SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)

K980625 · Siemens Medical Solutions USA, Inc. · DSI · May 19, 1998 · Cardiovascular

Device Facts

• Record ID: K980625
• Device Name: SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: May 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

This device is capable of connecting to one or more bedside monitors via a network. The device allows the user to monitor the patients connected to these monitors at a central location. The monitoring ability of the device is determined by the bedside monitors. In addition, this device can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability. This device is intended for use with adults and pediatrics in an 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.

Device Story

Siemens MultiView WorkStation (MVWS) functions as central monitoring station; receives preprocessed ECG data from bedside monitors (SC9000/SC9015) via network. MVWS performs ST segment analysis and generates interpretive diagnostic statements/reports for physician review. Used in hospital/clinic environments by physicians, nurses, and technicians. Provides centralized oversight of patient status; assists clinicians in diagnostic decision-making by automating ECG interpretation and ST deviation reporting. Benefits include improved efficiency in monitoring multiple patients and standardized diagnostic support.

Clinical Evidence

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

Technological Characteristics

Centralized workstation for ECG data processing; utilizes Megacart algorithm for ST segment analysis and diagnostic interpretation. Supports up to 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6). Connectivity via network to bedside monitors. Complies with ANSI/AAMI EC11-R-8-90.

Indications for Use

Indicated for adult and pediatric patients in clinical settings requiring central monitoring of bedside ECG data and interpretive diagnostic reporting. No specific contraindications listed.

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 (SC3000) WorkStation (K955059)

Submission Summary (Full Text)

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K980623

MAY 19 1998

510(k) SUMMARY as required per 807.92(c)

#### Submitters Name, Address: 1.

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: February 12, 1998

Trade Name, Common Name and Classification Name: 2. A. Trade Name: Siemens MultiView WorkStation™ (MVWS) Enhanced with Diagnostic Statements (Rest ECG)

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

| Common Name | Classification<br>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 Cathode-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 |

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### 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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#### Predicate Device Identification: 3.

Siemens MEGACART™ granted SE (substantial equivalence) under 510(k) file number K915225)

#### 4. Device Description:

The Siemens MultiView (SC3000) WorkStation™ enhanced with Diagnostic Statements (Rest ECG) is a modified version of the MultiView (SC3000) WorkStation granted clearance under 510(k) # K955059. This enhancement enables the MultiView WorkStation to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations.

#### 5. Intended Use:

The MultiView WorkStation (MVWS) with Rest ECG collects preprocessed ECG data derived from the SC9000/SC9015 bedside monitor. The data is analyzed by the MVWS to produce reports and possible patient diagnosis for review by the physician (this functionality is currently part of interpretive cardiographs).

This device is intended to be used in an 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.

2

## 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) ్లో వై

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

| | Substantial Equivalent<br>Device<br>Siemens Megacart | Applicant<br>Siemens Medical Systems<br>MultiView WorkStation enhanced with<br>Diagnostic Statements (Rest ECG) | Explanation of<br>Differences |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Manufacturer | Siemens-Elema | Siemens Medical Systems | |
| 510(k) Number | K915225 | To be assigned | |
| Intended Use | The device determines the<br>ST Segment of the ECG<br>signal and computes the<br>deviation of this ST<br>Segment from the iso-<br>electric point (baseline).<br>The device is suitable forcapable of analyzing the<br>data and providing output<br>with interpretation. | The device is suitable for use in<br>resting ECGs and is capable of<br>analyzing the data and providing<br>output with interpretation. | ST Segment data is<br>processed in the<br>bedside monitor,<br>not the MVWS |
| Intended<br>Population | Adult, Pediatric | Same | |
| Intended<br>Environment | In the medical clinic or<br>hospital environment for<br>use by physicians, nurses<br>and ECG technicians. | In an environment where healthcare is<br>provided by healthcare professionals,<br>i.e. doctors, nurses, technicians. | |
| ST Analysis | Up to 12 ST complexes | Same | |
| | ST analysis performed on<br>all available leads at 500<br>s/s | Same | |
| ECG<br>Processing | Megacart Algorithm | Same | |
| | Up to 12 leads<br>I, II, III, aVR, aVL, aVF,<br>V1, V2, V3, V4, V5, V6 | Same | |
| Reporting | 12 leads ST<br>measurements | Same | |
| | Interpretation and<br>proposed diagnosis | Same | |
| | Resting ECG | Same | |
| | Annotations | Same | |

### 3

# COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronies Avenue Danvers, MA 01923 USA

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

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- Assessment of non-clinical performance data for equivalence: 7. Currently there are no FDA standards for this device.
# 8. Assessment of clinical performance data for equivalence: Not applicable. Performance was qualified by testing versus a standard clinical database per AAMI recommendations.

- 9. Biocompatability: Not applicable
- 10. Sterilization: Not applicable
- 11. Standards and Guidances: Currently there are no FDA standards for this device. "American National Standard for Diagnostic Electrocardiographic Devices" ANSI/AAMI EC11-R-8-90

4

## 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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Image /page/4/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1998

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

K980625 Re: Siemens MultiView Workstation™ Enhanced with Diagnostic Statements Requlatory Class: III (three) Product Code: 74 DSI February 12, 1998 Dated: February 18, 1998 Received:

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 aqainst 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as setforth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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,

Sincerely yours,

Thomas J. Callahon

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): K980625

#### Siemens MultiView WorkStation Enhanced with Diagnostic Statements Device Name: (Rest ECG)

Indications for Use:

This device is capable of connecting to one or more bedside monitors via a network. The device allows the user to monitor the patients connected to these monitors at a central location. The monitoring ability of the device is determined by the bedside monitors. In addition, this device can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability.

This device is intended for use with adults and pediatrics in an 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.

#### MRI Compatibility Statement:

The Siemens MultiView WorkStation Enhanced with Diagnostic Statements (Rest ECG) 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)

Mr. Piny

(Division Sign Division of Cardic and Neurological De 510(k) Number