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510(k) Data Aggregation

    K Number
    K160338
    Device Name
    Triton System
    Manufacturer
    GAUSS SURGICAL INC.
    Date Cleared
    2016-08-05

    (179 days)

    Product Code
    PBZ
    Regulation Number
    880.2750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAUSS SURGICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Triton System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton System is intended to be used with surgical sponges, software and accessory devices which have been validated for use with the Triton System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value. The validated surgical sponges, hardware, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time. The Triton System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.
    Device Description
    The Triton System is a software program (mobile medical application) used on an Apple iPad® tablet to capture images of used surgical sponges to assist surgical personnel in the management of surgical sponges after surgical use and to aid in the estimation of blood loss.
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