SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM

{0} 510 (K) Notification Siemens SC9000/ SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis K970920 29 1997 # 510(k) SUMMARY as required per 807.92(c) ## 2: Submitter's Name, Address: Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: David Simard, Director Quality Assurance and Regulatory Affairs. Contact person for this submission: Jacqueline E. M. Emery Date submission was prepared: February 12, 1997 ## 3: Trade Name, Common Name and Classification Number: A. Trade Name: Siemens SC9000/ SC9015 Bedside Monitoring System B. Common Name, Classification Number, Class and Regulation Number: | Common Name | Classification Number | Class | Regulation Number | | --- | --- | --- | --- | | Cardiac monitor | 74DRT | II | 21 CFR 870.2300 | | Arrhythmia detector & Alarm System | 74DSI | III | 21 CFR 870.1025 | | Breathing frequency monitor | 73BZQ | II | 21 CFR 868.2375 | | Pulse rate monitor | 74BWS | II | 21 CFR 870.2300 | | Non-indwelling blood pressure monitor | 74DXN | II | 21 CFR 870.1130 | | Clinical electronic thermometer | 80BWX | II | 21 CFR 880.2910 | | Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 | | Cardiac Output Monitor | 74KFN | II | 21 CFR 870.1435 | | end-tidal Carbon-Dioxide Monitor | 73CCK | II | 21 CFR 868.1400 | | Indwelling Blood Pressure Monitor | 74CAA | II | 21 CFR 870.1110 | | Indwelling blood pressure monitor | 74CAA | II | 21 CFR 870.1110 | | Heart Rate Monitor, Neonatal | 74FLO | II | 21 CFR 870.2300 | | Ventilatory Effort Monitor (Apnea Detector) | 73FLS | II | 21 CFR 868.2375 | | Monitor Blood pressure, Neonatal, Invasive | 74FLP | II | 21 CFR 870.1110 | Siemens Medical Systems, Inc. Electromedical Group 16 Electronics Avenue Danvers, MA 01923 USA Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) {1} 510 (K) Notification Siemens SC9000/ SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis ## 4: Predicate Device Identification: The Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with ST Segment Analysis is an updated software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The Siemens SC9000/SC9015 Bedside Monitoring Systems was granted 510(K) clearance under the following 510(K) numbers: - K946306 Siemens SC9000/SC9015 Monitor (Original Submission) - K954632 Siemens SC9000/SC9015 Monitor with etCO₂ Functionality - K962291 Siemens SC9000/SC9015 Monitor modified with Neonatal Functionality - K964624 Siemens SC9000/SC9015 Monitor with modified Arrhythmia Monitoring (Pending) The software for the ST Segment Analysis was granted 510(K) clearance under: - K951371 Siemens 1481 (T) Digital Telemetry with ST Segment Analysis Option ## 5. Device Description The Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with ST Segment Analysis is an updated software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the iso-electric point (baseline). This is the same algorithm that is used in the Siemens 1481(T) Digital Telemetry System with S-T Segment Analysis Option (K951371). The hardware of the SC9000/SC9015 is unchanged. The ST Segment Analysis is not active when the Siemens SC9000/SC9015 Monitor is in the neonatal functionality The modified software (version VB2) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions. There are no hardware changes required for the upgrade. ## 6. Intended Use: The intended use of the Siemens SC9000/ SC9015 Bedside Monitoring System is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, temperature, arrhythmia (adult only), cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide, (central) apnea, and ST segment analysis (adult only). This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity (Olympus) network. Siemens Medical Systems, Inc. Electromedical Group 16 Electronics Avenue Danvers, MA 01923 USA Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) {2} 510 (K) Notification Siemens SC9000/ SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis 7. Table of device similarities and differences to predicate device. | ST Segment Analysis | Substantially Equivalent Device Siemens Medical Systems 1481T Digital Telemetry Option with ST segment analysis option K951371 | Applicant Siemens Medical Systems SC9000/SC9015 enhanced with ST analysis | Explanation of the modified version | | --- | --- | --- | --- | | Manufacturer | Siemens Medical Systems | Same | | | 510K number | K951371 | To be assigned | | | Intended patient population | Adult only | Same | | | ST segment deviation measurement accuracy | +/- 1 mm | +/- 0.5 mm | +/- 0.1 mV = 1 mm Improvements made in beat classification (K964624) enable higher accuracy. | | Leads processed | I, II, III, aVR, aVL, aVF, V | I, II, III, aVR, aVL, aVF, V, V+, V1 - V6 | Depends on cable type connected | | Iso point adjustment range | complex start to fiducial point | Same | | | Iso point default | QRS onset - 30 msec | QRS onset - 28 msec | Sample rate change necessitated QRS onset point to be changed to be a multiple of 4 msec. | | ST measurement point adjustment range | fiducial point to complex end | Same | | | measurement point default | QRS offset + 80 msec | Same | | | ST complex length | 900 msec. | Same | | | Sample rate | 100 samples/ second | 250 samples/sec. | Higher sample rate results in higher fidelity signals with finer resolution for alignment. | | Update interval | 20 seconds | 15 seconds | Improved update rate | | Alarms | Yes | Same | | Siemens Medical Systems, Inc. Electromedical Group 16 Electronics Avenue Danvers, MA 01923 USA Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) {3} 510 (K) Notification Siemens SC9000/ SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis 8. Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device. 9. Assessment of clinical performance data for equivalence: NA Performance was qualified by testing versus a standard clinical patient database per AAMI recommendations 10. Biocompatibility Data: Not applicable 11. Sterilization data: Not applicable Siemens Medical Systems, Inc. Electromedical Group 16 Electronics Avenue Danvers, MA 01923 USA Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) {4} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Ms. Jacqueline Emery Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923 JUL 29 1997 Re: K970920 Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis (SW Version VB2) Regulatory Class: III (three) Product Code: 74 DSI Dated: May 31, 1997 Received: June 4, 1997 Dear Ms. Emery: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {5} Page 2 - Ms. Jacqueline Emery This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6} Page 1 of 1 510(k) Number (if known): K970920 Device Name: Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis Indications for Use: This device is capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult only), temperature, cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide and (central) apnea and ST Segment Analysis (adult only). This device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition. ## MRI Compatibility Statement: The Siemens SC9000/SC9015 Series is not compatible for use in a MRI magnetic field. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) M. Pung Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _______________