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510(k) Data Aggregation

    K Number
    K024108
    Device Name
    SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2002-12-18

    (5 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K972714,K983980,K003179
    Why did this record match?
    Device Name :

    SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM

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

    Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patien populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

    • Heart rate
    • ECG Arrhythmia Analysis
    • Arterial oxygen saturation
    • Pulse rate
    • ST segment analysis
    Device Description

    The current conventional 5-lead telemetry transmitter has been modified with a sixth electrode connection.

    By adding this sixth electrode connection to the current telemetry, more data is available to clinicians with which to evaluate the patient. This new 6-lead transmitter complies with the Wireless Medical Telemetry Service (WMTS) operating in the dedicated frequency band of 608-614 MHz.

    To adapt the current telemetry transmitter/receiver to accommodate the sixth electrode connection, hardware and software modifications were implemented.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Siemens INFINITY MultiView WorkStation Telemetry Modification. It focuses on a modification to an existing telemetry system, specifically adding a sixth electrode connection to a conventional 5-lead telemetry transmitter. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document states that "Testing has been performed in accordance with internal design control procedures and the FDA Draft Reviewer Guidance, November 1993, and indicates no affect on the safety or efficacy of the INFINITY MVWS Telemetry System." This statement indicates that testing was performed, but the specific details of that testing, including acceptance criteria, results, sample sizes, ground truth establishment, or expert reviews, are not provided.

    Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study that proves the device meets them based solely on the provided text. The submission is a regulatory filing that declares substantial equivalence to a predicate device, rather than a detailed report of validation study findings.

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