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510(k) Data Aggregation

    K Number
    K162108
    Device Name
    Pressio 2 ICP Monitoring System
    Manufacturer
    SOPHYSA, SA
    Date Cleared
    2017-04-17

    (262 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOPHYSA, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments. Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracranial temperature. According to the clinical situation, users choose the appropriate Pressio® catheters: - Pressio® kit for monitoring intracranial parenchymal pressure and temperature with bolt (PSO-PBT) indicated for use in parenchymal pressure and temperature monitoring. - Pressio® kit for monitoring intracranial parenchymal pressure and temperature with tunneling (PSO-PTT) indicated for use in parenchymal pressure and temperature monitoring. - Pressio® kit for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure and temperature monitoring and cerebrospinal fluid drainage application. The following Pressio® kits for Intracranial Pressure Monitoring are also compatible with the Pressio® 2 ICP Monitor: - Pressio® kit for monitoring intracranial parenchymal pressure with bolt (PSO-PB) indicated for use in parenchymal pressure monitoring - Pressio® kit for monitoring intracranial parenchymal pressure with tunneling (PSO-PT) indicated for use in parenchymal pressure monitoring. - Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application.
    Device Description
    The Pressio® 2 ICP Monitoring System is composed of a monitor (PSO-4000) with accessories and implantable catheters. The PSO-4000 monitor is an electromedical device designed for monitoring patient's intracranial pressure and temperature via catheters implanted in parenchyma (PSO-PBT and PSO-PTT) or in ventricles with drainage of cerebrospinal fluid (PSO-VTT). Previously marketed Pressio® kits (K062584) are also available on the Pressio® 2 ICP Monitor and allows monitoring of intracranial pressure via catheters implanted in parenchyma (PSO-PB and PSO-PT) or in ventricles (PSO-VT) with also drainage of cerebrospinal fluid. The Pressio® 2 ICP Monitor can also be connected to a patient monitor via a compatible monitor connection cable. This connection is not necessary for Pressio® 2 Intracranial Pressure Monitor functioning. The Pressio® 2 Monitor can also extract data to external computer via a USB cable. The Pressio® 2 ICP Monitoring System is sold as a kit containing a Pressio® 2 ICP Monitor (PSO-4000), a power supply cable (PSO-AC), a catheter extension cable (PSO-EC30).
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