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510(k) Data Aggregation

    K Number
    K103277
    Device Name
    3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
    Manufacturer
    3M COMPANY-3M HEALTH CARE
    Date Cleared
    2011-04-19

    (165 days)

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

    3M COMPANY-3M HEALTH CARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use the 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below. | Sterilization Type | Temperature | Time | |-------------------------------------------------------|---------------|------------| | Gravity Displacement | 270°F (132°C) | 3 minutes | | Immediate Use Steam<br>Sterilization Cycle<br>(Flash) | 270°F (132°C) | 10 minutes | | | 275°F (135°C) | 3 minutes | | | 275°F (135°C) | 10 minutes | The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.
    Device Description
    The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator (hereafter referred to as the 1491 Bl) is a self-contained biological indicator designed to be used with the 3M™ Attest™ 490 Auto-reader (hereafter referred to as the 490 Auto-reader) to routinely challenge 270°F (132°C) and 275°F (135°C) gravity-displacement steam sterilization cycles having exposure times > 3 minutes in length. The 1491 BI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a blue cap. On each 1491 BI is a chemical process indicator that changes color from rose to brown when exposed to steam. The 1491 Bl is a further improvement over the current 3M Attest Rapid Readout technology. Both the Attest Rapid Readout BIs and the Attest Super Rapid Readout Bls utlize the a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus spores. The a -glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 490 Auto-reader. The detection of fluorescence upon incubation of the 1491 BI in the 490 Auto-reader indicates steam sterilization failure. The 490 Auto-reader is designed to incubate at 56°C and automatically read the 1491 BI for a fluorescent result within 30 minutes. The 490 Auto-reader is also designed to allow further incubation of the 1491 BI for an optional visual pH color change of the growth media at 24 hours. Both the fluorescent readout at 30 minutes and the optional visual color readout at 24 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
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    K Number
    K080620
    Device Name
    MODIFICATION TO 3M TEGADERM CHG DRESSING
    Manufacturer
    3M COMPANY-3M HEALTH CARE
    Date Cleared
    2008-05-19

    (76 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M COMPANY-3M HEALTH CARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M™ Tegaderm™ CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.
    Device Description
    3M™ Tegaderm™ CHG Dressing, Chlorhexidine Gluconate I.V. Securement Dressing, is used to cover and protect catheter sites and to secure devices to skin. Available in a variety of shapes and sizes to meet the needs of the caregiver. Tegaderm™ CHG Dressing consists of a transparent adhesive dressing and an integrated pad containing Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and viruses* and yeast, and protects the IV site from outside contamination. The pad absorbs up to eight times its weight in fluid. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing. Tegaderm™ CHG Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange. * In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage.
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