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510(k) Data Aggregation

    K Number
    K050399
    Device Name
    MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
    Manufacturer
    INVIVO RESEARCH, INC.
    Date Cleared
    2005-08-26

    (191 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K040915,K041918
    Why did this record match?
    Device Name :

    MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160

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

    The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

    The 3160 MRI Patient Monitoring System is intended for use by health care professionals.

    Device Description

    The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 orovides accurate, continuous, and reliable performance during all phase of MRI applications.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for the K050399 device, based solely on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    ParameterAcceptance Criteria (Specification)Reported Device Performance
    ELECTRICAL AND MECHANICAL CHARACTERISTICS
    Operating Voltage90 to 264 VACPassed all tests (implied by "met the performance requirements")
    Power Consumption30 Volt-Amperes with Charged batteries (48 VA maximum during charging)Passed all tests (implied by "met the performance requirements")
    Battery Capacity> 8 hours (Lithium Ion)Passed all tests (implied by "met the performance requirements")
    Electrical SafetyPer EN 60601-1Passed all tests (explicitly stated in "Summary of Performance Testing")
    Electromagnetic CompatibilityPer EN 60601-1-2Passed all tests (explicitly stated in "Summary of Performance Testing")
    Heart Rate Monitor
    Range/Resolution (Adult)30 to 249 BPM / 1 BPMMet performance requirements (accuracy and precision)
    Range/Resolution (Neonate)30 to 300 BPM / 1 BPMMet performance requirements (accuracy and precision)
    Rate Accuracy (30-200 BPM)± 1%Met performance requirements (accuracy and precision)
    Rate Accuracy (201-250 BPM)± 1.5%Met performance requirements (accuracy and precision)
    Rate Accuracy (251-300 BPM)± 2% (Neonate only)Met performance requirements (accuracy and precision)
    Defibrillator ProtectionAccepts and recovers from discharge up to 5 KVMet performance requirements (accuracy and precision)
    Non-Invasive Blood Pressure Monitoring
    Auto Mode Set IntervalsOFF, 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45 Min, or 1, 2 and 4 HrsMet performance requirements (accuracy and precision)
    Pop-Off Pressure Level285 +/- 14 mmHgMet performance requirements (accuracy and precision)
    Cuff Inflation Time3 to 20 secondsMet performance requirements (accuracy and precision)
    Pulse Oximetry
    Range0 to 100% saturationMet performance requirements (accuracy and precision)
    Accuracy
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