DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02

{0}------------------------------------------------ Page 1 of 4 K070421 MAR 1 3 2007 # Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT.02 # 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: February 3, 2007 ## DEVICE NAME as required by 807.92(a)(2) # TRADE NAME: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02 ## COMMON NAME: Medical device data converter ### CLASSIFICATION NAME: ### The following Class II classification appears applicable: Product Code Classification Name System, Network And Communication, MSX Physiological Monitors CFR Section 870.2300 # NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3) The S/5TM Device Interfacing Solution, N-DISxxxx.01 with N-DISVENT..02 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5™ Device Interfacing Solution, N-DISxxxx..01 (K051634). {1}------------------------------------------------ # DEVICE DESCRIPTION as required by 807.92(a)(4) S/5 Device Interfacing Solution (later referred to as DIS) is a module that transfers data between an external device and S/5 monitor. External devices are connected to the monitoring system by using small plug-in converter modules that handle the communication between the device and S/5 monitoring system. These DIS converter modules convert the data coming from the connected device to a format that can be utilized in the Datex-Ohmeda S/5 Anesthesia Monitor, Datex-Ohmeda S/5 Critical Care Monitor, Datex-Ohmeda S/5 Compact Anesthesia Monitor, Datex-Ohmeda S/5 Compact Critical Care Monitor, or Datex-Ohmeda S/5 FM. The use of a DIS system consists of making the physical connections connecting external devices to DIS and linking DIS modules together to make a complete bus. Then the DIS transfers data between a device and the S/5 monitoring system. The user can then select the source of measurement data for physiologic parameters displayed on the Datex-Ohmeda monitor. The first DIS converter module is connected to the socket at the Datex-Ohmeda S/5 monitor. In S/5 Anesthesia Monitor and S/5 Critical Care Monitor the DIS socket is located at the rear of the monitor in the F-CU8 monitor frame option and at the front of the monitor in the F-CU5(P) monitor frame option. In S/5 Compact Anesthesia Monitor, S/5 Compact Critical Care Monitor, and S/5 FM monitor the DIS socket is located in left hand side of the monitor. Additional DIS converter modules in a system are connected to each other with the bus cable. The external device is connected to the DIS converter module with a device specific cable. Up to ten DIS converter modules can be connected in the system. The maximum number of simultaneous interfaces is ten. The maximum length of interface cable is 10 meters (33ft). The number of DIS interfaces that can be used depend on the length of the interface cables and the particular monitor used. The Device Interfacing Solution supports interfacing of the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines. The Device Interfacing Solution can interface numerical, waveform and event type of data from the external device. Alarms are not transferred but alarm status events are transferred. Interfaced data can be displayed on the monitor screen, trended, printed and used for record keeping purposes. Also, interfaced physiologic data is sent to the network to be viewed at the Central station monitor. #### INTENDED USE as required by 807.92(a)(5) #### Intended Use: Intended use: The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transferring data between external devices and a monitor. #### Indications for use: The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx.01 with N-DISVENT..02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only. {2}------------------------------------------------ # SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6) The S/5™ Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5™ Device Interfacing Solution, N-DISxxxx... 01 (K051634). The N-DISxxxx..01 with N-DISVENT..02 like the predicate N-DISxxxx..01 (K051634) does not perform any physiological measurements itself. It transfers data between connected external devices and S/5™ monitoring system. The Datex-Ohmeda S/5™ monitor displays, trends and uses data for calculations and transfers it to the record keeping system and network accordingly. The N-DISxxxx..01 with N-DISVENT..02, in terms of general function is identical to its S/5™ Device Interfacing Solution, N-DISxxxx..01 (K051634). The N-DISxxxx..01 with N-DISVENT..02 simply extends capability of Interfacing Solution to the Datex-Ohmeda S/5TM monitor by introducing an enhanced version of the N-DISVENT. Neither the Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02 nor the predicate N-DISxxxx..01 (K051634) transfer alarms. A new feature of the N-DISVENT..02 module is that it can transfer ventilator alarm status events (e.g. "FiO2 low", "Replace O2 sensor", "Inspiration stopped", "MVexp low", "Circuit leak", "RR low", "FiCO2 low. Absorbent OK?", "FiSEV high", "Alternate O2, Aisys", etc.) to the monitor. The other new features of the N-DISVENT..02 are: patient demographics data transfer between the monitor and the ventilator, gas consumption event data transfer from the ventilator to the monitor. The main differences between the new N-DISxxxx..01 with N-DISVENT..02 and the predicate N-DISxxxx..01 (K0516341) are as follows: - Demographics data of patient (Patient ID, weight, height and BSA) is transferred between 1. the S/5 Monitor and the external device with N-DISVENT..02. - Ventilator alarm status events are transferred from the ventilator through 2. N-DISVENT..02 and S/5 Monitor to the network. - Ventilator gas consumption event data is transferred from the ventilator through N-3. DISVENT..02 and S/5 Monitor to the network after the patient case has been ended at the ventilator. - 4. Modifications to Labeling: Changes to the labeling include revised Installation Guides, and Brochure for S/5 Device Interfacing Solution. The N-DISA2000 Installation Guide is updated with compatibility information of BIS Monitoring System's software BIS Engine version 3.31 and BIS Vista Monitoring System's version 1.01. Uset's Guides for Anesthesia, Critical Care and Flexible Monitors are essentially same. The User's Guide for S/5 Anesthesia Monitor has been updated with additional safety precautions, warnings and corrections. Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the S/5™ Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02 is substantially equivalent to the predicate S/57M Device Interfacing Solution, N-DISxxxxx.01 (K051634). {3}------------------------------------------------ # SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3) The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02 has been assessed against the standards below and details of conformity are presented in the attached 510(k) notification. The device has been thoroughly tested through validation and verification of specifications. - . EN 60601-1:1990 + Amdt 1:1993 + Amdt 2:1995 + Amdt 3:1996 Medical electrical equipment Part 1: General requirements for safety - IEC 60601-1:1988 +Amdt 1:1991 + Amdt 2:1995 . - CAN/CSA C22.2 No. 601.1-M90 + S1:1994 + Amdt 2:1998 . - UL 2601-1,October 24, 1997 . - IEC 60601-1-2:2001, Electromagnetic compatibility Requirements and tests . - . EN 980: 1996, Terminology, symbols and information provided with medical devices- Graphical symbols for use in the labeling of medical devices - . EN 1041 1998, Terminology, symbols and information provided with medical devices; information supplied by the manufacturer with medical devices. - . Protection against ingress of liquid: EN 60529 (IPX1): 1992 ### CONCLUSION: The summary above shows that the S/5™ Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT.. 02 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5TM Device Interfacing Solution, N-DISxxxx..01 (K051634). {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the top of the seal. The seal is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Joel C. Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492 MAR 1 3 2007 Re: K070421 Trade/Device Name: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISENT..02 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II Product Code: MSX Dated: February 4, 2007 Received: February 13, 2007 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. {5}------------------------------------------------ # Page 2 - Mr. 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 (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. Clues Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental 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 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02 Indications for Use: The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only. | Prescription Use | X | |-----------------------------|---| | (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) | | |--------------------------------------------------------|---------| | | Page | | | | | | K070421 |