The LiquoGuard CSF system 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 intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiquoGuard CSF system also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.

Device Description

The LiquoGuard CSF System consists of a pump and a corresponding tube set with pressure sensors. The dynamic range of this system is from -15mmHg to +75 mmHg. The tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via Luer-Lock and the LiquoGuard CSF System device via cable connector. The device then continuously measures the pressure inside the tube and operates a tube pump whenever the actual pressure is higher than a preselected target pressure. Thus the LiquoGuard CSF System combines CSF drainage and intracranial pressure (ICP) monitoring with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient mobility (by its battery back-up).

AI/ML Overview

Acceptance Criteria and Device Performance for LiquoGuard CSF System (K121248)

The provided document describes the Moller Medical LiquoGuard CSF System, which is indicated for external drainage and monitoring of cerebrospinal fluid (CSF). The acceptance criteria for this device are established through a combination of bench tests and a comparative clinical study against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the bench tests and the demonstration of equivalence in adverse event rates during the clinical study. No specific numerical thresholds for acceptance were explicitly stated beyond "all tests passed according to the predetermined pass/fail criteria."

Acceptance Criteria Category	Specific Test/Criterion	Reported Device Performance
Pressure Measurement	Absence of sensor drift during packaging / sterilization	Passed
	Absence of sensor drift during ageing	Passed
	Precision of displayed pressure at various pump rates and pressure loads	Passed
Pressure Regulation	Endurance test with in-vitro simulated patient	Passed
	Performance comparison with drip chamber	Passed
	Reliability of pump shut-off with negative pressures	Passed
	Device functions independent of positioning	Passed
Volume and Flow Measurement	Precision of total volume and flow (pump rate) measurement	Passed
Alarm Functions (Patient Condition)	Pressure alarms	Passed
	Pulsation alarm (e.g., catheter occlusion, collapsed ventricles, disconnected catheter)	Passed
	Pressure too constant alarm (e.g., catheter occlusion, collapsed ventricles, disconnected catheter)	Passed
	Influence of pressure on catheter walls	Passed
	Detection of clogged catheter	Passed
Alarm Functions (Device Functions)	Defective/disconnected sensors	Passed
	Disconnected/leaking tube set	Passed
	Battery low	Passed
	Main controller/watchdog cross-check	Passed
	Double safety	Passed
	Tube set too old	Passed
	Battery defective	Passed
Mechanical Handling and Operation	Disposable check for single-use	Passed
	Wrong tube set insertion	Passed
	Opening of front panel	Passed
	Disposable check for age	Passed
Endurance	Automatic switch to battery upon power failure	Passed
	Tube set durability	Passed
Other	External connectivity	Passed
Clinical Equivalence (Adverse Events)	Total rates of incidence of adverse events compared to predicate devices	"Very close, with most small variations in favor of the LiquoGuard." Supports equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 413 patient records.
Data Provenance: The records were collected from "several hospitals," indicating a multi-center study. The clinical study combines "similar, independent studies," suggesting a retrospective collection and aggregation of existing patient data rather than a new prospective study exclusively for this submission. The country of origin of the data is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The clinical study compares "adverse events" between the LiquoGuard and predicate devices, implying that these events were recorded as part of standard clinical practice.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical study's adverse event data. It mentions identifying and comparing rates of incidence, which suggests a quantitative analysis of pre-recorded data rather than a consensus-based adjudication process for individual cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study focused on comparing adverse event rates between the device and predicate devices in a clinical setting, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The device is not an AI-driven diagnostic algorithm. It is a medical device that combines hardware (pump, sensors) and software for CSF drainage and monitoring. Therefore, a standalone (algorithm only) performance study as typically understood for AI/CAD devices was not performed. Its performance is assessed through the comprehensive bench tests and clinical comparison.

7. Type of Ground Truth Used for the Test Set

The ground truth for the "test set" (clinical study) was based on clinical outcomes data, specifically "adverse events" recorded in patient records resulting from CSF drainage using either the LiquoGuard or predicate drip chambers.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as would be typical for machine learning models. The device's development and validation relied on engineering principles, bench testing, and a clinical comparison to existing devices. Therefore, a specific sample size for a "training set" in the context of an AI/ML model is not applicable from the provided information.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit mention of a training set in the context of machine learning, the question of how its ground truth was established is not directly applicable. The device's functionality is based on established fluid dynamics, pressure sensing, and pump control mechanisms. Its design and performance would have been refined through iterative engineering development and testing against specifications derived from medical requirements and predicate device functions.

Summary

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K121248

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510(k) Summary

DEC 1 3 2013

Submitter Information: Möller Medical GmbH Wasserkuppenstrasse 29-31 36043 Fulda, Germany

Establishment Registration Number: 3006611221

יי

Contact Person:

Grant Geckeler Free lance consultant 4375 Prado Road, Suite 103 Corona, CA 92880 Phone: +1 714 283 1683 Fax: +1 714 637 2460 E-mail: ggeckeler@geoinc.org

Name of Device:

Common Name:	External CSF Drainage System
Proprietary Name:	LiquoGuard CSF SystemConsists of: LiquoGuard CSF System pump and LiquoGuard CSF System tube set
Classification:	Shunt, Central Nervous System and Components, Class II, 21 CFR § 882.5550
Product Code:	JXG

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. For CSF drainage, dripping chambers are still being used widely. In contrast, dripping chambers for IV infusion have been mostly replaced by perfusors (syringe pumps).

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Intended Use:

The LiquoGuard CSF system 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 intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiguoGuard CSF system also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.

Substantial Equivalence:

The Moller Medical LiquoGuard CSF System is substantially equivalent to the CSF drainage systems listed below with regard to intended use, design, operating principles, and materials.

Integra NeuroSciences Corporation Codman & Shurtleff, Inc.

K030289. K032817 K061568

The Moller Medical LiquoGuard CSF System shares features with, the intracranial pressure monitor listed below (the shared features include CSF pressure monitoring, semiconductor sensor principle, display, alarm functions and data recording).

Camino NeuroCare. ™ Inc.

K962928

By using the LiquoGuard CSF System, in the same way as in existing systems, intrathecal pressure can be measured; critical intrathecal pressure 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 8 and Table 9.

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Traditional 510(k) Submission 510(k) Summary

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Product		Dipping chamber systems	ICP Monitorsystem	Combination
Component	Hermetic PlusExternal CSFDrainageSystem	CODMAN EDS3 CSF	Multi-ParameterMonitor (MPM)	LiquoGuardCSF System
Tube set disposable	●	●		●
CSF drainage bag	●	●		●
Pressure transducer			●	●
Micro controller			●	●
Software operated			●	●
Data storage			●	●
Button / Foil keypad			●	●
Screen			●	●
Ports			●	●
Casing			●	●
Power supply			●

Table 8: System Comparison

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SemöllerMedical

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Table 9: Device Comparison

		Primary Predicate Devices		Reference Device		Primary Predicate Devices		Reference Device		Primary Predicate Devices		Reference Device
		Integra LifeSciencesCorporation(K030289, K032817)	Codman & Shrutleff, Inc.(K061568)	Camino NeuroCare,™ Inc.(K962928)	Device	Möller MedicalLiquoGuard CSF System	Integra LifeSciencesCorporation(K030289, K032817)	Codman & Shrutleff, Inc.(K061568)	Camino NeuroCare,™ Inc.(K962928)		Möller MedicalLiquoGuard CSF System	Integra LifeSciencesCorporation(K030289, K032817)	Codman & Shrutleff, Inc.(K061568)	Camino NeuroCare, ™ Inc.(K962928)
Indication	Möller MedicalLiquoGuard CSF System	External draining ofcerebrospinal fluid (CSF)from the lateral ventriclesof the brain or the lumbarsubarachnoid space toreduce intracranialpressure and measurementof CSF pressure.	External draining ofcerebrospinal fluid (CSF)and other fluids of similarphysical characteristicsfrom a patient at acontrolled rate based ondifferential pressurebetween the device andpatient.	Measurement ofintracranial pressure in theventricles and during thecerebrospinal fluid (CSF)drainage.	Device adjustingfluid flow	sensor needs to be aligned.LiquoGuard CSF Systemperistaltic pump controlledby pressure at sensorlocation.	target pressure.None - fluid flow is notcontrolled or limited.	target pressure.None - fluid flow is notcontrolled or limited.	incorporated.No drainage.	Measuredpressure range	-15mmHg to +75mmHg.	No measurement.	No measurement.	-10mmHg to +250mmHg.
CSF steriletubing set withpressure sensorand drainagebag		Tubing material:Polyvinyl chloride (PVC).Pressure sensor:Dual transducers.CSF Collection Bag:500ml.	Tubing material:Polyvinyl chloride (PVC).Pressure sensor:None.CSF Collection Bag:700ml.	Tubing material:Not applicable.Pressure sensor:Single transducer.CSF Collection Bag:Not applicable.	Monitoringfunctions	Drained volume andpressure curve insidetubing (equal to intracranialpressure unless blockage)are monitored and recordedby LiquoGuard CSFSystem.	Pressure is sensed andmay be recorded byexternal device. Drainedvolume is unmonitored.	No monitoring functions.	Pressure, pressure curveand temperature aremonitored and recorded.	Physicaldimensions	315mm x 210 mm x 280 mm (H x W x D).4.8 kg.			274 mm x 216 mm x 89 mm (H x W x D).4.3 kg.
Pressurecontrollingmechanism'		Based on pressureequivalence (Pascal's lawof fluid statics) betweenpatient and pressuresensors inside the tubing.From the sensor location,drainage is performedusing a peristaltic pumpcontrolled by the sensedpressure inside the tubing.	Based on differentialpressure (Pascal's law offluid statics) caused byheight difference betweenpatient and drippingchamber.	Based on pressureequivalence (Pascal's lawof fluid statics) inside thehead.	Alarm functionsenhancingpatient safety	Many alarm functionsintegrated in the system:* Pressure too high.* Pressure too low.* Physiological pressurepulsation lost.* Pressure remainsconstant for too long.* Dual sensors deviate inreadings (defective sensor).* Watchdog or maincontroller does not respondto each other's requests(device or softwaremalfunction).* Battery low.	No integrated alarmfunctions.	No alarm functions.	Few integrated alarmfunctions:* Pressure too high.* Battery low.	Displayedparameters	Actual ICP value, ICPwaveform, ICP trend.Display resolution of 1 mmHg.	No display.	No display.	Actual ICP value, ICPwaveform, ICP trend,intracranial temperature,Cerebral Perfusion,Pressure.Display resolution of 1 mmHg.
Height alignmentof patient and		Device can be positionedarbitrarily, only the pressure	Alignment is criticalbecause it controls the	Device can be positionedarbitrarily; the pressuresensors need to be	Sensor type	Dual transducer.	Single transducer.	No sensor.	Fiber-optic single pressuretransducer.
Scheduledpreventivemaintenance	Every 12 months	No	No	Every 18 months
Battery	Rechargeable sealed leadacid.Charge time: 8h.Operation time: 3h.	No battery.	No battery.	Rechargeable sealed leadacid.Charge time: 8-10h.Operation time: 1-2h.

2013-12

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SMöllerMedical

raditional 510(k) Submission

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SemöllerMedical

raditional 510(k) Submission

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2013-12

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Summary of substantial equivalence discussion

Many if not all risks leading to accidental, cerebral herniation in both systems (traditional drainage and ICP monitors) can be reduced or even eliminated by the LiquoGuard CSF Svstem.

The LiquoGuard CSF System is working equivalently to a drip chamber, with the additional safety that, using LiguoGuard CSF System, a partial or intermittent catheter occlusion may be detected in many cases: In difference to the dripping chamber which must be an open system during drainage the LiquoGuard CSF System can measure the hydrostatic pressure inside the tube (drainage system) during drainage because the drainage system is closed, combined with a CSF pressure monitor and its features like displaying pressure values, curves and trends and enabling alarm functionality. The principles of measurement are comparable to the ICP monitor and its pressure transducer as both systems measure the pressure of the surrounding liquid. The only difference is the position of the transducers, and the fact that LiquoGuard uses dual transducers for redundancy.

The LiguoGuard CSF System behaves comparable to a traditional drainage system even in the case of a clotted catheter or collapsed ventricles. 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 monitor systems, same as the Multi Parameter Monitor.

By combining the functionality of dripping chambers with the features of a computer operated device (ICP monitor) and adding a peristaltic pump the LiguoGuard CSF System benefit is potentiated as some major problems are solved (elimination of sensor drift problematic, protection of accidental over and / or under drainage, pressure measurement simultaneously with CSF drainage, etc.).

Summary and Conclusion of the Performance Testing:

The LiguoGuard CSF System has the same indication for use as the predicate devices (measurement and drainage of CSF). In addition, the LiquoGuard CSF System 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 10 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 were appropriate performed and all tests passed according to the predetermined passifiall 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.

2013-12

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. '

. .

Traditional 510(k) Submission

510(k) Summary

Table 10: List of bench test
Pressure measurement	✓ Absence of sensor drift during packaging / sterilization✓ Absence of sensor drift during ageing✓ Precision of displayed pressure at various pump rates and pressure loads
Pressure regulation	✓ Endurance test with in-vitro simulated patient✓ Performance comparison with drip chamber✓ Reliability of pump shut-off with negative pressures✓ Device functions independent of positioning
Volume and flowmeasurement	✓ Precision of total volume and flow (pump rate) measurement
Alarm functions related topatient condition	✓ Pressure alarms✓ Pulsation alarm (indication for events like: catheter occlusion collapsed ventricles and disconnected catheter)✓ Pressure too constant (indication for events like: catheter occlusion collapsed ventricles and disconnected catheter)✓ Influence of pressure on catheter walls✓ Detection of clogged catheter
Alarm functions related todevice functions	✓ Defective/disconnected sensors✓ Disconnected/leaking tube set✓ Battery low✓ Main controller/watchdog cross-check✓ Double safety✓ Tube set too old✓ Battery defective
Mechanical handling andoperation	✓ Disposable check for single-use✓ Wrong tube set insertion✓ Opening of front panel✓ Disposable check for age
Endurance	✓ Automatic switch to battery upon power failure✓ Tube set durability
Other	✓ External connectivity

Table 10: List of bench test

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Summary and Conclusion of the Clinical Study:

Drawing on the user base and combining similar, independent studies from several hospitals into one data basis, we collected 413 patient records on treatments using the LiquoGuard (LG) as well as the predicate devices (drip chambers). We identified a number of "adverse events" and compared their rate of incidence for both cases (LG vs. predicate) for the total patient population as well as certain patient categories, e.g. medical indication.

Since the two CSF drainage methods (LiquoGuard and drip chamber) apply the same therapy (drainage) to the patients, we expected to obtain similar results. Indeed, the data show a great similarity. E.g., total rates of incidence of adverse events are for each type of event very close, with most small variations in favor of the LiquoGuard.

The findings support the equivalence of LiquoGuard and the listed predicate devices.

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Image /page/9/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's emblem, which includes a stylized caduceus-like symbol with three wavy lines and a circle containing the words "DEPARTMENT OF HEALTH & HUMAN SERVICES". Above the emblem, there are the letters "JXG".

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

December 13, 2013

Möller Medical GmbH c/o Mr. Grant Geckeler 1612 Jenks Drive Corona, CA 92880

Re: K121248

Trade/Device Name: LiquoGuard CSF System Regulation Number: 21 CFR 882.5550 Regulation Name: Shunt, Central Nervous System and Components Regulatory Class: Class II Product Code: JXG Dated: May 13, 2013 Received: September 16, 2013

Dear Mr. Geckeler:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

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

Sincerely yours.

Joyce M. Whang -S

for .

for Victor Krauthamer, Ph.D. Acting 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: K121248

Device Name: LiquoGuard CSF System

Indications for Use:

Prescription Use A (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH)

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).