FSYX Ocular Pressure Adjusting Pump

The FSYX Ocular Pressure Adjusting Pump System is an external ocular negative pressure device indicated for reducing intraocular pressure during sleep in adult patients with open-angle glaucoma and baseline IOP ≤ 21 mmHg who are on other IOP-lowering treatments. It consists of a programmable pump unit and goggles that create and maintain negative pressure in front of the eyes.

Compared to the predicate (DEN230055), the subject device removes mechanical relief valves from the manifold sub-assembly while maintaining the same essential performance requirement (-40 mmHg for <10 seconds) through active pressure control and a hardware watchdog. It adds a cellular module for unidirectional transmission of usage data to a cloud platform and introduces a new Care App that runs on user-provided Windows computers with cloud-based usage data access and user login controls.

IEC 60601-1-2 (Electromagnetic compatibility), IEC 60601-1 (Electrical safety), IEC 62304 (Medical device software life cycle), and FDA Guidance for Software Content in Medical Devices with Enhanced Documentation determination.

The device has the same intended use and principle of operation as the predicate. Although it removes relief valves and adds cellular connectivity and a cloud-based care app, these differences do not raise new or different types of questions of safety or effectiveness. Non-clinical testing including pressure limiting functionality, hardware/system verification, software validation, cybersecurity assessment, and EMC/electrical safety evaluations demonstrate substantial equivalence to the predicate device.