Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on pressure sensing, pumping, and alarm functions based on preselected target pressures, which are typical features of automated control systems, not necessarily AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.

Therapeutic

Yes

Explanation: The device is indicated for the external drainage of cerebrospinal fluid to reduce intracranial pressure, which is a therapeutic intervention. It actively controls CSF pressure using sensors and a pump for this purpose.

Diagnostic

No

The device is primarily an external drainage system for cerebrospinal fluid that also monitors intracranial pressure. While it provides monitoring data, its main function is therapeutic (draining CSF and controlling pressure), not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a pump and a corresponding tube set with pressure sensors, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the external drainage of cerebrospinal fluid (CSF) and monitoring intracranial pressure. This is a therapeutic and monitoring function performed directly on the patient, not an in vitro test performed on a sample outside the body.
Device Description: The device description details a system that physically interacts with the patient's CSF drainage system to control pressure and monitor flow and pressure. This is a medical device used for treatment and monitoring, not for analyzing a biological sample to diagnose a condition.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like CSF itself for diagnostic markers), reagents, or laboratory procedures typically associated with IVD devices.

Therefore, the LiquoGuard CSF system is a medical device used for patient management and monitoring, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

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).

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lateral or third ventricle of the brain or lumbar subarachnoid space

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030289, K032817, K061568

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K962928

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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K121248

Image /page/0/Picture/1 description: The image contains the logo for MöllerMedical. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be a cluster of three circular shapes.

Page: 1 (9)

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 System
Consists 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).

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).

1

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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Image /page/2/Picture/0 description: The image contains the logo for "MöllerMedical". The logo consists of a cluster of four irregular circles on the left side of the text. The text "MöllerMedical" is written in a sans-serif font and is positioned to the right of the circles.

Traditional 510(k) Submission 510(k) Summary

Page: 3 (9)

.

| Product | | Dipping chamber systems | ICP Monitor
system | Combination |
|----------------------|-----------------------------------------------------|-------------------------|----------------------------------|--------------------------|
| Component | Hermetic Plus
External CSF
Drainage
System | CODMAN EDS
3 CSF | Multi-Parameter
Monitor (MPM) | LiquoGuard
CSF 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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Table 9: Device Comparison

		Primary Predicate Devices		Reference Device
		Integra LifeSciences
Corporation
(K030289, K032817)	Codman & Shrutleff, Inc.
(K061568)	Camino NeuroCare,™ Inc.
(K962928)	Device	Möller Medical
LiquoGuard CSF System	Integra LifeSciences
Corporation
(K030289, K032817)	Codman & Shrutleff, Inc.
(K061568)	Camino NeuroCare,™ Inc.
(K962928)		Möller Medical
LiquoGuard CSF System	Integra LifeSciences
Corporation
(K030289, K032817)	Codman & Shrutleff, Inc.
(K061568)	Camino NeuroCare, ™ Inc.
(K962928)
Indication	Möller Medical
LiquoGuard CSF System	External draining of
cerebrospinal fluid (CSF)
from the lateral ventricles
of the brain or the lumbar
subarachnoid space to
reduce intracranial
pressure and measurement
of CSF pressure.	External draining of
cerebrospinal fluid (CSF)
and other fluids of similar
physical characteristics
from a patient at a
controlled rate based on
differential pressure
between the device and
patient.	Measurement of
intracranial pressure in the
ventricles and during the
cerebrospinal fluid (CSF)
drainage.	Device adjusting
fluid flow	sensor needs to be aligned.
LiquoGuard CSF System
peristaltic pump controlled
by pressure at sensor
location.	target pressure.
None - fluid flow is not
controlled or limited.	target pressure.
None - fluid flow is not
controlled or limited.	incorporated.
No drainage.	Measured
pressure range	-15mmHg to +75mmHg.	No measurement.	No measurement.	-10mmHg to +250mmHg.
CSF sterile
tubing set with
pressure sensor
and drainage
bag		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.	Monitoring
functions	Drained volume and
pressure curve inside
tubing (equal to intracranial
pressure unless blockage)
are monitored and recorded
by LiquoGuard CSF
System.	Pressure is sensed and
may be recorded by
external device. Drained
volume is unmonitored.	No monitoring functions.	Pressure, pressure curve
and temperature are
monitored and recorded.	Physical
dimensions	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.
Pressure
controlling
mechanism'		Based on pressure
equivalence (Pascal's law
of fluid statics) between
patient and pressure
sensors inside the tubing.
From the sensor location,
drainage is performed
using a peristaltic pump
controlled by the sensed
pressure inside the tubing.	Based on differential
pressure (Pascal's law of
fluid statics) caused by
height difference between
patient and dripping
chamber.	Based on pressure
equivalence (Pascal's law
of fluid statics) inside the
head.	Alarm functions
enhancing
patient safety	Many alarm functions
integrated in the system:

Pressure too high.
Pressure too low.
Physiological pressure
pulsation lost.
Pressure remains
constant for too long.
Dual sensors deviate in
readings (defective sensor).
Watchdog or main
controller does not respond
to each other's requests
(device or software
malfunction).
Battery low. | No integrated alarm
functions. | No alarm functions. | Few integrated alarm
functions:
Pressure too high.
Battery low. | Displayed
parameters | Actual ICP value, ICP
waveform, ICP trend.
Display resolution of 1 mmHg. | No display. | No display. | Actual ICP value, ICP
waveform, ICP trend,
intracranial temperature,
Cerebral Perfusion,
Pressure.
Display resolution of 1 mmHg. |
| Height alignment
of patient and | | Device can be positioned
arbitrarily, only the pressure | Alignment is critical
because it controls the | Device can be positioned
arbitrarily; the pressure
sensors need to be | Sensor type | Dual transducer. | Single transducer. | No sensor. | Fiber-optic single pressure
transducer. | | | | | |
| Scheduled
preventive
maintenance | Every 12 months | No | No | Every 18 months | | | | | | | | | | |
| Battery | Rechargeable sealed lead
acid.
Charge time: 8h.
Operation time: 3h. | No battery. | No battery. | Rechargeable sealed lead
acid.
Charge time: 8-10h.
Operation time: 1-2h. | | | | | | | | | | |

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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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Image /page/7/Picture/0 description: The image shows the logo for MöllerMedical. The logo consists of the text "MöllerMedical" with a stylized graphic to the left. The graphic appears to be a cluster of oval shapes, possibly representing cells or other biological elements.

. '

. .

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 flow
measurement	✓ Precision of total volume and flow (pump rate) measurement
Alarm functions related to
patient 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 to
device 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 and
operation	✓ 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

8

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.

9

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.

10

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

11

Indications for Use

510(k) Number: K121248

Device Name: LiquoGuard CSF System

Indications for 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 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.

Prescription Use A (Part 21 CFR 801 Subpart D)

AND/OR

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

Page 1 of 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)