SPACELABS MEDICAL PCIS PATIENT MONITORS

K972282 · Spacelabs Medical, Inc. · DSI · Sep 25, 1997 · Cardiovascular

Device Facts

• Record ID: K972282
• Device Name: SPACELABS MEDICAL PCIS PATIENT MONITORS
• Applicant: Spacelabs Medical, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical. The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters currently available through Spacelabs Medical. The PC Scout Monitor is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical. Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network-based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated: (b) the alarm priority (i.e. high, medium or low); (c) alarm limits: and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications. Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission.. Through this network, a patient's data may be displayed at the bedside monitor, central station or a clinical information system.

Device Story

PCIS patient monitors (Viper) function as passive displays for patient parameter modules, gas analyzers, and Flexport interfaces; also operate as generic computer terminals for networked applications. Inputs: data from SDLC-based modules/interfaces via hardwire or wireless network. Transformation: device processes and displays incoming data; manages alarm tones triggered by parameter modules (which define alarm conditions, limits, and priority). Output: visual display of patient parameters and alarm status; audio alarm tones. Used in hospital bedside or central station settings; operated by clinicians. Provides clinicians with real-time patient data access across the network, facilitating clinical decision-making through centralized monitoring and Alarm Watch features. Benefits: continuous patient surveillance and integrated data management.

Clinical Evidence

Bench testing only. No clinical data provided. System subject to extensive safety and performance testing to ensure functional requirements and specifications are met; compliance with industry and safety standards verified by third-party agencies.

Technological Characteristics

Microcomputer-based patient monitor; VxWorks operating system. Connectivity: hardwire or wireless network (SDLC-based). Interfaces: patient parameter modules, Flexport, gas analyzers, serial devices, audio systems, recorders. Power: line or battery (PC Scout).

Indications for Use

Indicated for use in hospital environments as bedside or central station patient monitors for patients requiring physiological parameter monitoring. Compatible with patient transport (PC Scout).

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

• PC1 Patient Monitor (K842616B)
• Universal Clinical Workstation (UCW) (K932734)
• PC Scout (K930095)

Submission Summary (Full Text)

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# K972282

## SEP 2 5 1997

## 510(k) SUMMARY

## Modified Spacelabs Medical PCIS Patient Monitors

| 1. Submitter's Name<br>Telephone:<br>Facsimile: | Russ Garrison<br>Spacelabs Medical Inc.<br>15220 N.E. 40th Street<br>Redmond, WA 98073<br>[phone]<br>[phone] |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device | Spacelabs Medical PCIS Patient Monitors |
| Classification: | Arrhythmia Detector and Alarm, 74DSI; 870.1025 (Class III) |
| 3. Predicate Device(s) | The Spacelabs Medical PCIS Patient Monitors are substantially equivalent to the PCIS patient monitors marketed by Spacelabs Medical, Inc. |
| | The PC1 Patient Monitor is marketed under K842616B. The Universal Clinical Workstation (UCW) is marketed under K932734. The PC Scout is a portable bedside monitor marketed under K930095. |
| 4. Device Description | Spacelabs Medical PCIS patient monitors (code name "Viper") passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network- based applications to open windows and display information on other networked monitors. |
| | The modifications to the Spacelabs Medical PCIS patient monitor design specified in this submission incorporate performance and functional enhancements. More specifically, different microcomputer processor hardware was incorporated into the modified design. In addition, the executive software has been changed to VxWorks, thereby requiring a significant change/conversion from the existing platform. |
| 5. Intended Use | The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical. |
| | The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters |

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currently available through Spacelabs Medical.

The PC Scout Monitor is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical.

#### General Spacelabs Medical PCIS Patient Monitor Intended Uses

Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network-based applications to open windows and display information on other networked monitors.

- · PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated: (b) the alarm priority (i.e. high, medium or low); (c) alarm limits: and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules.

In all applications. Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission.. Through this network, a patient's data may be displayed at the bedside monitor, central station or a clinical information system.

- Comparison of We consider the devices to be substantially equivalent to the ర్. Spacelabs Medical PCIS Patient Monitors currently marketed by Technological Spacelabs Medical Inc. The design, components used in the modified Characteristics Spacelabs Medical PCIS Patient Monitors, and energy source are similar to its predicate devices.
- The modified Spacelabs Medical PCIS Patient Monitors shall be 7. Testing subject to extensive safety and performance testing prior to release. Final testing for the system shall includes various performance tests designed to ensure that the device will meet all of its functional requirements and performance specifications. Safety and standards testing are to be performed by third party agencies to ensure the system complies to applicable industry and safety standards.

In conclusion, the modified Spacelabs Medical PCIS Patient Monitors are as safe and effective as the predicate devices and raises no new issues.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and head. The eagle is facing right. 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

SEP 2 5 1997

Mr. Russ Garrison Spacelabs Medical, Inc. 15220 N.E. 40th Street P.O. Box 97013 Redmond, Washington 98073-9713

Re: K972282 Spacelabs Medical PCIS Patient Monitors Regulatory Class: III (three) Product Code: 74 DSI Dated: September 15, 1997 Received: September 17, 1997

Dear Mr. Garrison:

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 Requlations, 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 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 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 - Mr. Russ Garrison

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 requlation (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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#### PREMARKET NOTIFICATION

Spacelabs Medical PCIS Patient Monitors

#### INDICATIONS FOR USE

510(k) Number: Pending

Spacelabs Medical PCIS Patient Monitors Device Name:

Indications for Use:

PC1 Monitor - The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical.

Universal Clinical Workstation (UCW) - The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters currently available through Spacelabs Medical.

PC Scout Monitor - The PC Scout is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical.

#### General Spacelabs Medical PCIS Patient Monitor Intended Use Statement

Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow networkbased applications to open windows and display information on other networked monitors.

PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules.

In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission .. Through this network, a patient's data may be displayed at the bedside monitor, central station or a clinical information system.

Arth A. Codd

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K972282