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The PROTOCO₂L Touch Colon Insufflator administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).

The Bracco Diagnostics Inc. (BDI) PROTOCO₂L Touch Colon Insufflator (PROTOCO₂L Touch) administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy). Insufflation during CTC is used to distend the colon with uniform pressure in order to properly present the colon during the given diagnostic procedure. The PROTOCO2L Touch consists of two (2) components: (1) the Colon Insufflator, and (2) the disposable, non-sterile Administration Set.

The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insufflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.

The Bracco Diagnostics Inc. (BDI) CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (ILTS) is intended for use with BDI CO2 Endoscopic Insufflators and OEM endoscope systems, in this specific case the Olympus® 140, 160, 180, and 190 series endoscopes. The ILTS is supplied sterilized using Gamma radiation to a Sterility Assurance Level (SAL) of 10-6. The ILTS is individually packaged At the time of this submission, accelerated aging tests confirmed a one (1) year shelf life.

The Bracco Diagnostics, Inc. (BDI) CO2MPACT ENDOSCOPIC INSUFFLATOR™ is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT ENDOSCOPIC INSUFFLATOR™ allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

The Bracco Diagnostics, Inc. (BDI), CO2MPACT ENDOSCOPIC INSUFFLATOR™ (CO2MPACT) is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT regulates CO2 flow rate and pressure during the insufflation process. The BDI CO2MPACT allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment. Consistent with the predicate devices, the BDI CO2MPACT is used to administer CO2 to the patient for distention purposes. For this application, the actual displacement of CO2 to the patient through the endoscope is controlled by the clinician modulating an "air-water" valve on the endoscope. The BDI CO2MPACT only provides source pressure and flow to the endoscope in a similar manner to the predicates BDI CO2Efficient Endoscopic Insufflator (K053008) and Olympus UCR Endoscopic CO2 Regulation Unit (K081173), or the internal air pump included within the endoscope light source.