Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

CereLink ICP Sensor Ventricular Catheter Kit (82-6854)

Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications

Device Description

The CereLink ICP Sensor Kits are used to monitor intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an External Ventricular Drainage (EVD) catheter. The probe, also known as the CereLink ICP Sensor is intended to be used in conjunction with all of Codman's neuromonitoring devices: the Codman ICP Express Monitor (product code 82-6634) and the DirectLink ICP Module (product code 82-6828). The ICP Express and DirectLink are intended for use in ICUs. The CereLink ICP Sensor converts the pressure sensor 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 Codman ICP Express or DirectLink as a result of the probe modifications described in this submission.

The CereLink ICP Sensor contains a small, thin pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board (PCB). Additionally, the CereLink ICP Sensor's connector housing includes a new memory PCB board. When the CereLink ICP Sensor is used with either the ICP Express or DirectLink, it functions identically to the cleared predicate Codman Microsensors. Additionally, the connector housing has an electrical connector to attach to any of the monitoring devices.

The CereLink ICP Sensor Kits include components needed to facilitate the surgical implantation of the Cerelink ICP sensor. The components that will be included with the proposed CereLink ICP Sensor Kits are currently cleared devices, and are identical to the components currently packaged within the predicate Codman Microsensor Kits (i.e. there are no changes being made to the kit components, only the ICP sensor is being modified). Each component and their function are described in the Description section of the Instructions for Use for each kit.

AI/ML Overview

The provided text is a 510(k) Summary for the CereLink ICP Sensor Kits, describing the device and its substantial equivalence to a predicate device. It is not an AI/ML device, and therefore does not contain information on acceptance criteria for algorithm performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating that the modified device (CereLink ICP Sensor Kits) is substantially equivalent to a previously cleared device (Codman Microsensor Kits) by showing that it has:

The same indications for use and intended use.
The same fundamental scientific technology and basic design.
Incorporates the same materials for the implantable portion.
Uses the same packaging and sterilization methods.

The changes primarily involve minor differences in the plastic connector housing (e.g., shape, addition of PCB and memory PCB, pad printing replacing a paper label) and updated labeling.

Instead, the document details performance testing for a medical device (intracranial pressure sensor) related to its physical and functional attributes, not AI/ML algorithm performance.

Here's a breakdown of the information that is present in the document, which primarily focuses on traditional medical device testing and comparisons for regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Summary of Testing" table (page 8) that lists various performance tests, relevant standards, and the general "Result" for the subject device. However, it does not provide specific numerical acceptance criteria or reported performance values in a typical table format that would be expected for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity with numerical thresholds).

Instead, the results are qualitative and confirm that the device "met the established acceptance criteria and is therefore substantially equivalent to the predicate" or "Pass".

Test Category	Standards/Criteria	Reported Performance/Result
Bench Testing (including MRI Compatibility)	EN 62366:2008 (Usability engineering), ASTM F2052-15 (MRI displacement force), ASTM F2182-11a (MRI RF heating), ASTM F2119-07 (MRI image artifacts), ASTM F2213-06 (MRI torque), ASTM F2503-13 (MRI marking)	"Pass - subject device design met the established acceptance criteria and is therefore substantially equivalent to the predicate" (page 8)
Electrical Safety and Electromagnetic Compatibility Testing	IEC 60601-1 (General requirements), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-6 (Usability), IEC 60601-1-9 (Environmentally conscious design)	"Pass - subject device design met the established acceptance criteria and is therefore substantially equivalent to the predicate" (page 8, also detailed on page 9: "The CereLink ICP Sensor design is compliant for Electrical Safety and EMC per IEC 60601-1 2nd and 3th editions.")
Sterilization	EN ISO 11135:2014 (Ethylene Oxide Sterilization), EN ISO 10993-7:2008/AC2009 (Ethylene Oxide Sterilization Residuals), EN ISO 11737-2:2009 (Sterility tests), ANSI ST72:2011 (Bacterial endotoxins)	"Pass - subject device design met the established acceptance criteria and is therefore substantially equivalent to the predicate" (page 8, also detailed on page 10: "validated to ensure a sterility assurance level (SAL) of 10^-6", "ethylene oxide residuals can be reduced to an acceptable level", "successfully adopted into Codman's existing sterilization cycle.")
Shelf Life - Functionality Testing	EN ISO 11607-1:2009 (Packaging - Materials), EN ISO 11607-2:2006 (Packaging - Validation)	"Pass - subject device design met the established acceptance criteria and is therefore equivalent to the predicate" (page 8, also detailed on page 10: "The shelf life for the proposed CereLink ICP Sensor Kits will be 2 years (same as predicate Codman Microsensor Kits).")
Biocompatibility	EN ISO 10993-1:2009/AC2010 (Biological Evaluation of Medical Devices), FDA's Guidance document, "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process " issued on June 16, 2016.	"Non-cytotoxic, Non-sensitizing, Non-irritating, Non-toxic, Non-pyrogenic, Non-mutagenic, Non-clastogenic, Non-toxic, and Met USP 37 <661> limits where applicable" (page 9, also detailed on page 10: "test results... demonstrates that the proposed Cerelink ICP Sensor Kits are biocompatible.")
Functional Pressure Range	Not explicitly stated as a test in the table, but listed as a "Device Characteristic" in comparison table.	-50mmHg to 250mmHg (Same as predicate) (page 7)
Functional Over Pressure Range Without Damage	Not explicitly stated as a test in the table, but listed as a "Device Characteristic" in comparison table.	-700mmHg to 1250mmHg (Same as predicate) (page 7)
Zero Drift	Not explicitly stated as a test in the table, but listed as a "Device Characteristic" in comparison table.	No greater than 5mmHg over 30 days (Same as predicate) (page 7)

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

This information is not applicable to this document as it describes a physical medical device, not an AI/ML algorithm. The "test set" here refers to the actual physical devices subjected to bench testing, sterilization validations, and biocompatibility assessments, rather than a dataset of images or patient records. No information on data provenance (country, retrospective/prospective) is relevant or provided beyond the general understanding that testing was conducted by or for the manufacturer (Codman & Shurtleff, Inc. in Raynham, Massachusetts).

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

This is not applicable to a physical device submission like this. Ground truth in this context would be physical measurements, chemical analyses, and adherence to engineering and biological safety standards, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for human interpretation of data, typically in studies involving subjective assessments or labeling of complex medical images, which is not what this document addresses.

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

No MRMC study was done, as this is not an AI/ML device that assists human readers.

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

Not applicable. This device is an intracranial pressure sensor, whose performance is measured physically (e.g., pressure readings, electrical characteristics, material safety), not as an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established through:

Adherence to recognized international and national standards (e.g., ISO, ASTM, IEC) for medical devices.
Bench testing to verify physical and functional characteristics (e.g., MRI compatibility, electrical safety, pressure range).
Sterilization validation confirming a specific sterility assurance level.
Biocompatibility testing to ensure no adverse biological reactions.
Comparison to the predicate device's established performance and characteristics, demonstrating "substantial equivalence."

8. The Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of this submission. The "training" here would be the design, engineering, and manufacturing processes.

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

Not applicable. No training set as described for AI/ML algorithms.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.

November 8, 2017

Codman & Shurtleff, Inc Megan Palumbo Regulatory Affairs Project Lead 325 Paramount Drive Raynham, Massachusetts 02767

Re: K173192

Trade/Device Name: CereLink ICP Sensor Basic Kit (82-6850), CereLink ICP Sensor Metal Skull (82-6851), CereLink ICP Sensor Plastic Skull (82-6852), CereLink ICP Sensor Ventricular Catheter Kit (82-6854) Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: September 29, 2017 Received: October 2, 2017

Dear Ms. 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. 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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.

Michael J. Hoffmann -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K173192

Device Name

CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852); CereLink ICP Sensor Ventricular Catheter Kit (82-6854)

Indications for Use (Describe)

CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852)

Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

CereLink ICP Sensor Ventricular Catheter Kit (82-6854)

Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. Submitter Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767

Establishment Registration Number: 1226348

Contact: Megan Palumbo Phone: (508) 828-3571 Fax: (508) 977-6979

Date of Submission: September 29, 2017

II. Device

Device Proprietary Name	CereLink ICP Sensor Kits
Common Name	Intracranial Pressure Transducer
Classification Name	Intracranial Pressure Monitoring Devices (21 CFR882.1620)
Regulatory Classification	II
Product Code	GWM
Rx or OTC Designation	Rx Only

The predicate device for this submission is the Codman Microsensor Kits III. Predicate Device (K153347), which was cleared on August 19, 2016.

IV. Device The CereLink ICP Sensor Kits are used to monitor intracranial pressure (ICP) Description through either a stand-alone probe, or a probe coupled with an External Ventricular Drainage (EVD) catheter. The probe, also known as the CereLink ICP Sensor is intended to be used in conjunction with all of Codman's neuromonitoring devices: the Codman ICP Express Monitor (product code 82-6634) and the DirectLink ICP Module (product code 82-6828). The ICP Express and DirectLink are intended for use in ICUs. The CereLink ICP Sensor converts the pressure sensor 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 Codman ICP Express or DirectLink as a result of the probe modifications described in this submission.

The CereLink ICP Sensor contains a small, thin pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected

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via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board (PCB). Additionally, the CereLink ICP Sensor's connector housing includes a new memory PCB board. When the CereLink ICP Sensor is used with either the ICP Express or DirectLink, it functions identically to the cleared predicate Codman Microsensors. Additionally, the connector housing has an electrical connector to attach to any of the monitoring devices.

	V. Indications The table below describes the Indications for Use statements for each of the 4
for Use	proposed CereLink ICP Sensor Kit product codes.

CereLink ICP Sensor Kit Indications for Use
DeviceDescription	ProposedProductCode	Proposed Indications for Use
CereLinkICP SensorBasic Kit	82-6850	Use of the CERELINK ICP SENSOR Basic Kit is indicated when direct ICP monitoringis required. The kit is indicated for use in both subdural and intraparenchymalpressure monitoring applications only.
CereLinkICP SensorMetal SkullBolt Kit	82-6851	Use of the CERELINK ICP SENSOR Metal Skull Bolt Kit is indicated when direct ICPmonitoring is required. The kit is indicated for use in both subdural andintraparenchymal pressure monitoring applications.
CereLinkICP SensorPlastic SkullBolt Kit	82-6852	Use of the CERELINK ICP SENSOR Plastic Skull Bolt Kit is indicated when direct ICPmonitoring is required. The kit is indicated for use in both subdural andintraparenchymal pressure monitoring applications only.
CereLinkICP SensorVentricularCatheter Kit	82-6854	Use of the CERELINK ICP SENSOR Ventricular Catheter Kit is indicated when directintraventricular pressure monitoring is required. The kit is indicated for use in ICPmonitoring and cerebrospinal fluid (CSF) drainage applications.

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

the same indications for use, ●
the same intended use, ●
the same fundamental scientific technology,
incorporates the same basic design (strain gauge ICP sensor connected to a plastic connector housing),
incorporates the same materials for the implantable portion of the device,
packaged and sterilized using the same packaging design, materials, and ● processes.

The minor differences between the predicate and subject device are contained within the plastic connector housing:

a slight difference in device design (shape of plastic connector housing ● top lid, addition of PCB and PCB retainer inside top lid),
pad printing replaces the paper label on the plastic connector housing (non-implantable component, only in contact with intact skin), and
the device labeling was updated (i.e. product labels, Instructions for Use and packaging art work).

The table below details the comparison of the predicate and subject devices.

Comparison of Predicate and Proposed ICP Sensor Kits
Characteristic	Predicate Device:Codman Microsensor Kits (K153347)	Subject Device:CereLink ICP Sensor Kits (ThisSubmission)
FDA Product Code	GWM	Same
Classification	21 CFR 882.1620	Same
Classification Name	Device, Monitoring, Intracranial Pressure	Same
Indication for Use	62-6631, 62-6632 & 62-6638Indicated when direct ICP monitoring isrequired. The kit is indicated for use in bothsubdural and intraparenchymal pressuremonitoring applications only.62-6633, 62-6653Indicated when direct intraventricular pressuremonitoring is required. The kit is indicated foruse in ICP monitoring and cerebrospinal fluid(CSF) drainage applications.	Same as predicate:82-6850, 82-6851 & 82-6852Indicated when direct ICP monitoring isrequired. The kit is indicated for use in bothsubdural and intraparenchymal pressuremonitoring applications only.82-6854Indicated when direct intraventricular pressuremonitoring is required. The kit is indicated foruse in ICP monitoring and cerebrospinal fluid(CSF) drainage applications.
Contraindications (82-6850)	This kit is not designed, sold, or intended forany use except as indicated.This kit is not designed, sold, or intended foruse as a therapeutic device.	Same
Contraindications (82-6851, 82-6852)	Use of the skull bolt is contraindicated inchildren less than one year of age.	Same

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Characteristic	Comparison of Predicate and Proposed ICP Sensor Kits	Subject Device:
	Predicate Device:	CereLink ICP Sensor Kits (ThisSubmission)
	Codman Microsensor Kits (K153347)
	This kit is not designed, sold, or intended forany use except as indicated.
	This kit is not designed, sold, or intended foruse as a therapeutic device.
Contraindications (82-6854)	Ventriculostomy is contraindicated in patientswith coagulopathy, or active infection in thearea of the catheter. Use of the VentricularCatheter is contraindicated in children less thanone year of age.	Same
	This kit is not designed, sold, or intended forany use except as indicated.
Device Materials
Printed Circuit Board(PCB) inside plasticconnector housing	Materials are the same for the predicate and proposed devices.
Memory chip PCBinside plastic connectorhousing	N/A	Materials are the same as those used in thepredicate PCB inside the plastic connectorhousing.
Solder Wires	Materials are the same for the predicate and proposed devices.
Thru-hole resistorlocated inside plasticconnector	Materials are the same for the predicate and proposed devices.
Epoxy Glue to cap tip ofsensor and to jointitanium housing tocatheter tubing	Materials are the same for the predicate and proposed devices.
Catheter 100cm tubing	Materials are the same for the predicate and proposed devices.
Printing on the lid ofthe plastic connectorhousing	Paper label	Pad printing with ink
Sensor Top Label forthe plastic connectorhousing. IncludesProduct Name, space toenter zero referencenumber and updatedsymbols.	Paper, adhesive and laminate	N/A
Sensor Bottom Label onplastic connectorhousing	Materials are the same for the predicate and proposed devices.
Catheter Strain Relief	Materials are the same for the predicate and proposed devices.
Titanium Case	Materials are the same for the predicate and proposed devices.
Silicone Membrane	Materials are the same for the predicate and proposed devices.
Plastic ConnectorHousing	Materials are the same for the predicate and proposed devices.
Retainer (in plasticconnector housing)	N/A	Materials are the same as those used in thepredicate plastic connector housing.

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Comparison of Predicate and Proposed ICP Sensor Kits
Characteristic	Predicate Device:Codman Microsensor Kits (K153347)	Subject Device:CereLink ICP Sensor Kits (This Submission)
Note: There is no change to the material used in the components provided with the proposed CereLink ICP Sensor Kits as compared to the current kits.
Packaging Materials	Materials are the same for the predicate and proposed packaging materials.
Pouch (82-6850, 82-6851, 82-6852, 82-6854)
Unit Box (82-6850, 82-6851, 82-6852)
Unit Box (82-6854)
Blister Lid (82-6850, 82-6851, 82-6852)
Blister Lid (82-6854)
Blister Tray (82-6850, 82-6851, 82-6852, 82-6854)
Device Characteristics
MRI claim	1.5T and 3T Conditional	Same
Sterilization	Ethylene Oxide	Same
Sterility Assurance Level(SAL)	10-6	Same
Shelf Life	2 years	Same
Energy Modality	5 volts DC when connected to the ICP monitoring device	Same
Microsensor Dimensions	Dimensions are the same for predicate and proposed device.
Sensing Element	Strain gauge silicon microchip	Same
Functional Pressure Range	-50mmHg to 250mmHg	Same
Functional Over Pressure Range Without Damage	-700mmHg to 1250mmHg	Same
Input/Output Impedance	1000 ohms nominal	Same
Output Signal (sensitivity)	5uV/V/mmHg	Same
Zero Drift	No greater than 5mmHg over 30 days	Same

The following performance testing (see "Summary of Testing" table below) has VII. Performance been conducted in support of the substantial equivalence determination. All Data testing was performed on final sterile devices unless otherwise specified.

Because the proposed CereLink ICP Sensor is almost identical to the predicate Codman Microsensor, Codman leveraged many verification tests from the previously cleared Codman Microsensor (K153347). Please see the Summary of Testing table below which identifies the types of tests that were both leveraged from the predicate device, as well as performed on the subject device. All test results were deemed acceptable.

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Summary of Testing
Test	Standards	Result
Bench Testing	EN 62366:2008	Application of usability engineering to medical devices	Pass - subject device
	ASTM F2052-15	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Imaging	design met the established acceptance criteria and is therefore
	ASTM F2182-11a	Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging	substantially equivalent to the predicate
	ASTM F2119-07	Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
	ASTM F2213-06	Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
	ASTM F2503-13	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Electrical Safety and Electromagnetic Compatibility Testing	IEC 60601-1 - Part 1	General requirements for basic safety and essential performance	Pass - subject
	IEC 60601-1-2	Collateral Standard: Electromagnetic disturbances - Requirements and tests	device design met
	IEC 60601-1-6	Collateral standard: Usability	the established
	IEC 60601-1-9	Collateral Standard: Requirements for environmentally conscious design	acceptance criteria and is therefore substantially equivalent to the predicate
Sterilization	EN ISO 11135: 2014	Validation and Routine Control of Ethylene Oxide Sterilization	Pass -
	EN ISO 10993-7:2008/AC2009	Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals	subject device design met
	EN ISO 11737-2:2009	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process	the established acceptance criteria and is therefore
	ANSI ST72:2011	Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing	substantially equivalent to the predicate
Shelf Life - Functionality Testing Complete after Two Year Accelerated Aging	EN ISO 11607-1: 2009EN ISO 11607-2: 2006	Packaging for Terminally Sterilized Medical Devices: Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems - Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes	Pass - subject device design met the established acceptance criteria and is therefore
			equivalentto thepredicate
Biocompatibility- ICP Probe Tipand Tubing &ElectricalHousingConnector	EN ISO 10993-1:2009/AC2010	Biological Evaluation of Medical Devices:Part 1: Evaluation and testing with a riskmanagement process	Non-cytotoxic,Non-sensitizing,Non-irritating,Non-toxic,Non-pyrogenic,Non-irritant,Non-mutagenic,Non-clastogenic,Non-toxic,andMet USP 37<661>limits whereapplicableSubjectdevicedesign mettheestablishedacceptancecriteria andis thereforesubstantiallyequivalentto thepredicate

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Bench Testing

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

Electrical Safety and Electromagnetic Compatibility Testing

The CereLink ICP Sensor design is compliant for Electrical Safety and EMC per IEC 60601-1 2nd and 3th editions. The CereLink ICP Sensor is listed as an applied part within the Codman ICP Express safety reports and documentation. No additional testing was required as the updates to the new sensor do not affect the performance of the probe or ICP Express, and do not affect patient safety.

Sterilization

The sterilization method of the proposed CereLink ICP product codes is identical to the sterilization method of the predicate Microsensor Kits. The

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CereLink ICP Senor Kits are sterilized via ethylene oxide and have been validated to ensure a sterility assurance level (SAL) of 10to in accordance with ISO 11135:2014. "Validation and Routine Control of a Sterilization Process for Medical Devices" and ISO 11737-2:2009, "Tests of sterility preformed in the definition, validation and maintenance of a sterilization process." Sterilization testing also demonstrated that ethylene oxide residuals can be reduced to an acceptable level in accordance with ISO 10993-7:2008. "Biological Evaluation of Medical Devices – Ethylene Oxide Sterilization Residuals" and the proposed device can be successfully adopted into Codman's existing sterilization cycle.

Shelf-Life Testing

The shelf life for the proposed CereLink ICP Sensor Kits will be 2 years (same as predicate Codman Microsensor Kits). The proposed CereLink ICP Sensor Kits device component materials and packaging materials are identical to those used for the predicate Microsensor Kits.

Biocompatibility Testing

In comparison to the predicate Microsensor Kits, the only new patient contacting material in the Cerelink ICP Sensor Kit is the pad printing ink used on the lid of the sensor's plastic connector housing. The ink will only be in contact with the patient's intact skin. Biocompatibility testing was conducted according to ISO 10993-1 and FDA's Guidance document, "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process " issued on June 16, 2016. The test results for the pad printing ink, in conjunction with the existing biocompatibility data for the predicate Microsensor Kits, demonstrates that the proposed Cerelink ICP Sensor Kits are biocompatible.

Animal Studies

No animal studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the predicate Microsensor Kits and the proposed CereLink ICP Sensor Kits.

Clinical Studies

No clinical studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the predicate Microsensor Kits and the proposed CereLink ICP Sensor Kits.

VIII. Conclusion Based upon the same indications for use, intended use, fundamental scientific technology, comparison to the predicate device, and testing conducted, it is concluded that the CereLink ICP Sensor Kits are substantially equivalent to the predicate device, the Microsensor Kits, and therefore does not raise any new issues of safety and effectiveness.

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).