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510(k) Data Aggregation

    K Number
    K190669
    Device Name
    Endotics
    Date Cleared
    2020-01-03

    (294 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Era Endoscopy s.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Endotics System is intended to provide 360° visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The Endotics Probe (colonoscope component of the Endotics Colonoscope System) is a single use disposable device. The Endotics Probe cannot be reprocessed.
    Device Description
    Endotics is an endoscopic system to be used for the examination of the final section of the intestine, the ends of which are marked by the anal sphincter and by the ileocecal valve, known as the colonrectum. The system comprises two parts, which can be sold separately, namely: the"disposable probe", and the "workstation", equipped with a command console. Thanks to its flexibility, the disposable probe can easily adapt its shape to that of the colon. The motion, based on the "caterpillar" principle, is ensured by an anchoring system, placed by the ends of a flexible body. The colonoscope includes on its distal segment a viewing system, featuring a CMOS digital camera and a LED light source. The probe is further equipped with a steering system, which enhances the efficiency in terms of both motion and vision (maximum flexion angle: 180° in every direction). The endoscope is activated pneumatically. This device allows the use of specific surgical tools through a working channel. The exit of the working channel is centred compared to the robot and it is located near the camera, which is therefore slightly decentred. When the tool exits the probe, it is immediately detected and the operator can then visually pilot it over the zone to be treated. The anchoring system performs a double action. By extracting the air from inside the intestine it enables the intestine linings to approach the robot precisely at the point in which they will then be mechanically anchored. This system produces a steady hold on the intestine lining but prevents any damage or trauma from occurring. Endotics Workstation is composed of an electro-pneumatic system, controlled by a Panel PC which displays the different progress phases of the device and the images delivered by the internal camera, and of a command console for controlling the probe's movements. Only the Endotics disposable probe can be connected to this workstation. The probe is linked to the workstation by means of an electro-pneumatic connector is placed on a twistable arm which is connected to the machine's main block. This arm is fitted on the inside with pneumatic tubes and electric cables which connect the probe to the workstation's electro-pneumatic system and which connect the camera (placed by the probe's head) to a video system. The arm is also equipped with an electronic board which acts as an opto-insulator between the camera and the electric features of the workstation. The electro-pneumatic distributor is controlled by a computerised system, on which specifically designed command software has been installed. The monitor also displays the probe's status, indicating its current motion phase e the captured pictures. The associated accessories include: Stiffening accessory, Waterjet accessory.
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