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510(k) Data Aggregation

    K Number
    K102599
    Device Name
    TOMOPHASE OCTIS
    Manufacturer
    TOMOPHASE CORPORATION
    Date Cleared
    2010-12-01

    (82 days)

    Product Code
    NQQ,NOO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K033783
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOMOPHASE CORPORATION

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

    The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

    Device Description

    The Tomophase OCTIS is an imaging tool for the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. The system consists of an Imaging Console and a detachable Probe.

    The Imaging Console contains optical and electrical components to utilize NIR light to create high resolution real-time images; and has a user interface for acquiring, displaying, saving and reporting the images.

    The Probe is a single-use, sterile device consisting of a sealed sheath and a flexible fiber optic mechanism.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study information based on the provided text for the Tomophase OCTIS 510(k) submission:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided 510(k) summary does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for a specific clinical task. Instead, the "acceptance criteria" are implied by the successful completion of various safety and bench tests, demonstrating the device's adherence to relevant standards and design objectives.

    Therefore, the table below reflects what can be inferred as "acceptance criteria" from the provided document, focusing on safety and technical performance, rather than clinical diagnostic performance.

    Acceptance Criteria (Implied from successful test completion)Reported Device Performance (as stated in the document)
    Safety and Standards Compliance
    Risk Management per ISO 14971Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
    Medical Electrical Equipment per IEC 60601-1Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
    Electrical Safety per IEC 60601-1-1Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
    Electromagnetic Compatibility per IEC 60601-1-2Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
    Safety of Endoscopic Equipment per IEC 60601-2-18Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
    Laser Safety per IEC 60825-1Laser Safety Class 3R; Optical Radiation Emission Safety:
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