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510(k) Data Aggregation

    K Number
    K143213
    Device Name
    INOmax DSIR Plus MRI
    Manufacturer
    INO Therapeutics/Ikaria
    Date Cleared
    2015-07-10

    (242 days)

    Product Code
    MRN, MRO, MRP, MRQ
    Regulation Number
    868.5165
    Why did this record match?
    Applicant Name (Manufacturer) :

    INO Therapeutics/Ikaria

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INOmax DSIR® Plus MRI delivery system is indicated for delivery of INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant on of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling. The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired 02, NO2, and NO. The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss. The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.
    Device Description
    The INOmax DSIR® uses a "dual-channel" design to provide delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shut down INOMAX® delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system. The INOmax DSIR Plus MRI incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source. The INOmax DSIR Plus MRI includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO, which along with user supplied 10 L/min of oxygen, provides 20 ppm of NO to a patient breathing circuit. The INOblender® can also be used for backup.
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    K Number
    K131686
    Device Name
    INOMAX DSIR (DELIVERY SYSTEM)
    Manufacturer
    INO THERAPEUTICS/IKARIA
    Date Cleared
    2013-11-29

    (172 days)

    Product Code
    MRN, MRP, MRQ
    Regulation Number
    868.5165
    Why did this record match?
    Applicant Name (Manufacturer) :

    INO THERAPEUTICS/IKARIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INOmax® DS delivery system delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOmax® DS provides continuous integrated monitoring of inspired O₂, NO₂, and NO, and a comprehensive alarm system. The INOmax® DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source. The INOmax® DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup. The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
    Device Description
    The INOmax DSIR® uses a "dual-channel" design to ensure the safe delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO₂, and O₂ cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX® delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
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