NEUROSYSTEMS 1TM MONITOR

K050702 · Neurosystems, LLC · GWM · May 17, 2005 · Neurology

Device Facts

• Record ID: K050702
• Device Name: NEUROSYSTEMS 1TM MONITOR
• Applicant: Neurosystems, LLC
• Product Code: GWM · Neurology
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

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 1TM 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.

Device Story

NeuroSystems 1 Monitor acts as secondary display system for neurosurgical ICU. Collects analog data from primary monitors measuring intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature, pH, CO2, and arterial blood pressure. Transforms inputs into digital/analog traces and trend graphs (1, 2, 8, 24 hours). Calculates cerebral perfusion pressure and displays interrelationships between variables to approximate cerebral autoregulation, vasoreactivity, and O2 metabolic index. Used in neurosurgical ICU by neurosurgeons. Output serves as clinical adjunct; not for sole diagnostic or therapeutic decision-making. Benefits include consolidated visualization of multi-modality data to assist clinical assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design, intended use, and performance characteristics compared to predicate devices.

Technological Characteristics

Secondary display monitor; receives analog inputs from primary monitoring devices. Displays digital/analog traces, trends, and relationship graphs. Connectivity via analog data inputs from primary monitors. No specific materials or software architecture details provided.

Indications for Use

Indicated for neurosurgical patients requiring multi-modality monitoring of intracranial pressure, cerebral blood flow, brain tissue oxygen, brain temperature, pH, carbon dioxide, and arterial blood pressure. Intended for use by qualified neurosurgeons as an adjunct to primary monitoring devices.

Regulatory Classification

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.

Predicate Devices

• Novus Monitoring Limited NeuroSensor® System (K013930)
• Diametrics Medical Limited Neurotrend System (K980380)

Submission Summary (Full Text)

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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: | [phone] |
| Facsimile: | [phone] |

#### 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<br>Class II as per 21 CFR Regulation Number 882.1620 and<br>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.

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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.

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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.

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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 [phone] 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

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# 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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