(60 days)
Not Found
No
The description focuses on data aggregation, display, and trend analysis, with no mention of AI or ML algorithms for interpretation, prediction, or decision support beyond simple calculations like cerebral perfusion pressure.
No
The device is described as a monitor and a secondary display system that collects and displays data from primary measuring devices. It does not provide any form of treatment or therapy itself.
No
Explanation: The device is described as a "secondary display system" that presents variables from existing primary measuring devices. Its function is to consolidate and display data, including trends and relationships, as an "adjunct" to information from primary monitors. It explicitly states that it "should not be used alone as the sole basis for decisions as to diagnosis or therapy," indicating it is not a diagnostic device itself but rather a tool to aid in monitoring and understanding physiological data.
No
The device description explicitly states it has "inputs to receive analog data from primary monitors" and is a "secondary display system," indicating it includes hardware components beyond just software.
Based on the provided information, the NeuroSystems 1™ monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NeuroSystems 1™ monitor, as described, is a secondary display system that receives and displays data from existing primary measuring devices that are monitoring physiological variables directly from the patient (intracranial pressure, cerebral blood flow, brain tissue oxygen, etc.).
- The device description focuses on displaying and analyzing real-time physiological data from the patient, not on analyzing biological samples.
- The intended use is as an adjunct to information from existing primary monitors for neurosurgical patients, not for analyzing biological specimens.
Therefore, the NeuroSystems 1™ monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroSystems 1™ monitor has been designed for use by a qualified neurosurgeon to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical patients. The variables displayed by the NeuroSystems 1™ monitor include intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure, and these are presented both continuously and as trends in these variables, and in the form of relationship graphs. The presentation of both measured variables and the relationships between them is intended as an adjunct to the information provided by existing primary monitors, and the NeuroSystems 1 ™ monitor should not be used alone as the sole basis for decisions as to diagnosis or therapy.
Product codes
GWM
Device Description
The NeuroSystems 1TM monitor is a secondary display system that collects together on a single large color display screen all of the measured variables relevant to the multi-modality monitoring of the patient in a neurosurgical intensive care unit. The NeuroSystems 17M monitor has inputs to receive analog data from primary monitors used in the measurement of intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure. The monitor can also derive the cerebral perfusion pressure.
The NeuroSystems 17M monitor displays the measured and derived variables in digital and analog trace form, and can store and display trends over periods of 1,2,8 or 24 hours. The system also facilitates the display of the interrelationships between the measured and derived variables. This allows the approximation of Cerebral Autoregulation, Vasoreactivity and O2 Metabolic Index.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified neurosurgeon / neurosurgical intensive care unit
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
K05 c70.2
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MAY 1 7 2005 510(k) Summary
March 16" 2005
1 Submitter
NeuroSystems LLC 103 Pomfret Road Woodstock Vermont 05091-8029 USA
| Contact Person: | Dr James R Petite Jr |
|---|---|
| Telephone: | (802) 457 9866 |
| Facsimile: | (802) 457 5785 |
2 Name of Device
| Proprietary Name: | NeuroSystems 1 TM Monitor |
|---|---|
| Common Name: | Multimodality Neurosurgical ICU monitor |
| Device Classification: | Intracranial pressure monitoring devices have been placed in |
| Class II as per 21 CFR Regulation Number 882.1620 and | |
| assigned the Product Code GWM. |
3 Predicate Devices
The components of the NeuroSystems 1TM system are substantially equivalent to the following legally marketed devices:
Novus Monitoring Limited NeuroSensor® System K013930 Diametrics Medical Limited Neurotrend System K980380
This statement is based on the subject device's similarity to the predicate devices in intended use, design and principles of operation.
4 Device Description
The NeuroSystems 1TM monitor is a secondary display system that collects together on a single large color display screen all of the measured variables relevant to the multi-modality monitoring of the patient in a neurosurgical intensive care unit. The NeuroSystems 17M monitor has inputs to receive analog data from primary monitors used in the measurement of intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure. The monitor can also derive the cerebral perfusion pressure.
1
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The NeuroSystems 17M monitor displays the measured and derived variables in digital and analog trace form, and can store and display trends over periods of 1,2,8 or 24 hours. The system also facilitates the display of the interrelationships between the measured and derived variables. This allows the approximation of Cerebral Autoregulation, Vasoreactivity and O2 Metabolic Index.
5 Intended Use
The NeuroSystems 1TM monitor has been designed for use by a qualified neurosurgeon to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical patients. The variables displayed by the NeuroSystems 11M monitor include intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure, and these are presented both continuously and as trends in these variables, and in the form of relationship graphs. The presentation of both measured variables and the relationships between them is intended as an adjunct to the information provided by existing primary monitors, and the NeuroSystems 1™ monitor should not be used alone as the sole basis for decisions as to diagnosis or therapy.
Summary of Substantial Equivalence 6
The NeuroSystems 1TM system is similar in design, intended use and performance characteristics to the predicate devices. It differs in requiring legally marketed primary monitors to be the interface between the secondary monitor and the patient connected sensors, and in providing the display of measured variables, derived variables and data relationships on a secondary monitor. No new issues of safety or effectiveness are introduced by using this device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services.
MAY 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. James R. Petite Jr. President NeuroSystems LLC 103 Pomfret Road Woodstock, Vermont 05091-8029
Re: K050702
Trade/Device Name: NeuroSystems 1™ Monitor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: March 16, 2005 Received: March 18, 2005
Dear Dr. Petite:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 3 re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and ment date of the Medical Device Amendments, or to Conniered phor to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). allu Cosmete Act (11ct) that do not request of the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 it may be subject to sadh additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oods of reacts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast oc advised that I Dri brounder over device complies with other requirements of the Act that I DA has made a decemmandiations administered by other Federal agencies. You must of any it cutting and regaranents and regarents and limited to: registration and listing (21 comply with an the Act 3 requirements, neisang, and manufacturing practice requirements as set CITY art 807), labeling (21 CFR Part 820); and if applicable, the electronic 10:11 m in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. James R. Petite Jr.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your antial equivalence of your device to a legally premarket notification. "The PDF Inturing of basistance of this 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 If you desire specific advice for your don't as a surver and the regulation entitled, comact and Office of Comphanes as (21 notification" (21CFR Part 807.97). You may obtain " Misoralianing by reference to premainteers. Internetions of Small other general information on your response Assistance at its toll-free number (800) 638-204 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if Known): KOS C 70 Z
Device Name:
NeuroSystems 1 TM Monitor
The NeuroSystems 1™ monitor has been designed Indications for Use: for use by a qualified neurosurgeon to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical patients. The variables displayed by the NeuroSystems 1™ monitor include intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure, and these are presented both continuously and as trends in these variables, and in the form of relationship graphs. The presentation of both measured variables and the relationships between them is intended as an adjunct to the information provided by existing primary monitors, and the NeuroSystems 1 ™ monitor should not be used alone as the sole basis for decisions as to diagnosis or therapy.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFGR 801 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Soncurrence of CDRH Office of Device Evaluation (ODE)
concurrence
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K050702
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