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510(k) Data Aggregation

    K Number
    K221540
    Device Name
    Synexis Sphere Rx
    Manufacturer
    Synexis, LLC
    Date Cleared
    2023-06-14

    (383 days)

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

    Synexis, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synexis Sphere Rx is a stand-alone air purifier device intended for medical purposes and is used for the reduction of bacteria and viruses in the air. The device is intended for use in professional healthcare environments. The Sphere Rx is not intended for use near HF surgical equipment or MRI settings. The Synexis Sphere Rx air purifier demonstrated a ≥ 4 log reduction of bacteria and viruses under the following exposure/ working conditions: | Organism Type | Organism Name | Test Temp/RH | Avg Net Log Reduction/Time@ High Fan Speed | |----------------|----------------|-----------------------|--------------------------------------------| | Gram- bacteria | K. aerogenes | 25±3 deg C, 60 ±5% RH | 4.25 / 240m | | Gram+ bacteria | S. epidermidis | 25±3 deg C, 60 ±5% RH | 4.19 / 360m | | Virus | MS2 | 25±3 deg C, 60 ±5% RH | 4.55 / 300m | | Organism Type | Organism Name | Test Temp/RH | Avg Net Log Reduction/Time@ Low Fan Speed | | Gram- bacteria | K. aerogenes | 25±3 deg C, 60 ±5% RH | 4.25 / 240m | | Gram+ bacteria | S. epidermidis | 25±3 deg C, 60 ±5% RH | 4.13 / 480m | | Virus | MS2 | 25±3 deg C, 60 ±5% RH | 4.11 / 480m |
    Device Description
    The Synexis Sphere Rx is a photocatalytic air purifier that utilizes a photocatalytic oxidation purification process involving a light-activated catalyst which reacts with organic pollutants to oxidize them. The Sphere Rx draws ambient air through multiple filters including a carbon filter, a MERV filter and a photocatalytic filter that Synexis refers to as a 'Sail'. When the ambient air containing oxygen and water molecules contacts the photocatalytic filter exposed to UV light, a chemical reaction is initiated inside the device that generates hydroxyl radicals, super oxides and hydrogen peroxides. Synexis refers to the hydrogen peroxide molecules as dry hydrogen peroxide or DHP to distinguish these molecules from the aqueous form of hydrogen peroxide. The mechanism of action for the Sphere Rx photocatalytic air purifier to reduce microorganisms, including bacteria and viruses, in the air for small room environments relies on combination of capture and destruction. Ambient air is continuously circulated through MERV and carbon filters and a photocatalytic medium under UV light exposure inside the device to achieve a 4 log reduction.
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