DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "K052975" in a large, bold font. Below this, the text "Page 1 of 4" is printed in a smaller font size. The text suggests that this is the first page of a document that is four pages long, and "K052975" may be a document or identification number. JAN 2 0 2006 ## Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software ## 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: - October 20, 2005 #### DEVICE NAME as required by 807.92(a)(2) #### TRADE NAME: Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software #### COMMON NAME: Remote monitoring device #### CLASSIFICATION NAME: The following Class II classifications appear applicable: | Product Code | Classification Name | CFR Section | |--------------|-----------------------------------------------------------|-------------| | MSX | System, network and communication, physiological monitors | 870.2300 | {1}------------------------------------------------ ## NAME OF LEGALI.Y MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3) The revised Datex-Ohmeda S/5 Web Viewer version and S/5 Pocket Viewer version and the new S/5 Cellular Viewer are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer versions (K033078) currently in distribution. #### DEVICE DESCRIPTION as required by 807.92(a)(4) The Datex-Ohmeda S/5 Web Viewer is a supplementary monitoring application running on a generic PC that is connected to the hospital LAN, either directly or via the Internet. It is based on the World Wide Web and Java technologies, and it is intended to be used for remote viewing of real-time patient information and trends from patient monitors that are connected to the Datex-Ohmeda \$/5 Network and Central. The Pocket Viewer is a Web Viewer version running on a Pocket PC PDA that is connected to the hospital LAN via wireless access within the hospital, or via a mobile connection outside the hospital. The PDA uses a standard WLAN (802,111b) or mobile connections (GSM, GPRS, HSCSD, CDMA) to gain access to the Hospital LAN and Web Server. The Cellular Viewer is a Web Viewer version running on a generic cellular phone that is connected to the hospital LAN via a mobile connection. The mobile phone uses standard mobile connections (GSM, GPRS, HSCSD) to gain access to the Hospital LAN and Web Server. The Web Viewer, Pocket Viewer and Cellular Viewer are not primary alarm sources but decisionmaking support tools that offer clinicians access to the patient data also outside the patient care area. The network architecture of the S/5 Web/Pocket/Cellular Viewer system consists of the following components: - Datex-Ohmeda S/5 Network that connects D-O monitors to one or more D O S/5 Centrals ◆ - The Hospital LAN to which the office PCs in the hospital are connected to . - . The S/5 Web Server that is connected to both of these networks - S/5 Web Viewer client programs running in desktop and laptop PCs, S/5 Pocket Viewer client . programs running in PDAs and S/5 Cellular Viewers running in generic cellular phones - . Optional VPN (virtual private network) or dial-up solutions enabling remote connection to patient monitoring data with the S/5 Web Viewer, Pocket Viewer and Cellular Viewer The hospital is responsible for ensuring a secure and functional interface between the Datex-Ohmeda S/5 Network and the Hospital LAN, by utilizing, for example, a gateway, router, switch or firewall, as shown in the figure above. If the Web Viewer clients are not connected to a hospital Intranet, a regular hub can be used instead. Wireless LAN access points are required to connect the Pocket Viewer to the WLAN. For Cellular phones the proper subscriptions with the telephone operators are needed. {2}------------------------------------------------ #### INTENDED USE as required by 807.92(a)(5) Indication for use for S/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only. Indication for use for S/5 Pocket Viewer: The Datex-Ohmeda S/5 Pocket Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Pocket Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Pocket Viewer clients. The S/5 Pocket Viewer client runs on a generic handheld computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only. Indication for use for S/5 Cellular Viewer: The Datex-Ohmeda S/5 Cellular Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Cellular Viewer client runs on a generic cellular phone that is connected to the hospital local area network. The Datex-Ohmeda S/5 Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 CellularViewer is not a primary alarm source. The device is for use by qualified personnel only. ### SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6) The revised Datex-Ohmeda S/5 Web Viewer version and S/5 Pocket Viewer version and the new S/5 Cellular Viewer are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer versions (K033078) currently in distribution, Similarities: The indications for use for the S/5 Web Viewer is identical to the predicate. The indications for use for the S/5 Pocket Viewer is identical to the predicate. The indications for use for the S/5 Cellular Viewer is the same as in predicate S/5 Pocket Viewer except that the term 'generic handheld computer' has been replaced by a term 'generic mobile phone'. The structure and functionality of the revised Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer and the new S/5 Cellular Viewer corresponds to the structure and functionality of the Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer (predicate). The basic architecture of the revised Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer and the new Cellular Viewer is the same as that of Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer (predicate). {3}------------------------------------------------ The revised Datex-Ohmeda S/5 Web Viewer and S/5 Pocket Viewer and the new S/5 Cellular Viewer can show real-time curves, numeric information, graphical and numerical trends and visual alarms from bedside monitors just like the predicate. The physical network components used by the revised S/5 Web Viewer and S/5 Pocket Viewer and the new S/5 Cellular Viewer are the same as in the predicate. #### Differences: The following functionality has been added to the revised Datex-Ohmeda S/5 Web Viewer, S/5 Pocket Viewer and the new S/5 Cellular Viewer: User interface changes: - A new viewer type Cellular Viewer is available . - Up to 30 concurrent Cellular Viewer users . - Entropy parameter numeric values and trends are provided ● - User specific configurations are possible through User Configuration Pages . - . User can change her/his own password - . No more support for S/5 Light Monitor trends In addition to the functional changes, the following technical improvements have been implemented in the revised S/5 Web Viewer and S/5 Pocket Viewer: - . The new version supports standard mobile phone technology - Support for HTTPS tunneling with advanced communication security is available . - PC hardware: A new version of the PC for the Web Server computer has been . specified because manufacturing of the earlier one was discontinued #### Summary: The changes above do not effect safety and effectiveness of the system, and the new Datex-Ohmeda S/5 Web Viewer, S/5 Pocket Viewer and S/5 Cellular Viewer, described in this submission, are substantially equivalent to the predicate device. ## SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3) Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications. - EN60950: 2000 (IEC60950 3rd edition) Product Safety . - EN 55022: 1998 (IEC-CISPR 22) Radio Frequency Interface � - EN 55024: 1998 (IEC-CISPR 24) Electromagnetic Immunity . - EN 61000-3-2:1995 + A1/A2/A14, Harmonic Currents . - EN 61000-3-3:1995, Voltage Fluctuation and Flicker . - EMC Directive 89/336/EEC (including amendments) . - Low Voltage Directive 73/23/EEC (amended by 93/68/EEC) . - . ISO 14971:2000, Medical devices - Risk analysis - IEC 60601-1-4Medical electrical equipment. Part 1: General requirements for safety4. . Collateral Standard: Safety requirements for programmable medical systems. - CAN/CSA-C22.2 No. 60950-00: Safety on Information Technology Equipment. . - . UL: IEC 60950 (1999) Third Edition, #### CONCLUSION: The summary above shows that there are no new questions of safety and effectiveness for the revised Datex-Ohmeda S/5 Web Viewer version and S/5 Pocket Viewer version and the new S/5 Cellular Viewer and they are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer versions (K033078). {4}------------------------------------------------ Public Health Service Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 0 2006 GE Healthcare c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492 Re: K052975 Trade Name: Datex-Ohmeda S/5 Web Viewer, Pocket Viewer and Cellular Viewer with L-WEB04 software Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Monitors Network and Communication System Regulatory Class: Class II (two) Product Code: MSX Dated: December 19, 2005 Received: December 21, 2005 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 mav publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ Page 2 -- Mr. Joel C. Kent 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 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 (OS) 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. B/Bummar for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ ## Device Name: Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software. #### Indications for use: Indication for use for \$/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only. Indication for use for S/5 Pocket Viewer: The Datex-Ohmeda S/5 Pocket Viewer displays information received from other networked devices. It is comprised of a \$/5 Web Server and S/5 Pocket Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Pocket Viewer clients. The S/5 Pocket Viewer client runs on a generic handheld computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda \$/5 Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only. Indication for use for S/5 Cellular Viewer: The Datex-Ohmeda S/5 Cellular Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Cellular Viewer client runs on a generic cellular phone that is connected to the hospital local area network. The Datex-Ohmeda \$/5 Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 CellularViewer is not a primary alarm source. The device is for use by qualified personnel only. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <img alt="Signature" src="signature.png"/> | |------------------------------------|--------------------------------------------| | (Division Sign-Off) | | | Division of Cardiovascular Devices | | | 510(k) Number | K052976 | | | Page __ of __ |