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.

AI/ML Overview

The CereLink ICP Monitor is an intracranial pressure monitoring system. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance benchmarks the CereLink ICP Monitor was tested against. The "Reported device performance" uniformly indicates that all tests passed, demonstrating "substantial equivalence of the proposed device" or that the results were "All results passed."

Category	Acceptance Criteria (Test Method Summary)	Reported Device Performance
Mechanical Performance	Verify mechanical specifications, including inspection, measurement, and demonstration analysis.	All results passed, demonstrating substantial equivalence.
Ingress Protection	Subject the monitor to ingress of liquid and solid materials as per IEC60529:2004 to an IP22 rating.	All results passed, demonstrating substantial equivalence.
Drop Testing	Verify that the monitor meets requirements for drop testing specified within IEC 60601-1 section: 15.3.4.2.	All results passed, demonstrating substantial equivalence.
Audible and Visual Indicators	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.
Extension Cable Testing	Verify that the ICP Extension Cable can transfer ICP signals from the sensor to the monitor as required.	All results passed, demonstrating substantial equivalence.
Electrical Performance	Verify electrical specifications for power adaptor output, battery operational time, automatic diagnostic tests, datasheet parameters, and SD storage card specifications.	All results passed, demonstrating substantial equivalence.
Patient Sensor Testing	Verify the functionality of the interface of the system with the ICP pressure sensor.	All results passed, demonstrating substantial equivalence.
Patient Monitor Related Tests	Verify the functionality of the interface of the system with external patient monitors.	All results passed, demonstrating substantial equivalence.
Device Reliability (MTBF)	Verify the device's expected service life.	No samples required; analysis of materials and components deemed to meet use and service life claim, demonstrating substantial equivalence.
Environmental Testing	Verify that specified temperature, humidity, and pressure do not impact the performance and physical state of the monitor.	All results passed, demonstrating substantial equivalence.
Summative Usability Testing	Verify that the monitor meets clinician requirements and expectations to operate the system as intended, safely, and effectively.	All results passed, demonstrating substantial equivalence.
System Validation Testing	Verify that the monitor can be used with ICP Microsensor probe, pressure simulator, and patient bedside monitor, including calibration and consistent ICP readings across different monitors and interface cables.	All results passed, demonstrating substantial equivalence.
Transit Testing	Test final finished devices (including accessories) showing that shipping did not impact package integrity and that packaging is capable of maintaining device integrity.	All results passed, demonstrating substantial equivalence.
Software Testing	Unit Testing, Code Review, Functional Testing, Graphical User Interface Review, Failsafe Testing, in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).	All software tests (Unit Testing, Code Review, Functional Testing, GUI Review, Failsafe Testing) passed, demonstrating the device performed as designed, suitable for intended use, and substantially equivalent.
Electrical Safety and EMC Testing	Compliance with IEC 60601-1 3rd, IEC 60601-1-2 4th edition, IEC 60601-1-8 2nd, IEC 60601-1-6, IEC 62366, IEC 62304.	All electrical safety and EMC tests passed.
Sterilization/Cleaning (Cleaning Validation)	Validation to support cleaning instructions (Instructions for Use) in accordance with FDA's Guidance Reprocessing Medical Devices in Health Care Settings (March 2015). Wipe-down reliability test with 70% isopropyl alcohol or Quaternary Ammonium + Isopropyl Alcohol combination wipe.	Wipe-down reliability test demonstrated passing results.
Sterilization (Extension Cable)	Sterilization in an autoclave steam sterilizer (if required by hospital, parameters provided in IFU).	Not explicitly stated as "passed" for a test, but provided as a capability. The cable can be sterilized.

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

The document does not explicitly state the specific sample sizes for each test set in the bench testing section beyond noting that for "Device Reliability and Mean Time Between Failure Calculation," no samples were required for execution of this test (analysis was based on materials and components).

For other bench tests, phrases like "All results passed" or "Testing was performed on final finished devices" imply that a sufficient number of devices were tested to validate the claims, but the exact count is not specified. The studies were likely internal verification and validation tests performed by the manufacturer on production-equivalent devices.

The provenance of this data is internal to Integra LifeSciences Corp. and is presented as part of their 510(k) submission. Therefore, it is retrospective in the sense that it was conducted prior to submission for regulatory clearance. There is no information regarding the country of origin of the data provided beyond the manufacturer's location (Mansfield, MA, USA).

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

N/A. This information is typically relevant for studies involving subjective interpretation (e.g., medical imaging diagnostics). For the CereLink ICP Monitor, the performance criteria are objective (e.g., electrical specifications, mechanical integrity, software functionality, physical measurements). The "Summative Usability Testing" involved clinicians, implying professional users, but it does not specify their number or qualifications, nor was their input used to establish "ground truth" in the diagnostic sense, but rather to assess usability and effectiveness of operation.

4. Adjudication Method for the Test Set

N/A. As the testing primarily involved objective performance metrics (electrical, mechanical, software functionality), an adjudication method (like 2+1 or 3+1 often used in clinical trials for diagnostic agreement) was not applicable. Test results were likely pass/fail based on predetermined quantitative criteria.

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

No MRMC comparative effectiveness study was mentioned or conducted. The device is an objective monitoring device, not a diagnostic tool requiring human interpretation with or without AI assistance. The submission focuses on demonstrating substantial equivalence to a predicate device through objective performance testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The device's core function is to monitor and display ICP. Its performance is inherently standalone in the sense that its measurements are objective and do not require human interpretation to generate the primary output (ICP values, waveforms, trends). The "algorithm" here refers to the internal processing of the sensor's voltage signal to display pressure measurements. The various "Bench Testing" and "Software Testing" categories evaluate this standalone performance. For example, "Electrical Performance Testing" and "System Validation Testing" directly assess how accurately the device measures and displays pressure from a sensor or simulator without human intervention affecting the measurement generation itself.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on known physical or electrical standards and predefined functional requirements. For example:

Pressure Accuracy: Likely tested against calibrated pressure simulators or reference devices with known pressure outputs. The acceptance criteria for input pressure accuracy are given as "+/- 0.5 mmHg over the range -50 to 50 mmHg and +/- 1% over the range 50 to 150 mmHg."
Electrical Specifications: Tested against known voltage and current standards, expected battery life, and data storage capacity.
Mechanical Integrity: Tested against engineering specifications for durability, drop resistance, and ingress protection.
Software Functionality: Tested against software requirements specifications to ensure features operate as intended.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The CereLink ICP Monitor is an objective measurement device, not an AI/ML-driven diagnostic or predictive algorithm that typically requires large training datasets. Its functionality is based on established engineering principles and signal processing.

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

N/A. As there is no "training set" in the machine learning sense, the method for establishing its ground truth is not applicable. The device's operation is deterministic based on its hardware and firmware design.

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 CFR882.1620)
Regulatory Classification	II
Product Code	GWM
Rx or OTC Designation	Rx Only

The predicate and reference devices for this submission are:

III. Predicate &ReferenceDevices		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 Cableand Patient Monitor InterfaceCables

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

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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.

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CereLink ICP Monitor and Extension Cable Indications for Use
DeviceDescription	ProposedProductCode	Proposed Indications for Use
CereLinkICP Monitor	82-6820	The ICP Monitor is intended for use as an interface between compatible strain gaugetype pressure transducers and standard physiological pressure monitoring systems. TheICP Monitor is also intended for use as an independent pressure monitor for displayingthe mean, systolic and diastolic values of a physiologic pressure waveform in theabsence of an external patient monitor.
CereLinkICPExtensionCable	82-6845	The CereLink ICP Extension Cable is intended for use as a connecting cable betweenthe 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.

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

Manufacturer	Codman & Shurtleff, Inc.	Same as predicate	n/a
FDA ProductCode	GWM	Same as predicate	n/a
Classification	21 CFR 882.1620	Same as predicate	n/a
ClassificationNameIndications	Device, Monitoring,Intracranial Pressure	Same as predicate	n/a
Indications forUse	The ICP Express isintended for use as aninterface betweencompatible strain gaugetype pressure transducersand standard physiologicalpressure monitoringsystems.The ICP Express is alsointended for use as anindependent pressuremonitor for displaying themean, systolic anddiastolic numeric valuesof a physiologic pressurewaveform in the absenceof an external patientmonitor.	Same as predicate*	*The word “numeric” was removed from theIndications from Use statement. The systolicand diastolic numeric values on the ICPExpress were necessary to show waveformpulsatility (i.e., waveform presence). TheCereLink ICP Monitor provides the user witha modernized graphical user interface, wherethe ICP waveform is displayed and pulsatilitycan be easily assessed, rather than using adigital number reading. This minor change tothe Indications for Use statement does notchange the overall Indications for Usestatement or intent.
Intended Use	Monitor: Intended to serveas an interface between theimplanted ICP pressuresensor and compatiblepatient monitoringsystems.Extension Cable: Intendedfor use as a connectingcable between the ICPinput channel of the ICPmonitor and an implantedICP pressure sensor.	Same as predicate	n/a
Basic Device Design
Reusable	Yes	Same as predicate	n/a
OperatingRange	-50 to 250 mmHg	-50 to 150 mmHg	Pressure values above 150mmHg are notphysiological. Reducing the overall pressurerange allows for accuracy improvements.
Input PressureChannel/ OutputPressureAccuracy	+/- 1% of reading or 1mmHg, whichever is larger(exclusive of sensor)	+/- 0.5 mmHg over therange -50 to 50mmHgand +/- 1% over therange 50 to 150 mmHg(exclusive of sensor)	Better accuracy from -50 to 50 mmHg andthe same accuracy from 50 to 150 mmHg.
Method ofOperation	Strain gauge technology toread the pressure sensor	Same as predicate	n/a
MonitorFeatures	LCD DisplayContinuous numericdisplay of the mean,systolic and diastolic ICPMust connect to patientmonitor for detailedwaveform analysisHigh and Low AlarmsRechargeable Battery touse during transport	LCD Display withtouch screenOn-screen ICPwaveform (systolic anddiastolic), Mean ICPnumeric display, meanICP trend and trendstatistics (AUC, timeabove threshold,histogram, boxplot)Can connect to patientmonitor to display theICP Waveform(optional)High and Low AlarmsRechargeable Batteryto use during transportStores 14-days' worthof patient dataCan capture and storescreen-shotsCan download variousdata to a USB devicefor analysis andprinting	Graphical user interface modifications arebeing made to modernize the device andprovide greater flexibility to the users
Materials	Non-patient contacting	Same as predicate	n/a
External PatientMonitorInterface	Excitation Voltage Range:0.5 to 10VDC or VACSensitivity:5 or 40uV/Vex/mmHg	Excitation VoltageRange:0 to 6.5VDCSensitivity:5uV/Vex/mmHg	Most patient monitors in the market have anexcitation voltage range of 5VDC andsensitivity of 5uV/Vex/mmHg. Limiting thespecifications has no impact on the use of thedevice.
Supply Voltage	120 VAC	85-240 VAC	The wider ranging supply voltage allowsusers world-wide to use the same CereLinkMonitor
SupplyFrequency	50/60 Hz	Same as predicate	n/a
AC Powered	Yes	Same as predicate	n/a
RechargeableBattery Powered	Yes	Same as predicate	n/a
Electrical SafetyTesting	IEC 60601-1IEC 60601-1-2	Same as predicate	n/a
Sterility	Non-Sterile	Same as predicate	n/a
Cleaning	Wipe external surface with70% isopropyl alcohol ormild hospital cleaningdetergent/bactericide	Wipe external surfacewith 70% isopropylalcohol or acombination wipeconsisting ofquaternary ammoniumand isopropyl alcohol	The combination wipes used for cleaning theproposed device are consistent with the mildhospital cleaning detergent/bactericidecommonly found in the hospital setting.
Reprocessing	The ICP ExpressExtension Cable cannot besterilized	The CereLink ICPExtension Cable can besterilized in anautoclave steamsterilizer if required bythe hospital	The CereLink ICP Extension Cable is almostidentical to the reference device, theDirectLink Monitor Extension cable(K152670). The CereLink ICP Extensioncable and the DirectLink Monitor ExtensionCable can be sterilized in an autoclave steamsterilizer if required by the hospital.
ICP Monitor Accessories and For-Use-With Devices
Compatible ICPSensors	Microsensors:626631US626632US626638US626633US626653USCereLink Semsors:826850826851826852826854	CereLink Sensors826850826851826852826854	The CereLink ICP Sensors, 82 series family,has been cleared by the FDA via K173192.The CereLink sensors contain a memory PCBthat stores the sensor's zero value when usedwith the proposed CereLink ICP Monitor.With this function, sensors can now bedisconnected and reconnected from the ICPmonitor without having to re-enter the zerovalue.The Microsensor, 62 series family is notcompatible with the CereLink ICP Monitorbecause it does not include the memory PCB.
CompatiblePatient MonitorInterface Cables	ICP Express PatientMonitor Interface Cables:826645826646826647	CereLink PatientMonitor InterfaceCables:826880826881826882	The CereLink Patient Monitor InterfaceCables are identical to the reference device,the Direct Link Monitor Interface cables(K152670). The CereLink ICP Monitor cableoutput was designed specifically to beidentical to the cable output on the DirectLinkdevice. No modifications to the cable wererequired.
IncludedAccessories	ICP Extension Cable,& Power Supply	Similar to predicate	Similar in design and serve the same purposeas those packaged with the predicate ICPExpress accessories.CereLink power supply uses an external ACto DC converter, while the power supply forICP Express is internal to the device.
ReplacementAccessories forPurchase	ICP Extension Cable,Replacement Battery,Replacement PowerSupply	Similar to predicate	Similar in design and serve the same purposeas predicate ICP Express accessories.CereLink power supply uses an external ACto DC converter, while the power supply forICP Express is internal to the device.Both devices use Li-Ion rechargeablebatteries.

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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.

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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
MechanicalPerformanceTesting	The purpose of this test is to verify themechanical specifications defined in theCodman CereLink ICP Monitor SystemRequirements Specification. There are threetest elements included: MechanicalInspection, Mechanical Measurement, andMechanical Demonstration Test Analysis.	All results passed,demonstratingsubstantialequivalence of theproposed device.
Ingress ProtectionTest	This test serves to subject the CereLink ICPMonitor against ingress of liquid and solidmaterials as per IEC60529:2004 to an IP22rating.	All results passed,demonstratingsubstantialequivalence of theproposed device.
Drop Testing	This test serves to verify that the CodmanCereLink ICP Monitor meets therequirements for drop testing specified withinIEC 60601-1 section: 15.3.4.2.	All results passed,demonstratingsubstantialequivalence of theproposed device.
Audible and VisualIndicators	This test is to verify that all alerts and alarmindicators volume and frequency, as well asvisual indicators, exist and function asrequired.	All results passed,demonstratingsubstantialequivalence of theproposed device.
Extension CableTesting	This test is to verify that the ICP ExtensionCable can transfer ICP signals from thesensor to the monitor as required.	All results passed,demonstratingsubstantialequivalence of theproposed device.
ElectricalPerformanceTesting	This test is to verify the electricalspecifications are as specified by design ofthe CereLink ICP Monitor:● Power adaptor output voltage and current● Battery operational time● Automatic diagnostic tests● Datasheet parameters related to electricalspecifications● SD storage card specifications	All results passed,demonstratingsubstantialequivalence of theproposed device.
Patient SensorTesting	This test is to verify the functionality of theinterface of the system with the ICP pressuresensor.	All results passed,demonstratingsubstantialequivalence of theproposed device.
Patient MonitorRelated Tests	This test is to verify the functionality of theinterface of the system with external patientmonitors.	All results passed,demonstratingsubstantialequivalence of theproposed device.
Device Reliabilityand Mean TimeBetween FailureCalculation	This test serves to verify the devices expectedservice life for the CereLink ICP Monitordevice.	No samples wererequired forexecution of thistest. Analysis onmaterials andcomponents havebeen deemed tomeet the use andservice life claim.This demonstratessubstantialequivalence of theproposed device.
EnvironmentalTesting	This test is to verify that specifiedtemperature, humidity and pressure do notimpact the performance and physical state ofthe CereLink ICP Monitor.	All results passed.demonstratingsubstantialequivalence of theproposed device.
SummativeUsability Testing	This test provides documentation that theCereLink ICP Monitor meets clinicianrequirements and expectations to operate thesystem as intended, safely and effectively.	All results passed,demonstratingsubstantialequivalence of theproposed device.
System ValidationTesting	This test is to verify that the CereLink ICPMonitor can be used in conjunction with theICP Microsensor probe, pressure simulatorand patient bedside monitor. The CereLinkmonitor can calibrate the pressure simulatoror the ICP Microsensor Probe which willthen be used to generate signals thatcorrespond to intracranial pressure. Pressurereadings will be displayed on a patientbedside monitor and on the CereLinkMonitor. Intracranial Pressure (ICP) readingshall be consistent among different CereLinkMonitors and common Patient BedsideMonitors when using different interfacecables.	All results passed,demonstratingsubstantialequivalence of theproposed device.
Transit Testing	Testing was performed on final finisheddevices, including accessories soldseparately, showing that shipping did notimpact package integrity and therefore thepackaging of the devices are capable ofmaintaining device integrity.	All results passed,demonstratingsubstantialequivalence of theproposed device.

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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.

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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.

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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.

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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

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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

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).