SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM

K962291 · Siemens Medical Solutions USA, Inc. · DSI · Jan 29, 1997 · Cardiovascular

Device Facts

• Record ID: K962291
• Device Name: SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jan 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, cardiac output, end-tidal carbon dioxide and (central) apnea. This device will produce visual and aural 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.

Device Story

Bedside monitoring system for neonatal patients; inputs include ECG, impedance respiration, invasive/non-invasive pressure, temperature, SpO2, and etCO2 sensors. Device processes physiological signals to calculate heart rate, respiration rate, cardiac output, and arrhythmia detection. Produces visual/aural alarms and recordings when parameters exceed user-defined limits. Used in clinical settings by healthcare providers; connects to SIRENET or Infinity networks for data integration. Output assists clinicians in real-time patient status assessment and clinical decision-making. Benefits include continuous monitoring and timely notification of physiological instability.

Clinical Evidence

No clinical data provided; assessment of clinical performance data for equivalence stated as not applicable.

Technological Characteristics

Bedside monitoring system; software-based neonatal parameter modules. Connectivity via SIRENET or Infinity network. Parameters: ECG, impedance respiration, cardiac output, invasive/non-invasive pressure, pulse, temperature, SpO2, etCO2. QRS duration measurement range 40-120 msec.

Indications for Use

Indicated for neonatal patient population requiring monitoring of heart rate, respiration, invasive/non-invasive blood pressure, arrhythmia, temperature, cardiac output, SpO2, and apnea detection.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Siemens Sirecust 1260/1261/1280/1281/960/961 series Neonatal Monitoring system (K952054)

Submission Summary (Full Text)

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JAN 29 1997
K96.2291
510 (K) Notification
Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with Neonatal Functionality

# 510(k) SUMMARY

as required per 807.92(c)

2: Submitters Name, Address:

Siemens Medical Systems, Inc.
16 Electronics Avenue
Danvers, MA 01923
Tel: [phone]
Fax: [phone]
Official Correspondent: Robert W. Becker
Contact person for this submission: Jacqueline E. M. Emery
Date submission was prepared: June 1, 1996

3: Trade Name, Common Name and Classification Name:

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 Bloodpressure, Neonatal, Invasive | 74FLP | II | 21 CFR 870.1110 |

Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923
USA
Tel: [phone]
Fax: [phone]
Telex: 511958 (Siemensm SD)

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510 (K) Notification

Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with Neonatal Functionality

4: Predicate Device Identification:
The Siemens Sirecust 1260/1261/1280/1281/960/961 series Neonatal Monitoring system, 510(K) file number K952054.

5. Device Description
The Siemens SC9000/ SC9015 Bedside Monitoring System, with enhanced Neonatal Functionality is an enhanced software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The enhancement adds neonatal monitoring.

6. Intended Use:
The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, cardiac output, end-tidal carbon dioxide and (central) apnea. This device will produce visual and aural 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.

7. Table of device similarities and differences to predicate device

| | Modified Software
SC9000/ SC9015
Neonatal Monitor | Substantially Equivalent Device
1200 series Neonatal Monitoring System
(K952054) | Explanation of the modified version differences when compared to the 1200 series Neonatal Monitoring System |
| --- | --- | --- | --- |
| Manufacturer | Siemens Medical Systems EMG | Siemens Medical Systems EMG | |
| 510K number | To be assigned | K952054 | |
| Intended population | Neonatal | Neonatal | Same neonatal application areas |
| Monitoring parameters | Software modules added for neonatal application:
ECG, Respiration (impedance), Cardiac Output, Invasive pressure, Pulse, Temperature, SpO2, non-invasive pressure, etCO2 | Software modules for neonatal application:
ECG, Respiration (impedance), Cardiac Output, Invasive pressure, Pulse, Temperature, SpO2, non-invasive pressure, etCO2 | |
| Apnea delay time (default) | 15 seconds | 10 seconds | Apnea alarm time is user selectable. Default was changed to 15 seconds based upon customer preference. |
| Neonatal Resp. Rate Monitoring (default) | ON | ON | |

Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923
USA
Tel: [phone]
Fax: [phone]
Telex: 511958 (Siemensm SD)

{2}

510 (K) Notification

Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with Neonatal Functionality

| | Modified Software
SC9000/ SC9015
Neonatal Monitor | Substantially Equivalent Device
1200 series Neonatal Monitoring System
(K952054) | Explanation of the modified version differences when compared to the 1200 series Neonatal Monitoring System |
| --- | --- | --- | --- |
| Heart Rate Limits (default) | 80 & 170 | 100 & 170 | Default was changed to 80 based upon customer preference. |
| Resp Rate limits (default)
(Impedance) | 20 & 60 | 6 & 85 | Defaults were changed based upon customer preference. |
| Impedance. Resp. Rate Apnea Alarm Grade (Default) | Serious | Serious | |
| SpO2 Pulse Limit (default) | 95 % | 100% | Defaults were changed based upon customer preference |
| Temperature Alarm Limit (default) | 34.0 & 39.0 °C | 30.0 & 40.0 °C | Defaults were changed based upon customer preference. |
| etCO2 alarm limits (default) | 30 & 50 mmHg | 20 & 25 mmHg | Defaults were changed based upon customer preference. |
| Max. NBP cuff inflation time | 90 sec. | 120 sec. | Reduced per customer preference. |
| Max. NBP cuff pressure | 150 mmHg | 150 mmHg | |
| QRS duration measurement
(neonatal) | 40 to 120 msec | 40 to 120 msec | |

8. Assessment of non-clinical performance data for equivalence: Not applicable
9. Assessment of clinical performance data for equivalence: Not applicable
10. Not applicable
11. Not applicable

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue

Danvers, MA 01923

USA

Tel: [phone]

Fax: [phone]

Telex: 511958 (Siemensm SD)