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510(k) Data Aggregation

    K Number
    K073276
    Device Name
    IONTOPHORESIS SYSTEM
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2008-03-05

    (105 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K884834,K870272
    Predicate For
    K110636
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Iontophoresis System is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.

    Device Description

    The Iontophoresis System (IPS) is a single-use device that employs electric current to transport drug solution, salts, or ions in the ear, including the tympanic membrane. The Iontophoresis System consists of 6 accessories: Control Unit, Ear Electrodes, Electrode Cable, Ear Plugs, Return Electrode, and Fill Nozzle.

    AI/ML Overview

    This document is a 510(k) K073276 summary for the Acclarent Iontophoresis System. It focuses on administrative information, device description, indications for use, and a statement of substantial equivalence to predicate devices, rather than detailed performance study results.

    Therefore, it is impossible to extract the requested information regarding acceptance criteria, specific performance data, sample sizes, ground truth establishment, or details of a comparative effectiveness study from this document.

    The only relevant line concerning performance is:
    "The Iontophoresis System met all performance testing acceptance criteria."

    This statement confirms that performance testing was conducted according to acceptance criteria, but it does not specify what those criteria were or detail the results of the performance testing.

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