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510(k) Data Aggregation

    K Number
    K153025
    Device Name
    Turbett Surgical Container
    Manufacturer
    TURBETT SURGICAL LLC
    Date Cleared
    2016-01-14

    (90 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURBETT SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Turbett Surgical Container is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical filters. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray. Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs. Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.
    Device Description
    The Turbett Surgical Container is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Actual expected loads in hospital settings are likely to be less. Sterilized instruments can be stored for up to 30 days within the closed container. The Turbett Surgical Container is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door. The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.
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