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    K Number
    K152975
    Device Name
    VDT985US Vicks SmartTemp Thermometer
    Manufacturer
    Kaz USA, Inc., a Helen of Troy Company
    Date Cleared
    2016-03-23

    (167 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K030580,K043110,K132761
    Why did this record match?
    Device Name :

    VDT985US Vicks SmartTemp Thermometer

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

    The VDT985US Vicks® SmartTemp™ Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only.

    Device Description

    The VDT985US Vicks® SmartTemp™ Thermometer is a general purpose thermometer. The thermometer is intended for oral, axillary temperature measurements of the human body. The main user interface for the thermometer is a smartphone or other Bluetooth smart device on which the Kaz SmartTemp app is installed. The thermometer communicates with the user's device through a Bluetooth smart connection.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the VDT985US Vicks® SmartTemp™ Thermometer, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance (VDT985US Vicks® SmartTemp™ Thermometer)
    Accuracy±0.2° F (±0.1 ° C) within measurement range 95.9-107.6° F and ±0.4° F outside this range
    Operating environmentComplies with ASTM E1112:2006 Standard
    Clinical Accuracy (clinical bias with uncertainty and repeatability)Per ASTM E 1965-09 Clinical Requirements
    Limit of agreement (clinical)Per ASTM E 1965-09 Clinical Requirements
    Clinical RepeatabilityStatistically and clinically acceptable (less than 0.3 °C or 0.58°F)
    BiocompatibilityComplies with ISO 10993-5 (cytotoxicity), 10993-10 (irritation/sensitization), and FDA memo G95-1

    Study Details

    2. Sample Size and Data Provenance

    The document states that a comparison study and clinical repeatability testing were performed on four age groups: 0-12 months, 12 months-

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