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 < 5% or < 2 mmHg.	All samples passed the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document repeatedly states "All samples passed the acceptance criteria" in the results column for each test. However, the specific sample size used for each individual test is not explicitly stated in the provided text. The data provenance is not mentioned, but the tests are described as bench tests and in-vitro simulated patient, indicating these are controlled laboratory tests rather than human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The nature of the device (CSF drainage system) and the tests (bench tests) suggests that ground truth would be established by predefined engineering and medical device standards and specifications, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For bench tests, the established criteria are typically objective and pass/fail, and do not require expert adjudication to establish ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a cerebrospinal fluid drainage and monitoring system, not an AI-assisted diagnostic tool that would involve human readers. The study described focuses on the device's technical performance and safety.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire study described is essentially a standalone (algorithm/device-only) performance evaluation through bench testing. The device operates automatically based on pressure sensors and a pump, and the tests verify its automated functions and alarms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the bench tests would be primarily based on:

Predefined engineering specifications and standards: e.g., AAMI NS28:1988 (Revision 2010).
Physical measurements: e.g., water column for pressure accuracy, calibrated flow meters for flow rate accuracy.
Simulated conditions: e.g., simulating low/high pressure to test alarms, simulating patient movement, mimicking tube set malfunctions.

8. The sample size for the training set

This information is not applicable/provided. The LiquoGuard 7 is a medical device, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. Its functionality is based on established engineering principles and programming, not data-driven learning.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2015

Möller Medical GmbH Ms. Juliane Dragon Regulatory Affairs Manager Wasserkuppenstr. 29-31 Fulda, Hessen 36043 Germany

Re: K150898

Trade/Device Name: LiquoGuard 7 Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: November 12, 2015 Received: November 20, 2015

Dear Ms. Dragon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150898

Device Name LiquoGuard 7

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submitter

Submitter:	Möller Medical GmbHWasserkuppenstraße 29-3136043 Fulda, GermanyTel.: +49 (0) 661-94195-0Fax: +49 (0) 661-94195-850
Establishment Registration Number: 3006611221
Contact Person:	Grant GeckelerFree lance consultant1612 Jenks DriveCorona, CA 92880Phone: +1 858 603 1838E-mail: grant.geckeler@gmail.com
Date Prepared:	March 24, 2015

2. Device

Trade name:	LiquoGuard 7Consists of: LiquoGuard 7 pump and LiquoGuard 7disposable drainage tube sets
Common or Usual Name:	External CSF Drainage System
Classification Name:	Shunt, Central Nervous System and Components (21 CFR882.5550)
Regulatory Class:	II
Product Code:	JXG

3. Predicate Device

The Möller Medical LiquoGuard 7 is substantially equivalent to the LiquoGuard CSF System listed below with regard to intended use, design, operating principles, materials, CSF pressure monitoring, semiconductor sensor principle, display, alarm functions and data recording.

LiquoGuard CSF System: K121248

4. Device Description

Cerebrospinal fluid (CSF) drainage and pressure monitoring in lumbar and ventricular applications is the "gold standard" for cases involving trauma, post-operation, shunt infection, subarachnoid hemorrhage (SAH) therapy, neurophysiological monitoring during vascular surgery (e.g. TAA and TAAA) and normal-pressure hydrocephalus (NPH) diagnosis.

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5. Indications for Use

The LiguoGuard 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.

6. Comparison of Technological Characteristics with the Predicate Device

The LiquoGuard 7 is working equivalently to the predicate device, with the additional safety that, using LiquoGuard 7, a bleeding or swelling of the brain may be detected in many cases (flow control and alarm). The principles of measurement are exactly the same as both systems measure the pressure of the surrounding liquid.

The LiguoGuard 7 behaves comparable to the predicate device. It is able to sound and display alarms to operators, is portable, can be used while not connected to the mains, records and stores data and can be connected to bedside monitoring systems.

The LiquoGuard 7 and its predicate device both utilize components such as sterile tubing's, pressure sensors, CSF drainage bags, microcontroller and interfaces. The LiquoGuard 7 tubing set is made from polyvinyl chloride, the same material that the predicate devices tubing sets are made of, along with numerous marketed IV administration tubing sets. The LiquoGuard 7 tubing set has two pressure transducers, such as the predicate device tubing's. Both systems include CSF drainage bags to collect drained CSF.

Both systems display values, curves and trends on a built in monitor, sound alarms via speaker and light emitting LED, are operated by pressing foil keypad buttons or a touch display and are basically computer and software controlled.

Both systems measure intrathecal pressure the same way; critical intrathecal pressure increase in the patient can be recognized, thereby enabling the required diagnostic and treatment steps to be taken. Since the pressure measurement in systems is done via piezo-resistive pressure sensors that are attached at reference height to the patient, there is no difference in intrathecal pressure measurement. Additional details for comparing these CSF Systems are contained in Table 1 and Table 2.

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ProductComponent	Predicate device(LiquoGuard CSFSystem)	LiquoGuard 7
Tube set disposable	●	●
CSF drainage bag	●	●
Pressure transducer	●	●
Micro controller	●	●
Software operated	●	●
Data storage	●	●
Screen	●	●
Ports	●	●
Casing	●	●
Power supply	●	●

Table 1: System Comparison

Table 2: Device Comparison

	Predicate device	LiquoGuard 7
Indication	External drainage ofcerebrospinal fluid (CSF) fromthe lateral ventricles of thebrain or the lumbarsubarachnoid space to reduceintracranial pressure andmeasurement of CSF pressure.	External drainage ofcerebrospinal fluid (CSF) fromthe lateral ventricles of the brainor the lumbar subarachnoidspace to reduce intracranialpressure and measurement ofCSF pressure.
CSF sterile tubing set withpressure sensor anddrainage bag	Tubing material: Polyvinylchloride (PVC).Pressure sensor: Dualtransducers.CSF Collection Bag: 500ml.	Tubing material: Polyvinylchloride (PVC).Pressure sensor: Dualtransducers.CSF Collection Bag: 500ml.
Pressure controllingmechanism	Based on pressure equivalence(Pascal's law of fluid statics)between patient and pressuresensors inside the tubing.From the sensor location,drainage is performed using aperistaltic pump controlled bythe sensed pressure inside thetubing.	Based on pressure equivalence(Pascal's law of fluid statics)between patient and pressuresensors inside the tubing.From the sensor location,drainage is performed using aperistaltic pump controlled bythe sensed pressure inside thetubing.
Height alignment of patientand device	Device can be positionedarbitrarily, only the pressuresensor needs to be aligned.	Device can be positionedarbitrarily, only the pressuresensor needs to be aligned.
Device adjusting fluid flow	LiquoGuard CSF Systemperistaltic pump controlled bypressure at sensor location.	LiquoGuard 7 peristaltic pumpcontrolled by pressure at sensorlocation.
	Predicate device	LiquoGuard 7
Monitoring functions	Drained volume and pressurecurve inside tubing (equal tointracranial pressure unlessblockage) are monitored andrecorded by LiquoGuard CSFSystem.	Drained volume and pressurecurve inside tubing (equal tointracranial pressure unlessblockage) are monitored andrecorded by LiquoGuard 7.
Alarm functions enhancingpatient safety	Many alarm functionsintegrated in the system:* Pressure too high.* Pressure too low.* Physiological pressurepulsation lost.* Pressure remains constant fortoo long.* Dual sensors deviate inreadings (defective sensor).* Watchdog or main controllerdoes not respond to eachother's requests (device orsoftware malfunction).* Battery low	Many alarm functions integratedin the system:* Pressure too high.* Pressure too low.* Physiological pressurepulsation lost.* Pressure remains constant fortoo long.* Dual sensors deviate inreadings (defective sensor).* Watchdog or main controllerdoes not respond to each other'srequests (device or softwaremalfunction).* Battery low* Sensor difference ICP vs.PCSF* No ICP sensor connected* High Flow Alarm* Low Flow Alarm
Measured pressure range	-15mmHg to +75mmHg.	-75mmHg to +100mmHg
Physical dimensions	315mm x 210 mm x 280 mm (Hx W x D).4.8 kg.	145mm x 238.1mm x 212.8mm(H x W x D).3.7 kg.
Displayed parameters	Actual ICP value, ICPwaveform, ICP trend.Display resolution of 1 mmHg.	Actual ICP and PCSF value, ICPand PCSF waveform, ICP andPCSF trend.Display resolution of 1 mmHg.
Sensor type	Dual transducer.	Dual transducer.
Scheduled preventivemaintenance	Every 12 months	Every 12 months
Battery	Rechargeable sealed lead acid.Operation time: 3h.	Rechargeable Lithium Ion.Operation time: 2h.

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510(k) Summary

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7. Performance Data

The LiquoGuard 7 has the same indication for use as the predicate devices (measurement and drainage of CSF). In addition, the LiquoGuard 7 tubing set is made from the same materials as the predicate devices, and because the risks associated with the surgical insertion of a CSF drain are not dependent on the CSF drainage system chosen, no new safety or effectiveness concerns are introduced over the predicate devices. Please refer to Table 3 for the list of bench tests – there you find a list of all bench tests that have been performed.

The test series exhibits a very wide range of performance tests and all necessary and required tests for the LiquoGuard 7 were appropriate performed and all tests passed according to the predetermined pass/fail criteria. Particularly highlighting are tests which serve to check the pressure and alarm systems. For this purpose, a plurality of measurements has been carried out to verify the critical components.

Test	Test method summary	Results
Accuracy ofmeasured anddisplayedpressure	Verify precision of displayed pressure atvarious pump rates and pressure loads.Criterion: Deviation of displayedpressures less than ± 2mmHg to watercolumn.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Endurance testwith in-vitrosimulatedpatient	Verify long term stability of the devicewith simulated patient > 30 days(includes 3 tube set changes).Criterion: No malfunction of the device.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Verify pumpstopping	Verify reliability of pump stopping withnegative pressure at different flow rates.Criterion: Pump stops at the predefinedpressure level Pmin-	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Pressurestability whilepatientmovement	Verify device function depending ofpressure sensor position.Criterion: Displayed pressure changeswith a deviation of ± 1mmHg whilemovement.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Minimum andmaximum flowrate andaccuracy of themeasured anddisplayedvolume atadjusted flowrate	Verify accuracy of the total volumemeasurement at different pump rates.Deviations of the real flow from theadjusted flow and deviations of thedisplayed flow and the actual flow aremeasured.Criterion: Deviations are smaller than± 15%.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
AAMINS28:1988(Revision 2010)	Verify all applicable requirements ofAAMI NS28:1988 (3.1.2.1, 3.1.2.2,3.1.2.3, 3.1.3 and 3.2).Criterion: According to AAMI NS28:1998(Revision 2010).	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Test	Test method summary	Results
Alarm: pressuretoo low	Verify pressure alarms: PCSF stays belowthe defined limit of PLOW an alarm has toactivate. Increase of PCSF > PLOW alarmhas to deactivate automatically.Criterion: Alarm is issued reliably afterintentional delay of 20 seconds.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Alarm: pressuretoo high	Verify pressure alarms: PCSF stays overthe defined limit of PHIGH an alarm has toactivate. Increase of PCSF < PHIGH alarmhas to deactivate automatically.Criterion: Alarm is issued reliably afterintentional delay of 20 seconds.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Alarm: pressuretoo constant	Verify pressure alarms: PCFS is tooconstant within the defined limits of Pmaxand Pmin and the pulse rate is below thedefined limit an alarm has to activate.Criterion: Alarm is issued reliably afterintentional delay of 120 seconds.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Alarm: pulsationis lost	Verify pressure alarms: If PCSF shows nopulsation and the motor test shows asubstantial drop of PCFS an alarm has toactivate.Criterion: Alarm is issued reliably afterintentional delay of 30 seconds.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Alarm: tip sensordisconnected	Verify pressure alarms: Tip sensor isconnected no alarm activates and tipsensor is disconnected an alarm has toactivate.Criterion: Alarm is issued reliably with nointentional delay.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Alarm: tube setdisconnected	Verify pressure alarms: Tube set isconnected no alarm has to activate andtube set is disconnected an alarm has toactivate.Criterion: Alarm is issued reliably with nointentional delay.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Alarm: tube ismalfunction	Verify pressure alarms: Simulated tubeset malfunction an alarm has to activate,stop simulation of tube set malfunctionthe alarm has to stop.Criterion: Alarm is issued reliably afterintentional delay of 10 seconds.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Alarm: Mainbattery	Verify main battery alarms: Startingdevice without main battery, main batterywith low capacity and main battery failurean error message is visible or an alarmhas to activate.Criterion: Error message or alarm isissued reliably.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Test	Test method summary	Results
Alarm: main battery low	Verify main battery alarms: Alarm is active while device is running on battery charged < 20%. Alarm is inactive while device is running on battery charged ≥ 20 %. Criterion: Main battery capacity alarm is issued reliably after intentional delay of 10 seconds.	All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Alarm: emergency battery behavior	Verify emergency battery behavior: Remove emergency battery and start device an error message has to be visible and an alarm has to activate. Criterion: Error message and alarm is issued reliably.	All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Alarm: communication motor controller	Verify alarm functions: When application is running (1) simulate motor controller malfunction the application has to stop, an alarm has to activate and an error message has to be visible and (2) simulate watchdog malfunction the application has to stop, an alarm has to activate and an error message has to be visible. Criterion: Alarms are issued reliably and application stops.	All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Alarm: watchdog audio	Verify device function alarms: When application is running with removed speaker cable: (1) produce any alarm the watchdog activates an alarm and (2) malfunction of watchdog device stops application and shows error message. Criterion: Alarm is issued reliably after intentional delay of 20 seconds.	All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Alarm: tube set usage time expires	Verify device function alarms: Simulation of the maximum usage time an alarm activates the tube set is about to expire. Criterion: Alarm is issued reliably for various tube set conditions.	All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Tube Set usage time expires	Verify single use and shelf life of tube set: Reconnection of an already used tube set and connection of an expired tube set to the device the application must not start. Criterion: Re-use of a tube set is not accepted.	All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Detection of opening and closing the cover	Verify the angle of the opened and closed pump cover for starting and stopping the pump. Criterion: The angle to stop and start the pump is ≤ 10°.	All samples passed the acceptance criteria. In relevancy of the test results the substantial equivalence is verified.
Test	Test method summary	Results
Device operationcontinues whileremoving mainspower	Verify automatic switching to batteryupon power failure: Device has tocontinue operation without anydisturbance or abnormal behavior. Thepower plug icon has to be visible on thescreen.Criterion: Device continues operationwithout any disturbances.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Tube SetDurability	Verify functionality after doublesterilization and accelerated aging of 4years.Criterion: Functionality of tube set mustbe fulfilled.	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.
Safety patientmonitor output	Verify external connectivity: Start deviceand connect to patient monitor. Pressuresimulation test with various values.Criterion: Deviation of device and monitorvalues < 5% or < 2 mmHg	All samples passed theacceptance criteria. Inrelevancy of the test results thesubstantial equivalence isverified.

Table 3: List of bench test

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8. Conclusion

The LiquoGuard 7 is a tube system with integrated redundantly designed pressure sensors, as well as a peristaltic pump device, into which a part of the tube system is inserted in order to perform pressure or volume-controlled CSF drainage. The intrathecal CSF drain is used independent of the LiquoGuard 7, and the products approved for intrathecal CSF drainage can be connected to the LiquoGuard 7 (but are not part of the system). The indication for insertion of intrathecal drainage will not be affected by using the LiquoGuard 7.

The control parameters for the CSF drainage (tarqet pressure, CSF flow) are identically between the predicate device and the LiquoGuard 7. The effective mechanism and the function of the CSF extraction by means of a target value-controlled peristaltic pump in the LiquoGuard 7 is also used in the predicate device, the LiguoGuard CSF System. Therefore, the LiquoGuard 7 offers comparable effectiveness to the predicate device.

The measuring sensor is also identically to the ones used in the predicate device, as well as many functions (ICP value display, trend analysis, etc.) and alarm settings (e.g. high pressure).

The LiquoGuard 7 is equivalent to the predicate devices in that:

. The devices have the same intended use and indication for use.
. The devices have equivalent design, function, procedures and features.
The devices demonstrate equivalent performance. ●

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).