SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM

K972714 · Siemens Medical Solutions USA, Inc. · DSI · Oct 17, 1997 · Cardiovascular

Device Facts

• Record ID: K972714
• Device Name: SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Oct 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The intended use statement for the Infinity Telemetry System Enhancement is to condition and transmit via radiofrequency physiological signals for display and/or measurement. ECG Ectopic beat detection, arrhythmic rhythm detection and alarm. Measure and alarm audibly and visually for heart rate. Measure and alarm audibly and visually for ECG ST segment elevations or depressions. Measure and alarm audibly and visually for heart arterial oxygen saturation and pulse rate. The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings. The device is also intended to provide telemetered physiological signals and measurements to the Siemens Infinity (Olympus) Communication Network.

Device Story

System consists of PC workstation, CRT displays, keyboard, mouse/trackball, laser printer, CPU/receiver, antenna system, transmitter programming port, and RF transmitters. Transmitters collect physiological signals (ECG, SpO2) from patients; transmit via GMSK modulation to CPU/receiver. Workstation processes signals for display, arrhythmia detection, ST segment analysis, and alarm generation. Used in clinical settings by healthcare professionals to monitor patient status. Provides real-time waveform visualization, tabular/graphic trends, and event recall. Enables clinical decision-making through continuous monitoring and automated alerts for parameter deviations. Benefits include improved patient surveillance and timely intervention for cardiac events.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance data and validation results.

Technological Characteristics

System components: PC workstation, CRT displays, RF transmitters. Modulation: GMSK. Operating bands: 174-216 MHz, 400-460 MHz, 430-480 MHz, 512-566 MHz. ECG sampling: 200 Hz, 10-bit A/D resolution. Connectivity: Infinity (Olympus) Communication Network. Shock resistance: EN 60601-2-27 compliant. Power: 9V alkaline/lithium or 8.4V mercury/Zinc Air batteries.

Indications for Use

Indicated for adult and pediatric patients in clinical environments where care is provided by healthcare professionals (physicians, nurses, technicians). Used for monitoring heart rate, ECG arrhythmia, ECG ST segment, pulse rate, and arterial oxygen saturation with audible/visual alarms.

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 1481 T Digital Telemetry system (K951371)

Submission Summary (Full Text)

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K972714

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

OCT 17 1997

#### Submitters Name, Address 2.

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

Official Correspondent: David Simard, Director, Quality Assurance & Regulatory Affairs Contact Person for this submission: Mark Kolnsberg, Senior Clinical Product Manager Date submission was prepared: July 11, 1997

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

A. Trade Name: Siemens MultiView Workstation Infinity Telemetry System

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

| Common Name | Classification 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 |
| Radiofrequency physiological<br>signal transmitter and receiver | 74DRG | II | 21 CFR 870.2910 |
| Arrhythmia detector & alarm | 74DSI | III | 21 CFR 870.1025 |
| Medical Cathode-Ray Tube<br>Display | 74DXJ | II | 21 CFR 870.2450 |
| ST Segment monitor w/alarm | 74MLD | III | 21 CFR 870.1025 |

#### Predicate Device Information 4.

Siemens 1481 T Digital Telemetry system granted premarket clearance under 510(k) file number K951371.

### న. Device Description

The Siemens MultiView Workstation consists of a PC workstation, up to two CRT displays, keyboard, mouse/trackball input devices and a laser printer.

The Infinity Telemetry System Enhancement adds a CPU/receiver that communicates with the MultiView Workstation PC, an antenna system, a transmitter programming port, radio frequency transmitters and a strip chart recorder. The CPU/receiver can be configured for 1 - 4, 1 - 12, and 1 - 16 receiver channels for the monitoring of 1 - 16 transmitters. For a more detailed device description refer to Exhibit G, Device Description in this submittal.

### Intended Use of the Device 6.

The intended use statement for the Infinity Telemetry System Enhancement is to condition and transmit via radiofrequency physiological signals for display and/or measurement.

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ECG Ectopic beat detection, arrhythmic rhythm detection and alarm. Measure and alarm audibly and visually for heart rate. Measure and alarm audibly and visually for ECG ST segment elevations or depressions. Measure and alarm audibly and visually for heart arterial oxygen saturation and pulse rate. The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.

The device is also intended to provide telemetered physiological signals and measurements to the Siemens Infinity (Olympus) Communication Network.

- Table of device similarities and differences to predicate device 7.
The comparison of intended use and technological features of these devices to other legally marketed devices taken together with the validation results and other information in this submission indicate that these devices are substantially equivalent to legally marketed predicated devices in safety, effectiveness and intended use.

| Parameter | 1481 T System | MultiView Workstation<br>with Infinity Telemetry<br>Enhancement | Explanation of the<br>differences between the<br>predicate and Infinity<br>Telemetry System |
|--------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Manufacture | Siemens | Same | |
| 510(k) Number | K951371 | New | |
| Intended Population | Adult | Adult, Pediatric | The Infinity system's<br>improved ECG<br>performance allows it to be<br>used with a pediatric<br>population. |
| Display | | | |
| No. Waveform Traces | 8 | 16 | |
| Recorder | | | |
| Strip Recorder | Yes | Same | |
| Physiological Parameters | | | |
| Parameters | HR, VPB minute rate, %<br>paced, % O2, Pulse rate,<br>S-T deviation | Same | |
| Alarms | HR, VPB minute rate,<br>arrhythmia events, %<br>paced, % O2, Pulse rate,<br>S-T deviation | Same | |
| Arrhythmia analysis | Yes | Same | |
| Event Recall | 100 2 ch. 1 minute<br>events/patient | 1000 2 ch. 20 second<br>events/patient | Infinity increases # of<br>events stored per patient. |
| ECG leads displayed | LI, LII, LIII, V | LI, LII, LIII, aVF, aVL,<br>AVR, V | Infinity adds AVF, AVL,<br>AVR ECG leads for |
| Range | 30 - 300 BPM | 15 - 300 BPM | display, extends HR range<br>and improves HR accuracy. |
| Accuracy | + / -10% or 5 BPM | + / -5% or 5 BPM | |
| Tabular trends | No | Yes | Infinity adds tabular trends<br>for customer preference. |
| Graphic Trends | Yes | Same | |
| Radiofrequency | | | |
| Transmission Parameters | | | |
| Transmission Scheme | FSK | GMSK | Infinity uses more<br>sophisticated modulation<br>technique for reduced<br>channel spacing. |

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усын | шы

: -

| | | | The Infinity RF system is | | | | | |
|-------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|------|--|--|--|
| Tuning ranges of<br>transmitter | 174 – 216 MHz.<br>Transmitter tunable over<br>entire 42 MHz range. | 174 – 216 MHz,<br>400 – 460 MHz,<br>430 – 480 MHz or<br>512 – 566 MHz<br>Transmitter tunable over<br>entire individual range. | offered in three new<br>operating bands to provide<br>more operating frequencies. | | | | | |
| Operator Tuning of Radio<br>Operating Frequency | Externally programmable | Same | | | | | | |
| Channel spacing | 40 or 50 Khz, even spacing | Same | | | | | | |
| Bit rate | 10.416 kbits/sec | Same | | | | | | |
| Receiver Type | Dual conversion<br>superhetrodyne | Same | | | | | | |
| Transmission | RA,LA,LL,RL, V lead wire<br>shields | Same | | | | | | |
| Transmitter EKG<br>Parameters | | | | | | | | |
| Input leads | I, II, V | Same | | | | | | |
| EKG Dynamic Range | + 5 mV | Same | | | | | | |
| Input Offset | + 300 mV max | Same | | | | | | |
| EKG sample rate | 200 Hz | Same | | | | | | |
| A/D resolution | 10 bits | Same | | | | | | |
| EKG Gain Accuracy | $\pm$ 5% | Same | | | | | | |
| EKG Noise | <40 uV r.t.i. | Same | | | | | | |
| Frequency response | 0.45 Hz (-2.4 to -3.7 dB) to<br>40 Hz (-1 to-3dB) | Same | | | | | | |
| Pacemaker detection<br>polarity | + or - | Same | | | | | | |
| Pacemaker spike width | 0.1 to 2mS | Same | | | | | | |
| Pacer spike detection<br>amplitude | $\pm$ 2.5 - $\pm$ 700m V r.t.i. | Same | | | | | | |
| Pacer detector 50/60 Hz<br>Rejection | 700m V p-p r.t.i. | Same | | | | | | |
| EKG input impedance | >25 Mohm at 10 Hz,<br>differential<br>>10 Mohm at 50 Hz,<br>differential | Same | | | | | | |
| EKG Analog Output | Yes | Same | | | | | | |
| EKG leads with pacer spike<br>detectors | I, II | Same | | | | | | |
| Transmitter Electrical & Mechanical Parameters | | | | | | | | |
| Dimensions | 116 x 65 x 30 mm | Same | | | | | | |
| Weight | 160 grams with lithium<br>battery | Same | | | | | | |
| Controls | Recorder start: timed &<br>continuous, staff alert | Same | | | | | | |
| Indicators | Lead off, low battery | Same | | | | | | |
| Water resistant | Yes | Same | | | | | | |
| Battery type | 9V alkaline or lithium<br>8.4 V mercury or Zinc Air | Same | | | | | | |
| Battery life | 2 days minimum with<br>Duracell MN1604 | Same | | | | | | |
| Shock resistance | Defibrillator protection | Withstands twenty 5 foot<br>drops onto tiled surface<br>with only minor cosmetic ,<br>blemishes to case | In accordance with EN<br>60601-2-27 | Same | Same | | | |

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510(k) Notification:

. . . . .

س

510(k) Notification:
MultiView Workstation Infinity Telemetry System Enhancement

| 8. | Assessment of non-clinical performance data for equivalence: | See Exhibit J |
|-----|--------------------------------------------------------------|---------------|
| 9. | Assessment of clinical performance data for equivalence: | See Exhibit Q |
| 10. | Biocompatibility: Not applicable | |

ﻟﻠﺘﻌﻠﻴ Not Applicable Sterilization:

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 1997

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

Re : K972714 Siemens MultiView Workstation Infinity Telemetry System Enhancement Regulatory Class: III (three) Product Code: 74 DSI Dated: July 16, 1997 Received: July 21, 1997

Dear Mr. Simard:

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 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 - 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 [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

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

K972714 510(k) Number (if known):

# Device Name: Siemens MultiView Workstation Infinity Telemetry System Enhancement

# Indications for Use:

Use of the MultiView (SC3000) Workstation Infinity Telemetry System is indicated for adult and pediatic patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician) when the professional determines that a device is required on moussional produce visual and audible alarms for any one or more of the following parameters:

- Heart rate .
- ECG arrhythmia analysis .
- . ECG ST segment elevation or depression
- Pulse rate .
- Arterial oxygen saturation.

# MRI Compatibility Statement:

The Multi View (SC3000) Workstation Infinity 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 V (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 K972714