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The InnovexView is intended to be used for direct viewing of the cervical canal and the uterine cavity, or female urinary tract, including the bladder for the purpose of performing diagnostic and therapeutic surgical procedures.

The types of procedures where the InnovexView could offer visualization include:

• Assessment of abnormal bleeding, pelvic pain, amenorrhea and abnormal findings from hysterosalpingogram;
• Assessment of infertility and pregnancy wastage;
• Confirmation of the presence of intrauterine foreign body;
• Assist in locating submucosal fibroids and polyps targeted for removal;
• Provide visual guidance during directed biopsy, polypectomy, submucosal myomectomy, transection of intrauterine adhesions and septa.

The InnovexView can also be used to permit viewing of the female adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

InnovexView (Model: GC146-17, GC150-20, GC155-23) is intended to be used with the video processor (model: EA101 cleared via K243497). When used with the compatible video processor and monitor, the endoscope system can be operated as intended and indicated. InnovexView is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Cable. The handle includes a deflection lever, an inflow port and an outflow port, to which luer connectors with flow control valve can be connected, a working channel port to which, a biopsy valve can be connected. The insertion section contains a working channel for access of endoscopic accessories and distention media outflow, space for inflow, and wiring to transmit the image signals to the video processor. The bending section at the distal portion of the insertion section is controlled by the user via the deflection lever on the handle. The distal tip of the insertion section contains a CMOS image sensor for capturing the anatomical image and transmitting video signals to the video processor, LEDs for illumination, and the distal openings of working channel and inflow. The endoscope cable connects the endoscope handle to the video processor for transmitting video signals and providing power to the LEDs.

Mechanism of action:
The light emitted from the distal tip of the InnovexView is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the video processor. The video processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the build in monitor or attached monitor. The video processor also controls the brightness of the LED on the endoscope.

InnovexView has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Rigid insertion cord
• LED and CMOS image sensor at the distal tip
• Sterilized by Ethylene Oxide
• For single use

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