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510(k) Data Aggregation

    K Number
    K102996
    Device Name
    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS
    Date Cleared
    2011-01-13

    (98 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVATORS REPROCESSING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medivators Advantage Plus Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the Advantage Plus system. The scopes must be precleaned immediatelv after use. The Advantage Plus Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Detergent in its cleaning cycle at a concentration of 0.5%. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used in the Advantage Plus System under the following contact conditions: Contact Time: 5 minutes Temperature: 30℃ MRC: 850ppm
    Device Description
    The Advantage AER is an electro-mechanical system intended to test, clean, and high level disinfect fiberoptic and video endoscopes and their related accessories between uses. The Advantage system uses the peracetic acid based Rapicide PA High Level Disinfectant. The AER machine has the capability of cleaning endoscopes as part of the overall cleaning/disinfection cycle of the machine. The users may use the cleaning cycle to replace manual cleaning of the endoscope, however, the users are instructed that they need to preclean the endoscope immediately after use to the SGNA and facility guidelines.
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    K Number
    K082988
    Device Name
    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS
    Date Cleared
    2009-02-13

    (129 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVATORS REPROCESSING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system. Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions: Claim: High Level Disinfection Time: 5 minutes Temperature: 30(°C) Minimum Recommended Concentration of Peracetic Acid (MRC): 850ppm
    Device Description
    The Advantage Plus AER is an electro-mechanical system intended to test, wash, and high level disinfect flexible fiberoptic and video endoscopes between uses. It is not intended for reprocessing rigid endoscopes. The Advantage is capable of asynchronously reprocessing two scopes at a time. The Advantage Plus system uses the peracetic acid based Rapicide PA High Level Disinfectant. The Advantage Plus is a single use system in that it mixes the Part A and Part B of the Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused. Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to placing in the system for reprocessing. After the scopes are connected to the AER, the system tests the endoscopes for blockages in the channels and leaks in the outer skin, and then proceeds to the washing step. The system also includes an optional channel connectivity test to verify proper connection of the fluid channels for reprocessing. If the endoscopes pass the blockage and leak tests and the washing cycle has been completed, the system proceeds to rinse the instruments and begins the disinfection cycle. For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC and then the disinfectant is emptied from the basin into the drain from the machine. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use. The machine has many built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product. The machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records. Rapicide PA High Level Disinfectant is a peracetic acid based, two part disinfectant. Part A contains the active ingredients and Part B contains anticorrosive agents and surfactants. Part A and Part B are mixed in the machine and diluted with water. The Minimum Recommended Concentration (MRC) of Rapicide PA is 850 ppm of peracetic acid. A test strip is used to ensure that the use solution is above the MRC.
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    K Number
    K063876
    Device Name
    MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS
    Date Cleared
    2007-06-14

    (167 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVATORS REPROCESSING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing tests, disinfects and rinses flexible endoscopes. such as fiberoptic and video endoscopes between patient uses. The MDS is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. It is indicated for use with FDA cleared, liquid high level disinfectants. The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.
    Device Description
    The Modular Disinfection System (MDS) is an electro-mechanical system intended to test and high level disinfect heat sensitive semi-critical endoscopes. It is not intended for reprocessing rigid endoscopes. The machine can use any FDA cleared, reusable liquid germicide which is on the market that is labeled for high level endoscope disinfection. The testing provided to the FDA used both Medivators Rapicide® High Level Disinfectant and Cidex® OPA High Level Disinfectant. The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS. During its software based reprocessing cycle, the machine tests the endoscopes for leaks and blockages. Before and during the machine eveles, connectivity with the machine through the connector blocks is evaluated. If the scopes pass these tests, they are flushed with water and detergent, disinfected and rinsed. The disinfection cycle takes approximately 30 minutes. The MDS is capable of asynchronously reprocessing two scopes at a time. The machine has many built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product. The machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records.
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