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510(k) Data Aggregation
K Number
K190541Device Name
MTS225 and MTS300 Multiple Tray Sterilization Systems
Manufacturer
Date Cleared
2019-11-05
(246 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
PMBS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MTS System (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. The unit must be used with the MTS System Transfer Cart, MTS System Filters and MTS System Integrity Locks.
The MTS 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 MTS 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 MTS System.
Device Description
The MTS System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. Single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. 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 a minimum of 4 minutes and a dry cycle of a minimum of 10 minutes. Sterility is maintained for up to 30 days.
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K Number
K152014Device Name
MTS300 Multiple Tray Sterilization System
Manufacturer
Date Cleared
2015-10-20
(91 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
PMBS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MTS300 System is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterlization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the MTS300 Transfer Cart, MTS300 filters and integrity locks.
The MTS300 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 MTS300 System 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 MTS300 System.
Device Description
The MTS300 Multiple Tray Sterilization System (also referred to as the MTS300 System) includes the stainless steel sterilization cabinet and adjustable transfer cart. Single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. An optional STEAMPlus TM tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. The MTS System is intended to sterilize a maximum weight of 300 pounds of devices and instruments for a single patient surgery. The loaded cabinet is deployed from the adjustable transfer cart and processed in a pre-vacuum steam sterilizer and then dried for 30 minutes. Sterility is maintained for up to 30 days.
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