The INTEGRA™ Electrode Tunneling Needle aids in externalizing the leads of the Integra Cortical Electrodes to avoid contamination with patient fluids.

Device Description

The INTEGRATM Electrode Tunneling Needle is a single use device intended to be used for externalizing the leads of the Integra Cortical Electrodes away from the craniotomy site for patients undergoing brain mapping procedures. The INTEGRATM Electrode Tunneling Needle creates a passage under the scalp through which the electrode leads can pass to a separate exit site without contaminating the lead contacts with patient fluids. The device consists of a stainless steel trocar with a plastic tunneling sheath attached to contain the leads during passage.

AI/ML Overview

The Integra™ Electrode Tunneling Needle is a single-use device designed to externalize the leads of Integra Cortical Electrodes away from the craniotomy site during brain mapping procedures. The device creates a passage under the scalp, allowing electrode leads to pass to a separate exit site without contamination from patient fluids. It consists of a stainless steel trocar with a plastic tunneling sheath.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Leads are well contained within the plastic tunneling sheath during tunneling.	"Functional testing ensured all the samples had the leads well contained within the plastic tunneling sheath during tunneling with no evidence of contamination/contact with animal tissue."
No evidence of contamination/contact with patient fluids (specifically, animal tissue in testing).	"Functional testing ensured all the samples had the leads well contained within the plastic tunneling sheath during tunneling with no evidence of contamination/contact with animal tissue."
Tunneling device does not adversely affect the electrode leads (e.g., resistance remains within acceptable limits).	"Testing was completed to check the resistance of the electrode before and after tunneling to ensure that the tunneling device did not adversely affect the electrode. All the test results were found to be in accordance with the passing criteria dictated in the Design Verification Protocol and the Product Specification." While specific numerical "passing criteria" for resistance are not provided, the statement indicates that all tested devices met these internal criteria.
The device meets all functional Design Output requirements consistent with Design Input.	"Performance Testing and Testing Results: The testing verified that the functional Design Outputs are consistent with the Design Input requirements for the INTEGRATM Electrode Tunneling Needle."

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

The document does not explicitly state the numerical sample size for the test set. It refers to "all the samples" and "all the test results," indicating that multiple devices were tested. The testing involved "animal tissue," suggesting the provenance of the data is a pre-clinical, in vivo or ex vivo animal study rather than human data. The study appears to be prospective as it's described as "functional testing" and "testing was completed."

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

This type of information is not applicable to the reported testing. The "ground truth" here is objective physical performance (lead containment, absence of contamination, electrical resistance). There is no mention of expert human interpretation being required to establish these physical facts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., radiology reads) where there can be disagreement among experts. The reported testing focuses on objective physical measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used

The ground truth used for the performance testing was objective physical measurements and observations based on the functional performance of the device. This included:

Visual confirmation of lead containment within the sheath.
Visual confirmation of the absence of contamination/contact with animal tissue.
Objective electrical resistance measurements of the electrode leads before and after tunneling.

8. The sample size for the training set

Not applicable. This device is a simple mechanical instrument, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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INTEGRATM Electrode Tunneling Needle

510(k) Summary

NOV 2 3 2010

Submitter's Name and Address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536 USA

Contact Person:

Derek Cao

Regulatory, Quality, Clinical Affairs Associate Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA Telephone: (609) 275-2794 Facsimile: (609) 275-9445 Email: derek.cao@integralife.com

Alternate Contact Person:

Kevin O'Connell Director, Regulatory Affairs, NeuroSurgery Division Integra LifeSciences Corporation 22 Terry Ave Burlington, MA 01803 USA Telephone: (781) 565-1227 Email: kevin.oconnell@integralife.com

Device Information

Proprietary Name: Common Name: Classification Name: Device Product Code: Classification Panel:

INTEGRA™ Electrode Tunneling Needle Tunneling Needle, Tunneler Cortical Electrode (21CFR 882.1310) GYC Neurology

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Device Description

Indications for Use:

The INTEGRA 110 Electrode Tunneling Needle aids in externalizing the leads of the Integra Cortical Electrodes to avoid contamination with patient fluids.

Substantial Equivalence:

The proposed INTEGRATM Electrode Tunneling Needle is identical to the existing . Integra's stainless steel trocar with scalp tunneling sheath that was reviewed by the FDA as part of K904883, OPTYX Intracranial Fiberoptic Pressure Monitoring Device, cleared to market on July 24, 1991. There are no changes to the material or design.

The proposed INTEGRATN Electrode Tunneling Needle is to be used with Integra Cortical Electrodes, cleared to market under 510(k) K926424 and K082250.

Performance Testing and Testing Results:

The testing verified that the functional Design Outputs are consistent with the Design Input requirements for the INTEGRATM Electrode Tunneling Needle. Functional testing ensured all the samples had the leads well contained within the plastic tunneling sheath during tunneling with no evidence of contamination/contact with animal tissue. Testing was completed to check the resistance of the electrode before and after tunneling to ensure that the tunneling device did not adversely affect the electrode. All the test results were found to be in accordance with the passing criteria dictated in the Design Verification Protocol and the Product Specification.

Conclusion:

Based on the predicate information and the performance testing summarized above, the device is as safe and effective as the legally marketed predicate device identified in the Substantial Equivalence section above.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Integra LifeSciences Corporation c/o Mr. Derek Cao Regulatory, Quality, Clinical Affairs Associate 311 Enterprise Drive Plainsboro, NJ 08536

NOV 2 3 2010

Re: K102802

Trade/Device Name: Integra Electrode Tunneling Needle Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: September 24, 2010 Received: September 27, 2010

Dear Mr. Cao:

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.

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Page 2 - Mr. Derek Cao

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Malvina B. Evdelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

NOV 2 3 2010

510(k) Number (if known):

INTEGRA™ Electrode Tunneling Néedle Device Name:

Indications for Use:

The INTEGRA™ Electrode Tunneling Needle aids in externalizing the leads of the Integra Cortical Electrodes to avoid contamination with patient fluids.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR .

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kristen Bowsher

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 882.1310 Cortical electrode.

(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).