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510(k) Data Aggregation

    K Number
    K222185
    Device Name
    Stratus Infusion Catheter
    Manufacturer
    InterVene, Inc.
    Date Cleared
    2023-04-13

    (265 days)

    Product Code
    NPG
    Regulation Number
    870.1210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K161402
    Why did this record match?
    Applicant Name (Manufacturer) :

    InterVene, Inc.

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

    In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.

    Device Description

    The Stratus™ Infusion Catheter is a peripheral infusion catheter designed to access an intraluminal, intramural, or perivascular vein wall layer and infuse fluid diagnostic and/or therapeutic agents. The Stratus Infusion Catheter is a non-implantable device that is provided sterile and is intended for single patient use. The Stratus Infusion Catheter is designed to accommodate individual vein anatomies or disease progression (e.g., thrombosis), by the catheter platform allowing multiple infusions and infusion locations per device.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Stratus Infusion Catheter," which focuses on establishing substantial equivalence to a predicate device.

    While it mentions "design verification and validation testing" including bench testing, biocompatibility, sterilization validation, and animal testing, it does not provide:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for a test set or data provenance.
    • Details about experts used for ground truth or their qualifications.
    • Adjudication methods.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Details of a standalone (algorithm only) performance study.
    • The specific type of ground truth used (beyond implying general animal study outcomes).
    • Sample size for a training set or how its ground truth was established.

    The document primarily focuses on a comparison of the characteristics of the Stratus Infusion Catheter to its predicate device (Bullfrog Micro-Infusion Device) to demonstrate substantial equivalence, rather than detailing a study that measures its performance against specific acceptance criteria.

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