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510(k) Data Aggregation

    K Number
    K110898
    Device Name
    S.C.O.R.E.S. UNIT
    Manufacturer
    AMMED SURGICAL EQUIPMENT, LLC
    Date Cleared
    2012-07-26

    (484 days)

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

    AMMED SURGICAL EQUIPMENT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCORES® Sterilization 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 must be used with the SCORES® transfer cart, SCORES® filters, and integrity locks. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270° and exposure time of 4 minutes. Use no more than 3 travs per shelf or 25 lbs. per tray. The SCORES® Unit was tested and validated with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm. Do not use with instruments containing lumens with an inner diameter smaller than 3.8mm and an overall length longer than 370mm. Use only uncovered, perforated or wire mesh general delivery trays within the SCORES® Sterilization Container.
    Device Description
    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit) is a sterilization container and delivery system capable of holding multiple instrument sterilization trays. The S.C.O.R.E.S. container can be loaded with multiple surgical instrument trays needed for a single surgery, steam sterilized, dried in the chamber drying cycle, removed from the autoclave on a transport cart, stored for up to 30 days, and delivered to the surgical suite for opening and use of the contents. The system includes the S.C.O.R.E.S. cabinet with wheels for loading into sterilizers, internal shelves for placement of sterilization trays, a filter system to allow steam penetration and maintain sterility, and an adjustable transport cart to allow for movement of the loaded system. Instrument trays within the S.C.O.R.E.S Unit do not need to be placed in sterilization containers or wrapped to maintain sterile integrity as the filtered Unit does so. Once opened in the surgical suite and the contents are to be used immediately. The subject device has been extensively tested, and verified to perform in a safe and effective manner. The S.C.O.R.E.S. Unit is a sterilization cabinet constructed from stainless steel and provided with a filtration system. The Unit can be loaded with all of the instrumentation needed for a surgical case. Instruments are placed into trays, which need not be wrapped. Individual trays of instruments should weigh no more than 251bs. and up to 12 trays can be arranged on the shelves of the S.C.O.R.E.S. Unit. The loaded unit has a filtration system to allow for steam penetration. The wheeled Unit is transported on an adjustable cart, which can be adjusted to the height of a prevacuum autoclave chamber. The sealed, loaded unit can be rolled into the chamber and processed in a normal cycle.
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