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510(k) Data Aggregation

    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
    Type
    Abbreviated
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K991685,K935693,K990801,K981772
    Why did this record match?
    Reference Devices :

    K 981772, K991685, K935693, K990801

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text describes the Prodose AAD System, a jet nebulizer. However, it does not contain a study section that outlines acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

    The document is a premarket notification (510(k)) that focuses on establishing substantial equivalence to predicate devices. It describes the device, its intended use, and compares its attributes and differences to a legally marketed predicate device (HaloLite AAD System).

    Therefore, I cannot provide the requested information from the given text as the detailed study data is absent.

    What the document does provide:

    • 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. It analyzes the patient's breathing pattern to pulse aerosol only during inspiration.
    • Intended Use: Aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by patients in home care, nursing homes, sub-acute institutions, or hospitals.
    • Differences from Predicate Device (HaloLite AAD System):
      • LCD graphic display vs. flashing LED lights for visual feedback.
      • Microprocessor disc stores pre-set dose information vs. colored buttons.
      • Internal DC supply from mains power vs. internal replaceable 9-volt battery.
      • Able to supply longer aerosol pulses into long inhalation cycles, shortening treatment times.
      • Utilizes a larger number of data points to compensate for inhalation airflows.
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