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510(k) Data Aggregation
(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 <24hrs. All studies were performed following the approved protocol under Good Laboratory Practices (GLP) in compliance to FDA GLP, 21 CFR Part 58." (Overall claim of meeting biocompatibility requirements) |
| Animal Study | Evaluation for vessel injury, patency, and gross thrombogenicity in the target vasculature. | Demonstrating substantially equivalent safety and performance, specifically no vessel injury (ruptures, hemorrhage, perforation, dissection) or histological signs of thromboembolism. | "There were no histological signs of thromboembolism noted in the treated vessels, there were no ruptures, hemorrhage, perforation, or dissection noted histologically in the treated veins. All the end points of this study were met." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Animal Study): The document states "An animal study was performed..." but does not specify the sample size (number of animals or procedures).
- Data Provenance: The animal study data provenance is "animal study," implying a prospective, controlled study within a laboratory setting. No country of origin for the animals or study location is explicitly stated, but it would typically be conducted under US regulations (GLP).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not describe the use of human experts to establish ground truth for a test set in the context of an AI algorithm or image analysis. The animal study's "ground truth" would be established by veterinary pathologists or other trained personnel performing histological analysis and gross observation, but the number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set
Not applicable, as the document doesn't describe ground truth establishment by multiple human readers for a test set in the context of an AI/image analysis setting. The animal study results would likely be adjudicated if multiple observers interpreted the findings, but no such method is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted or described. This type of study is typically done to assess the impact of an AI system on human reader performance, which is not the focus of this 510(k) submission for a mechanical thrombectomy device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a mechanical thrombectomy system, not an AI algorithm. Its performance is inherent in its physical and mechanical operation.
7. The Type of Ground Truth Used
For the animal study, the ground truth was based on post-procedural histological analysis of treated vessels and gross observation for signs of injury or thrombosis. For bench-top testing, the ground truth is against engineering specifications and physical measurements.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set.
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