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510(k) Data Aggregation

    K Number
    K230083
    Device Name
    SAFIRA
    Manufacturer
    Date Cleared
    2023-10-31

    (293 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medovate Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medovate SAFIRA system is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia.
    Device Description
    The Medovate SAFIRA device is an infiltration pump used to infuse local anesthetic drugs into the body as part of a Regional Anaesthesia procedure. The SAFIRA device consists of a sterile, single-use plastic Syringe (20mL capacity) fitted with a custom collar and plunger, a non-sterile reusable Driver, and a non-sterile reusable Operator. SAFIRA is a battery powered motorized syringe driver for use in delivering anaesthetic via injection during a Peripheral Nerve Block (PNB) Procedure. The user fills the syringe with the fluid of choice, then locks the filled Syringe into the Driver, where the specially designed Syringe Plunger rack mates with the Driver Gear. When the SAFIRA Syringe is attached to the Driver, the collar locks the Syringe to the Driver housing, and the Plunger engages with the Driver Gear to advance or retract the Syringe Plunger. The female Luer or NRFit connection of a sterile, single-use needle set (not supplied by Medovate) is attached to the standard male Luer or NRFit fitting on the SAFIRA Syringe. The Operator (Foot Pedal or Palm Operator) connector is plugged into the receptacle on the Driver, ready for use. The Driver contains non-replaceable AAA batteries which power a small DC motor which in turn controls the movement of the Syringe Plunger. The Operator consists of 2 color-coded controls; when the user applies pressure to the appropriate control (green = infuse, yellow = aspirate), the motor activates the Plunger movement mechanism to move the Plunger forwards (infuse/inject) or backwards (aspirate). The Driver is designed to deliver fluid at a maximum flow rate of 0.5mL/sec. The motor is designed with an overpressure safety feature, which causes the Plunger movement to stop if the pressure in the syringe exceeds 17psi ±3psi regardless of whether the "infuse" control of the operator is depressed.
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