SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS

K974698 · Siemens Medical Solutions USA, Inc. · DSI · Jul 8, 1998 · Cardiovascular

Device Facts

• Record ID: K974698
• Device Name: SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jul 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

To determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the iso-electric point (baseline) in a health care environment by health care professionals, i.e. Physicians, Nurses, Technicians.

Device Story

The Siemens SC9000/SC9015 is a bedside monitoring system that collects physiological data, including 12-lead ECG signals via the MultiMed-12 pod. The system downsamples ECG signals to 500 samples/s and performs QRS detection and 12-lead ST segment analysis. It calculates ST vector magnitude (STVM) and ST change vector magnitude (STCVM) to identify deviations from the iso-electric baseline. Used in hospitals and clinics by physicians, nurses, and technicians, the system displays real-time data and trends on the SC9000 unit or MultiView WorkStation. It supports optional connectivity to a Cardiology Review Station for data archiving and review. By providing continuous ST segment monitoring, the device assists clinicians in detecting cardiac changes, enabling timely clinical decision-making and patient management. The system also integrates with various third-party ventilators and blood monitoring devices.

Clinical Evidence

No clinical data. Performance was qualified by bench testing versus a standard clinical database per AAMI recommendations.

Technological Characteristics

System components include MultiMed-12 ECG pod, SC9000 monitor with optional processing board, and MultiView WorkStation. Sensing principle: 12-lead ECG acquisition. Processing: 500 samples/s downsampling, QRS detection, and ST segment analysis. Connectivity: Networked to central station (MultiView WorkStation) and compatible with third-party ventilators/monitors. Software: Version VC0.0. No specific biocompatibility or sterilization requirements listed as the device is a bedside monitor.

Indications for Use

Indicated for monitoring heart rate, respiration, invasive/non-invasive pressure, arrhythmia, temperature, cardiac output, SpO2, pulse rate, EtCO2, apnea, and ST segment analysis in adult, pediatric, and neonatal populations. Arrhythmia detection is indicated for adults only. ST segment analysis is indicated for adults and pediatrics only. Used in clinical environments by healthcare professionals.

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 MEGACART (K915225)

Reference Devices

• MultiView WorkStation (K955059)

Submission Summary (Full Text)

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JUL - 8 1998

K974698

#### 510(k) SUMMARY

as required per 807.92(c)

### 2. Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline Emery Date submission was prepared: December 5, 1997

#### Trade Name, Common Name and Classification Name: 3.

A. Trade Name: Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis

#### B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Classificatio<br>n 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 |
| 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 |
| Arrhythmia detector & Alarm | 74DSI | III | 21 CFR 870.1025 |
| Medical Cathodc-Ray Tube Display | 74DXJ | II | 21 CFR 870.2450 |
| ST Segment Monitor with Alarm | 74MLD | III | 21 CFR 870.1025 |
| Non-indwelling Blood Pressure Monitor | 74DXN | II | 21 CFR 870.1130 |
| End-tidal Carbon-Dioxide Monitor | 73CCK | II | 21 CFR 868.1400 |

#### COMPANY CONFIDENTIAL

-

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers. MA 01923 ાડત

Tcl: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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- 4. Predicate Device Identification:
Siemens MEGACART™ granted SE (substantial equivalence) under 510(k) file number K915225)

### 5. Device Description:

The Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST The Siement SC9000/SC9015 Bedside Montoning SC900/SC9015 Bedside Monitoring
Segment Analysis is an updated version of the Siemens of Child (arigures System Analysis is an apared version in the 510(k) file number K946306 (primary submission).

The system is comprised of the following components:

- MultiMed-12™ ECG pod .
- SC9000 with a new, optional processing board and enhanced software .
- MultiView WorkStation with enhanced software •
- Cardiology Review Station (optional) .

A new 12-lead ECG patient cable, the MultiMed-12™ "pod', collects data from the patient and A fiew 12-lead LCG patient cable, the works one would (code named ARIES).

To enable 12-lead ST processing, the new, optional processing hoard must be installed in the SC9000 unit. In addition, the SC9000 must have the new software version VC0 installed. The SC9000 unn. "In addition, the SC7000 mact 7.0 signals from the MultiMed-12™ ECG pod, downsamples them to 500 samples/s and performs QRS detection. The SC9000 then performs 12-lead ST analysis on the ECG leads provided, using the same algorithm as the predicate device ST analysis on the LCG feast provided, and and only and one of the SC9000 with YCU software and (STEMS Megacan "", RY13225) With Minor meanerate ST vector magnitude (STVM) and an ST change magnitude (STCVM) vector.

The SC9000 may be connected to a central station, the MultiView WorkStation (K955059). The SC 7000 may be comments to a commercially available LaserPinter™, ECG reports can be printed. VC0 software needs to be installed in the MultiView WorkStation to reports can be printed. VCo software need to requires no hardware modifications.

The Cardiology Review Station (CRS), a derivative of a MVWS, receives all available ST The Cardiology Neview Station (CRD), a Gorrith of SC9000, and collects and archives the trend data for review by the user.

#### 6. Intended Use:

To determine the ST Segment of the ECG signal and to compute the deviation of this ST For delections the iso-electric point (baseline) in a health care environment by health care professionals, i.e. Physicians, Nurses, Technicians.

1

#### COMPANY CONFIDENTIAL

### Siemens Medical Systems, Inc.

Electromedical Systems Group, PC'S

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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# 7. Table of Device Similarities and differences to predicate device

| | Substantial Equivalent Device<br>Siemens Megacart | Applicant<br>Siemens Medical Systems<br>SC9000/SC9015 enhanced with<br>12 Lead ST Segment Analysis | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Manufacturer | Siemens-Elema | Siemens Medical Systems | |
| 510(k) Number | K915225 | To be assigned | |
| Intended Use | To determine the ST Segment<br>of the ECG signal and to<br>compute the deviation of this<br>ST Segment from the iso-<br>electric point (baseline). | Same | |
| Intended<br>Population | Adult, Pediatric | Same | |
| Intended<br>Environment | In the medical clinic or hospital<br>environment for use by<br>physicians, nurses and ECG<br>technicians. | Same | |
| ST Analysis | Up to 12 ST complexes | Same | |
| | ST analysis performed on all<br>available leads at 500 s/s | Same | |
| | Computes ST Vector<br>Magnitude ( $STCVM$ ) | Same | |
| | | Computes Change in ST<br>Vector Magnitude<br>( $STCVM$ ) | A mathematical equation<br>that involves no signal<br>processing |
| ECG<br>Processing | Megacart Algorithm | Same | |
| | Analog Devices ADSP2101 | SC9000 with new processor<br>Board installed | |
| | 12 leads | Same | |

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: Not applicable. Performance was qualified by testing versus a standard clinical database per AAMI recommendations.
درا

### COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers. MA (01923 USA

Tcl: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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- 10. Biocompatability: Not applicable
l l . Sterilization: Not applicable

- 12. Standards and Guidances:
and the same of the same of the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the

Standards and Guidances.
Currently there are no FDA standards for this device rently there are no FDA standards for this device.
"ST Segment Monitor Preliminary Guidance", US Department of Health and Human Services, July 1994.

ﻨﻨ

## COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers. MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1998

Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

K974698 Re: K974690
Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis Regulatory Class: III (three) Product Code: 74 DSI Dated: April 10, 1998 Received: April 13, 1998

Dear Mr. Simard:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosien on we have determined the device is the device fereiched above and indications for use stated in the enclosure) to legally marketed predicate devices marketed in enclosure) to regally marketed products 76, the enactment date of the Interstate Commerce proble do the have been reclassified Medical Device Amendments) of to devilose of the Federal Food, Drug, and In accordance with the provider and the device, subject to Cosmeric Act (ACC). Tourmaly) the Act. The general controls the general concroro provide requirements for annual registration, provisions of the not on manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class IT (Special II your device is crassiried (boo oproval), it may be subject to such Controls) of Class III (Frenalitions affecting your device nudicional ocheroly Code of Federal Regulations, Title 21, Parts 800 can be round in the ollualent determination assumes compliance with the Current Good Manufacturing Practice requirements, as society with the Current Cood namem Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regulation od and Drug Administration (FDA) will verify such Inspections, Ent rood and Brog muith the GMP regulation may result in assumption. In addition, FDA may publish further announcements reguratory dostronivice in the Federal Register. Please note: this concerning your device in the ification submission does not affect any response to your premater sections 531 through 542 of the Act obrigation you might or other Federal laws or regulations.

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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 [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/dsma/csmamain.html".

Sincerely yours,

Thomas J. Callahan

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead Device Name: ST Segment Analysis

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 .
- End-tidal carbon dioxide .
- (central) apnea ◆
- ST segment analysis .

With the MultiGas™ and MultiGas+™ modules the SC9000/SC9015 is capable of measuring:

- Respiration rate .
- Inspired and expired Carbon Dioxide (CO2) �
- Inspired and expired Oxygen (MultiGas+TM only) .
- Average inspired Oxygen (MultiGas™ only) .
- Avelage inspired Oxygen (man Bas of Enflurane, Halothane, Isoflurane, Desflurane, . Sevoflurane, and Nitrous Oxide.

The SC9000/SC9015 is capable of performing 12-lead ST Segment analysis.

This device can be connected to third party devices: Siemens SV 300™ ventilator, the Baxter Vigilance™ blood This device can be connected to mira party devices. Stematics,
I his device can be connected formity, Puritan Bennett 7200™. Draeger Evita IV™, & Babylog™, and Siemens SV900™ ventilators.

The device is intended to be used in the environment where patient care is provided by Healthcared beard upon he I he device is intended to be used in the environment 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 The device Is intended to be asea on Analysis which are intended for use in the adult and pediarric purations only: and Arrhythmia which is intended for use in the adult population only

#### MRI Compatibility Statement:

MRT Companibility Statement.
The Siemens SC9000SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis is not compatible for use in a MRI magnetic field.

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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) |
|---------------------------------------|--|----|-----------------------------------------------|
|---------------------------------------|--|----|-----------------------------------------------|

Mark Krame
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices

| 510(k) Number | K974112 |
|---------------|---------|
|---------------|---------|