(129 days)
The Mini-ClotTriever Thrombectomy 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 Mini-ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The Mini-ClotTriever Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
The Mini-ClotTriever (“MCT”) Thrombectomy 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 two main components packaged separately:
Mini-ClotTriever Sheath (8 Fr)
Mini-ClotTriever Catheter (8 Fr)
The MCT Sheath is placed in the target vessel, and, after its funnel is expanded, the MCT Catheter is inserted through the sheath and advanced past the thrombus. The MCT Catheter coring element is deployed to engage the clot and retracted into the MCT Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the MCT Catheter and MCT Sheath are removed from the patient.
The provided text describes the 510(k) premarket notification for the Mini-ClotTriever Thrombectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device (Inari ClotTriever Thrombectomy System, K210689) through non-clinical testing. It does not present a study proving the device meets acceptance criteria related to AI/algorithm performance.
The document primarily covers:
- Device Description: A mechanical thrombectomy system for non-surgical removal of emboli and thrombi from blood vessels in the peripheral vasculature.
- Comparison to Predicate: Details on the similarities and differences in design, materials, and operational principles between the Mini-ClotTriever and its predicate device.
- Non-Clinical Testing: A list of bench tests performed (e.g., biocompatibility, sterilization, dimensional inspections, simulated use, tensile testing, corrosion testing) to demonstrate that the device conforms to established product specifications and the modifications do not raise new questions of safety or effectiveness.
- Conclusion: The device is substantially equivalent to the predicate device based on non-clinical testing, and neither animal nor clinical testing was required for this determination.
Based on the provided text, none of the specific information requested about AI/algorithm acceptance criteria and performance (e.g., sample size for test sets, expert consensus, MRMC studies, standalone performance, training set details) can be extracted because the device is a medical instrument, not an AI/algorithm-based diagnostic or therapeutic tool for which such criteria would apply.
Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance. The document describes a mechanical device and its testing, not an AI study.
§ 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).