(107 days)
The Cleaner™ Plus 18F 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™ 18F 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 an aspiration control and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum reservoir with pump known as the Aspiration Canister.
The system is inserted percutaneously into the vessel using an introduction catheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and wall adherent thrombus with a maceration wire. The macerated thrombus is removed from the vessel using an aspiration system. The aspiration of the clot can be performed simultaneous or independently.
Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.
The provided text describes information about the Cleaner™ Plus 18F Thrombectomy System, a medical device, and the basis for its FDA clearance through a 510(k) premarket notification (K233909). The information primarily focuses on establishing substantial equivalence to a predicate device (K211798), rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, many of the requested items related to AI/ML device study design (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this document, as it concerns a mechanical thrombectomy system, not an AI/ML-driven device.
However, I can provide the available information regarding the device's performance assessment and the basis for its clearance.
Acceptance Criteria and Device Performance (Non-AI/ML Medical Device)
The document does not present a table of numerical "acceptance criteria" in the same way one might find for an AI/ML model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are qualitative, based on established industry standards, guidance, and the successful outcome of various performance and safety tests demonstrating substantial equivalence to a predicate device.
The "reported device performance" refers to the successful completion and meeting of predefined parameters for each test, indicating the device performs as intended and is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical device, not an AI/ML system, the "acceptance criteria" are the successful completion of various tests and the demonstration of substantial equivalence. The "reported device performance" refers to the outcomes of these tests.
| Test Category / Characteristic | Acceptance Criteria (Qualitative) | Reported Device Performance (Outcome) |
|---|---|---|
| Substantial Equivalence | Demonstrates comparable indications for use, mechanism of action, materials, technological characteristics, principle of operation, design features, and sterilization process to the predicate device, introducing no additional clinical risk. | Established based on in vitro performance testing, similarities in indications for use, materials, technological characteristics, principle of operation, design features, and sterilization process with the predicate device. Confirmed by in-vitro and in-vivo tests. Conclusion: Cleaner Plus 18F Thrombectomy System is substantially equivalent to the predicate device and introduces no additional clinical risk. |
| In-Vitro Performance Testing | Meet acceptance criteria based on requirements outlined in guidance and industry standards for each specific test. | Cleaner Plus 18F Thrombectomy System Performance: Visual, Dimensional, Simulated Use, Leak Testing. |
| Handpiece Performance: Aspiration and Maceration Performance, Tensile and Torque, Kink Testing, Catheter Torque. | ||
| Canister Performance: Simulated Use Maceration and Aspiration Performance. | ||
| Maceration Wire Performance: Bond Strength, Resistance to Corrosion, Shape Retention, Flexing and Fracture, Kink Radius, Fatigue, Endurance, Torque, Tensile, Dimensional, Visual. | ||
| Handpiece and Catheter Performance: Peel-Away Introducer Removal Force, Maceration Wire RPM, Wire to Coupler Tensile, Peel-Away Introducer Functionality, Tip Collapse. | ||
| Other Tests: Particulates, Canister Performance (Visual, Functional, Tensile - joint strength), Luer Compliance, Pump Performance, IEC Compliance, Software Testing, Shipping Qualification. All tests met acceptance criteria. | ||
| Biocompatibility | Compliant with ISO 10993-1:2020 for an external communicating, circulating blood device with 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).