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The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.

The Third Eye Panoramic Auxiliary Endoscopy System - Resposable consists of two main portions: 1. Resposable Panoramic Device (catheter with cameras and LED light sources at the distal end and connections to video processors at the proximal end) packaged and supplied as a non-sterile unit. 2. Facility Equipment: The non-disposable facility equipment portions of the device includes Third Eye Video Processors and cables (No change from predicate). The TEPR is designed as an adjunct device for use with a standard colonoscope to provide lateral and partial retrograde visualization and illumination of the colon during a colonoscopy procedure. Prior to insertion of a standard colonoscope, the TEPR is attached to the distal end of the colonoscope with a flexible clip. The TEPR travels with the colonoscope and provides continuous left-side and right-side views of the colon that supplement the forward view of the colonoscope. The images from the colonoscope (forward) and the Panoramic Device (left and right lateral) are displayed simultaneously on three separate monitors, providing a panoramic image with a total angle of view of approximately 310° as shown schematically below. The TEPR utilizes the same video processors as used in the predicate.

The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.

Third Eye Panoramic Auxiliary Endoscopy System consists of two main portions: - Disposable device components packaged and supplied together as a 1. single-use sterilized unit. - a. The Panoramic Device: (catheter with cameras and LED light sources at the distal end and connection to video processors at the proximal end) - b. Attached Water Module to rinse the camera lenses: (catheter with water rinse sprayer distal end and connection to water source at the proximal end) - 2. Facility Equipment: The non-disposable facility equipment portions of the device include two Third Eye Video Processors and cables (No change from predicate except for a minor label change). The Panoramic Device is designed as an accessory device for use with a standard colonoscope to provide lateral and partial retrograde visualization and illumination of the colon during a colonoscopy procedure. Prior to insertion of a standard colonoscope, the Panoramic Device (including the Water Module) is attached to the distal end of the colonoscope with a flexible clip. The Panoramic Device travels with the colonoscope and provides continuous left-side and right-side views of the colon that supplement the forward view of the colonoscope. The images from the colonoscope and the Panoramic Device are displayed simultaneously on three separate monitors, providing a panoramic image with a total angle of view of approximately 310° as shown schematically below.

The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories. The Third Eve is designed as an auxiliary device for use with a colonoscope during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eve Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eve then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eve Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eye Retroscope image.

The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories. The Third Eye is designed as an auxiliary device for use with a colonoscope during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eye then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eye Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eye Retroscope image.

The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories. The Third Eye is designed as an auxiliary device for use during a colonoscopy procedure. After a colonoscope has been advanced to the cecurn, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eye then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eve Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eve Retroscope image.

The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory. The system consists of both disposable portions, and facility equipment. The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope. The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eve Retroscope, the video output signals, and user input controls. The output video signals from the video processor are displayed on a monitor for viewing by the physician. Application software that runs on the video processor allows the user to adjust various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.