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    K Number
    K180148
    Device Name
    ATS Thermal Imaging Probe, ATS Patient Interface Unit
    Manufacturer
    Securus Medical Group, Inc.
    Date Cleared
    2018-03-21

    (61 days)

    Product Code
    FLL,CLI
    Regulation Number
    880.2910
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K152402
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.

    The ATS Patient Interface Unit is intended to display continuous temperature measurements (C°) from the ATS Thermal Imaging Probe.

    Device Description

    The Securus Aurora Thermographic System (ATS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on the Patient Interface Unit.

    Aurora Thermographic System (ATS) consists of two components:

    • A. ATS Thermal Imaging Probe
    • B. ATS Patient Interface Unit

    The ATS Thermal Imaging Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. In addition, the ATS Thermal Imaging Probe incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system).

    AI/ML Overview

    The ATS Thermal Imaging Probe and ATS Patient Interface Unit is a medical device intended for continuous esophageal temperature monitoring and displaying these temperature measurements. The product is a modification of the previously cleared InfraRed Thermographic System (IRTS). The modifications include combining two connectors into one handle, modifying the distal tip to include BaSO4 filler, changing the housing and circuit boards of the patient interface unit, and modifying the software.

    Here's an analysis of the acceptance criteria and study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Device Modification / Test AspectAcceptance CriteriaReported Device Performance
    ATS Thermal Imaging Probe Modifications
    Accuracy (Thermocouple)Accuracy ± 0.3° C across the rated output range.All samples tested met the accuracy acceptance criteria of ± 0.3° C.
    Response Time (Thermocouple)Response time same as predicate,
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