(29 days)
The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:
-The non-surgical removal of emboli and thrombi from blood vessels.
-Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature.
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately: Aspiration Guide Catheter (AGC), FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm), Retraction Aspirator.
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.
The provided text describes a 510(k) premarket notification for the FlowTriever Retrieval/Aspiration System. However, it does not include detailed acceptance criteria or a comprehensive study report with quantified performance metrics to address all aspects of your request.
Based on the available information, here's what can be extracted:
Acceptance Criteria and Device Performance:
The document states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." However, the specific quantitative acceptance criteria and the actual reported device performance (e.g., success rates, flow rates, pressure tolerances) are not provided in this summary. The table below lists the types of tests performed, implying their successful outcome met an unstated acceptance criterion for each.
| Acceptance Criteria (Implied from tests performed) | Reported Device Performance (Implied as "Met") |
|---|---|
| Visual & Dimensional Inspections | Met |
| Leakage Testing: Guide Catheter Hemostasis Valve and Devices | Met |
| Air Leakage from Guide Catheter Hemostasis Valve During Syringe Pullback | Met |
| Retraction Testing: Retraction Aspirator | Met |
| Check Valve & Vent Plug Testing: Tube set | Met |
| Leakage Verification: Tube Set, Clot Reservoir | Met |
| Valve Cracking Pressure: Clot Reservoir | Met |
| Simulated use Track and Tensile: Guidewire Compatibility | Met |
| Simulated use Track and Tensile: Flush Port, Guide Catheter, Tube Set | Met |
| Vacuum Testing: Guide Catheter, Clot Reservoir, Tube Set | Met |
| Torque Testing: Clot Reservoir Luer Activated Valve | Met |
| Clot Burden: Clot Reservoir | Met |
| Valve Dilator Insertion Force: Guide Catheter | Met |
| Corrosion Resistance: Clot Reservoir | Met |
Study Details:
The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This means that the information you've requested regarding test sets, ground truth establishment, expert involvement, and MRMC studies is not applicable to the non-clinical testing presented here.
Therefore, for your specific questions:
- A table of acceptance criteria and the reported device performance: This is partially addressed above, with implied "Met" for performance as no quantitative values are given.
- Sample size used for the test set and the data provenance: Not applicable, as clinical testing was not performed. The non-clinical tests would have internal sample sizes (e.g., N units tested for leakage), but these are not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical testing was not performed, and thus no expert ground truth was established for a test set in this context.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
- 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, as no clinical study or AI component is described. The device is a physical medical device (embolectomy catheter).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, the device is a physical catheter system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be engineering specifications and standards (e.g., a specific leakage rate is acceptable, a certain tensile strength is required).
- The sample size for the training set: Not applicable, no AI algorithm is involved that would require a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, this 510(k) submission relies on non-clinical (bench and physical) testing to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy studies with human subjects or AI performance evaluations.
§ 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).