ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841

K992749 · Spacelabs Medical, Inc. · MSX · Jan 14, 2000 · Cardiovascular

Device Facts

• Record ID: K992749
• Device Name: ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
• Applicant: Spacelabs Medical, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Ultraview™ Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring network. The Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot. The Spacelabs Medical Ultraview™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.

Device Story

System interfaces with Spacelabs patient-monitoring network to provide secondary alarm notification to mobile caregivers. Components include server (collects/formats network data), transmitter (broadcasts data), and receiver (graphical pager). Upon alarm event at bedside monitor, system transmits patient ID, alarm parameters, and up to 12-second waveform snapshot to pager within 4-8 seconds. Pager provides audio/vibrating alerts. Administration module allows patient-to-caregiver assignment via network workstations. System supplements primary monitoring; does not replace bedside alarms or clinical judgment. Benefits include increased caregiver mobility while maintaining awareness of patient status.

Clinical Evidence

Bench testing only. System performance verified through extensive safety and functional testing to ensure compliance with requirements and specifications.

Technological Characteristics

System consists of server, transmitter, and receiver (lightweight graphical pager). Operates via Spacelabs monitoring network integration. Uses standard paging technology for data transmission. Features high-resolution display and 12-second waveform snapshot capability.

Indications for Use

Indicated for real-time monitoring of routine patient status and alarm events in hospital environments using Spacelabs patient-monitoring networks. Intended as a secondary, parallel, redundant alarm notification system for mobile healthcare providers. Not for use as a replacement for primary bedside/remote alarm systems or clinical judgment.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Data Critical Corporation's Cardio-Pager System (K973527)
• Marquette Medical Systems Impact Pager System (K971868)

Submission Summary (Full Text)

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1/14/00

K992749

## 510(K) SAFETY AND EFFECTIVENESS SUMMARY

Spacelabs Medical Ultraview™M Waveform Pager System

| 1. Submitter's Name | Irene Jaworski<br>Director, Regulatory Affairs and Quality |
|---------------------|----------------------------------------------------------------------|
| Company | Spacelabs Medical, Inc.<br>15220 NE 40th Street<br>Redmond, WA 98073 |
| Telephone | [phone] |
| Facsimile | [phone] |

- Spacelabs Medical Ultraview™ Waveform Pager System 2. Name of the Device
System, Network and Communication, Physiological Classification Monitors 74MSX, 870.2910 Class III

- The Spacelabs Medical Waveform Pager System is 3. Predicate Device(s) substantially equivalent to the K973527 Data Critical Corporation's Cardio-Pager System and the K971868 Marquette Medical Systems Impact Pager System. (Note: Data Critical Corporation's Cardio-Pager System is the same device as the Marquette Medical System's Impact Pager System.) The Spacelabs Medical Waveform Pager System and its predicate devices serve as secondary alarm notification systems that forward patient data (text and waveforms) from the patient monitoring devices to a graphics pager(s). The Waveform Pager System and its predicate devices passively gather alarm event information (including waveforms) from the patient monitoring devices to a graphics pager(s). The Waveform Pager System and its predicate devices passively gather alarm event information (including waveforms) from the patient monitoring network and use standard paging technology to deliver this information to mobile caregivers.
- The Spacelabs Medical Ultraview™M Waveform Pager 4. Device Description System provides caregivers within a clinical environment the ability to remain mobile and be notified when an alarm event occurs. Typically, alarm notification by the pager occurs within 4-8 seconds of an alarm event on the patient

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monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.

The administration module allows convenient assignment of patients to caregivers from any location on the network, including WinDNA-enabled Universal Clinical Workstations. Patient status updates can also be scheduled for dispatch to the pager on a repeating basis if desired.

This system is not a replacement for the primary alarm notification system. The delivery of pages cannot be guaranteed or verified. The Waveform Paging System is intended to augment alarm notification. It is not intended or designed to replace monitoring personnel, good clinical judgment, or to be used in place of bedside and remote alarm notification, or the Alarm Watch function of the monitor

The device subject to this submission is Model 91841. Each Spacelabs Medical Ultraview™™ Waveform Pager System consists of a Server which collects and formats data from the monitoring network, a Transmitter which broadcasts the information to the mobile caregiver, and a Receiver which receives the broadcast and displays the formatted information.

The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient The Ultraview™ Waveform Pager System is events. intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring network The Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8

- ત્ત્વ Intended Use

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seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.

The Spacelabs Medical Ultraview™M Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.

- The underlying technological characteristics of the Comparison of 6. Spacelabs Medical Ultraview™ Waveform Pager System Technological are similar to and functionally equivalent to those of the Characteristics The systems collect substantially the predicate devices. same information. The collected data is transmitted to the mobile caregiver(s) using standard technologies. The Receivers are lightweight graphical pagers. The transmitted information is displayed on the pagers as a sequence of message displays that can be saved for later The systems can be configured to forward reference. patient vital sign updates to caregivers at defined intervals.
The differences between the Spacelabs Medical Ultravicw™ Waveform Pager System and its predicate devices are minor and do not raise new issues of safety and/or effectiveness in comparison with the predicate devices. The Spacelabs Medical Ultraview™™ Waveform Pager System has a higher resolution display than the predicate devices The Spacclabs Medical Ultraview™M Waveform Pager System provides a longer snapshot of waveform data for the alarming parameter than the predicate devices.

- The Spacelabs Medical Ultraview™M Waveform Pager 7 Testing System will be subject to extensive safety and performance Final testing for the system testing prior to release includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications.
In conclusion, the Spacelabs Medical Ultraview™™ Waveform Pager System is as safe and effective as its predicate devices and raises no new issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2000

Irene Jaworski Director Regulatory Affairs and Quality Spacelabs Medical 15220 N.E. 40th Street P.O. Box 97013 Redmond, Washington 98073-9713

Re: K992749 Trade Name: Ultraview Waveform Pager System Regulatory Class: III (three) Product Code: MSX Dated: November 29, 1999 Received: November 30, 1999

Dear Ms. Jaworski:

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 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). 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. Irene Jaworski

This letter will allow you to begin marketing your device as described inis receed will area you tification. The FDA finding of substantial in your 310 m, prom device to a legally marketed predicate device equivalence or your donion 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 reguration (Er CFF), please contact the Office of Compliance at draghostic devices), productions on the promotion and (301) 39 4040. Addressarif, as a contact the Office of Compliance at Also, please note the regulation entitled, [phone]. [phone]. HIBO) premarket notification" (21CFR 807.97). MISDIanding by reference to promains on your responsibilities under the Act may Other general Information of your responant of Small Manufacturers at its be obtained from the broises: 41 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known): K992749

Device Name: Spacelabs Medical Ultraview™ Waveform Pager System

Indications for Use:

The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Ultraview™™ Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring ar onvironment Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.

The Spacelabs Medical Ultravicw™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------|----------------------|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K992749 |
| Prescription Use | Over-The-Counter Use |

(Per 21 CFR 801 109) (Optional format 1-2-96)