PENTAX Medical Video Colonoscope (EC38-i20cWL)

The PENTAX Medical Video Colonoscope EC38-i20cWL is a flexible endoscope designed for optical visualization and therapeutic access to the lower gastrointestinal tract, including the large bowel to the cecum and terminal ileum. It is introduced via the rectum and is intended for patients weighing greater than 20 kg, used in conjunction with a video processor and monitor.

The subject device is functionally equivalent to its predicate with minor technological differences including the application of wide field of view capability. The device maintains identical or enhanced specifications for scope working length, field of view, depth of field, tip angulation, rigid distal width, insertion tube width, maximum insertion portion width, minimum instrument channel width, and software requirements compared to the predicate device.

ISO 10993-1:2018 (biocompatibility), IEC 62304:2006 + A1:2015 (software), IEC 60601-1-2:2014 + A1:2020 (EMC), IEC 60601-1:2005 + A1:2012 + A2:2020 (electrical safety), IEC 60601-1-6:2010 + A1:2013 + A2:2020, IEC 60601-2-18:2009, FDA 2015 Reprocessing Guidance, and AAMI TIR 30:2011 (reprocessing validation).

The device shares the same fundamental technology and principle of operation as the predicate—illuminating and viewing the inside of the human body. The only meaningful difference is the addition of wide field of view capability, which is a minor design enhancement rather than a new technological feature. Performance testing confirmed no safety or effectiveness concerns, and all optical, system performance, biocompatibility, sterilization, and reprocessing parameters demonstrated equivalence to the predicate device.