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The invendo C25 Colonoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendo C25 Colonoscopy System, the SC20 colonoscope, is a single-use disposable device. The SC20 colonoscope cannot be reprocessed.

The invendo C25 Colonoscopy System is a modified version of the invendo C20 Colonoscopy System. Like the predicate device, the invendo C25 Colonoscopy System is steered and controlled by the operator. The distal tip of the colonoscope is deflectable and includes a CMOS camera and LEDs for illumination. A working channel is incorporated to enable biopsies and polypectomies. The invendo C25 Colonoscopy System includes insufflation, irrigation and suction functions. The invendo C25 Colonoscopy System consists of two components: (1) the invendo C25 base system; and (2) a single-use, disposable colonoscope, the SC20 colonoscope. The invendo C25 base system provides the SC20 colonoscope with the above mentioned functions and transfers user commands to the colonoscope. To control the colonoscope, the operator uses a handheld control unit. All colonoscope functions are solely activated by the user. The invendo C25 base system consists of the Supply and Processing Unit (SPU or base unit), the handheld control and the drive unit.

The invendo C20 Colonoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopy surgery. The colonoscope component of the invendo C20 Colonoscopy System, the SC20 Colonoscope, is a single use disposable device. The SC20 Colonoscope cannot be reprocessed. The device is contraindicated in patients with fulminant colitis; acute diverticulitis; severe cardiopulmonary illness; or where there is a lack of cooperation on the part of the patient.

The invendo C20 Colonoscopy System has many features in common with currently marked colonoscopes. The invendo C20 Colonoscopy System consists of two separate components: a single use disposable colonoscope and a base system that supplies and controls the colonoscope according to user commands via a handheld control unit. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendo C20 Colonoscopy System is equipped with insufflation, irrigation and suction functions. Deflection, rinsing, insufflation and suction are activated and controlled by the base unit, according to user commands. Unlike other colonoscopes, the invendo C20 Colonoscopy System is not manually pushed or otherwise manually manipulated by the operator, but instead, moves under the operator's direction through use of a handheld controller that controls, among other things, the device's drive unit. The colonoscope uses a lubricated inverted sleeve technology for advancement and retraction. Unlike other colonoscopes, the invendo C20 Colonoscopy System uses pressure controlled bellows for the deflecting function. The endoscope deflects in any direction depending on the pressure in the bellows. The handheld control is connected to the base unit. Depending on the user commands, the base unit activates and controls the functions of the invendo SC20 Colonoscope. The colonoscope component of the system is a single-use disposable device. The SC20 colonoscope cannot be reprocessed. The main materials with direct contact with the patient are silicone and polycarbonate. The whole colonoscope, including the lubricant, were demonstrated to be biocompatible per ISO 10993.