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    K Number
    K240784
    Device Name
    Temperature Sensor Probe (ABL-18TP20)
    Manufacturer
    Varian Medical Systems, Inc.
    Date Cleared
    2024-05-29

    (69 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K200796
    Why did this record match?
    Device Name :

    Temperature Sensor Probe (ABL-18TP20)

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

    The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.

    Device Description

    Temperature Sensor Probe is an optional accessory designed for use with compatible Varian ablation systems. Principal components of the temperature sensor probe include:

    • Needle
    • Handle
    • Lead cable and connector
    AI/ML Overview

    The provided text describes the regulatory clearance of a Temperature Sensor Probe (ABL-18TP20) for use with Varian ablation systems for monitoring tissue temperature. The submission focuses on demonstrating substantial equivalence to a predicate device, the Emprint™ Ablation System with Thermosphere Technology: K200796, specifically the Ablation Remote Temperature Probe (RTP20).

    Here's an analysis of the acceptance criteria and study information:

    Acceptance Criteria and Reported Device Performance

    Feature/CharacteristicAcceptance Criteria (Predicate Device K200796, RTP20)Reported Device Performance (Subject Device: Temperature Sensor Probe)
    Intended Use/Indications for UseMonitoring tissue temperature at or near the ablation site.Monitoring tissue temperature near the ablation site.
    Operating PrincipleMeasures tissue temperature in real time via a thermocouple within the tip of the probe.Measures tissue temperature in real time via a thermocouple within the tip of the probe.
    Product code, FDA regulation, classNEY, 21 CFR 878.4400, Class IINEY, 21 CFR 878.4400, Class II
    Prescription (Rx only)YesYes
    Optional AccessoryYesYes
    Measuring SiteAt or near ablation siteTissue near ablation site
    Temperature Range (Accuracy)37°C - 60°C (±1.5°C)10°C - 60°C (±2°C)
    Thermocouple-based sensor at tipYesYes
    Signal Processing & DisplayReal-time, continuous display of tissue temperature.Real-time, continuous display of tissue temperature.
    Tissue Contact per ISO 10993-1External communicating device, in contact with tissue/bone/dentin and limited contact duration (A) (
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