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    K Number
    K071873
    Device Name
    MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2007-08-09

    (34 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K050296
    Predicate For
    K073020,K112778
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

    Device Description

    The Varian Eclipse™ Treatment Planning System (Eclipse TPS) (K050296) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation, (brachytherapy) treatments.

    AI/ML Overview

    The provided document is a 510(k) premarket notification summary for the Eclipse Treatment Planning System (Eclipse TPS). This device is a software tool used by trained medical professionals to design and simulate radiation therapy treatments.

    However, the 510(k) summary (K071873) and the FDA letter do not contain information about acceptance criteria, performance studies with specific metrics, sample sizes for testing or training, methods for establishing ground truth, or details about human reader studies (MRMC or standalone AI performance).

    The document primarily focuses on establishing substantial equivalence to a predicate device (Eclipse Treatment Planning System, K050296) and outlining the general indications for use and classification. This type of regulatory submission for a software device generally relies on verification and validation activities to ensure the software performs as intended, but the detailed results of these activities are typically not included in the public 510(k) summary.

    Therefore, I cannot provide the requested information based on the provided text. To answer your questions, one would need access to the full 510(k) submission including the detailed validation documentation.

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