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510(k) Data Aggregation

    K Number
    K220415
    Device Name
    Protrieve Sheath
    Manufacturer
    Inari Medical, Inc.
    Date Cleared
    2022-07-12

    (148 days)

    Product Code
    QEW,KRA
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K191710,K211013,K173672,K212632
    Why did this record match?
    Reference Devices :

    K191710, K211013, K173672

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ClotTriever Thrombectomy System is indicated for:

    • · The non-surgical removal of thrombi and emboli from blood vessels.
    • · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

    The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

    Device Description

    The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and the ClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.

    The sheath is an introducer sheath with a distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).

    AI/ML Overview

    The provided text is a 510(k) summary for the Protrieve Sheath, a medical device. It details the device's technical characteristics and the non-clinical testing performed to establish substantial equivalence to a predicate device.

    Crucially, this document states: "Clinical testing was not required to support substantial equivalence." This means there was no clinical study involving human subjects for this specific submission to prove the device meets performance criteria, especially as it relates to AI/machine learning performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device, as the provided document does not pertain to an AI/ML device or a clinical study for performance.

    The acceptance criteria mentioned in the document relate to the non-clinical (engineering and material) testing of the physical device to demonstrate mechanical and material properties are consistent with the predicate device, not performance benchmarks for an AI algorithm.

    If you would like to know about the non-clinical acceptance criteria and the tests performed for this specific device, I can provide that information based on the text. However, it will not involve AI/ML performance, ground truth, expert consensus, or clinical effectiveness studies in the way your prompt describes.

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