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510(k) Data Aggregation

    K Number
    K170304
    Device Name
    Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
    Manufacturer
    Astell Scientific Limited
    Date Cleared
    2018-03-02

    (395 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Astell Scientific Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A steam sterilizer (Autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam. Typical applications: Metal Medical Instruments (Unwrapped) Metal Medical Instruments (Wrapped) Glassware (Unwrapped) Hand Pieces (Pouches) The electronic control has four pre-programmed sterilization cycles. The four pre-programmed sterilization cycles are for: Cycle 1; Metal Medical Instruments (Unwrapped); 134°C for 3 minutes; Drying Time 15 minutes Cycle 2: Metal Medical Instruments (Wrapped); 134°C for 4 minutes; Drying time 30 minutes Cycle 3: Glassware (Unwrapped); 121°C for 30 minutes; Drying time 15 minutes Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes
    Device Description
    The Astell Scientific range of UMB benchtop steam sterilizers are designed to offer convenience and flexibility in the sterilization of medical and surgical instruments. Instruments for sterilization include wrapped and unwrapped Metal Medical instruments, unwrapped Glassware and pouched dental hand pieces. A steam sterilizer (Autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam. Autoclaves/sterilizers heat water to generate steam as the sterilization agent, producing steam in the chamber to create a gravity displacement, pulsed dynamic air removal sterilization environment. Steam sterilization is a widely used sterilization process due to its versatility and speed. The sterilizers include as its main components a pre-programmed electronic control module, autofill water reserve, electronic heaters and an auto-drain sterilization chamber. The free-steaming phase of the sterilization process incorporates a 20-minute dynamic air removal program pulsing at low; 1200 mbar/ high;1600 mbar The autoclaves are equipped with multiple safety features. The door contains a safety locking mechanism that does not permit operation unless the door is closed and locked, and does not permit the door to be opened until the internal chamber pressure is no greater than 100mbar above atmospheric pressure. Additional safety features include an automatic safety shutoff to prevent the chamber overheating; two (2) thermostats; one to detect overheating of the heaters and one to prevent opening of the door if the chamber temperature is unsafe to do so (80 °C). There is also a safety valve for the pressure vessel. A touch screen digital display with a user log, data archiving for up to 5000 cycles and multiple user access levels and multi-level password protection is used for precision control and monitoring purposes. The differences between the UMB Autoclaves/Sterilizers in this submission is the chamber volumes: UMB 220 (Total volume 33 Litres) UMB 230 (Total volume 43 Litres) UMB 240 (Total volume 63 Litres) There is an optional printer available to record cycle parameters. Only United States Food and Drug Administration cleared accessories such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes should be used with this Autoclave.
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