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510(k) Data Aggregation
(56 days)
TurboHawk Plus Directional Atherectomy System
The TurboHawk Plus directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Plus catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The TurboHawk Plus catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.
The TurboHawk Plus Directional Atherectomy System (TurboHawk Plus Catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and noncalcified lesions located in native peripheral arteries. When treating complex, hard, calcified lesions, pairing the TurboHawk Plus catheter with the SpiderFX embolic protection device mitigates risk of distal embolization that may be generated when heavily calcified plaque breaks down.
The TurboHawk Plus catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. The distal end of the TurboHawk catheter is comprised of a small cutting unit with an inner blade that rotates within a tubular housing. The proximal end of the TurboHawk Plus catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver is a battery-driven, internally powered device, designed to power the TurboHawk Plus directional atherectomy catheter.
The TurboHawk Plus directional atherectomy system has two switches: 1) the main power switch on the cutter driver and 2) the cutter positioning lever (thumb switch) on the TurboHawk Plus catheter. The main power switch on the cutter driver supplies power to the device when turned on. When the thumb switch is pulled proximally to the On position, the TurboHawk Plus catheter activates the drive shaft and the cutter. With the cutter engaged, the TurboHawk Plus 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 Plus catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the TurboHawk Plus catheter thumb switch is fully advanced distally to the Off position, excised tissue is packed into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.
This document describes the FDA's 510(k) premarket notification for the TurboHawk Plus Directional Atherectomy System. The provided text does not contain a study comparing AI performance, but rather outlines the performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, focusing on the device performance and acceptance criteria for the TurboHawk Plus Directional Atherectomy System:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the performance tests were conducted using internal Risk Analysis procedures and that "The results from these tests demonstrate that TurboHawk Plus meets the product performance specifications." It does not provide specific numerical acceptance criteria or detailed numerical results for each test. Instead, it broadly asserts that the device meets those specifications.
| Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Device Inspections | Meets internal quality and design specifications. | Met product performance specifications. |
| Simulated Use (trackability, rotational fatigue, cycling and cutting) | Meets functional requirements under simulated use conditions. | Met product performance specifications. |
| Kink resistance | Maintains structural integrity and functionality despite kinking. | Met product performance specifications. |
| Heat generation | Operates within safe temperature limits. | Met product performance specifications. |
| Torsional Strength | Maintains structural integrity under torsional stress. | Met product performance specifications. |
| Tensile Strength | Withstands tensile forces without failure. | Met product performance specifications. |
| Catheter to cutter driver interaction | Proper and safe functional interaction between components. | Met product performance specifications. |
| Cut Mass/Pass (Plaque Removal Efficiency) | Achieves effective plaque removal. | Met product performance specifications. |
| Capture Efficiency (Debris removal and collection) | Effectively captures and collects excised tissue. | Met product performance specifications. |
| Cycle & Life | Performs reliably over its intended lifespan. | Met product performance specifications. |
| Cutting embolization analysis | Minimizes the risk of clinically significant embolization. | Met product performance specifications. |
| Consistency of Tissue Removal | Achieves consistent tissue removal. | Met product performance specifications. |
| Coating integrity | Maintains integrity of the coating. | Met product performance specifications. |
| Particulate evaluation | Minimizes particulate generation. | Met product performance specifications. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Haemocompatibility tests) | Meets ISO 10993-1 standards for intended use. | Considered biocompatible for its intended use under ISO 10993-1 category: externally communicating device, circulating blood contact with limited ( |
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