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510(k) Data Aggregation

    K Number
    K041076
    Device Name
    DELTA T
    Manufacturer
    PENLON LTD.
    Date Cleared
    2004-08-09

    (105 days)

    Product Code
    CAD
    Regulation Number
    868.5880
    Type
    Special
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DELTA T

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

    The Sigma Delta 'T' vaporizer range is designed to attach to the back bar of an anaesthetic machine and deliver controlled concentrations of anaesthesia gasses into a fresh gas. The fresh gas is then delivered into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient. The Vaporizer is calibrated in Vol % of the fresh gas flow and is compensated for changes in both fresh gas flows and temperature changes within the specified range. The indicated use of the Sigma Delta 'T' has therefore not changed from that of the legally marketed device the Sigma Delta.

    Device Description

    Anaesthetic Vaporizer

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for an "Anaesthetic Vaporizer." It does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging diagnostics. The device described is a traditional medical device (anesthetic vaporizer), not a software device that would typically have performance metrics like sensitivity, specificity, and a ground truth study.

    Therefore, I cannot provide the requested information.

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