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510(k) Data Aggregation
K Number
K222328Device Name
SteriCUBE® Multiple Tray Sterilization Systems
Manufacturer
Date Cleared
2022-09-28
(57 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
SteriCUBE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SteriCUBE Multiple Tray Sterilization System) 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 SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks.
The SteriCUBE System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The SteriCUBE System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the SteriCUBE System.
Device Description
The SteriCUBE® Multiple Tray Sterilization Systems are also referred to as the “SteriCUBE Systems” and include the SteriCUBE MTS225 System and the SteriCUBE MTS300 System. The SteriCUBE System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. An optional reusable ceramic drain filter and single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. The optional ceramic drain filter should be replaced every 6 months or after 160 uses, whichever comes first. An optional STEAMPlus™ tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. Adjustable shelves within the cabinet can hold up to three trays (uncovered, perforated or wire mesh) of devices and/or surgical instruments intended for a single patient surgery. No more than 25 pounds can be loaded per tray for a maximum of 75 pounds per shelf. The MTS300 Cabinet (with four shelves) can hold up to 300 pounds per load and the MTS225 Cabinet (with three shelves) can hold up to 225 pounds per load. The loaded cabinet is deployed from the adjustable transfer cart and processed in pre-vacuum steam sterilizers. Processing includes the standard conditioning phase of the autoclave followed by a sterilization cycle time of 4 minutes and a dry cycle of a minimum of 5 minutes. Sterility is maintained for up to 30 days.
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