NEUROSYSTEMS 1TM MONITOR

{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 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. {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 .