(60 days)
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.
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.
This document describes the NeuroSystems 1™ Monitor, a secondary display system for neurosurgical intensive care units (NICU). It consolidates data from primary monitors measuring intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature, pH, carbon dioxide, and arterial blood pressure. The monitor displays these variables in digital, analog trace, and trend forms, and can also visualize relationships between them.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria or performance metrics for the NeuroSystems 1™ Monitor in a tabular format. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance validation studies often seen for novel devices.
The key claim regarding performance is:
- "The NeuroSystems 1TM system is similar in design, intended use and performance characteristics to the predicate devices." (Section 6)
- "No new issues of safety or effectiveness are introduced by using this device." (Section 6)
This implies that the device's performance is considered acceptable because it is substantially equivalent to already legally marketed devices (Novus Monitoring Limited NeuroSensor® System K013930 and Diametrics Medical Limited Neurotrend System K980380), which are presumed to meet established performance and safety standards. The "performance" in this context refers to its ability to accurately receive, display, and process data from primary monitors, consistent with its intended use as a secondary display system.
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any specific sample size for a test set or the provenance of data used for validation. This is typical for 510(k) submissions focusing on substantial equivalence where extensive de novo clinical trials or performance studies with specific sample sizes might not be required if predicate devices provide sufficient evidence of safety and effectiveness. The device's function is data presentation and derivation, not direct measurement or diagnosis, which would typically necessitate specific test sets for accuracy validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
No information is provided regarding experts or ground truth establishment for a test set. As the device is a secondary display and data aggregator, its validation would likely involve engineering verification of data display accuracy, calculation correctness for derived variables, and software functionality, rather than expert-adjudicated ground truth scenarios.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there's no reported test set or expert evaluation described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. This type of study is usually conducted for diagnostic or AI-assisted devices that directly influence clinical decision-making or improve human reader performance. The NeuroSystems 1™ Monitor is an information display system, not a diagnostic aid that would typically undergo MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" does not directly apply in the way it would for an AI diagnostic algorithm. The NeuroSystems 1™ Monitor is inherently a "human-in-the-loop" device in that it presents information to a qualified neurosurgeon. Its performance would be assessed on the accuracy and reliability of its data presentation and derived calculations, independent of direct human interaction during those processes, but ultimately for human interpretation. The document does not describe specific tests for this, relying on the overall substantial equivalence claim.
7. The Type of Ground Truth Used
No specific type of ground truth is mentioned. For a device of this nature (secondary display), "ground truth" would likely involve:
- Engineering verification: Ensuring the device accurately receives data inputs from primary monitors.
- Software validation: Confirming that the display of digital and analog traces correctly reflects the input data.
- Calculation verification: Ensuring derived variables (e.g., cerebral perfusion pressure, O2 Metabolic Index) are calculated correctly based on established physiological formulas and input data.
- Comparison to predicate devices: Demonstration that its functionality for display and derivation is comparable to previously approved devices.
8. The Sample Size for the Training Set
No training set is mentioned. The device is not described as using machine learning or AI that would require a "training set" in the conventional sense. Its functionality is based on pre-programmed logic, data display, and calculation rather than learning from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no mention of a training set.
{0}------------------------------------------------
K05 c70.2
Page 1 of 2
3
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 inClass II as per 21 CFR Regulation Number 882.1620 andassigned 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}------------------------------------------------
Page [2] of 2 - 10
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
Page 1 of 1
6
.
§ 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).