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510(k) Data Aggregation

    K Number
    K150898
    Device Name
    LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
    Manufacturer
    MOLLER MEDICAL GMBH
    Date Cleared
    2015-12-18

    (260 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K121248
    Why did this record match?
    Device Name :

    LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LiquoGuard 7 is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intrathecal pressure. The LiquoGuard 7 controls CSF pressure using pressure sensors and a pump and also monitors CSF pressure and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions.

    Device Description

    The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristalticpump of LiguoGuard 7 whenever the current patient's CSF pressure is higher than a preselected target pressure. Thus the LiguoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient's mobility.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study that proves the device (LiquoGuard 7) meets these criteria. The study mainly involves bench testing.

    Here's the information extracted and organized:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Criterion)Reported Device Performance (Results)
    Accuracy of measured and displayed pressure: Deviation of displayed pressures less than ± 2mmHg to water column.All samples passed the acceptance criteria.
    Endurance test with in-vitro simulated patient: No malfunction of the device after > 30 days (includes 3 tube set changes).All samples passed the acceptance criteria.
    Verify pump stopping: Pump stops at the predefined pressure level Pmin.All samples passed the acceptance criteria.
    Pressure stability while patient movement: Displayed pressure changes with a deviation of ± 1mmHg while movement.All samples passed the acceptance criteria.
    Minimum and maximum flow rate and accuracy of the measured and displayed volume at adjusted flow rate: Deviations are smaller than ± 15%.All samples passed the acceptance criteria.
    AAMI NS28:1988 (Revision 2010): According to AAMI NS28:1998 (Revision 2010) for applicable requirements (3.1.2.1, 3.1.2.2, 3.1.2.3, 3.1.3 and 3.2).All samples passed the acceptance criteria.
    Alarm: pressure too low: Alarm is issued reliably after intentional delay of 20 seconds.All samples passed the acceptance criteria.
    Alarm: pressure too high: Alarm is issued reliably after intentional delay of 20 seconds.All samples passed the acceptance criteria.
    Alarm: pressure too constant: Alarm is issued reliably after intentional delay of 120 seconds.All samples passed the acceptance criteria.
    Alarm: pulsation is lost: Alarm is issued reliably after intentional delay of 30 seconds.All samples passed the acceptance criteria.
    Alarm: tip sensor disconnected: Alarm is issued reliably with no intentional delay.All samples passed the acceptance criteria.
    Alarm: tube set disconnected: Alarm is issued reliably with no intentional delay.All samples passed the acceptance criteria.
    Alarm: tube is malfunction: Alarm is issued reliably after intentional delay of 10 seconds.All samples passed the acceptance criteria.
    Alarm: Main battery: Error message or alarm is issued reliably.All samples passed the acceptance criteria.
    Alarm: main battery low: Main battery capacity alarm is issued reliably after intentional delay of 10 seconds.All samples passed the acceptance criteria.
    Alarm: emergency battery behavior: Error message and alarm is issued reliably.All samples passed the acceptance criteria.
    Alarm: communication motor controller: Alarms are issued reliably and application stops.All samples passed the acceptance criteria.
    Alarm: watchdog audio: Alarm is issued reliably after intentional delay of 20 seconds.All samples passed the acceptance criteria.
    Alarm: tube set usage time expires: Alarm is issued reliably for various tube set conditions.All samples passed the acceptance criteria.
    Tube Set usage time expires: Re-use of a tube set is not accepted.All samples passed the acceptance criteria.
    Detection of opening and closing the cover: The angle to stop and start the pump is ≤ 10°.All samples passed the acceptance criteria.
    Device operation continues while removing mains power: Device continues operation without any disturbances.All samples passed the acceptance criteria.
    Tube Set Durability: Functionality of tube set must be fulfilled after double sterilization and accelerated aging of 4 years.All samples passed the acceptance criteria.
    Safety patient monitor output: Deviation of device and monitor values
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