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510(k) Data Aggregation

    K Number
    K093510
    Device Name
    LUMENVU CATHETER GUIDANCE SYSTEM
    Manufacturer
    SONOSITE,INC.
    Date Cleared
    2010-08-23

    (284 days)

    Product Code
    OMF
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K083121,K081625,K052908
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.

    Device Description

    The SonoSite LumenVu™ Catheter Guidance System consists of a control box, a display screen, a camera, and a sterile optical stylet. The system uses a near-infrared light source to provide immediate visual feedback to the user on the location of a peripherally inserted central catheter tip. The optical stylet replaces traditional stiffening wire and provides a path for NIR light to its tip.

    AI/ML Overview

    This document describes the SonoSite LumenVu™ Catheter Guidance System, which is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not contain a specific table of detailed acceptance criteria with numerical targets and the device's corresponding performance metrics for its primary intended use (catheter tip navigation performance). However, it does state that the system demonstrated compliance with general safety and performance standards.

    Acceptance Criteria CategoryReported Device Performance
    Device Functionality"Test results demonstrated that the LumenVu™ System functioned as intended."
    Safety and Effectiveness"The observed test results demonstrate that the Lumen Vu™ System is as safe and effective as the predicate devices."
    Electrical Safety"Testing demonstrated that the system meets the requirements of IEC 60601-1 for electrical safety."
    Electromagnetic Compatibility (EMC)"Testing demonstrated that the system meets the requirements of IEC 60601-1-2 for electromagnetic compatibility."
    Laser Safety"Testing demonstrated that the system meets the requirements of IEC 60825-1 for laser safety."

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not explicitly state the sample size used for specific performance tests related to the catheter guidance functionality. It broadly refers to "Performance testing and engineering analysis."
    The data provenance (e.g., country of origin, retrospective or prospective) is not specified.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

    This information is not provided in the document. The study described appears to be an engineering performance and safety study rather than a clinical study requiring expert-established ground truth for diagnostic accuracy.

    4. Adjudication Method for the Test Set

    This information is not provided in the document. It is not relevant given the type of performance testing described.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general performance, not on direct comparison of human reader performance with and without AI assistance.

    6. If a Standalone Study Was Done

    Yes, safety and performance testing was done on the "algorithm only" in the sense that the LumenVu™ System itself (the device) underwent testing to ensure it functioned as intended and met safety standards in a standalone capacity, independent of clinical human-in-the-loop performance measurement. The described "Performance testing and engineering analysis" supports this.

    7. The Type of Ground Truth Used

    The "ground truth" for the performance claims appears to be based on:

    • Engineering specifications and standards conformance: For electrical, EMC, and laser safety (IEC 60601-1, IEC 60601-1-2, IEC 60825-1).
    • Intended functionality: The system's ability to "function as intended" for real-time visual navigation, likely assessed against pre-defined engineering criteria.
    • Comparison to predicate devices: The assertion that the system is "as safe and effective as the predicate devices" implies a comparison against the established performance of existing devices.

    8. The Sample Size for the Training Set

    This information is not applicable and is not provided in the document. The LumenVu™ Catheter Guidance System, as described, uses a light-based visual navigation system rather than a machine learning or AI algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable and is not provided. No training set for an AI/ML algorithm is mentioned.

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