CereLink ICP Monitor, CereLink ICP Extension Cable

K183406 · Integra Lifesciences Corp. · GWM · Jan 11, 2019 · Neurology

Device Facts

• Record ID: K183406
• Device Name: CereLink ICP Monitor, CereLink ICP Extension Cable
• Applicant: Integra Lifesciences Corp.
• Product Code: GWM · Neurology
• Decision Date: Jan 11, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

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 Story

CereLink ICP Monitor is a bedside device for ICU/OR use; monitors intracranial pressure (ICP) via parenchymal sensors or external ventricular drainage catheters. Input: voltage signals from implanted ICP sensors via extension cable. Processing: monitor provides sensor power, interprets voltage, calculates mean ICP, and generates trend statistics (AUC, time above threshold, boxplot, histogram). Output: 7" color touch screen displays real-time waveforms, mean pressure, and trends; stores 14 days of mean data and 24 hours of waveforms; supports USB data export. Clinicians use output to assess patient neurological status and adjust treatment. Benefits: continuous monitoring during transport, improved user interface, and data visualization compared to legacy systems.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical performance, ingress protection, drop testing, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation, and summative usability testing.

Technological Characteristics

Reusable, non-sterile monitor with 7" color touch screen. Uses strain gauge technology for pressure sensing. Connectivity: USB for data export, output channel for external patient monitors. Power: 85-240 VAC or internal rechargeable Li-Ion battery. Software: embedded firmware for signal processing and GUI. Compliant with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring intracranial pressure (ICP) monitoring in ICU or OR settings. Used with compatible strain gauge pressure transducers or integrated into external ventricular drainage catheters. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• CU-II (Codman ICP Express) (K945585)

Reference Devices

• DirectLink Extension Cable and Patient Monitor Interface Cables (K152670)
• CereLink ICP Sensor Kits (K173192)

Submission Summary (Full Text)

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# K183406 - 510(k) Summary

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

Primary Contact: Megan Palumbo Phone: [phone]

Secondary Contact: Jocelyn Raposo Phone: [phone]

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<br>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 &<br>Reference<br>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<br>and Patient Monitor Interface<br>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

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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

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.

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

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| To Table Comparison of the Predicate and Subject Device | | | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device:<br>Codman ICP Express<br>(K945585) | Subject Device:<br>CereLink ICP<br>Monitor<br>(This Submission) | Discussion |
| FDA Regulatory Information | | | |
| | | | |
| Manufacturer | Codman & Shurtleff, Inc. | Same as predicate | n/a |
| FDA Product<br>Code | GWM | Same as predicate | n/a |
| Classification | 21 CFR 882.1620 | Same as predicate | n/a |
| Classification<br>Name<br>Indications | Device, Monitoring,<br>Intracranial Pressure | Same as predicate | n/a |
| Indications for<br>Use | The ICP Express is<br>intended for use as an<br>interface between<br>compatible strain gauge<br>type pressure transducers<br>and standard physiological<br>pressure monitoring<br>systems.<br>The ICP Express is also<br>intended for use as an<br>independent pressure<br>monitor for displaying the<br>mean, systolic and<br>diastolic numeric values<br>of a physiologic pressure<br>waveform in the absence<br>of an external patient<br>monitor. | Same as predicate* | *The word “numeric” was removed from the<br>Indications from Use statement. The systolic<br>and diastolic numeric values on the ICP<br>Express were necessary to show waveform<br>pulsatility (i.e., waveform presence). The<br>CereLink ICP Monitor provides the user with<br>a modernized graphical user interface, where<br>the ICP waveform is displayed and pulsatility<br>can be easily assessed, rather than using a<br>digital number reading. This minor change to<br>the Indications for Use statement does not<br>change the overall Indications for Use<br>statement or intent. |
| Intended Use | Monitor: Intended to serve<br>as an interface between the<br>implanted ICP pressure<br>sensor and compatible<br>patient monitoring<br>systems.<br>Extension Cable: Intended<br>for use as a connecting<br>cable between the ICP<br>input channel of the ICP<br>monitor and an implanted<br>ICP pressure sensor. | Same as predicate | n/a |
| Basic Device Design | | | |
| Reusable | Yes | Same as predicate | n/a |
| Operating<br>Range | -50 to 250 mmHg | -50 to 150 mmHg | Pressure values above 150mmHg are not<br>physiological. Reducing the overall pressure<br>range allows for accuracy improvements. |
| Input Pressure<br>Channel/ Output<br>Pressure<br>Accuracy | +/- 1% of reading or 1<br>mmHg, whichever is larger<br>(exclusive of sensor) | +/- 0.5 mmHg over the<br>range -50 to 50<br>mmHg<br>and +/- 1% over the<br>range 50 to 150 mmHg<br>(exclusive of sensor) | Better accuracy from -50 to 50 mmHg and<br>the same accuracy from 50 to 150 mmHg. |
| Method of<br>Operation | Strain gauge technology to<br>read the pressure sensor | Same as predicate | n/a |
| Monitor<br>Features | LCD Display<br>Continuous numeric<br>display of the mean,<br>systolic and diastolic ICP<br>Must connect to patient<br>monitor for detailed<br>waveform analysis<br>High and Low Alarms<br>Rechargeable Battery to<br>use during transport | LCD Display with<br>touch screen<br>On-screen ICP<br>waveform (systolic and<br>diastolic), Mean ICP<br>numeric display, mean<br>ICP trend and trend<br>statistics (AUC, time<br>above threshold,<br>histogram, boxplot)<br>Can connect to patient<br>monitor to display the<br>ICP Waveform<br>(optional)<br>High and Low Alarms<br>Rechargeable Battery<br>to use during transport<br>Stores 14-days' worth<br>of patient data<br>Can capture and store<br>screen-shots<br>Can download various<br>data to a USB device<br>for analysis and<br>printing | Graphical user interface modifications are<br>being made to modernize the device and<br>provide greater flexibility to the users |
| Materials | Non-patient contacting | Same as predicate | n/a |
| External Patient<br>Monitor<br>Interface | Excitation Voltage Range:<br>0.5 to 10VDC or VAC<br>Sensitivity:<br>5 or 40uV/Vex/mmHg | Excitation Voltage<br>Range:<br>0 to 6.5VDC<br>Sensitivity:<br>5uV/Vex/mmHg | Most patient monitors in the market have an<br>excitation voltage range of 5VDC and<br>sensitivity of 5uV/Vex/mmHg. Limiting the<br>specifications has no impact on the use of the<br>device. |
| Supply Voltage | 120 VAC | 85-240 VAC | The wider ranging supply voltage allows<br>users world-wide to use the same CereLink<br>Monitor |
| Supply<br>Frequency | 50/60 Hz | Same as predicate | n/a |
| AC Powered | Yes | Same as predicate | n/a |
| Rechargeable<br>Battery Powered | Yes | Same as predicate | n/a |
| Electrical Safety<br>Testing | IEC 60601-1<br>IEC 60601-1-2 | Same as predicate | n/a |
| Sterility | Non-Sterile | Same as predicate | n/a |
| Cleaning | Wipe external surface with<br>70% isopropyl alcohol or<br>mild hospital cleaning<br>detergent/bactericide | Wipe external surface<br>with 70% isopropyl<br>alcohol or a<br>combination wipe<br>consisting of<br>quaternary ammonium<br>and isopropyl alcohol | The combination wipes used for cleaning the<br>proposed device are consistent with the mild<br>hospital cleaning detergent/bactericide<br>commonly found in the hospital setting. |
| Reprocessing | The ICP Express<br>Extension Cable cannot be<br>sterilized | The CereLink ICP<br>Extension Cable can be<br>sterilized in an<br>autoclave steam<br>sterilizer if required by<br>the hospital | The CereLink ICP Extension Cable is almost<br>identical to the reference device, the<br>DirectLink Monitor Extension cable<br>(K152670). The CereLink ICP Extension<br>cable and the DirectLink Monitor Extension<br>Cable can be sterilized in an autoclave steam<br>sterilizer if required by the hospital. |
| ICP Monitor Accessories and For-Use-With Devices | | | |
| Compatible ICP<br>Sensors | Microsensors:<br>626631US<br>626632US<br>626638US<br>626633US<br>626653US<br>CereLink Semsors:<br>826850<br>826851<br>826852<br>826854 | CereLink Sensors<br>826850<br>826851<br>826852<br>826854 | The CereLink ICP Sensors, 82 series family,<br>has been cleared by the FDA via K173192.<br>The CereLink sensors contain a memory PCB<br>that stores the sensor's zero value when used<br>with the proposed CereLink ICP Monitor.<br>With this function, sensors can now be<br>disconnected and reconnected from the ICP<br>monitor without having to re-enter the zero<br>value.<br>The Microsensor, 62 series family is not<br>compatible with the CereLink ICP Monitor<br>because it does not include the memory PCB. |
| Compatible<br>Patient Monitor<br>Interface Cables | ICP Express Patient<br>Monitor Interface Cables:<br>826645<br>826646<br>826647 | CereLink Patient<br>Monitor Interface<br>Cables:<br>826880<br>826881<br>826882 | The CereLink Patient Monitor Interface<br>Cables are identical to the reference device,<br>the Direct Link Monitor Interface cables<br>(K152670). The CereLink ICP Monitor cable<br>output was designed specifically to be<br>identical to the cable output on the DirectLink<br>device. No modifications to the cable were<br>required. |
| Included<br>Accessories | ICP Extension Cable,<br>& Power Supply | Similar to predicate | Similar in design and serve the same purpose<br>as those packaged with the predicate ICP<br>Express accessories.<br>CereLink power supply uses an external AC<br>to DC converter, while the power supply for<br>ICP Express is internal to the device. |
| Replacement<br>Accessories for<br>Purchase | ICP Extension Cable,<br>Replacement Battery,<br>Replacement Power<br>Supply | Similar to predicate | Similar in design and serve the same purpose<br>as predicate ICP Express accessories.<br>CereLink power supply uses an external AC<br>to DC converter, while the power supply for<br>ICP Express is internal to the device.<br>Both devices use Li-Ion rechargeable<br>batteries. |

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