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510(k) Data Aggregation

    K Number
    K233049
    Device Name
    TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator
    Manufacturer
    CS Medical LLC
    Date Cleared
    2023-11-21

    (57 days)

    Product Code
    PSW, JOJ, MED
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    PSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant be reused in the system. TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes. TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use. TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector: High-Level Disinfectant: TD-12® Time: 3 minutes Temperature: 38°C Minimum Recommended Concentration: 1750 ppm peracetic acid QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.
    Device Description
    The TD 200 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12 disinfectant. The TD 200 disinfector is for use only with TD-12 disinfectant. The TD-12 is for use only in the TD 200 disinfector. Thus, the TD 200 disinfector and TD-12 disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200 disinfector. A fresh, unopened bottle of TD-12 disinfectant is loaded into the TD 200 disinfector. The TD 200 disinfector heats the TD-12 disinfectant to at least 38°C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200 disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding cvcle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
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    K Number
    K230381
    Device Name
    Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
    Manufacturer
    CS Medical LLC
    Date Cleared
    2023-06-07

    (114 days)

    Product Code
    PSW
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    PSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system. AquaCide cleaner/disinfectant is intended for use as a single use cleaner and high-level disinfectant, used exclusively in the Ethos automated cleaner disinfector for cleaning and high-level disinfection of surface and endocavity ultrasound probes. AquaCide cleaner/disinfectant should be used with the following contact conditions in the Ethos automated cleaner disinfector: High-level Disinfectant: AquaCide Time: 3 minutes Temperature: 47 degrees C Minimum Recommended Concentration: 1750 ppm peracetic acid The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm. The Ethos cleaner disinfector with AquaCide and QwikCheck are intended for use by qualified individuals trained in its use.
    Device Description
    The Ethos cleaner disinfector provides cleaning and high-level disinfection of surface and endocavity ultrasound probes when used according to the operating instructions and when used with AquaCide cleaner/disinfectant. The Ethos cleaner disinfector is for use only with AquaCide cleaner/disinfectant. The AquaCide cleaner/disinfectant is for use only in the Ethos cleaner disinfector. Thus, the Ethos cleaner disinfector, AquaCide cleaner/disinfectant represent a dedicated system. Each soiled ultrasound probe has the condom/cover removed and is bedside cleaned according to the ultrasound probe manufacturer's instructions before insertion into the Ethos cleaner disinfector. If a condom/cover is not used the user must manually clean the probe. A fresh, unopened bottle of granular PAA AquaCide cleaner/disinfectant is loaded into the Ethos brings in water, mixes and heats the AquaCide solution to a minimum of 47 degrees. While that is occurring, the Ethos brings in water and the ultrasound probe is pre-rinsed. After temperature is achieved and MRC is confirmed, the Ethos bring the AquaCide solution to the probe and cleans and disinfects the ultrasound probe for at least three minutes. Then the Ethos thoroughly rinses the AquaCide off the ultrasound probe before the cycle is complete. The ultrasound probe is then removed from the Ethos and dried according to the ultrasound probe manufacturer's instructions. The Ethos is ready for a new cycle immediately after the preceding cycle is completed. The Ethos cleaner disinfector incorporates a method for validating the PAA solution through an automatic chemical indicator to ensure each dose of PAA is at or above the MRC. The Ethos cleaner disinfector prints a verification report indicating a successful cleaning and disinfection cycles as well as the time and the average temperature during the cleaning/disinfection. The ultrasound probe is then removed from the Ethos cleaner disinfector and dried according to the ultrasound probe manufacturer's instructions. The Ethos cleaner disinfector is ready for a new cycle immediately after the preceding cycle is completed.
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    K Number
    K192228
    Device Name
    CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
    Manufacturer
    CS Medical L.L.C.
    Date Cleared
    2020-04-01

    (229 days)

    Product Code
    PSW, MED
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    PSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system. TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes. TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use. TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector: High-level disinfectant: TD-12® Time: 3 minutes Temperature: 38°C Minimum Recommended Concentration: 1.75% peracetic acid
    Device Description
    The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12® disinfectant. The TD 200® disinfector is for use only with TD-12® disinfectant. The TD-12® is for use only in the TD 200® disinfector. Thus, the TD 200® disinfector and TD-12® disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200® disinfector. A fresh, unopened bottle of TD-12® disinfectant is loaded into the TD 200® disinfector. The TD 200® disinfector heats the TD-12® disinfectant to at least 38 C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200® disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding cycle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
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    K Number
    K182891
    Device Name
    TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
    Manufacturer
    CS Medical L.L.C.
    Date Cleared
    2019-04-12

    (179 days)

    Product Code
    PSW
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    PSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TEEClean® automated cleaner disinfector is intended to replace manual cleaning of Transesophageal (TEE) ultrasound probes and automate high-level disinfection of TEE probes. The system uses TEEZyme® enzymatic cleaner to clean TEE probes as well as TD-5 or TD-8 disinfectant to high level disinfect TEE probes. TEE probes must undergo bedside cleaning prior to insertion into the TEEClean®. The TD-5® or TD-8® disinfectant bottles cannot be reused in the system. TD-5® disinfectant is intended for use as a single use high-level disinfectant used exclusively in the TEEClean® automated cleaner disinfector for high-level disinfection of TEE ultrasound probes. TD-5® disinfectant should be used with the following contact conditions in the TEEClean® automated cleaner disinfector: High-level disinfectant TD-5® Time - 5 minutes Temperature - 38° - 40°C Minimum Recommended Concentration 1.7% glutaraldehyde TD-8® disinfectant is intended for use as a single use high-level disinfectant used exclusively in the TEEClean® automated cleaner disinfector for high-level disinfection of TEE ultrasound probes. TD-8® disinfectant should be used with the following contact conditions in TEEClean® automated cleaner disinfector: High-level disinfectant TD-8® Time - 5 minutes Temperature - 38° - 40°C Minimum Recommended Concentration 0.3% ortho-phthalaldehyde TEEZyme® enzymatic cleaner, TD-5® and TD-8® high level disinfectant, and TEEClean® automated cleaner disinfector system are intended for use by qualified individuals trained in its use.
    Device Description
    The TEEClean® cleaner disinfector provides cleaning and high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TEEZyme® enzymatic cleaner and TD-5® or TD-8 disinfectant. The TEEClean® cleaner disinfector iss for use only with TEEZyme® enzymatic cleaner and TD-5® or TD-8® disinfectant. Thus, the TEEClean® cleaner disinfector, TEEZyme® enzymatic cleaner, and TD-5º or TD-8º disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned to the TEE probe manufacturer's instructions before insertion into the TEEClean® cleaner disinfector. A fresh, unopened bottle of TD-5° or TD-8° disinfectant is loaded into the TEEClean® cleaner disinfector. The TEEClean® cleaner disinfector heats the TEEZyme®, soaks the TEE probe, and thoroughly rinses the enzymatic cleaner off the TEE probe before the cleaning cycle is complete. The TEEClean® cleaner disinfector then heats TD-5® or TD-® disinfectant to 38°-40°C, soaks the TEE probe at least five (5) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the disinfection cycle is complete. The TEEClean® cleaner disinfector prints a verification report indicating a successful cleaning and disinfection cycles as well as the time and the average temperature during the disinfection. The TEE probe is then removed from the TEEClean® cleaner disinfector and dried according to the TEE probe manufacturer's instructions. The TEEClean® cleaner disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5% or TD-80 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.
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    K Number
    K160921
    Device Name
    CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
    Manufacturer
    CS Medical LLC
    Date Cleared
    2016-11-03

    (213 days)

    Product Code
    PSW
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    PSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TD 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-50 or TD-80 disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system. TD-50 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100@ disinfector for high-level disinfection of TEE ultrasound probes. TD-50 high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its use. TD-50 disinfectant should be used with the following contact conditions in TD 1008 disinfector: High-Level Disinfectant: TD-5® Time: 5 minutes Temperature: 38°C - 40°C Minimum Recommended Concentration: 1.7% glutaraldehyde TD-80 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 1000 disinfector for high-level disinfection of TEE ultrasound probes. TD-8@ high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its usc. TD-80 disinfectant should be used with the following contact conditions in TD 1008 disinfector: High-Level Disinfectant: TD-8® Time: 5 minutes Temperature: 38°C - 40°C Minimum Recommended Concentration: 0.3% ortho-phthalaldehyde
    Device Description
    The TD 100® disinfector provides high level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-50 or TD-80 disinfectants. The TD 1000 disinfector is for use only with TD-50 or TD-8® disinfectants. The TD-5º and TD-8º disinfectants are for use only in the TD 100 disinfector. Thus, the TD 100® disinfector with TD-50 and TD-80 disinfectants represents a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 100 disinfector. A fresh, unopened bottle of TD-50 or TD-80 disinfectant is loaded into the TD 100% disinfector. The TD 100% disinfector heats the TD-5% or TD-8% disinfectant to 38°-40°C, soaks the TEE probe for at least five minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 100 disinfector prints a verification report indicating a successful disinfection cycle and the time and average temperature during the disinfection. The TEE probe is then removed from the TD 100® disinfector and dried according to the TEE probe manufacturer's instructions. The TD 100® disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 or TD-8 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.
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    K Number
    K150504
    Device Name
    GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
    Manufacturer
    PCI MEDICAL, INC.
    Date Cleared
    2015-11-16

    (263 days)

    Product Code
    PSW
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    PSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GUS ASTRA TEE™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transsophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants. The GUS ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.
    Device Description
    The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned. The GUS ASTRA TEE and GUS ASTRA VR are automated reprocessors which are identical with the exception of the disinfection chamber configuration necessary to compensate for two different types of ultrasound probes. The GUS ASTRA TEE is an automated reprocessor which enables high-level disinfection and rinsing for transesophageal (TEE) ultrasound probes. The GUS ASTRA VR is an automated reprocessor which enables high-level disinfection and rinsing for endovaginal and/or endorectal ultrasound probes. Both ASTRA systems utilize predefined programs based upon the high-level liquid disinfectant (HLD) used during the disinfection and potable water rinsing cycles. The system controls the HLD temperature and cycle times which are fixed, no user configuration is available. The device will perform the defined automated disinfection and rinsing cycles based upon the HLD specifications. The microprocessor controlled interface monitors temperature and liquid levels of the HLD in the disinfection chamber and the reservoir. Optical sensors are used for HLD reservoir presence and probe identification. Additional user inputs include unique probe identification (for disinfection records) and the results entry of the Minimum Recommended Concentration (MRC) test using test strips and minimum concentration levels as defined by the HLD manufacturer. A sensor located on the disinfection chamber door is used to initiate the cycle after the user has input the required information. User retrievable data/information regarding reprocessing is accessible through a USB port.
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    K Number
    K051305
    Device Name
    CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
    Manufacturer
    CS Medical LLC
    Date Cleared
    2005-08-18

    (91 days)

    Product Code
    PSW
    Regulation Number
    892.1570
    Why did this record match?
    Product Code :

    PSW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TD-100 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses the TD-5 disinfectant, which is designed to be used only with the TD-100. The disinfectant bottles cannot be reused in the system. TD-5 is intended for use as a single use high-level disinfectant to be used exclusively in the TD-100 for the high-level disinfection of TEE ultrasound probes. The TD-5 High Level Disinfectant and TD-100 disinfector system is intended for use by qualified individuals trained in its use.
    Device Description
    The TD-100 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-5 disinfectant. Each soiled TEE probe is pre-cleaned manually before insertion into the TD-100 disinfector. A fresh, unopened bottle of TD-5 disinfectant is loaded into the TD-100 disinfector. The TD-100 disinfector heats the TD-5 disinfectant to 38-40C, soaks the TEE probe at least fiveminutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TEE probe is then removed from the TD-100 disinfector and dried according to the TEE probe manufacturer's instructions. The TD-100 disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 disinfectant is used with each cycle no monitoring of the disinfectant's potency required, nor is there any requirement for daily testing of the disinfectant solution.
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