EvoEndo Single-Use Endoscopy System

The EvoEndo Single-Use Endoscopy System is a sterile, single-use gastroscope intended for visualization and diagnosis of the upper digestive tract in adults and pediatric patients. It can be inserted orally or transnasally to observe, diagnose, and perform endoscopic treatment of the esophagus, stomach, and duodenal bulb. The system includes the endoscope with an HD camera and a separate Controller that displays the captured video on a medical-grade monitor.

The subject device is identical to the predicate device in all technological specifications: 3.5mm outer diameter, 2.0mm working channel, 1100mm working length, 120° field of view, 4-way steering, identical maximum bending angles, and same air/water/suction functionality. The only differences are the extended shelf life from 6 months to 14 months and removal of the age restriction from the indication (now includes patients under 5 years).

ISO 10993-1 for biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity); IEC/TR 62471 for photobiological safety; IEC 60601-1:2005, IEC 60601-1-2:2014, and IEC 60601-2-18:2009 for electrical safety and electromagnetic compatibility; FDA Guidance on Off-The-Shelf Software Use in Medical Devices.

Substantial equivalence is based on zero technological changes between the subject and predicate device; all prior testing on the predicate device applies. The extended shelf life from 6 to 14 months was validated using the same protocol established for K213606 and does not affect safety or effectiveness. The indication expansion to include patients under 5 years is supported by published literature demonstrating safety of endoscopy in younger pediatric patients and anatomical compatibility of the device with smaller patient populations, without any design modifications.