(140 days)
The Cleaner™ Pro Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The Cleaner™ Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary embolism.
The Cleaner Pro Thrombectomy System is a single use device in the removal of fresh, soft emboli and thrombi and for the infusion of physician-selected fluids through the side-port of the aspiration catheter.
The disposable system consists of: (1) the Aspiration Catheter with Dilator, (2) the Handpiece with Flushing Adapter, and (3) the external vacuum reservoir with pump known as the Aspiration Canister.
The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the target site. Once in the target site, to complete the system, the Aspiration Canister is connected to the handpiece. The dilator is removed, and the device is activated by the user to aspirate soft emboli and thrombi. The clot is aspirated from the distal portion of the device through the handpiece and then collected in the aspiration canister reservoir.
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 is a 510(k) Summary for the Cleaner™ Pro Thrombectomy System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria based on clinical outcomes or standalone AI algorithm performance.
Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not present in this type of regulatory submission. This document describes the bench-top and animal performance testing to support the claim of substantial equivalence for a medical device, which is different from studies demonstrating efficacy of an AI algorithm or performance directly tied to a specific set of clinical acceptance criteria.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria with quantitative performance metrics for a clinical outcome study. Instead, it lists performance testing conducted to demonstrate substantial equivalence to the predicate devices. The acceptance criteria for these tests are generally that the device performs comparably to the predicate or meets established engineering/design specifications for safety and functionality.
| Test Category | Specific Tests Performed (examples) | Acceptance Criteria (Implied) | Reported Performance (Implied) |
|---|---|---|---|
| In-Vitro (Bench-top) Performance Testing | Catheter - Dimensional, Visual, Radiopacity, Hemostasis Valve Leak, System Leak, Burst, Kink Radius, Tensile Break, Torsional Break, Aspiration Tip Collapse. Dilator - Dimensional, Leak, Burst, Functional, Visual, Tensile Break, Radiopacity. Aspiration Canister - Visual, Functional, Tubing Tensile Break, Weld Strength. Handpiece - Functional, Simulate Use. System - Functional, Vacuum Decay, Noise Level, Integrity, Visual, Simulated Use. Shipping Qualification, IEC-60601 Compliance, Software Validation. | The device must meet predefined engineering specifications and perform comparably to predicate devices for these physical and functional characteristics, ensuring safety and intended function. | "The below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." (General statement that tests were successful) |
| Biocompatibility Testing | Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation or Intracutaneous Reactivity (ISO 10993-10), Material Mediated Pyrogen (ISO 10993-11), Acute Systemic Toxicity (ISO 10993-11), Hemocompatibility (ISO10993-4) - In-vitro Blood Assay Complement Activation, SC5b-9 Heparinized Platelet and Leucocyte Counts, Partial Thromboplastin Time (PTT), ASTM Hemolysis Assay (Direct and Extract Methods). | Compliance with ISO 10993 standards for the specified biological endpoints, ensuring the device is biocompatible for its intended use. | "Biocompatibility is established for the Cleaner Pro Thrombectomy System according to ISO 10993-1:2020 as an external communicating, circulating blood 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).