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510(k) Data Aggregation

    K Number
    K050664
    Device Name
    SPOR-TEST PA BIOLOGICAL INDICATOR KIT
    Manufacturer
    Date Cleared
    2005-04-07

    (23 days)

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

    GETINGE USA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. SPOR-TEST PA Biological Indicators are qualified using Getinge Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.
    Device Description
    The SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris System 1 liquid chemical sterilization process, with Steris 20 sterilant. The product contains chromatography strips that are inoculated with Geobacillus stearothermophilus spores at a nominal population of 10^6 per strip. Sterile tubes of Getinge Media (modified soybean casein digest broth) and a transfer loop are also included. The SPOR-TEST PA Biological Indicator Kit is used in the same manner as the Steris® Process Biological Indicator Kit.
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    K Number
    K032723
    Device Name
    BIOSIGN STEAM-24 BIOLOGICAL INDICATOR
    Manufacturer
    Date Cleared
    2003-10-01

    (28 days)

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

    GETINGE USA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Getinge Biosign Steam-24 Biological Indicator is a steam sterilization monitor designed specifically for biological testing of 121°C, 134°C gravity and pre-vacuum and flash gravity and prevacuum steam sterilization cycles with results available after 24 hours incubation.
    Device Description
    The Getinge Biosign Steam-24 Biological Indicator is a self-contained biological indicator designed for biological testing of steam 121°C and 134°C pre-vacuum and gravity and flash steam sterilization cycles. When used to monitor steam cycles, the product is intended to give the user results after 24 hours incubation. The Biosign Steam-24 Biological Indicator contains 10^6 Geobacillus stearothermophilus (nee Bacillus stearothermophilus) spores/carrier. The Biological Indicator is selfcontained with an ampule containing culture medium in the same vial as the spore strip.
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    K Number
    K031647
    Device Name
    BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
    Manufacturer
    Date Cleared
    2003-07-29

    (63 days)

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

    GETINGE USA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C. The instant readout integrator card gives the operator a prediction of the biological test outcome. When the chemical integrator "PASS" changes from purple to green, it indicates correct exposure conditions of temperature, time and steam.
    Device Description
    The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a test pack designed specifically for biological testing of steam 132°C pre-vacuum sterilization cycles. When used to monitor steam 132°C pre-vacuum cycles, the product is intended to give the user an instant reassurance based on a result from a steam integrator card, and after biological indicator incubation, even greater assurance that the sterilizer operated at proper sterilization parameters. The Biosign SSI Test Pack with Instant Readout Integrator is constructed using a self-contained Geobacillus stearothermophilus biological indicator (10"spores/strip), placed inside a small package of porous and nonporous materials, and includes a steam integrator card. The package simulates the biological indicator 16-towel test pack as defined by ANSI/AAMI ST46-1993. The instant readout integrator card provides immediate verification that the test pack was exposed to sterilization parameters, when the word "PASS" imprinted with a purple indicator ink, changes to green. The biological indicator gives an even greater assurance that sterilization occurred, when the incubated spores display no growth, as indicated by no color change (red) in the growth media. The shelflife of the new Biosign SSI Test Pack with Instant Readout Integrator is the same as the predicate Biosign EZ-VU Test pack (18 months). The biological indicator is the generally limiting factor and the shelflife of the product can never go beyond the shelflife of the biological indicator, or the shelflife of the integrator card, whichever is shortest. The Getinge Biosign SSI Test Pack with Instant Readout Integrator is the same size as, utilizes the same materials and is constructed the same as the Biosign EZ-VU Test pack, only with the addition of the instant readout indicator card printed with the integrator ink utilized in the SteriTec Biological Test Pack with Instant Readout Integrator. Since the integrator card was designed to function inside a test pack, its placement in the biological test pack offers no difference in functional environment. The same Biosign biological indicator with Geobacillus stearothermophilus is utilized in the Biosign SSI Test Pack with Instant Readout Integrator, as is used in the Biosign EZ-VU Test pack.
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    K Number
    K031259
    Device Name
    MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
    Manufacturer
    Date Cleared
    2003-05-12

    (21 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    GETINGE USA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam.
    Device Description
    The 833HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a large sized chamber and has the same control system and offers similar overall features as those on the 733HC Vacuum/Gravity Steam Sterilizers. These include: additional functionality, ease of use to the end user, large color display that will allow the user to choose from the entire list of available cycles, allows renaming and re-sequencing of sterilization cycles.
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