(45 days)
Not Found
No
The description focuses on data collection, display, storage, and basic offline analysis using commercially available software. There is no mention of AI/ML algorithms for data interpretation, prediction, or automated analysis.
No
The device is described as a "neurological monitoring system" that displays and records parameters for the purpose of "treating patients with neurological disorders," but it does not directly treat or provide therapy. It is an "adjunct monitor" to other primary source bedside monitors, providing data for analysis, not for therapeutic intervention.
No
The "Intended Use" section states that the system is "not as the sole basis for diagnosis," and the "Device Description" states it is "an adjunct to conventional vital sign monitoring," indicating it provides data for monitoring rather than direct diagnosis.
No
The device description explicitly states that the system consists of a computer platform (PC) and an interface module, in addition to the software. This indicates the presence of hardware components.
Based on the provided text, the Integra Mobius™ Multi-Modality Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Integra Mobius™ system monitors and displays physiological parameters (ICP, ICT, CBF, etc.) directly from the patient or from other bedside monitors. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the system as an "adjunct monitor for displaying and recording parameters" and for "treating patients with neurological disorders." This aligns with a patient monitoring system, not an in vitro diagnostic test.
- Device Description: The description details the system's components (PC, interface module, software) and its function of receiving and displaying data from other monitoring devices. There is no mention of sample handling or analysis.
Therefore, the Integra Mobius™ Multi-Modality Monitoring System falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integra Mobius™ Multi-Modality Monitoring System is intended as an adjunct monitor for displaying and recording parameters such as Intracranial Pressure (ICP), Intracranial Temperature (ICT), Cerebral Blood Flow (CBF), Cerebral Perfusion Pressure (CPF), Cerebrovascular Resistance (CVR), Partial Pressure Brain Tissue Oxygen (PbtO>) and other parameters from primary source bedside monitors for the purpose of treating patients with neurological disorders.
The Integra Mobius™ System data is presented both continuously and as trends to be used in concert with other clinical parameters, not as the sole basis for diagnosis.
Product codes
84GWM
Device Description
The Integra Mobius™ Multi-Modality Monitoring System is a neurological monitoring system that records and displays information that is electronically communicated from primary source monitors such as the Integra LICOX Brain Tissue Oxygen Monitoring System, Multi Parameter Monitor (MPM), NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System and other bedside systems. The Integra Mobius™ System is also capable of recording data from the primary source bedside monitors on to an internal hard drive.
The Integra Mobius™ System will allow the received data to be displayed and stored in real time and analyzed offline with commercially available data analysis software packages. Collecting information in a common computing structure will allow application of "multimeasurement" concepts to applications in neurological monitoring. The Integra Mobius™ System is designed to be used as an adjunct to conventional vital sign monitoring.
The Integra Mobius™ Multi-Modality System consists of a computer platform (PC), an interface module for connection to the monitoring devices, software to record, display and archive the data and multimedia content to assist the user in carrying out a monitoring protocol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) SUMMARY
Submitter's Name and Address:
Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 609-275-0500 (Telephone) 609-275-9445 (Fax)
Contact Person and Telephone Number:
Jon Caparotta, RAC Director Regulatory Affairs Integra LifeSciences Corporation 609-936-2495
Date Summary was Prepared:
June 9, 2006
Name of the Device:
| Trade Name: | Integra Mobius™ Multi-Modality Monitoring System |
|---|---|
| Common Name: | Neurological Diagnostic Device |
| Classification Name: | Intracranial Pressure Monitoring Device. |
| 21 CFR 882.1620, Product Code 84GWM | |
| Classification Panel: | Neurology Device Panel |
Substantial Equivalence:
The Integra Mobius™ Multi-Modality Monitoring System is substantially equivalent in function and intended use to the NeuroSystems 1™ Monitor (K050702) and Bravo System (K991054).
Device Description:
The Integra Mobius™ Multi-Modality Monitoring System is a neurological monitoring system that records and displays information that is electronically communicated from primary source monitors such as the Integra LICOX Brain Tissue Oxygen Monitoring System, Multi Parameter Monitor (MPM), NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System and other bedside systems. The Integra Mobius™ System is also capable of recording data from the primary source bedside monitors on to an internal hard drive.
The Integra Mobius™ System will allow the received data to be displayed and stored in real time and analyzed offline with commercially available data analysis software packages. Collecting information in a common computing structure will allow application of "multimeasurement" concepts to applications in neurological monitoring. The Integra Mobius™ System is designed to be used as an adjunct to conventional vital sign monitoring.
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The Integra Mobius™ Multi-Modality System consists of a computer platform (PC), an interface module for connection to the monitoring devices, software to record, display and archive the data and multimedia content to assist the user in carrying out a monitoring protocol.
Indications for Use:
The Integra Mobius™ Multi-Modality Monitoring System is intended as an adjunct monitor for displaying and recording parameters such as Intracranial Pressure (ICP), Intracranial Temperature (ICT), Cerebral Blood Flow (CBF), Cerebral Perfusion Pressure (CPF), Cerebrovascular Resistance (CVR), Partial Pressure Brain Tissue Oxygen (PbtO>) and other parameters from primary source bedside monitors for the purpose of treating patients with neurological disorders.
The Integra Mobius™ System data is presented both continuously and as trends to be used in concert with other clinical parameters, not as the sole basis for diagnosis.
| Feature | Mobius | Predicates | Product Characteristic |
|---|---|---|---|
| Multi-Modality | |||
| Monitor System | Yes | Yes | PC based processor with a digital data |
| recorder for continuous monitoring of | |||
| various types of neurological information | |||
| Software Driven | Yes | Yes | Interactive |
| Multi-Parameter | |||
| Display | Yes | Yes | Data presented both continuously and as |
| trends and in the form of relationship | |||
| graphs. | |||
| Data Archiving | CD/DVD | Yes | Unknown |
Technological Characteristics:
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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 caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2006
Integra LifeSciences Corporation % Mr. Jon Caparotta, RAC Director Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K061640
Trade/Device Name: Integra Mobius" Multi-Modality Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: June 9, 2006 Received: June 13, 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 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.
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Page 2 - Mr. Jon Caparotta, RAC
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
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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510(k) Number: 1 06 1640
Device Name: Integra Mobius™ Multi-Modality Monitoring System
Indications for Use:
The Integra Mobius™ Multi-Modality Monitoring System is intended as an adjunct monitor for displaying and recording parameters such as Intracranial Pressure (ICP), Intracranial Temperature (ICT), Cerebral Blood Flow (CBF), Cerebral Perfusion Pressure (CPP), Cerebrovascular Resistance (CVR), Partial Pressure Brain Tissue Oxygen (PbtO2) and other parameters from primary source bedside monitors for the purpose of treating patients with neurological disorders.
The Integra Mobius™ System data is presented both continuously and as trends to be used in concert with other clinical parameters, not as the sole basis for diagnosis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 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)
Juker Lendoo
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K061640
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