PENTAX Medical Video Processor (EPK-i8020c)

The PENTAX Medical Video Processor EPK-i8020c is a video processor system used with endoscopes and monitors for gastrointestinal and pulmonary endoscopic diagnosis, treatment, and video observation. It includes digital post-processing imaging enhancement (i-Scan™) and optical imaging enhancement (OE) technologies designed as optional adjuncts to white light endoscopy, not as replacements for histopathological sampling.

The subject device is functionally equivalent to the predicate, with minor software modifications including a new Light Limit Mode feature and automatic cancellation of OE Mode when the endoscope is removed. The hardware components remain unchanged, consisting of the same fundamental technology and principle of operation as the predicate device, including a video processor for illuminating and viewing the inside of the human body.

Software verification and validation including cybersecurity assessments were conducted according to IEC 62304:2006 + A1:2015 and FDA Guidance documents on device software functions, cybersecurity in medical devices, and postmarket management of cybersecurity.

The subject and predicate devices have identical indications for use and intended use with no differences. The technological changes are limited to software modifications that do not affect core device performance, function, or general intended use. System performance testing demonstrated equivalence to the predicate, and electrical safety/EMC evaluation was not required since hardware remained unchanged. Therefore, the minor design feature changes do not create unique safety or effectiveness concerns.