Intellidrop

The Intellidrop system is an external cerebrospinal fluid (CSF) drainage and monitoring device for ventricular or lumbar use. It continuously monitors intracranial or spinal pressure and manages automated gravity-based drainage to a user-selected pressure or volume target, with real-time ICP waveform display, historical trend data, and configurable alarms.

The Intellidrop uses a wearable sensor array for position-agnostic pressure monitoring at the level of the external auditory meatus, supports pressure targets of -20 to 50 cm H₂O (versus -5 to 40 cm H₂O for the predicate), and permits hourly drainage volumes up to 60 mL/hr (versus 45 mL/hr for the predicate). Both systems employ gravity-based drainage with automated actuator-controlled tube compression, disposable tubing sets, and software-based consoles with battery backup.

Testing was conducted per IEC 60601-1:2020 (electrical safety), ISO 11135:2014/A1:2018 (sterilization), ISO 11607:2019 (sterile barrier), ISO 10993-1:2018 (biocompatibility), ISO TS 10974:2018 (MR compatibility), IEC 60601-1-2:2014 (electromagnetic immunity), AAMI NS28:1988/R:2015 (accuracy and performance), and IEC 62366-1:2015+AMD1:2020 (human factors validation).

The Intellidrop is substantially equivalent to the Smart External Drain (SED) System (K172759) because both devices share identical intended use (external ventricular or lumbar CSF drainage and pressure monitoring), employ the same fundamental design architecture (gravity-based automated drainage, wearable pressure transducers, software-controlled consoles), and differ only in minor technical specifications (pressure range and hourly drainage volume) that do not raise new safety or effectiveness questions. Comprehensive testing confirms compliance with applicable safety, biocompatibility, and performance standards.