SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM

K030738 · Siemens Medical Solutions USA, Inc. · MHX · Jun 6, 2003 · Cardiovascular

Device Facts

• Record ID: K030738
• Device Name: SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The INFINITY MultiView WorkStation (MVWS) Telemetry System is intended to measure and produce visual and audible alarms for one or more physiological parameters. The INFINITY MVWS telemetry System with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes. This device is intended for use 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

The Siemens INFINITY MultiView WorkStation Telemetry System with TruST enables continuous 12-lead ECG monitoring using a reduced set of 6 electrodes. The system utilizes the TruST matrix, which applies general reconstruction coefficients to compute 4 precordial leads from the reduced electrode input. The device processes these signals to provide real-time assessment of ST segment changes and generates visual and audible alarms for physiological parameters including heart rate, arrhythmia, SpO2, and pulse rate. Used in hospital or clinical environments, the system is operated by healthcare professionals (physicians, nurses, technicians) to monitor patient status. The output is displayed on the workstation, allowing clinicians to assess ST segment changes and make informed clinical decisions regarding patient care.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

The system uses a 6-electrode configuration to reconstruct a 12-lead ECG. It employs a TruST matrix with general reconstruction coefficients to compute 4 precordial leads. The device is a physiological monitor for ECG, SpO2, and blood pressure. It is a networked telemetry system. No specific materials or sterilization methods are listed as applicable.

Indications for Use

Indicated for adult and pediatric patients in clinical settings under professional care (physicians, nurses, technicians) requiring monitoring of heart rate, ECG arrhythmia, arterial oxygen saturation, pulse rate, or ST segment analysis. TruST feature indicated for 12-lead ECG monitoring using a reduced electrode set for real-time ST segment change assessment. Not MRI compatible.

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

• Philip's (HP) Viridia Component Monitoring System with EASI™ ST Segment (K992595)
• INFINITY MultiView WorkStation Telemetry System Modification (K024108)
• INFINITY MultiView WorkStation Modifications (K022889)
• SC 9000 / SC 9015 Enhanced with 12-Lead ST Segment Analysis (K974698)
• MultiView WorkStation Enhanced with Diagnostic Statement (Rest ECG) (K980625)
• SC 7000 / SC 9000XL Infinity Modular Bedside Monitors (K982730)
• SC 8000 w/Advanced Communication Option (K990563)

Submission Summary (Full Text)

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'JUN - 6 2003

# 510(k) SUMMARY

as required per 807.92(c)

## 1. Submitters Name, Address:

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope Greco Date submission was prepared: March 7, 2003

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

### A. Trade Name:

SIEMENS INFINITY MultiView WorkStation™ Telemetry System with TruST™

| Common Name | Classification<br>Number | Class | Regulation Number |
|--------------------------------------------------------------------------|--------------------------|-------|-------------------|
| Monitor, Physiological, Patient (with arrhythmia<br>detection or alarms) | MHX | III | 21 CFR 870.1025 |
| Radiofrequency physiological signal transmitter<br>and receiver | 74DRG | II | 21 CFR 870.2910 |
| 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 |

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

Page 1 of 4

## COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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### 3. Predicate Device Identification:

Philip's (HP) Viridia Component Monitoring System with EASI™ ST Segment- 510(k) K992595

INFINITY MultiView WorkStation Telemetry System Modification - K024108 INFINITY MultiView WorkStation Modifications - K022889 SC 9000 / SC 9015 Enhanced with 12-Lead ST Segment Analysis - 510(k) K974698 MultiView WorkStation Enhanced with Diagnostic Statement (Rest ECG) - 510(k) K980625 SC 7000 / SC 9000XL Infinity Modular Bedside Monitors - 510(k) K982730 SC 8000 w/Advanced Communication Option - 510(k) K990563

#### Device Description: 4.

Siemens' INFINITY MultiView WorkStation Telemetry with TruST enables continuous 12-lead ECG monitoring with a reduced number of electrodes. With TruST only 6 lead wires are required to acquire 12 leads of ECG. TruST relies on conventional lead placement and the INFINITY TruST telemetry transmitters. The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads.

#### 5. Intended Use:

The INFINITY MultiView WorkStation (MVWS) Telemetry System is intended to measure and produce visual and audible alarms for one or more physiological parameters

The INFINITY MVWS telemetry System with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

This device is intended for use 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.

Page 2 of 4

### COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

: Of

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030738 50F )

510(k) Notification
SIEMENS INFINITY MultiView WorkStation™ Telemetry with TruST™

| Table of Device Similarities and differences to predicate device | | | | |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Substantial Equivalent Device | Substantial Equivalent Device | Applicant | Explanation of<br>Differences |
| (k) Number | HP Viridia Component<br>Monitoring System with EASITM<br>ST Segment Measurement<br>Philips (HP) | SC 9000 / SC 9015 Bedside<br>Monitoring System Enhanced with<br>12-Lead ST Segment Analysis<br>Siemens Medical Solutions | Siemens Medical Systems Infinity<br>MultiView WorkStation Telemetry<br>System with TruST<br>Siemens Medical Solutions | |
| | K992595 | K974698 | To be assigned | |
| Intended Use | Assessment of real time ST<br>segment analysis in adult<br>patients. | To determine the ST Segment of the<br>ECG signal and to compute the<br>deviation of this ST Segment from<br>the iso-electric point (baseline). | The INFINITY MultiView<br>WorkStation (MVWS) Telemetry<br>System is intended to measure and<br>produce visual and audible alarms<br>for one or more physiological<br>parameters | Similar to Philips' Easi<br>in that the MVWS with<br>TruST monitors 12-lead<br>ECG with a reduced set<br>of electrodes. |
| Intended Population | Adult | Adult/Pediatric | The INFINITY MVWS telemetry<br>System with TruST is intended<br>for 12-Lead ECG monitoring with a<br>reduced set of electrodes.<br>Reconstructed leads are intended for<br>real-time assessment of ST segment<br>changes. | |
| Intended<br>Environment | In the medical clinic or hospital<br>environment for use by<br>physicians, nurses and ECG<br>technicians. | Adult/Pediatric | Same | |
| Diagnostic<br>ST Analysis | No | Yes | No | |
| | Up to 12 Derived Complexes | Up to 12 Measured ST Complexes | Up to 8 Measured ST Complexes<br>Up to 4 Derived ST Complexes | dV1, dV3, dV4, dV6 |
| | 5 | 12 | 6 | |

Page 3 of 4

COMPANY CONFIDENTIA

16 Electronics Avenue
Danvers, MA 01923

Tel: [phone]
Fax: [phone]

Siemens Medical Solutions,
Electromedical Systems Group, PCS

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- 7. Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device.
- 8. Assessment of clinical performance data for equivalence: Section J
- 9. Biocompatability: Not applicable
- 10. Sterilization: Not applicable
- 11. Standards and Guidances: Section P

Page 4 of 4

## COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

K 0 30 7 38 by afy

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K030738

Trade Name: MultiView WorkStation Telemetry System with TruSTTM Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: March 7, 2003 Received: March 10, 2003

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Penelope H. Greco

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K030738

### Siemens Infinity MultiView WorkStation Telemetry System Device Name: Enhanced with TruST™

Indications for Use:

Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

- . Heart rate
- ECG Arrhythmia Analysis ●
- Arterial oxygen saturation ●
- Pulse rate
- ST segment analysis .

The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

### MRI Compatibility Statement:

The Infinity MultiView WorkStation Telemetry 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)

N. Carter