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510(k) Data Aggregation

    K Number
    K091871
    Device Name
    DK50 DS
    Manufacturer
    EKOM S.R.O.
    Date Cleared
    2009-10-23

    (122 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K060781,K041406
    Why did this record match?
    Device Name :

    DK50 DS

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

    Indicated for supplying compressed air for medical ventilators.

    Device Description

    The Ekom model DK50 DS is a portable air compressor designed to supply air to medical equipment, i.e., ventilators.

    The Model DK50 DS contain an oil-free piston compressor driven by a low maintenance single phase electric motor. Compressed air is cooled where condensed water is separated into a vessel. Incoming air passes through 2 filters and undergoes double filtration as it passes through the system. Constant output pressure is maintained by a pressure regulator. There is a built-in air tank which allows peak air consumption of 200 Lpm.

    The device may be used as a standby source of air. In this configuration, the respiratory equipment is supplied with compressed air from the facilities central air distribution. Air pressure in this central distribution is sensed by the Ekom pressure sensor. If the pressure is sufficient, the compressor stays in the STANDBY mode. If the pressure falls the compressor automatically starts and becomes the main air supply.

    When the compressor is used as the main source, the control unit determines its operation according to the current need for air. If air consumption is zero, the device switches to STANDBY.

    The compressor is equipped with indicators for output pressure, operation hours, power status, drying efficiency and battery condition as well as acoustic and optic alarms to warn of high operating temperature, low output pressure and loss power.

    AI/ML Overview

    The provided document describes a medical device (portable air compressor DK50 DS) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML or diagnostic device.

    The document focuses on:

    • Device Description: A portable air compressor designed to supply air to medical ventilators.

    • Indications for Use: Supplying compressed air for medical ventilators in hospital or sub-acute institution environments.

    • Substantial Equivalence: A comparison of the DK50 DS with two predicate devices (K060781 - Ekom Model DK50 D and K041406 - Newport Model C250) based on specifications like output flow, power, alarms, and physical dimensions.

    This is a 510(k) premarket notification for a traditional medical device (a portable air compressor), not an AI/ML-driven diagnostic or image analysis tool. Therefore, the concepts of acceptance criteria for diagnostic performance (like sensitivity, specificity), ground truth, test/training sets, expert adjudication, or MRMC studies are not applicable to the information provided.

    The "acceptance criteria" discussed in the document are effectively the technical specifications and performance characteristics compared against the predicate devices to establish substantial equivalence.

    Therefore, I cannot provide the requested information because it is not present in the given text.

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