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510(k) Data Aggregation

    K Number
    K052941
    Device Name
    I-NEB INSIGHT AAD SYSTEM
    Manufacturer
    PROFILE THERAPEUTICS PLC
    Date Cleared
    2005-12-09

    (50 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROFILE THERAPEUTICS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended purpose of the I-neb Insight AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the acute care, nursing home, sub-acute institution, or hospital environment.
    Device Description
    The I-neb Insight AAD System is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (Vibrating Thesh) nebuilder System for inhalation by the patient in the approved for ass mursing home, sub-acute institution, or hospital environment. I-neb insight has a monitoring function and it provides feedback to both patient and clinician regarding different aspects of inhaled aerosol therapy. The I-neb insight is designed to be used by the clinician to display a patients THE I Theo InSight is adaly. And it can be used to aid the teaching of optimized breathing. It may also be used by the clinician to interrogate the I-Neb AAD AND AND AND AND Andress (RLC) which can provide the clinician with de breathing. It Thay also be used by the clinician provide the clinician with device System Patient Logging System (1 ES) Which can provide we was and the make information that they need to
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    K Number
    K042991
    Device Name
    I-NEB AAD SYSTEM
    Manufacturer
    PROFILE THERAPEUTICS PLC
    Date Cleared
    2005-09-23

    (326 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROFILE THERAPEUTICS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended purpose of the I-neb AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
    Device Description
    The I-neb AAD system is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment. The I-neb AAD system consists of a hand-piece containing:- - an ultrasonic horn (to vibrate the mesh) . - a pressure transducer, (to monitor patient breathing) . - a microprocessor (to calculate aerosol pulse time based on breathing pattern) ● - a medication chamber (to hold the medication) . - a porous mesh (to create aerosol and determine particle size). . - a mouthpiece, which includes a bi-directional flap valve (to guide aerosol to the patient) . - a disc, which has a bi-directional, inductively coupled, Rf transponder (to enable fine . tuning operational parameters to be sent to the device). The I-neb AAD system incorporates the vibrating mesh technology developed and utilized in Omron's ultrasonic nebulizers, and the Adaptive Aerosol Delivery (AAD) technology developed and utilized by Profile's AAD system jet nebulizers. The vibrating mesh technology creates a low velocity aerosol by squeezing the liquid medication through 5-6,000 separate 3 micron holes during each vibration, creating thousands of droplets. the AAD technology is based on sensitive pressure transducers, microprocessors and firmware which together analyses a patient's breathing pattern and determines the appropriate aerosol wilse time to ensure that medication is only delivered during patient inspiration. The length of each pulse of aerosol is calculated based on the measured inspiration time of the r ne single or breaths and the I-neb continues to monitor the breathing pattern throughout provious into creatis any changes in the breathing pattern. When the appropriate dose of medication has been delivered, the system indicates that the treatment is complete.
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    K Number
    K030747
    Device Name
    PRODOSE AAD SYSTEM
    Manufacturer
    PROFILE THERAPEUTICS PLC
    Date Cleared
    2004-04-22

    (409 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROFILE THERAPEUTICS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A jet nebulizer system designed to aerosolize commonly prescribed liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institutions or hospital environment.
    Device Description
    The Prodose AAD system is a single patient reusable portable pneumatic jet nebulizer, designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a base unit containing a dedicated air compressor and a hand-piece containing a pressure or a base ann versant control system, a medication chamber, a baffle, and a mouthpiece. The pre-set dose volume is stored on a disc, which has a bi-directional inductively coupled transponder with data storage capacity in a non-volatile memory (EEPROM) embedded in the disc. The Prodose AAD system analyses the patient's breathing pattern to determine the acrosol pulse time. The system then pulses aerosol during patient inspiration only. The length of each pulse of acrosol is calculated according to the measured inspiratory time. Prodose continues to monitor the breathing pattern throughout treatment in order to adapt to changes in the breathing pattern. When the pre-set dose of medication has been delivered, the system indicates that the treatment is complete.
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