SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS

{0} 02/26/98 14:53 978 907 7605 SIEMENS MED STS 003 Siemens SC6000/SC6000P Portable Bedside Monitoring Series with ST Segment Analysis FEB 26 1998 510(k) SUMMARY as required per 807.92(c) K974492 2. Submitters Name, Address: Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 750-7500 Fax: (978) 777-3398 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline Emery Date submission was prepared: November 14, 1997 3. Trade Name, Common Name and Classification Name: A. Trade Name: Siemens SC6000/ SC6000P Bedside Monitoring Series enhanced with ST Segment Analysis B. Common Name, Classification Name, Class and Regulation Number: | Common Name | Classification Number | Class | Regulation Number | | --- | --- | --- | --- | | Cardiac Monitor | 74DRT | II | 21 CFR 870.2300 | | Pulse Rate Monitor | 74BWS | II | 21 CFR 870.2300 | | Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 | | Breathing Frequency Monitor | 73BZQ | II | 21 CFR 868.2375 | | Clinical Electronic Thermometer | 80BWX | II | 21 CFR 880.2910 | | Indwelling Blood Pressure Monitor | 74CAA | II | 21 CFR 870.1110 | | Noninvasive Blood Pressure Monitor | 74DXN | II | 21 CFR 870.1130 | | 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 | | ST Segment Monitor with Alarm | 74 MLD | III | 21 CFR 870.1025 | | Arrhythmia Detector & Alarm System | 74DSI | III | 21 CFR 870.1025 | 2. Predicate Device Identification: The Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371) 1 COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD) {1} 02/26/98 14:54 978 907 7605 SIEMENS MED SYS 004 # Siemens SC6000/SC6000P Portable Bedside Monitoring Series with ST Segment Analysis ## 3. Device Description: The SC 6000 / SC 6000P Bedside Monitoring Series Enhanced with ST Segment Analysis is an updated software version of the SC 6000 / SC 6000P Bedside Monitoring Series. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the isoelectric point (baseline). This is the same algorithm that is used in the Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371). The hardware of the SC 6000 / SC 6000P (510(k) K944350) is unchanged. The ST Segment Analysis is not active when the SC 6000/SC 6000P is in the neonatal mode. The modified software (version VC0) is not compatible with all previously sold versions of the monitor. Therefore, a software upgrade will be offered to the owners of units with previous software revisions. No hardware changes are required for the upgrade. ## 4. Intended Use: The intended use of the SC 6000/SC 6000P Bedside Monitoring Series is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult) temperature, arterial oxygen saturation, pulse rate, central apnea, and ST Segment Analysis (adult). The device will produce visual and audible alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings. 2 # COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD) {2} 02/26/98 14:54 978 907 7605 SIEMENS MED SYS 005 # Siemens SC6000/SC6000P Portable Bedside Monitoring Series with ST Segment Analysis | | Substantial Equivalent Device Siemens Medical Systems 1481T Digital Telemetry with ST Segment Analysis Option | Applicant Siemens Medical Systems SC 6000/SC 6000P Series Enhanced with ST Segment Analysis | Explanation of the modified version | | --- | --- | --- | --- | | Intended Use | The intended use of this device is to detect a patient’s EKG signals and to transmit this data via radiofrequency to a central monitoring station. At the central monitoring station, cardiac arrhythmias, ST segment deviation values and heart rates are determined. The patient’s pulse rate and arterial oxygen saturation values, heart rate values, ST segment deviation values are displayed and visual and aural alarms and recordings are initiated if these parameters vary beyond preset limits. | The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult only), ST Segment Analysis (adult), temperature, arterial oxygen saturation, pulse rate, and (central) apnea. 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 | The intended use for the ST Segment Analysis is the same for both the SC6000 and the predicate, 1481T. The devices themselves have different intended uses (patient monitor vs. telemetry system) | | Intended Population | Adult | Adult | | | Intended Environment | Where patient care is provided by healthcare professionals | Same | | | ST Segment deviation measurement accuracy | ±1mm / ±0.1mV | Same | | | Leads processed | Any two of I, II, III, V | Any one of I, II, III, V, aVR, aVL, aVF | The SC6000 series measures only one lead and supports augmented leads. | | ISO point adjustment range | Complex start to fiducial point | Same | | | ISO point default | 30 msec before QRS onset | Same | | | ST measurement point adjustment range | Fiducial point to complex end | Same | | | ST complex length | 900 msec | Same | | | Sample Rate | 100 samples per second | Same | | | Update interval | 20 Seconds | 15 Seconds | | | Alarms | Yes | Same | | ## 3 COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD) {3} 02/26/98 14:55 978 907 7605 SIEMENS MED S13 006 Siemens SC6000/SC6000P Portable Bedside Monitoring Series 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: The ST Segment Analysis of the SC6000/SC6000P series patient monitors is equivalent to the ST Segment Analysis of the predicate device. 10. Biocompatibility: Not applicable (Same as original submission) 11. Sterilization: Not applicable (Same as original submission) 12. Standards and Guidance: Currently there are no FDA standards for this device. The Siemens Series SC 6000/SC 6000P Bedside Monitoring Series enhanced with ST Segment Analysis complies with: "Performance Measurements for Algorithms to Detect Transient Ischemic ST Segment Changes", IEEE 1992 "ST Segment Monitor Preliminary Guidance", US Department of Health and Human Services, July 1994. 4 COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD) {4} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 26 1998 Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Re: K974492 Siemens SC6000/SC6000P Bedside Monitoring Series Enhanced with ST Segment Analysis Regulatory Class: III (three) Product Code: 74 MLD Dated: November 25, 1997 Received: November 28, 1997 Dear Mr. Simard: 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 - Mr. David Simard 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): K974492 Device Name: Siemens SC6000 / SC6000P Bedside Monitoring Series enhanced with ST Segment Analysis ## Indications for Use: The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition. ST Segment Analysis is intended for use in the adult population. The SC6000/SC6000P is not for home use. ## MRI Compatibility Statement: The Siemens SC6000 / SC6000P Bedside Monitoring System 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)