PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)

PENTAX Medical Video Upper GI Scope EG27-i20c and PENTAX Medical Video Colonoscope EC34-i20cL are flexible endoscopes designed to provide optical visualization and therapeutic access to the upper and lower gastrointestinal tracts respectively. The upper scope is introduced via the mouth for patients over 20 kg body weight; the colonoscope is introduced via the rectum for patients over 5 kg body weight. Both devices work with a video processor and monitor to illuminate and visualize internal anatomy.

The subject devices incorporate CMOS image sensor technology as a minor change from predicate devices. They maintain identical or enhanced specifications for scope working length, field of view, depth of field, tip angulation, insertion tube width, instrument channel width, and software requirements compared to the predicates. No new technological features are introduced; the fundamental operating principle of illuminating and viewing internal body structures remains unchanged.

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

The devices are substantially equivalent because they have identical indications for use and intended use as their predicates, with no differences in how they will be used clinically. The only technological difference—implementation of CMOS image sensor technology—is a minor design refinement that does not affect overall performance, functionality, or safety. Performance testing including optical properties, animal image capture studies, electrical safety, biocompatibility, reprocessing validation, and software verification all demonstrate equivalence to predicate devices, and no unique safety or effectiveness questions are raised by this modification.