® Peripheral Plaque Excision System. It details the device, its indications for use, comparison to a predicate device, and performance testing, including a clinical summary.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance (Achieved) |
|---|---|
| 30-day freedom from Major Adverse Event (MAE) | 93.1% (122/131 subjects event-free) |
| Successful revascularization (≤ 50% residual diameter stenosis per Angiographic Core Lab) | 92.0% (150/163 lesions) |
| Successful revascularization (≤ 50% residual diameter stenosis per Site Assessment) | 97.0% (162/167 lesions) |
Note: The document states "The primary safety and effectiveness endpoints were derived from historical registry data using plaque excision," but it does not explicitly list the specific numerical acceptance thresholds for these endpoints. The table above presents the achieved performance, implying these met the pre-determined, but unquantified, acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 133 subjects. The document also states 163 lesions for the Angiographic Core Laboratory assessment and 167 lesions for the site assessment of the primary effectiveness endpoint.
- Data Provenance: Prospective, multi-center study ("DEFINITIVE Cat+"). The country of origin is not explicitly stated, but the context implies data from the United States, given the FDA regulatory submission. The study enrolled subjects from 17 centers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated as a number of individual experts.
- Qualifications of Experts: The ground truth for safety and effectiveness endpoints was established through an "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC)." While specific individual qualifications (e.g., "Radiologist with 10 years of experience") are not provided, these are standard bodies in clinical trials, implying qualified medical professionals (e.g., interventional radiologists, cardiologists) with expertise in reviewing angiograms and clinical events. Their independence is highlighted.
4. Adjudication Method for the Test Set
- The document explicitly states that the "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC) were employed to ensure unbiased review and classification of events and endpoints." This indicates a formal adjudication process was in place. While a specific "2+1" or "3+1" method is not detailed, the mention of "adjudication" by these committees suggests a consensus or formal review process for discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. This study focuses on the performance of the device itself, with outcomes assessed by human experts (Core Lab, CEC). The device is an atherectomy system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No, a standalone algorithm performance study was not done. The device is a physical medical device (atherectomy system), not a software algorithm. The "performance testing" referenced (e.g., biocompatibility, cycle and life, tissue removal) are all related to the physical device's function.
7. The Type of Ground Truth Used
- The ground truth used was based on expert consensus/adjudication by an "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC)" for both safety (30-day freedom from MAE) and effectiveness (residual diameter stenosis) endpoints.
8. The Sample Size for the Training Set
- The document does not mention a training set or its sample size. This is a medical device 510(k) submission, not an AI/algorithm development submission that would typically involve distinct training and test sets in the same manner. The "predicate device" (K093301) and the data supporting its clearance could be considered analogous to a "training" or "prior experience" in device safety and effectiveness, but it's not a formal dataset used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly referred to in the context of algorithm development, this question is not applicable. The device's design and performance are related to engineering principles and prior iterations of the device (K093301). The "ground truth" for the device's acceptable performance, more broadly, is established through various performance tests (bench and in-vivo) whose results "met the specified acceptance criteria" (refer to Section 7).
§ 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).