Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)

Three endoscope devices intended for visualizing and performing therapeutic procedures in the digestive tract. The CF-EZ1500DL/I colonovideoscopes are used in the lower digestive tract (colon, rectum, sigmoid colon, anus, ileocecal valve) while the GIF-EZ1500 gastrointestinal videoscope is used in the upper digestive tract (esophagus, stomach, duodenum). All are used with video system centers, documentation equipment, and therapeutic accessories such as biopsy forceps for endoscopy and endoscopic surgery.

CF-EZ1500DL/I differs from predicate CF-HQ1100L/I in image sensor type (CMOS with RGB color filter vs. CCD with CYM filter), pixel count, depth of field, and airflow rate (30 cm³/s vs. 25 cm³/s); lacks electronic shutter function but retains focus switching. GIF-EZ1500 differs from predicate GIF-1100 in similar imaging parameters (CMOS vs. CCD, different pixel specifications, altered depth of field, larger distal end diameter 9.9 mm vs. 8.9 mm, increased airflow); lacks electronic shutter but adds focus switching function.

ISO 10993-1 for biocompatibility (cytotoxicity, intracutaneous, sensitization); ANSI AAMI ES60601-1:2005/(R)2012 with amendments for electrical safety; IEC 60601-2-18:2009 for specific endoscope safety; IEC 60601-1-2 Edition 4.1 for electromagnetic compatibility; ISO 14971:2019 for risk management. Reprocessing validation followed FDA guidance; software validation followed FDA guidance for medical device software and cybersecurity.

The subject devices maintain identical intended uses, indications for use, direction of view, field of view, geometric distortion, instrument channel diameters, control section configuration, angulation ranges, and reprocessing methods as their predicates. The technological differences (CMOS sensor with RGB filtering vs. CCD with CYM filtering, improved pixel magnification, refined depth of field, increased airflow) represent enhancements in image capture technology that do not alter the fundamental operational principle or clinical function. Removal of the electronic shutter function is not clinically significant given alternative imaging modes remain available. The addition of focus switching in GIF-EZ1500 adds capability without changing the basic intended use. All differences have been verified through bench testing, animal imaging studies, and compliance with applicable safety and performance standards.