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510(k) Data Aggregation

    K Number
    K232059
    Device Name
    Tympanostomy Tubes
    Manufacturer
    Grace Medical, Inc.
    Date Cleared
    2023-11-24

    (136 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K062385,K830228
    Why did this record match?
    Reference Devices :

    K062385, K062385, K830228

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • 1 ) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent.
      1. Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
      1. A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or timitus.
      1. Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.
    Device Description

    The Grace Medical, Inc. ETFE (Fluoroplastic) Ventilation Tubes are intended to ventilate the middle ear subsequent to otitis media. The placement of the tympanic membrane provides the means for any fluid buildup in the middle ear while creating an avenue of the passage of air to equalize pressure on either side of the drum. These ventilation tubes will be made from ETFE (fluoroplastic). ETFE has been used as a material for ventilation tubes and other middle ear application for many years.

    AI/ML Overview

    This document describes an FDA 510(k) premarket notification for a medical device, specifically a Tympanostomy Tube. The submission aims to demonstrate "substantial equivalence" to previously cleared devices rather than providing clinical performance data with acceptance criteria for a new AI application.

    Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable to this document.

    This document focuses on:

    • Device: Grace Medical, Inc. ETFE Tympanostomy Tube (K232059)
    • Predicate Devices: Grace Medical, Inc. PTFE Tympanostomy Tube (K062385) and Micromedic, Inc. ETFE Tympanostomy Tube (K830228)
    • Primary Change: Material change from PTFE to ETFE for the Grace Medical device.
    • Demonstration of Substantial Equivalence: By comparing technological characteristics, indications for use, and presenting non-clinical bench testing, biocompatibility, sterility, and packaging testing data.

    There is no mention of an AI component or software in this document.

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