K Number

Device Name

CereLink ICP Monitor, CereLink ICP Extension Cable

Manufacturer

Integra LifeSciences Corp.

Date Cleared

2019-01-11

(32 days)

Product Code

GWM

Regulation Number

882.1620

Intended Use

The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension Cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

Device Description

The CereLink ICP Monitor is intended for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions: - Displays mean pressure values - Displays the pressure waveform - Displays the historic mean pressure as a trend - Displays trend statistics (Area Under the Curve (AUC), time above threshold, boxplot, histogram) - Stores 14-days' worth of mean ICP values - Stores 24 hours of pressure waveform - Can capture and store screen-shots - Can download various data to a USB device for printing or analysis The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is sold with an external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (code 82-6845). The CereLink ICP Monitor and CereLink ICP Extension Cable are intended to be used in conjunction with Codman's other neuromonitoring devices: the CereLink ICP Sensor Kits (codes 82-6850, 82-6851, 82-6852, and 82-6854 cleared via K173192) and the patient monitor interface cables (codes 82-6880, 82-6881, and 82-6882 cleared via K152670). The CereLink ICP Sensor converts the patients intracranial pressure to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed CereLink ICP Sensor Kits or the patient monitor interface cables as a result of the monitor modifications described in this submission.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K945585

Reference Devices

K173192, K152670

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on basic signal processing, display, storage, and data transfer functions, with no mention of AI/ML algorithms for analysis or interpretation. The performance studies also do not indicate any AI/ML components.

Therapeutic

No
The device is described as a monitor that displays, stores, and transfers intracranial pressure (ICP) data and activates alarms when ICP is outside user-set limits. It does not actively treat or modify the patient's condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the device is for "displaying the mean, systolic and diastolic values of a physiologic pressure waveform". The "Device Description" further clarifies that it monitors "intracranial pressure (ICP) via a solid state sensor" and "displays the corresponding pressure measurements". This process of monitoring and displaying physiological parameters to aid in medical assessment falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it includes hardware components such as a 7" color touch screen, external power supply, internal rechargeable battery, input/output channels, and is sold with an extension cable. It also mentions bench testing and electrical safety testing, which are typically associated with hardware devices.

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 clearly states that the device is for monitoring intracranial pressure (ICP) via a sensor placed directly in tissue or a catheter. It acts as an interface and display for physiological pressure data.
Device Description: The description reinforces that the device monitors ICP, displays pressure values and waveforms, and stores historical data. It interacts with an implanted sensor that converts pressure to a voltage signal.
Lack of In Vitro Activity: An IVD is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro). This device does not perform any tests on such samples. It directly measures a physiological parameter within the body.

The device is a physiological monitoring device, specifically for intracranial pressure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CereLink ICP Extension Cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

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

GWM

Device Description

Displays mean pressure values
Displays the pressure waveform
Displays the historic mean pressure as a trend
Displays trend statistics (Area Under the Curve (AUC), time above. threshold, boxplot, histogram)
Stores 14-days' worth of mean ICP values ●
Stores 24 hours of pressure waveform
Can capture and store screen-shots
Can download various data to a USB device for printing or analysis

The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is sold with an external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (code 82-6845).

The CereLink ICP Monitor and CereLink ICP Extension Cable are intended to be used in conjunction with Codman's other neuromonitoring devices: the CereLink ICP Sensor Kits (codes 82-6850, 82-6851, 82-6852, and 82-6854 cleared via K173192) and the patient monitor interface cables (codes 82-6880, 82-6881, and 82-6882 cleared via K152670). The CereLink ICP Sensor converts the patients intracranial pressure to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed CereLink ICP Sensor Kits or the patient monitor interface cables as a result of the monitor modifications described in this submission.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial (via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended user: clinician
Care setting: ICU or OR environment

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)

Bench Testing:

Mechanical Performance Testing: All results passed, demonstrating substantial equivalence of the proposed device.
Ingress Protection Test: All results passed, demonstrating substantial equivalence of the proposed device.
Drop Testing: All results passed, demonstrating substantial equivalence of the proposed device.
Audible and Visual Indicators: All results passed, demonstrating substantial equivalence of the proposed device.
Extension Cable Testing: All results passed, demonstrating substantial equivalence of the proposed device.
Electrical Performance Testing: All results passed, demonstrating substantial equivalence of the proposed device.
Patient Sensor Testing: All results passed, demonstrating substantial equivalence of the proposed device.
Patient Monitor Related Tests: All results passed, demonstrating substantial equivalence of the proposed device.
Device Reliability and Mean Time Between Failure Calculation: No samples were required for execution of this test. Analysis on materials and components have been deemed to meet the use and service life claim. This demonstrates substantial equivalence of the proposed device.
Environmental Testing: All results passed, demonstrating substantial equivalence of the proposed device.
Summative Usability Testing: All results passed, demonstrating substantial equivalence of the proposed device.
System Validation Testing: All results passed, demonstrating substantial equivalence of the proposed device.
Transit Testing: All results passed, demonstrating substantial equivalence of the proposed device.

Software Testing:

Software Unit Testing: Pass
Software Code Review: Pass
Software Functional Testing: Pass
Graphical User Interface Review: Pass
Failsafe Testing: Pass

Electrical Safety and Electromagnetic Compatibility Testing:

IEC 60601-1:2005/A1:2012, Edition 3: Pass
IEC 60601-1-2:2014, Edition 4: Pass
IEC 60601-1-8:2006, Edition 2: Pass
IEC 60601-1-6:2010: Pass
IEC 62366:2007: Pass
IEC 62304:2006/AMD1:2015: Pass

Sterilization/Cleaning: A validation was performed to support cleaning instructions in the device labeling (Instructions for Use). The CereLink ICP Monitor and accessories can be cleaned using 70% isopropyl alcohol or using a combination wipe consisting of Quaternary Ammonium and Isopropyl Alcohol. A wipe-down reliability test was conducted and demonstrated passing results. If required by the hospital, the CereLink ICP Extension Cable can be sterilized in an autoclave steam sterilizer.

Shelf-Life Testing: Not applicable.
Biocompatibility Testing: Not applicable (non-patient contacting).
Animal Studies: Not required.
Clinical Studies: Not required.

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.

K945585

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.

K152670

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

§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).

Summary

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K183406 - 510(k) Summary

I. Submitter Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048

Primary Contact: Megan Palumbo Phone: (781) 971-5679

Secondary Contact: Jocelyn Raposo Phone: (781) 971-5688

Date of Submission: December 7, 2018

II. Device

Device Proprietary Name	CereLink ICP Monitor
Common Name	Intracranial Pressure Monitoring System
Classification Name	Intracranial Pressure Monitoring Devices (21 CFR
882.1620)
Regulatory Classification	II
Product Code	GWM
Rx or OTC Designation	Rx Only

The predicate and reference devices for this submission are:

| III. Predicate &
Reference

Devices		510(k) Number	Date Cleared	Title
	Predicate Device	K945585	October 26, 1995	CU-II (Codman ICP Express)
	Reference Device	K152670	January 22, 2016	DirectLink Extension Cable
and Patient Monitor Interface
Cables

IV. Device The CereLink ICP Monitor is intended for use in the ICU or OR environment Description for monitoring intracranial pressure (ICP) via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

. Displays mean pressure values
Displays the pressure waveform
Displays the historic mean pressure as a trend

Displays trend statistics (Area Under the Curve (AUC), time above . threshold, boxplot, histogram)

Stores 14-days' worth of mean ICP values ●
Stores 24 hours of pressure waveform
Can capture and store screen-shots
Can download various data to a USB device for printing or analysis

V. Indications The table below describes the Indications for Use statements for the proposed for Use CereLink ICP Monitor product codes.

CereLink ICP Monitor and Extension Cable Indications for Use
Device
Description	Proposed
Product
Code	Proposed Indications for Use
CereLink
ICP Monitor	82-6820	The ICP Monitor is intended for use as an interface between compatible strain gauge
type pressure transducers and standard physiological pressure monitoring systems. The
ICP Monitor is also intended for use as an independent pressure monitor for displaying
the mean, systolic and diastolic values of a physiologic pressure waveform in the
absence of an external patient monitor.
CereLink
ICP
Extension
Cable	82-6845	The CereLink ICP Extension Cable is intended for use as a connecting cable between
the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is substantially equivalent to the predicate device, Comparison to the Codman ICP Express, and is eligible for the Special 510(k) process, as the Predicate proposed device has the following similarities to the predicate device:

the same intended use, ●
VI.

Device

the same indications for use, ●
the same clinical utility,
the same patient population, ●
the same fundamental scientific technology (analog front end input compatible with the same ICP Sensors, analog back end output compatible with external patient monitors, pressure signal digitalization for mean ICP calculation and an algorithm to detect an implanted sensor to avoid re-zeroing), and
incorporates the same basic design (small profile, light weight, ideal for monitoring patients during transport)

The differences between the predicate and subject device are intended to enhance the user interface of the device, and to improve ease of use and accuracy. With the addition of the color touch-screen, users are able to review additional data directly on the CereLink ICP Monitor without the need to connect to an additional patient monitoring system.

The table below provides a comparison between the subject device and the predicate device.

To Table Comparison of the Predicate and Subject Device
	Predicate Device:
Codman ICP Express
(K945585)	Subject Device:
CereLink ICP
Monitor
(This Submission)	Discussion
FDA Regulatory Information

Manufacturer	Codman & Shurtleff, Inc.	Same as predicate	n/a
FDA Product
Code	GWM	Same as predicate	n/a
Classification	21 CFR 882.1620	Same as predicate	n/a
Classification
Name
Indications	Device, Monitoring,
Intracranial Pressure	Same as predicate	n/a
Indications for
Use	The ICP Express is
intended for use as an
interface between
compatible strain gauge
type pressure transducers
and standard physiological
pressure monitoring
systems.
The ICP Express is also
intended for use as an
independent pressure
monitor for displaying the
mean, systolic and
diastolic numeric values
of a physiologic pressure
waveform in the absence
of an external patient
monitor.	Same as predicate*	*The word “numeric” was removed from the
Indications from Use statement. The systolic
and diastolic numeric values on the ICP
Express were necessary to show waveform
pulsatility (i.e., waveform presence). The
CereLink ICP Monitor provides the user with
a modernized graphical user interface, where
the ICP waveform is displayed and pulsatility
can be easily assessed, rather than using a
digital number reading. This minor change to
the Indications for Use statement does not
change the overall Indications for Use
statement or intent.
Intended Use	Monitor: Intended to serve
as an interface between the
implanted ICP pressure
sensor and compatible
patient monitoring
systems.
Extension Cable: Intended
for use as a connecting
cable between the ICP
input channel of the ICP
monitor and an implanted
ICP pressure sensor.	Same as predicate	n/a
Basic Device Design
Reusable	Yes	Same as predicate	n/a
Operating
Range	-50 to 250 mmHg	-50 to 150 mmHg	Pressure values above 150mmHg are not
physiological. Reducing the overall pressure
range allows for accuracy improvements.
Input Pressure
Channel/ Output
Pressure
Accuracy	+/- 1% of reading or 1
mmHg, whichever is larger
(exclusive of sensor)	+/- 0.5 mmHg over the
range -50 to 50
mmHg
and +/- 1% over the
range 50 to 150 mmHg
(exclusive of sensor)	Better accuracy from -50 to 50 mmHg and
the same accuracy from 50 to 150 mmHg.
Method of
Operation	Strain gauge technology to
read the pressure sensor	Same as predicate	n/a
Monitor
Features	LCD Display
Continuous numeric
display of the mean,
systolic and diastolic ICP
Must connect to patient
monitor for detailed
waveform analysis
High and Low Alarms
Rechargeable Battery to
use during transport	LCD Display with
touch screen
On-screen ICP
waveform (systolic and
diastolic), Mean ICP
numeric display, mean
ICP trend and trend
statistics (AUC, time
above threshold,
histogram, boxplot)
Can connect to patient
monitor to display the
ICP Waveform
(optional)
High and Low Alarms
Rechargeable Battery
to use during transport
Stores 14-days' worth
of patient data
Can capture and store
screen-shots
Can download various
data to a USB device
for analysis and
printing	Graphical user interface modifications are
being made to modernize the device and
provide greater flexibility to the users
Materials	Non-patient contacting	Same as predicate	n/a
External Patient
Monitor
Interface	Excitation Voltage Range:
0.5 to 10VDC or VAC
Sensitivity:
5 or 40uV/Vex/mmHg	Excitation Voltage
Range:
0 to 6.5VDC
Sensitivity:
5uV/Vex/mmHg	Most patient monitors in the market have an
excitation voltage range of 5VDC and
sensitivity of 5uV/Vex/mmHg. Limiting the
specifications has no impact on the use of the
device.
Supply Voltage	120 VAC	85-240 VAC	The wider ranging supply voltage allows
users world-wide to use the same CereLink
Monitor
Supply
Frequency	50/60 Hz	Same as predicate	n/a
AC Powered	Yes	Same as predicate	n/a
Rechargeable
Battery Powered	Yes	Same as predicate	n/a
Electrical Safety
Testing	IEC 60601-1
IEC 60601-1-2	Same as predicate	n/a
Sterility	Non-Sterile	Same as predicate	n/a
Cleaning	Wipe external surface with
70% isopropyl alcohol or
mild hospital cleaning
detergent/bactericide	Wipe external surface
with 70% isopropyl
alcohol or a
combination wipe
consisting of
quaternary ammonium
and isopropyl alcohol	The combination wipes used for cleaning the
proposed device are consistent with the mild
hospital cleaning detergent/bactericide
commonly found in the hospital setting.
Reprocessing	The ICP Express
Extension Cable cannot be
sterilized	The CereLink ICP
Extension Cable can be
sterilized in an
autoclave steam
sterilizer if required by
the hospital	The CereLink ICP Extension Cable is almost
identical to the reference device, the
DirectLink Monitor Extension cable
(K152670). The CereLink ICP Extension
cable and the DirectLink Monitor Extension
Cable can be sterilized in an autoclave steam
sterilizer if required by the hospital.
ICP Monitor Accessories and For-Use-With Devices
Compatible ICP
Sensors	Microsensors:
626631US
626632US
626638US
626633US
626653US
CereLink Semsors:
826850
826851
826852
826854	CereLink Sensors
826850
826851
826852
826854	The CereLink ICP Sensors, 82 series family,
has been cleared by the FDA via K173192.
The CereLink sensors contain a memory PCB
that stores the sensor's zero value when used
with the proposed CereLink ICP Monitor.
With this function, sensors can now be
disconnected and reconnected from the ICP
monitor without having to re-enter the zero
value.
The Microsensor, 62 series family is not
compatible with the CereLink ICP Monitor
because it does not include the memory PCB.
Compatible
Patient Monitor
Interface Cables	ICP Express Patient
Monitor Interface Cables:
826645
826646
826647	CereLink Patient
Monitor Interface
Cables:
826880
826881
826882	The CereLink Patient Monitor Interface
Cables are identical to the reference device,
the Direct Link Monitor Interface cables
(K152670). The CereLink ICP Monitor cable
output was designed specifically to be
identical to the cable output on the DirectLink
device. No modifications to the cable were
required.
Included
Accessories	ICP Extension Cable,
& Power Supply	Similar to predicate	Similar in design and serve the same purpose
as those packaged with the predicate ICP
Express accessories.
CereLink power supply uses an external AC
to DC converter, while the power supply for
ICP Express is internal to the device.
Replacement
Accessories for
Purchase	ICP Extension Cable,
Replacement Battery,
Replacement Power
Supply	Similar to predicate	Similar in design and serve the same purpose
as predicate ICP Express accessories.
CereLink power supply uses an external AC
to DC converter, while the power supply for
ICP Express is internal to the device.
Both devices use Li-Ion rechargeable
batteries.

VII. The following performance testing has been conducted in support of the Performance substantial equivalence determination. All testing was performed on Data production equivalent devices unless otherwise specified.

Bench Testing

Results of verification and validation testing conducted on the proposed CereLink ICP Monitor demonstrated that the proposed device performed as designed, is suitable for the intended use, and is substantially equivalent to the predicate device.

Performance Bench Test Results
Test	Test Method Summary	Results
Mechanical
Performance
Testing	The purpose of this test is to verify the
mechanical specifications defined in the
Codman CereLink ICP Monitor System
Requirements Specification. There are three
test elements included: Mechanical
Inspection, Mechanical Measurement, and
Mechanical Demonstration Test Analysis.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Ingress Protection
Test	This test serves to subject the CereLink ICP
Monitor against ingress of liquid and solid
materials as per IEC60529:2004 to an IP22
rating.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Drop Testing	This test serves to verify that the Codman
CereLink ICP Monitor meets the
requirements for drop testing specified within
IEC 60601-1 section: 15.3.4.2.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Audible and Visual
Indicators	This test is to verify that all alerts and alarm
indicators volume and frequency, as well as
visual indicators, exist and function as
required.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Extension Cable
Testing	This test is to verify that the ICP Extension
Cable can transfer ICP signals from the
sensor to the monitor as required.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Electrical
Performance
Testing	This test is to verify the electrical
specifications are as specified by design of
the CereLink ICP Monitor:
● Power adaptor output voltage and current
● Battery operational time
● Automatic diagnostic tests
● Datasheet parameters related to electrical
specifications
● SD storage card specifications	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Patient Sensor
Testing	This test is to verify the functionality of the
interface of the system with the ICP pressure
sensor.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Patient Monitor
Related Tests	This test is to verify the functionality of the
interface of the system with external patient
monitors.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Device Reliability
and Mean Time
Between Failure
Calculation	This test serves to verify the devices expected
service life for the CereLink ICP Monitor
device.	No samples were
required for
execution of this
test. Analysis on
materials and
components have
been deemed to
meet the use and
service life claim.
This demonstrates
substantial
equivalence of the
proposed device.
Environmental
Testing	This test is to verify that specified
temperature, humidity and pressure do not
impact the performance and physical state of
the CereLink ICP Monitor.	All results passed.
demonstrating
substantial
equivalence of the
proposed device.
Summative
Usability Testing	This test provides documentation that the
CereLink ICP Monitor meets clinician
requirements and expectations to operate the
system as intended, safely and effectively.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
System Validation
Testing	This test is to verify that the CereLink ICP
Monitor can be used in conjunction with the
ICP Microsensor probe, pressure simulator
and patient bedside monitor. The CereLink
monitor can calibrate the pressure simulator
or the ICP Microsensor Probe which will
then be used to generate signals that
correspond to intracranial pressure. Pressure
readings will be displayed on a patient
bedside monitor and on the CereLink
Monitor. Intracranial Pressure (ICP) reading
shall be consistent among different CereLink
Monitors and common Patient Bedside
Monitors when using different interface
cables.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.
Transit Testing	Testing was performed on final finished
devices, including accessories sold
separately, showing that shipping did not
impact package integrity and therefore the
packaging of the devices are capable of
maintaining device integrity.	All results passed,
demonstrating
substantial
equivalence of the
proposed device.

Software Testing

Software testing was conducted in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005. Results of verification and validation testing conducted on the CereLink ICP Monitor demonstrated that the proposed device performed as designed, is suitable for the intended use, and is substantially equivalent to the predicate device.

Software Test Results
Test	Conclusion
Software Unit Testing	Pass
Software Code Review	Pass
Software Functional Testing	Pass
Graphical User Interface Review	Pass
Failsafe Testing	Pass

Electrical Safety and Electromagnetic Compatibility Testing

The CereLink ICP Monitor design is compliant for Electrical Safety and EMC per IEC 60601-1 3rd and IEC 60601-1-2 4th edition. The CereLink ICP Sensor Kits, ICP Extension Cable, Patient Monitor Interface Cables, Power Supply and Battery are listed as applied parts within the CereLink ICP Monitor safety reports and documentation.

Electrical Test Results
Test	Conclusion
IEC 60601-1:2005/A1:2012, Edition 3	Pass
IEC 60601-1-2:2014, Edition 4	Pass
IEC 60601-1-8:2006, Edition 2	Pass
IEC 60601-1-6:2010	Pass
IEC 62366:2007	Pass
IEC 62304:2006/AMD1:2015	Pass

Sterilization/Cleaning

The CereLink ICP Monitor and accessories are non-sterile capital equipment and not intended to be sterilized. Therefore, sterilization is not applicable for these devices. A validation was performed to support cleaning instructions in the device labeling (Instructions for Use) in accordance with FDA's Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued March 17, 2015.

The CereLink ICP Monitor and accessories can be cleaned using 70% isopropyl alcohol or using a combination wipe consisting of Quaternary Ammonium and Isopropyl Alcohol, which is commonly available in the hospital setting. A wipe-down reliability test was conducted and demonstrated passing results.

If required by the hospital, the CereLink ICP Extension Cable can be sterilized in an autoclave steam sterilizer using the parameters provided in the CereLink ICP Extension Cable Instructions for Use.

Shelf-Life Testing

The CereLink ICP Monitor is a reusable, non-sterile device. Therefore, there is no expiry date and shelf-life is not applicable for this device.

Biocompatibility Testing

The CereLink ICP Monitor is non-patient contacting. Therefore, biocompatibility is not applicable for these devices.

Animal Studies

No animal studies were required as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, and electrical/safety testing.

Clinical Studies

No clinical studies were required as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, and electrical/safety testing.

Based upon the intended use, design, operating principles, fundamental VIII. Conclusion scientific technology, comparison to the predicate device, and testing conducted, it is concluded that the CereLink ICP Monitor is substantially equivalent to the predicate device, the Codman ICP Express, and therefore does not raise any new issues of safety and effectiveness.

January 11, 2019

Image /page/11/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

Integra LifeSciences Corp. Megan Palumbo Regulatory Affairs Project Lead 11 Cabot Blvd Mansfield, Massachusetts 02048

Re: K183406

Trade/Device Name: CereLink ICP Monitor, CereLink ICP Extension Cable Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: December 7, 2018 Received: December 10, 2018

Dear Megan Palumbo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Enclosure