(259 days)
The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids. including thrombolytics, in the peripheral venous vasculature.
The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.
The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister.
The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.
The provided text describes the evaluation of a medical device, the Cleaner Plus™ Thrombectomy System, for substantial equivalence to predicate devices, as part of an FDA 510(k) submission. This document is a regulatory submission, and as such, it focuses on non-clinical data (bench-top and animal studies) rather than clinical study data involving human patients or complex AI performance metrics.
Therefore, many of the requested points related to AI performance, human reader studies (MRMC), data provenance, expert consensus on ground truth, and training data for AI models are not applicable to this type of medical device submission.
Here's an analysis of the acceptance criteria and study information provided, focusing on what is relevant in this context:
1. Table of Acceptance Criteria and Reported Device Performance
The document details non-clinical performance tests that were conducted and states that the device "were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list quantified acceptance criteria for each test or detailed performance results in a table format. Instead, it lists the types of tests performed.
| Test Category | Specific Tests Performed | Device Performance (as stated) |
|---|---|---|
| Bench-top Testing | - Wire - Atraumatic Tip Pull, Corrosion Resistance, Fatigue, Dynamic Retention, Flexing and Fracture, Kink, Tensile Break, Dimensional | Met acceptance criteria to demonstrate substantial equivalence for all tests in this category. Specific quantitative results or acceptance thresholds are not provided in this summary. |
| - Catheter - Dimensional, Aspiration Tip Collapse, Kink, Hemostasis Valve Leak, Torsional Break, System Leak, Tensile Break, Coating Performance and Integrity | ||
| - Shipping Qualification, Luer Functional, Luer Dimensional, Software Validation, IEC 60601 Compliance, Canister & Dead Volume Study, Pump Functionality - Relief Valve, Pump Tubing Pull, Pump Performance, Pump Button Press Endurance, Simulated Use, Handpiece Motor & Battery Performance, Pump Battery Performance, Handpiece Dimensional, Handpiece Functionality, Handpiece – Peel-away Introducer, System - Vacuum Decay, Radiopacity, Functional, Performance, and Software Testing, Float Valve Study | ||
| Biocompatibility | - Cytotoxicity (ISO 10993-5) | All studies were performed following approved protocol under GLP and in compliance with FDA GLP, 21 CFR Part 58. The device is established as biocompatible for its intended use (external communicating, circulating blood, limited duration |
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).