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510(k) Data Aggregation
Device Name
IntellidropManufacturer
Date Cleared
2025-12-10
(197 days)
Product Code
Regulation Number
882.5550Type
TraditionalPanel
NeurologyAge Range
All
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Intellidrop system is indicated for use to provide external drainage of cerebrospinal fluid (CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) for ventricular or lumbar use.
Device Description
The Intellidrop system continuously monitors intracranial or spinal pressure and manages external drainage of cerebrospinal fluid (CSF) and other body fluids to a user-selected pressure target or volume target.
Key features of the Intellidrop include:
- Wearable sensor array facilitating position-agnostic pressure monitoring
- Closed-loop, gravity-based drainage to a pressure or volume target
- Real-time display of intracranial pressure (ICP) waveform
- Historical trend data of daily, hourly, and minute-by-minute ICP and drainage volume
- User selectable audio-visual alarm thresholds for both pressure and volume
- Patented Continuous Drift Detection Technology
- Continuous operation on AC power and up to 4 hours of continuous operation on rechargeable battery power
- Real-time data streaming of ICP to a patient monitor via cable
- Proximal sampling port and optional distal sampling port
AI/ML Overview
N/A
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