LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT

K053244 · Integra Lifesciences Corp. · GWM · May 10, 2006 · Neurology

Device Facts

• Record ID: K053244
• Device Name: LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
• Applicant: Integra Lifesciences Corp.
• Product Code: GWM · Neurology
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

Device Story

LICOX IT2 Complete Brain Tunneling Probe Kit functions as part of LICOX Brain Oxygen Monitoring System; measures intracranial oxygen and temperature. Probe placed in cerebral tissue; provides local perfusion status data. Used in clinical settings; operated by healthcare professionals. Output provides trend data for clinical reference; not for sole diagnostic or therapeutic decision-making. Benefits include supplemental monitoring for patients at risk of hypoxia or ischemia. Device components are MR Conditional per ASTM F 2503-05.

Clinical Evidence

Bench testing only. No clinical data presented. MR testing performed for Radio Frequency Induced Heating, Magnetically Induced Displacement Force, and Torque.

Technological Characteristics

Intracranial oxygen and temperature monitoring probe. MR Conditional per ASTM F 2503-05. Complies with FDA and European standards for medical device manufacturing.

Indications for Use

Indicated for patients requiring intracranial oxygen and temperature monitoring as an adjunct to clinical practice where cerebral hypoxia or ischemia is a concern.

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

• LICOX® IT2 Complete Brain Tunneling Probe Kit (K040235)

Submission Summary (Full Text)

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K053244

# LICOX® IT2 Complete Brain Tunneling Probe Kit

# 510(k) SUMMARY

MAY 10 2006

#### Submitter's name and address:

Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536

## Contact person and telephone number:

Jon Caparotta, RAC Director, Regulatory Affairs 609-936-2495

#### Date summary was prepared:

11/10/2005

### Name of the device:

| Proprietary Name: | LICOX® IMC Complete NeuroMonitoring System |
|-----------------------|-----------------------------------------------|
| | LICOX® IT2 Complete Brain Tunneling Probe Kit |
| Common Name: | Brain Oxygen Monitoring Device |
| Classification Name: | Intracranial Pressure Monitoring Device, |
| | 21 CFR 882.1620, 84GWM |
| Classification Panel: | Neurology Device Panel |

### Substantial Equivalence:

The LICOX® IT2 Complete Brain Tunneling Probe Kit components was designed to have the same indications for use and perform to the same specifications as the components used with the LICOX® IT2 Complete Brain Tunneling Probe Kit (510(k) K040235).

#### Device Description:

The LICOX® IT2 Complete Brain Tunneling Probe Kit is intended for use with the LICOX Brain Oxygen Monitoring System. The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature.

### Statement of Intended Use:

The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

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## Safety:

No material changes were made to the LICOX® IT2 Complete Brain Tunneling Probe Kit components therefore no new Biocompatibility studies were necessary.

The LICOX® IT2 Complete Brain Tunneling Probe Kit components were subjected to MRJ testing, which included Radio Frequency Induced Heating, Magnetically Induced Displacement Force and Torque. Results of the testing showed that the kit components were "MR Conditional" as defined in Draft ASTM F 2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

The LICOX® IT2 Complete Brain Tunneling Probe Kit manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.

## Conclusion:

The LICOX® IT2 Complete Brain Tunneling Probe Kit is substantially equivalent to the unmodified LICOX® IT2 Complete Brain Tunneling Probe Kit. The labeling revision does not affect the intended use or the fundamental scientific technology of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2006

Integra™ % Mr. Jon Caparotta, RAC Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K053244

Trade/Device Name: LICOX IT2 Complete Brain Tunneling Probe Kit Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: May 7, 2006 Received: May 12, 2006

Dear Mr. Caparotta:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Jon Caparotta, RAC

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification LICOX® IT2 Complete Brain Tunneling Probe Kit Integra NeuroSciences

# Indications for Use

510(k) Number (if known):

033244

Device Name: LICOX® IT2 Complete Brain Tunneling Probe Kit

Indications For Use:

The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

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)

ECGMCC

"ivision of General, Restorative, :d Neurological Devices

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