MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN

{0}------------------------------------------------ Page 1 of 5 # Kob2324 UEL - 6 2006 ## Premarket Notification 510(k) Summary As required by section 807.92 MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories ### GENERAL COMPANY INFORMATION as required by 807.92(a)(1) #### COMPANY NAME/ADDRESS/PHONE/FAX: GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344 #### NAME OF CONTACT: Mr. Joel Kent #### DATE: August 7, 2006 ### DEVICE NAME as required by 807.92(a)(2) #### TRADE NAME: The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories #### COMMON NAME: Patient Monitor {1}------------------------------------------------ #### CLASSIFICATION NAME: The following Class II and Class I classifications appear applicable: | Product Code | Classification Name | CFR Section | |--------------|--------------------------------------------------------------|-------------| | MHX | Arrhythmia detector & alarm | 870.1025 | | MLD | Monitor ST-segment & alarm | 870.1025 | | DSF | Paper Chart Recorder | 870.2810 | | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-phase | 868.1400 | | CCL | Analyzer, Gas, Oxygen, Gaseous-phase | 868.1720 | | BZK | Spirometer, Monitoring (W/WO alarm) | 868.1850 | | CBR | Analyzer, Gas, Nitrous-Oxide,Gaseous-phase (Anesthetic co) | 868.1700 | | BZL | Computer, Oxygen-uptake | 868.1730 | | CBQ | Analyzer, Gas, Enflurane, Gaseous-phase (Anesthetic conc.) | 868.1500 | | CBS | Analyzer, Gas, Halothane Gaseous-phase (Anesthetic conc.) | 868.1500 | | NHO | Analyzer, Gas, Desflurane, Gaseous-phase (Anesthetic conc.) | 868.1500 | | NHQ | Analyzer, Gas, Isoflurane Gaseous-phase (Anesthetic conc.) | 868.1500 | | NHP | Analyzer, Gas, Sevoflurane, Gaseous-phase (Anesthetic conc) | 868.1500 | | DQA | Oximeter | 870.2700 | | DRT | Cardiac Monitor (including cardiotachometer and rate alarm) | 870.2300 | | DPS | Electrocardiograph | 870.2340 | | DXN | Non-invasive blood pressure measurement system | 870.1130 | | DSK | Blood pressure computer | 870.1110 | | DRQ | Transducer signal amplifier and conditioner | 870.2060 | | DSA | Cable, transducer and electrode, Patient including connector | 870.2900 | #### NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3) The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG. N-SNGV, N-SNG. N-PSN, N-SN, E-MRICAiOVX. E-MRICAiOV, E-MRICAiOV, E-MRICAiO. E-MRICO and accessories is substantially equivalent to the predicates D-E MRI Monitor (980651), S/5™ CAM with L-CANE05 and L-CANE05A (K061185), Datex-Ohmeda S/57M E-CAiOVX Module (K051092) and accessories and Datex-Ohmeda S/5TM E-PRESTN Module (K051217) and accessories. #### DEVICE DESCRIPTION as required by 807.92(a)(4) The MRI Monitor has the following key components: MRI Shield in which the Compact Monitor Frame is placed, Monitor software and Built-in measurement modules. The optional components consist of Remote Controller, Anesthesia Record Keeper Keyboard and an aluminum/plastic MRI cart with locking casters. The MRI Monitor can be controlled by the keys on the monitor's keyboard, Remote Controller or by Active Remote Screen keyboard. Function keys provide direct access to menu functions determined to be most important to the user. The ComWheel™ provides access to any menu function. The command board located on the lower front face of the monitor contains seventeen function keys, a wheel (ComWheel) for selection of monitor from menus as well as the on/off switch for the monitor. Function keys provide direct access to menu functions determined to be most important to the user. The ComWheelTM provides access to any menu function. There are keys on the monitor's side panel for ON/Standby, NIBP, Invasive Pressures and Recorder functions. With these keys, you can start or end a function immediately. {2}------------------------------------------------ The built-in recorder is a thermal printer and records up to three real time waveforms simultaneously or displays recordings of numerical information in horizontal and vertical plane. The recorder prints up to 24 hours or graphical and numerical trend data. The remote controller (K-CREMCO) has twelve function keys and a ComWheel for accessing all other monitor functions. It also has some direct function keys, which start or end a function immediately. To enter functions that do not have their own key, press the Menu key. The remote controller is not cordless but remains attached to the command board via a cable. The anesthesia record keeper keyboard (K-ARKB) is attached to the frame with a cable. The record keeper keyboard features command board, record keeper function keys and letter and number keys (alphanumeric keys). The bar code reader can be used to facilitate quick access to menus. The bar code reader is connected to the LCD display or to the record keeper keyboard. The manufacturing of the bar code reader has been discontinued, but the monitor software L-CANE05(A) still supports the use of it The parameter modules for the MRI monitor are built into the Compact Monitor frame during manufacturing. They cannot be removed during monitoring. Depending on the configuration the MRI Monitor features a different set of parameters. #### INTENDED USE as required by 807.92(a)(5) #### Intended Use: The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is intended for multiparameter patient monitoring. #### Indications for use: The MRI Monitor with I -CANE05 or L-CANE05 A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for monitoring of hemodynamic (comprising ECG (including heart rate, ST-segment and arrhythmia), NIBP, SpO2, and invasive blood pressure), respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE, Gas exchange monitoring is not indicated in the presence of N2O+O2 mixtures), status of hospital patients during magnetic resonance scanning. The NIBP measurement is indicated for patients who weigh 5kg (11 lb) and up. The MRI Monitor with L-CANE05 or L-CANE05A software is also indicated for documenting patient care related information. The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for use in the MR environment up to 300 Gauss with static magnets up to 3.0 Tesla. SpO2 and ECG monitoring is indicated only with accessories (OXY-FMR, OXY-WMR, 897986 (ECG cable, AAMI) and 897987, ECG Cable, IEC) specifically designed for the MR environment. The MRI Monitor with L-CANE05 or L-CANE05A software is indicated for use by qualified medical personnel only. {3}------------------------------------------------ #### SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6) The MRI Monitor design follows similar principles as the predicate Datex-Engstrom MRI Monitor (K980362). The predicate Datex-Engstrom MRI Monitor (K980362) utilized the existing technology of Datex-Engstrom Compact Anesthesia Monitor and its modules of that time. These monitor components were placed in an RF Shield to eliminate the RF interference. The combination of the RF shield, the monitor frame and the parameter modules was called Datex-Engstrom MRI Monitor (K980362). The MRI Monitor has been designed in the same way. The existing technology of S/5 Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software (K061185) and its parameter modules are placed in the new RF Shield. This combination of a RF shield, S/5 Compact Anesthesia Monitor and its parameter modules is called MRI Monitor. The main difference is in performance. The predicate Datex-Engstrom MRI Monitor (K980362) was intended for use in MRI room up to the 20 Gauss line. The 20 Gauss line specification does not allow the use of the predicate Datex-Engstrom MRI Monitor (K980362) close to the MRI system. It might degrade the MRI image quality due to the RF emissions. The new MRI Monitor is intended for use in the MRI Room up to the 300 Gauss line. This has been achieved by using a new RF shield, which eliminates the RF interference better than the predicate. Thus, the MRI Monitor can be closer to the MRI system giving more flexibility to move the MRI Monitor in and out of the MRI Room. The MRI Monitor uses the F-MRICM1, which is modified from the F-CM1 S/5 Compact Anesthesia Frame (K061185). The MRI Monitor with N-PSNGV option utilizes the technology of the Datex-Ohmeda E-PRESTN (K051217) modules. The MRI Monitor with E-MRICAiOVX option utilizes the technology of the Datex-Ohmeda E-CAiOVX (K051092) modules. Based on the above analysis and a detailed analysis and other documentation included in this submission and attachments, it is evident that the main features and indications for use of the MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is substantially equivalent to the predicates D-E MRI Monitor (980651), S/5TM CAM with L-CANE05 and L-CANE05A (K061185), Datex-Ohmeda S/5TM E-CAiOVX Module (K051092) and accessories and Datex-Ohmeda S/5TM E-PRESTN Module (K051217) and accessories. {4}------------------------------------------------ #### SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3) The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications. - . FDA 21 CFR Part 898, § 898.12 - ◆ IEC 60601-1:1998, Amendment 1: 1991, Amendment 2: 1995 - EN60601-1:1990 Medical electrical equipment Part 1:General requirements for safety . Amendment 1: 1993 Amendment 2: 1995, Amendment 13: 1996 - CAN/CSA C22.2 No. 601.1-M90: Medical Electronical Equipment. Part 1: General . requirements for safety + Supplement 1: 1994, Amendment 2: 1998 - UL 2601-1 . - . IEC 60601-1-2 / EN 60601-1-2 - IEC 60601-1-4:1996 / EN 60601-1-4, Amendment 1: 1999 � - . IEC 60601-2-49:2001 - EN 60601-2-49:2001 . - IEC 60601-2-27 / EN 60601-2-27: - IEC 60601-2-30 /EN 60601-2-30 ● - . IEC 60601-2-34 / EN 60601-2-34 - ISO 7767 / EN 12598 - ISO 9918 / EN 864 . - . ISO 9919 / EN 865 - ♥ ISO 11196:1995 + Corr.1:1997 / EN ISO 11196:1997 - � IEC 60068-2 - . ANSI/AAMI ES-1: 1993 - . FDA /ODE Guidance for Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005 - . FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm", Oct 28 2003 - . ANSI/AAMI EC57:1998 - . AAMI EC13-2002 - . FDA GGP: A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, CDRH Magnetic Resonance Working Group. #### CONCLUSION: The summary above shows that there are no new questions of safety and effectiveness for the MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories as compared to the predicates D-E MRI Monitor (980651), S/5TM CAM with L-CANE05 and L-CANE05A (K061185), Datex-Ohmeda S/5TM E-CAiOVX Module (K051092) and accessories and Datex-Ohmeda S/5™ E-PRESTN Module (K051217) and accessories. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 6 2006 GE Healthcare c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492 Re: K062324 Trade Name: MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, F-MRICAiOV, E-MRICAiO, E-MRICO and accessories Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: II Product Code: MHX Dated: October 24, 2006 Received: October 25, 2006 Dear Mr. Kent: 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, listing 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 {6}------------------------------------------------ Page 2 - Mr. Joel C. Kent 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. 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 240-276-0120. 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 vours. B. Zimmermann fo Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): Jous2324 Device Name: MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories. Indications for use: The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG. N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAIOVX, E-MRICAIOV, E-MRICAIO, E-MRICO and accessories is indicated for monitoring of hemodynamic (comprising ECG (including heart rate, ST-segment and arrhythmia), NIBP, SpO2, and invasive blood pressure), respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE, Gas exchange monitoring is not indicated in the presence of N20+02 mixtures), status of hospital patients during magnetic resonance scanning. The NIBP measurement is indicated for patients who weigh 5kg (11 lb) and up. The MRI Monitor with L-CANE05 or L-CANE05A software is also indicated for documenting patient care related information. The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAIOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for use in the MR environment up to 300 Gauss with static magnets up to 3.0 Tesla. SpO2 and ECG monitoring is indicated only with accessories (OXY-FMR, OXY-WMR, 897986 (ECG cable, AAMI) and 897987, ECG Cable, IEC) specifically designed for the MR environment. The MRI Monitor with L-CANE05 or L-CANE05A software is indicated for use by qualified medical personnel only. Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) B. Bimmerman Division Signi-C Division of Cardiovascular Devices 510(k) Number_1506232 Page of of !