(170 days)
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.
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.
The provided 510(k) summary for the LICOX® IT2 Complete Brain Tunneling Probe Kit does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria. Instead, it describes a substantial equivalence submission based on an existing predicate device (K040235) and states that no material changes were made to the components.
The main claims in the document relate to safety testing for MR compatibility and compliance with manufacturing standards, rather than performance according to specific functional acceptance criteria.
Here's an analysis based on the information provided, highlighting the absence of the requested details:
Acceptance Criteria and Device Performance Study
The 510(k) submission for K053244, concerning the LICOX® IT2 Complete Brain Tunneling Probe Kit, primarily relies on substantial equivalence to a previously cleared device (K040235). The document explicitly states: "No material changes were made to the LICOX® IT2 Complete Brain Tunneling Probe Kit components therefore no new Biocompatibility studies were necessary." and "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."
This type of submission typically means that detailed performance studies against new acceptance criteria are not required because the device's fundamental function and performance characteristics are considered identical to the predicate. Therefore, the document does not report specific quantitative acceptance criteria or a study designed to demonstrate the device's performance against such criteria for its primary function (measuring intracranial oxygen and temperature).
The only "testing" mentioned is related to safety for MR compatibility.
Detailed Breakdown of Available Information:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the submitted text. The document asserts substantial equivalence without outlining specific performance metrics, acceptance thresholds, or reported values for the primary function of measuring intracranial oxygen and temperature.
Acceptance Criterion Reported Device Performance (Not specified) (Not specified) -
Sample size used for the test set and the data provenance: This information is not provided. As no new performance study was conducted, there is no test set or related data provenance mentioned for the core function of the device.
- For the MRJ testing (Radio Frequency Induced Heating, Magnetically Induced Displacement Force and Torque), the sample size of devices tested is not specified, nor is the data provenance. These were likely internal engineering tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. There was no clinical test set for which ground truth would need to be established by experts for performance evaluation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided, as no clinical test set was used for performance evaluation.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not applicable and not provided. The LICOX® IT2 Complete Brain Tunneling Probe Kit is a medical device for measuring physiological parameters (intracranial oxygen and temperature), not an AI diagnostic tool that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable and not provided. The device is a measurement probe and system, not an algorithm. Its performance is measured directly through its physical and electronic capabilities, not through an algorithm's standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided, as no new performance study with a test set requiring ground truth was conducted for the device's primary function. For MRJ testing, "ground truth" typically relates to physical measurements and established safety limits.
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The sample size for the training set: This information is not applicable and not provided. The device does not employ an AI or machine learning model requiring a training set.
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How the ground truth for the training set was established: This information is not applicable and not provided, as there is no training set for this device.
Summary of Device Evaluation in the Document:
The provided 510(k) submission primarily focuses on demonstrating that the LICOX® IT2 Complete Brain Tunneling Probe Kit, as modified (in terms of labeling and possibly minor manufacturing aspects), remains substantially equivalent to its predicate device (K040235). The key points of the submission are:
- No material changes were made to the components, thus no new biocompatibility studies were needed.
- Safety assessment for MR compatibility was performed, and the device components were deemed "MR Conditional" as per Draft ASTM F 2503-05. This test involved evaluating Radio Frequency Induced Heating, Magnetically Induced Displacement Force, and Torque. The results of these tests serve as the "performance" for the MR compatibility aspect.
- The manufacturing process complies with FDA and European standards.
In essence, the "study" for this 510(k) was an declaration of substantial equivalence, supported by MR safety testing, rather than a new performance study against specific acceptance criteria for measuring brain oxygen and temperature.
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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 (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
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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
Page 1 of 1
"(k) Numb KOS3244
E-001
§ 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).