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510(k) Data Aggregation

    K Number
    K152748
    Device Name
    Braun Thermoscan PRO 6000 Ear Thermometer
    Manufacturer
    KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC)
    Date Cleared
    2016-03-01

    (160 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K030580,K103800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC)

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

    The Braun Thermoscan® PRO 6000 Ear Thermometer is indicated for the intermittent measurement and monitoring of human body temperature for patients of all ages in a professional use environment. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.

    Device Description

    The Braun Thermoscan® PRO 6000 Ear Thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. The Braun Thermoscan® PRO 6000 Ear Thermometer also includes a technique compensation feature to detect depth of insertion to compensate for common methods of misuse, this feature uses capacitive rings mounted in the speculum of the thermometer to detect insertion and depth and measurements of the outer ear temperature during insertion to detect misuse and correct accordingly. The Braun Thermoscan® PRO 6000 Ear Thermometer is meant for professional use in hospitals and healthcare or professional office settings.

    AI/ML Overview

    The provided document describes the KAZ USA, Inc. Braun Thermoscan® PRO 6000 Ear Thermometer and its clinical study to demonstrate substantial equivalence to its predicate device, the Braun Thermoscan® PRO 4000 Ear Thermometer, in accordance with ASTM E1965-03.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Criterion (from ASTM E1965-03)Acceptance Criteria for Braun Thermoscan® PRO 6000Reported Device Performance (Reference Thermoscan® PRO 4000 and SureTemp Plus)
    Bias (vs. Reference)"within clinical acceptability" (specifically, bias less than predicate device when compared to reference)Bias reported as "within clinical acceptability" and "less than predicate device when compared to reference" against the SureTemp Plus Oral/Rectal and Axillary Contact Thermometer
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