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510(k) Data Aggregation

    K Number
    K200886
    Device Name
    StimSite
    Date Cleared
    2020-11-10

    (222 days)

    Product Code
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allotrope Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    StimSite is a non-sterile device intended to provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability.
    Device Description
    StimSite is a non-sterile, non-patient contacting device that generates an electrical signal that elicits visible contractions of smooth muscle tissue. StimSite is a software-controlled signal box that is placed outside of the surgical field, and connects to standard, FDA cleared surgical instruments (sterile disposable, and reprocessed) that are designed to carry bipolar electrical signals through them such as laparoscopic Kleppingers, Maryland graspers and atraumatic graspers among others. StimSite is designed to provide the surgeon with the ability to generate a visible physiologic smooth muscle contraction response intraoperatively to identify and verify the ureter via characteristic muscle tissue movement. This device is intended for use as an adjunct to the standard of care visual assessment currently performed by surgeons to manually stimulate muscle tissue to identify ureters during surgical procedures. StimSite is non-sterile, a piece of durable medical equipment that resides in the operating room. It is comprised of a Signal Box, a connected Footswitch with cable, and an Interconnect Cable. StimSite also utilizes a disposable Activation Card which tracks and manages device use, allowing a select number of procedures before it is exhausted and needs to be replaced. All materials of construction are common to use and comply with industry standards for use as durable medical equipment. Using the provided Interconnect Cable, surgeons have the option to connect to a currently marketed electrosurgical unit (ESU) or generator such as the Medtronic FT10, Conmed 2450, and the Megadyne Mega Power. StimSite is controlled by user selection buttons on the face of the device and a Footswitch is used to trigger a stimulation signal by the user. Through the selection buttons, StimSite can be placed in one of two modes: STIM (for stimulation) or ESU (for passthrough from the generator).
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