(170 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on direct measurement of physiological parameters.
No.
The device is a monitoring system that measures physiological parameters (intracranial oxygen and temperature) and provides data for assessment, but it does not directly treat or provide therapy.
Yes
The device measures intracranial oxygen and temperature to indicate the perfusion status and provide data for concerns of hypoxia or ischemia, which are diagnostic indicators. However, it explicitly states it "should not be used as the sole basis for decisions as to diagnosis or therapy," indicating it is an adjunct diagnostic tool.
No
The device description explicitly mentions a "LICOX® IT2 Complete Brain Tunneling Probe Kit" and describes it as components intended for use with the system, indicating hardware is involved. The performance studies also focus on testing of these hardware components (Biocompatibility and MRJ testing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system "measures intracranial oxygen and temperature" and is an "adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement." This describes a device that measures physiological parameters within the body, not a device that examines specimens in vitro (outside the body).
- Device Description: The description reinforces this by stating it "measures intracranial oxygen and temperature."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are hallmarks of IVD devices.
Therefore, the LICOX Brain Oxygen Monitoring System is a medical device used for in vivo monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, cerebral tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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.
2
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
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
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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"(k) Numb KOS3244
E-001