SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM

K964624 · Siemens Medical Solutions USA, Inc. · DSI · Sep 11, 1997 · Cardiovascular

Device Facts

• Record ID: K964624
• Device Name: SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Sep 11, 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 (adult), 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. The SC9000/SC9015 Modified Patient Monitoring System is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, which is intended for use in the adult and pediatric populations only, and Arrhythmia, which is intended for use in the adult population only.

Device Story

Bedside monitoring system; processes physiological signals including ECG, pressure, temperature, SpO2, and CO2. Modification involves updated software (VB1.1-W) to improve arrhythmia detection via increased sampling rate (250 samples/sec vs 100) and 2-lead processing. System provides visual/aural alarms for parameter limit violations; generates recordings. Used in clinical settings by healthcare professionals to support patient assessment and decision-making. Connects to Siemens SIRENET/Infinity networks and third-party devices (SV300 ventilator, Baxter Vigilance monitor). Benefits include enhanced arrhythmia monitoring accuracy for adult patients.

Clinical Evidence

No clinical trial data provided. Performance equivalence supported by bench testing against AAMI standards (ECAR-D-94, EC13-1992) and FDA guidelines for arrhythmia detectors. Clinical performance assessment mentioned as attached in appendix V, claiming equivalence or superiority to the predicate.

Technological Characteristics

Bedside monitor; Type CF protection against electrical shock; defibrillation protection per IEC 6-1-2-27. Sampling rate: 250 samples/sec. QRS detection amplitude: 0.5-5.0 mV; duration: 40-120 msec. Frequency ranges: 0.5-40 Hz (Monitor), 0.5-20 Hz (ESU), 0.05-40 Hz (Off). Connectivity: Siemens SIRENET/Infinity network, third-party device integration. Software version: VB1.1-W.

Indications for Use

Indicated for monitoring heart rate, respiration, invasive/non-invasive pressure, arrhythmia (adults only), temperature, cardiac output (adults/pediatrics only), SpO2, pulse rate, and end-tidal CO2/apnea in adult, pediatric, and neonatal populations. Used by healthcare professionals (physicians, nurses, technicians) in clinical care environments.

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 SC9000/SC9015 Monitor (K946306)
• Siemens SC9000/SC9015 Monitor with etCO2 Functionality (K954632)

Reference Devices

• Siemens SC9000/SC9015 Monitor modified with Neonatal Functionality (K962291)
• Siemens SV300 ventilator
• Baxter Vigilance blood gas/continuous cardiac output monitor

Submission Summary (Full Text)

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510 (K) Notification
Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring
K964624

SEP 11 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: [phone]
Fax: [phone]
Official Correspondent: Robert W. Becker
Contact person for this submission: Jacqueline E. M. Emery or Fred Geheb
Date submission was prepared: October 24, 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 Blood Pressure, Neonatal, * Invasive | 74FLP | II | 21 CFR 870.1110 |

* Pending FDA clearance of 510(K) K962291

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 with modified Arrhythmia Monitoring

## 4: Predicate Device Identification:

The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The hardware of the SC9000/SC9015 is unchanged. The modification improves the detection and monitoring of arrhythmia. 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

The following submission is currently awaiting FDA 510(K) clearance:

K962291 - Siemens SC9000/SC9015 Monitor modified with Neonatal Functionality.

## 5. Device Description

The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The modification improves the detection and monitoring of arrhythmia. The hardware of the SC9000/SC9015 is unchanged.

## 6. Intended Use:

The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult), 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.

The SC9000/SC9015 Modified Patient Monitoring System is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, which is intended for use in the adult and pediatric populations only, and Arrhythmia, which is intended for use in the adult population only.

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 with modified Arrhythmia Monitoring

7. Table of device similarities and differences to predicate device

| | Modified Algorithm | Predicate Device Algorithm | Explanation of the modified version |
| --- | --- | --- | --- |
| Manufacturer | Siemens Medical Systems EMG | same | |
| Device name | SC9000 with modified arrhythmia algorithm | SC9000 | 2 leads improve arrhythmia detection |
| 510(K) Number | To be assigned | K946306 | |
| Intended Population | Adult, pediatric and neonatal * | same | Same-application areas. Arrhythmia detection is inactive in the neonatal mode. |
| Software Revision | VB1.1-W | VA2-W | |
| Display: | up to 2 leads | same | |
| Available leads: | I, II, III, aVR, aVF, aVL, V, MCL1, MCL6 (MCL1, MCL6 only with 3-lead set; V, aVR, aVF, aVL only with 5 lead set) | same | |
| Measuring range: | 15 - 300 bpm | same | |
| Accuracy: | ±5 bpm /min. or ± 5% (whichever is greater) | same | |
| QRS detection: amplitude: duration: | 0.5 - 5.0 mV
40-120 msec | same
70 - 120 msec | extended to 40 for neonatal. |
| Frequency ranges: filter setting = Monitor: filter setting = ESU: filter setting = Off: | 0.5 to 40 Hz
0.5 to 20 Hz
0.05 to 40 Hz | same
same
same | |
| Degree of protection against electrical shock | Type CF | same | |
| Defibrillation protection | In accordance with IEC 6-1-2-27 | same | |
| Arrhythmia Detection: | Yes | same | |
| Pacer Detection: | Yes | same | |
| Samples/Sec | 250 Samples/Second | 100 Samples/Sec | Increased sample rate for improved QRS processing. |

* with the exception of the parameter Cardiac Output, which is intended for use in the adult and pediatric populations only, and Arrhythmia, which is intended for use in the adult population only.

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue

Danvers, MA 01923

USA

Tel: [phone]

Fax: [phone]

Telex: 511958 (Siemensm SD)

{3}

510 (K) Notification

Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring

8. Assessment of non-clinical performance data for equivalence:
Currently there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Monitor with modified arrhythmia detection complies with:

AAMI (ECAR - D-94) “Draft: Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms” March 1994.

AAMI (EC13 - 1992) “Cardiac monitors, heart rate meters, and alarms”.

FDA “Guidelines for Submitting Data in Support of Pre-market Notification (510(K)) Applications for Arrhythmia Detectors (1990)”.

9. Assessment of clinical performance data for equivalence:
Clinical performance is equal to, or surpasses that of the predicate device. The assessment of clinical performance is attached in appendix V.

10. Bio-compatibility Data:
Not applicable

11. Sterilization data:
Not applicable

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

SEP 11 1997

Ms. Jacqueline E.M. Emery
Siemens Medical Systems, Inc.
16 Electronics Avenue
Danvers, Massachusetts 01923

Re: K964624
Siemens SC9000/SC9015 Bedside Monitoring System with Modified Arrhythmia Monitoring
Regulatory Class: III (three)
Product Code: 74 DSI
Dated: March 8, 1997
Received: June 10, 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.

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Page 2 - Ms. Jacqueline E.M. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Page 1 of 1

510(k) Number (if known): K964624

Device Name: Siemens SC9000/SC9015 Bedside Monitoring System with Modified Arrhythmia Monitoring

Indications for Use:

This device is capable of monitoring:
- 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 can be connected to third party devices, Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac output monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output which is intended for use in the adult and pediatric populations only; and Arrhythmia which is intended for use in the adult population only.

## MRI Compatibility Statement:

The Siemens SC9000/SC9015 Series is not compatible for use in an 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)

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

703170