Revi System

The Revi System is an implanted tibial electrical urinary continence device that wirelessly receives power from a wearable external unit to stimulate the tibial nerve near the ankle. It treats urgency incontinence alone or combined with urinary urgency by modulating nerve function through electrical pulses that reach the sacral plexus.

Key differences from the predicate (K240037) include: updated wearable unit with replaceable battery (versus non-replaceable), software version v5.0.0.3 (versus v4.3), redesigned user interface with three enlarged buttons and four LED indicators in linear arrangement (versus three buttons with single multi-color LED in triangular layout), enhanced power consumption via circuit and firmware improvements, and redesigned enclosure using plastic injection molding with newer electronic component equivalents.

IEC 60601-1 Ed. 3.2 (electrical safety), IEC 60601-1-2:2020 and IEC TS 60601-4-2 Edition 1.0 2024-03 (EMC), ASTM D4169 (transportation and storage), FDA Guidance on device software, cybersecurity, and radio frequency wireless technology.

The subject device and predicate have identical indications for use and similar technological characteristics. Modifications to the wearable unit, software, and labeling do not affect the implantable component, principles of operation, underlying technology, or principal functionality. Performance testing and human factors evaluation show no new safety or effectiveness questions, and results support the device is as safe and effective as the predicate.