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    K Number
    K041918
    Device Name
    INTEGRATED PATIENT MONITORING SYSTEM
    Manufacturer
    INVIVO RESEARCH, INC.
    Date Cleared
    2004-10-15

    (91 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K002030,K974581
    Why did this record match?
    Device Name :

    INTEGRATED PATIENT MONITORING SYSTEM

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

    The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.

    Device Description

    The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is a significant modification of the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System. This device has been integrated into the Philips Physiotrak patient gurney used with the Philips MRI System. The Philips Medical Systems Integrated Patient Monitoring System is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner. The IPMS works on DC (battery) power supplies and monitors ECG, non-invasive blood pressure, SPO2, respiration and temperature. This information can be displayed either at the monitor or remotely. The monitor sounds an alarm if any monitored parameter falls outside the range indicated by the alarm limits. The alarm limits is programmable either manually or programmally based on the current value of the parameter(s). This monitoring system is MRI-compatible. It utilizes technology from the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System and the Invivo Research Millennia Patient Monitor. The IPMS consists of three major component parts; the MCB (Patient Connector Box), MEB (Monitoring Electronics Box), and MDCU (Monitoring Display and Control Unit) which are integrated into the Phillips Physiotrak patient gurney.

    AI/ML Overview

    The provided text describes the acceptance criteria and a summary of performance testing for the Philips Medical Systems Integrated Patient Monitoring System (IPMS). However, it does not include a detailed study description with information like sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing full clinical study details.

    Here's the information that can be extracted from the provided text based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria / Specification (Stated)Reported Device Performance (Implied by "Validation and Verification Testing confirmed that this device operates as designed and intended")
    ELECTRICAL AND MECHANICAL CHARACTERISTICS
    Line Voltage115 VAC +/- 10%, 50/60 HzMeets specification
    Power Sources AvailableAC Power, or internal battery power with remote chargerMeets specification
    Power Consumption8 hours with 4 batteriesMeets specification
    Electrical SafetyPer EN 60601-1Meets specification
    Electromagnetic CompatibilityPer EN 60601-1-2Meets specification
    PERFORMANCE REQUIREMENTS
    Heart Rate Monitor
    Range/Resolution0 to 250 BPM / 1 BPMMeets specification
    Rate Accuracy0.5% of reading, +/- 1BPMMeets specification
    Defibrillator ProtectionAccepts and recovers from a defibrillator discharge up to 5 KVMeets specification
    Non-Invasive Blood Pressure Monitoring
    Auto Mode Set IntervalsOFF, 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45 Min, or 1,2, 4 HrsMeets specification
    Pop-Off Pressure Level270 +/- 14 mmHgMeets specification
    Cuff Inflation Time3 to 20 secondsMeets specification
    Pulse Oximetry
    Range0 to 100% saturationMeets specification
    Accuracy
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