(181 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. Mechanical thrombectomy is 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 a 510(k) submission for a device modification to the Cleaner Plus™ Thrombectomy System. This is a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm-only) performance," and "ground truth for the test and training set," are not applicable.
The submission focuses on demonstrating the substantial equivalence of a modified device to a predicate device through non-clinical performance testing.
Here's the relevant information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Test results demonstrate that all acceptance criteria were met." However, the specific acceptance criteria values are not detailed in the provided text. The types of tests performed indicate the areas for which acceptance criteria would have been established.
| Acceptance Criteria Category (implied from tests) | Reported Device Performance |
|---|---|
| Corrosion Resistance | Met acceptance criteria |
| Tensile Break | Met acceptance criteria |
| Simulated Use (Handpiece performance with Helical component) | Met acceptance criteria |
| Simulated Use (Aspiration Performance) | Met acceptance criteria |
| Torque Strength (Helical Component to Wire) | Met acceptance criteria |
| Wire Fatigue | Met acceptance criteria |
| Particulates | Met acceptance criteria |
| Biocompatibility (Cytotoxicity - MEM Elution) | Met acceptance criteria |
| Biocompatibility (Sensitization – Guinea Pig Maximization) | Met acceptance criteria |
| Biocompatibility (Irritation - Intracutaneous Reactivity) | Met acceptance criteria |
| Biocompatibility (Systemic Toxicity - Material Mediated Pyrogen) | Met acceptance criteria |
| Biocompatibility (Systemic Toxicity - Acute Systemic Toxicity) | Met acceptance criteria |
| Biocompatibility (Hemocompatibility – Hemolysis Indirect) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the individual tests. The tests were non-clinical (laboratory/bench testing), so data provenance from countries or whether it was retrospective/prospective is not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a medical device performance study, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical studies or studies involving expert interpretation, not for bench testing of device components.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The documentation did not specify a "ground truth" in the context of clinical or diagnostic outcomes. For performance testing of a physical device, the "ground truth" would be established physical measurements and material properties relevant to the device's function and safety (e.g., tensile strength, torque, aspiration volume, biocompatibility assays).
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set with established ground truth.
Summary of Study Type:
The study described is a non-clinical verification testing of a medical device modification to support substantial equivalence to a predicate device. The tests included various engineering performance tests (e.g., corrosion, tensile, torque, fatigue, simulated use) and biocompatibility assessments. Clinical and animal testing were not required for this determination of substantial equivalence.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).