LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072033
    Device Name
    OTODYNAMICS OTOPORT
    Manufacturer
    OTODYNAMICS, LTD.
    Date Cleared
    2007-11-13

    (112 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K983350,K983352
    Why did this record match?
    Device Name :

    OTODYNAMICS OTOPORT

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

    The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.

    Device Description

    The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use. The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise. The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.

    AI/ML Overview

    The provided text is a 510(k) summary for the Otodynamics Otoport, an Otoacoustic emission analyzer. This document focuses on demonstrating substantial equivalence to a predicate device and lacks specific information regarding acceptance criteria and the detailed study results that would typically be presented in a clinical trial report.

    Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and study methodologies are not available in the provided document.

    Here's what can be extracted and what is missing:

    Description of the Acceptance Criteria and Device Performance

    The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a new study. Instead, it presents a comparison table showing the specifications of the new device (Otodynamics Otoport) against two predicate devices (Otodynamics ILO2088 Echocheck and Otodynamics ILO292 DP EchoportPlus). The implication is that the Otodynamics Otoport is acceptable because its specifications are comparable to or exceed those of the legally marketed predicate devices.

    1. A table of acceptance criteria and the reported device performance

    ParameterAcceptance Criteria (from Predicate Devices)Reported Device Performance (Otodynamics Otoport)
    Signal output:
    Frequency range: TEOAE1,500 to 3,200Hz (ILO2088) / 500 to 6,000Hz (ILO292)500 to 6,000Hz
    Frequency range: DPOAEN/A (ILO2088) / 500 to 8,000Hz (ILO292)500 to 10,000Hz
    Level range: TEOAE94 to 44dB SPL (Both Predicates)94 to 44dB SPL
    Level range: DPOAEN/A (ILO2088) / 35 to 75dB SPL (ILO292)35 to 75dB SPL
    Level increments: TEOAE1.5dB steps +/-0.5 (Both Predicates)1dB steps +/-0.5 (Improved resolution compared to ILO2088)
    Level increments: DPOAEN/A (ILO2088) / 1dB steps +/-0.5 (ILO292)1dB steps +/-0.5
    Signal to noise ratio>85dB (Both Predicates)>85dB
    Harmonic distortion: DPOAEN/A (ILO2088) /
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1