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510(k) Data Aggregation

    K Number
    K223328
    Device Name
    Purgo
    Manufacturer
    AeroClean Technologies, Inc.
    Date Cleared
    2022-11-30

    (30 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Applicant Name (Manufacturer) :

    AeroClean Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pūrgo™ is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo™ is non-sterile. Pūrgo™ has been demonstrated to remove the following organisms under the following exposure conditions: | Organism | Name | Avg. max log reduction / exposure<br>time (min) | |-----------------|-----------------------------------------------------|-------------------------------------------------| | Gram + Bacteria | Methicillin resistant Staphylococcus<br>epidermidis | 4.6 (45) at normal speed | | Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed | | Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed | | RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed | | RNA Virus | SARS-CoV-2 | 4.2 (60) at normal speed | | DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed | | Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
    Device Description
    Pūrgo™ is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo™ may be used in medical facilities and commercial home healthcare environments. Pūrgo™'s main components consist of: - LED UV-C lamps that generate irradiation to destroy microorganisms that are not . filtered; - . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material: - a filtration system with pre-filter, activated carbon filter, and HEPA filter; . - . a motor / impeller to move air through the filtration system; - . sensors to monitor UV irradiance and airflow: - . an electronic control system to power and control the device; and - . a touch panel interface equipped with LEDs to indicate the working status of the device. Pūrgo™ has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air. Pūrgo™ pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and funqi). The filter cartridge contains a series of three filters, the first of which is a pre-filter that removes physically large particulate matter (such as dust) and protects the finer particle filters downstream. This is followed by an Activated Carbon filter. Finally, a HEPA (highefficiency particulate air) filter that removes 99.995% of the remaining airborne particles above a particle size of 0.1 µm. Any microbes that still manage to make it through the filters, pass through the SteriDuct chamber where they are subjected to Ultraviolet Radiation at 265 nm (UV-C). UV radiation at this wavelength is particularly effective at destroying microbes. UV-C irradiation has been shown to damage the microbe's RNA and DNA genetic materials sufficiently to prevent the microbe's ability to reproduce. After passing through the filtration and SteriDuct UV-C chamber, the purified air then exits back into the room. The exit air does not destroy laminar air flow in a typical operating room environment.
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