GeckoSystems Intl. Corp. (GOSY)

[XenaLives]

RP-VITA's navigation - Ain't no SafePath™

Expanding on the predicate device, the Remote Presence System, Model RP-VTATM is available with an
optional autonomous navigation system ("autonavigation"), providing the ability to autonomously navigate and
position the RP-VITATM end point to a pre-determined location. Developed in partnership with iRobot, the RPVITATM
contains similar Auto Drive technology that is already being used successfully by the defense and
public safety communities (e.g., PackBot bomb disposal robots), as well as by consumers in household
environments (e.g., Roomba vacuum cleaners). With a single click or tap, a bedside nurse or a remote
clinician will be able to send the RPNVITA TM to the target destination. The RP-VlTATM features mapping and
Obstacle Detection Obstacle Avoidance ("ODOA') technologies that support safe, fast, and highly flexible
navigation in a clinical environment. As the technology name suggests, the ODOA system allows the RPVITATM
to steer clear of obstacles in its path and maneuver around them. The RP-VlTA'SrM mapping
technology creates and stores a digital map of a clinical environment that it can access in the future, labeling
rooms, controlling device speed in certain areas, and marking areas where the RP-VlTA should not travel.
Risk analysis and the necessary verification and validation testing were performed to demonstrate that the
design outputs of the RP-VTATM meet the design input requirements.

Redundant safeguards are designed into the Remote Presence System, Model

http://www.accessdata.fda.gov/cdrh_docs/pdf12/K123229.pdf