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510(k) Data Aggregation

    K Number
    K120892
    Manufacturer
    Date Cleared
    2013-06-10

    (444 days)

    Product Code
    Regulation Number
    870.1650
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPOSABLE 330PSI EXTENSION LINES

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

    to be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

    Device Description

    Disposable, 330psi Extension Lines

    AI/ML Overview

    This document is a 510(k) summary for a medical device (Disposable 330psi Extension Lines) and does not contain the type of acceptance criteria and study information requested. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

    • Acceptance criteria or reported device performance in a table format.
    • Sample sizes, data provenance, or details about test sets.
    • The number or qualifications of experts, nor adjudication methods.
    • Any multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • The type of ground truth used.
    • Sample size or ground truth establishment for a training set.

    This information would typically be found in a separate clinical or non-clinical study report submitted as part of the 510(k) premarket notification, not in the FDA's substantial equivalence determination letter.

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