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510(k) Data Aggregation

    K Number
    K122024
    Device Name
    SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2013-11-26

    (503 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SporView 10 Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes. SporView 10 self-contained biological indicators have a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: | Sterilization Mode | Temperature | Time | |--------------------|-------------|------------| | Gravity | 121°C | 30 minutes | | Gravity | 132°C | 15 minutes | | Gravity | 134°C | 4 minutes | | Gravity - Flash | 132°C | 3 minutes | | Gravity - Flash | 132°C | 10 minutes | | Dynamic Air | 121°C | 20 minutes | | Dynamic Air | 121°C | 30 minutes | | Dynamic Air | 132°C | 3 minutes | | Dynamic Air | 132°C | 4 minutes | | Dynamic Air | 134°C | 4 minutes | | Dynamic Air | 135°C | 3 minutes |
    Device Description
    The SporView 10 Self Contained Steam BI (SCBI) consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carier and a small glass ampoule containing a nutrient broth culture medium containing bromocresol purple as a pH indicator encased in a plastic vial that serves as the culture tube. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow. A visual pH color change and/or turbidity indicates' a steam sterilization process failure. SporView® 10 SCBI's are conventional spore growth readout biological indicators specifically designed for rapid and reliable monitoring of steam sterilization processes without the use of enzyme based technology or specific and specialized incubators or monitoring devices.
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    K Number
    K130211
    Device Name
    AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2013-07-05

    (157 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a prevacuum sterilizer operating at 134°C the indicator will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilization conditions have been met and no air is detected. It is designed to be used for daily Bowie Dick testing of steam sterilizers as described in ANSVAAMI ST79.
    Device Description
    The SPSmedical AirView™ Bowie Dick Test Pack is a disposable device which is intended for use as a replacement for the ANSI/AAMI ST79 Bowie Dick Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AAMI ST79 Bowie Dick test pack. The layers of paper within the SPSmedical AirView™ Bowie Dick Test Pack provide resistance to steam penetration and also trap air between them which is difficult for marginal performing prevacuum sterilizers to remove. Both products are comprised of paper sheets, foam, a containment box or wrap, external chemical indicator label and printed indicator sheet.
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    K Number
    K111515
    Device Name
    SPSMEDICAL SPORVIEW STEAM BI
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2012-02-01

    (245 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles. Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.
    Device Description
    The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
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    K Number
    K102363
    Device Name
    SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2011-01-27

    (160 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K090650
    Device Name
    SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2009-10-09

    (212 days)

    Product Code
    JOJ, PRE
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.
    Device Description
    SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators are process indicators used to verify exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. Indicators will identify if an item has seen H2O2 during the sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.
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    K Number
    K081879
    Device Name
    SPSMEDICAL SPORVIEW PA CULTURE SET
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2008-07-30

    (28 days)

    Product Code
    MRB
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 10 processing cycle. A reduced incubation time of 16 hours has been wallated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.
    Device Description
    SporView® PA Culture Set is intended to monitor the STERIS System 1 sterilization process, with STERIS® 20 sterilant. The product contains paper strips that are process, with G. stearothermophilus spores. Sterile tubes of SporView® Culture Media (modified soybean casein broth) and a transfer clip are included.
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    K Number
    K063799
    Device Name
    STEAMPLUS STEAM INTEGRATOR
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2007-01-05

    (14 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STEAMPlus™ Sterilization Integrators are intended to be used to monitor parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (under the presence of saturated steam). The integrators are intended to be used in steam cycles operating at 121°C - 134°C.
    Device Description
    The SPSmedical STEAMPlus™ Steam Integrator is designed to monitor sterilization parameters in steam sterilizers. It is a wicking style integrator which provides a visual indication that proper sterilization parameters were present within the sterilizers' chamber. Once the defined sterilization parameters have been reached the integrators pellet will melt and its dye will migrate from the non safe zone into the integrators safe zone. This will indicate to the user that the defined parameters for the integrator have been met.
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    K Number
    K051173
    Device Name
    SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2005-05-27

    (21 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPSmedical SporView®Plus Steam B1 Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at indication for ace in rouintes exposure time or longer and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.
    Device Description
    The SPSmedical modified SporView Plus Steam BI Test pack is a single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles.
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    K Number
    K043135
    Device Name
    SPSMEDICAL SPORVIEW PA CULTURE SET
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2005-01-13

    (62 days)

    Product Code
    MRB
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.
    Device Description
    Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.
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    K Number
    K041017
    Device Name
    SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
    Manufacturer
    SPS MEDICAL SUPPLY CORP.
    Date Cleared
    2004-06-25

    (66 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPS MEDICAL SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a pre-vacuum sterilizer operating at 134 C, the indicator sheet will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilizations have been met and no significant amounts of air are present. This test pack and indicator sheets are intended for use as described in AAMI/ANSI ST-46.
    Device Description
    The SPSmedical Air View™ Bowie Dick Test Pack (BD Test Pack) is a disposable device which is intended for use as a replacement for the ANSI/AMMI ST46:2002 BD Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AMMI ST46:2002 BD Test Pack.
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