ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)

K962827 · Marquette Electronics, Inc. · DSI · Feb 24, 1997 · Cardiovascular

Device Facts

• Record ID: K962827
• Device Name: ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
• Applicant: Marquette Electronics, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Feb 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual’s attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager.

Device Story

ADU/Pager-LAN System; receives event signals from central stations, telemetry systems, or bedside monitors; provides secondary annunciation of patient conditions; alerts clinical staff via pager device; intended to draw attention to specific zones/patients; does not replace primary monitoring; primary care workflow remains unchanged.

Clinical Evidence

Bench testing only; validation test results indicate device meets requirements for intended use.

Technological Characteristics

Pager-based alarm annunciation system; integrates with existing central station/telemetry/bedside monitoring infrastructure; provides zone-specific event notification.

Indications for Use

Indicated for clinical staff requiring secondary notification of patient events or zone-specific information to supplement primary monitoring systems.

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.

Submission Summary (Full Text)

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K962827
2/24/97

Date: June 11th, 1996

## Submitter/ Manufacturing Information

The sponsor of this 510(k) Premarket Notification is:

Marquette Electronics, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223 USA

Establishment registration number is 2124823.

The Pagers and People Finder Series are manufactured by:

Motorola Inc.
Paging Terminal Products Division
1500 NW 22nd Avenue
Boynton Beach, CA 93426-8292 USA

Any questions regarding the contents of this submission may be directed to:

Dianne Schmitz
Corporate Regulatory Affairs
Marquette Electronics Inc.
Phone: [phone]
Fax: [phone]

## General Information

### Trade/ Proprietary Name

Marquette Electronics, Inc. name for this device is the ADU/ Pager-LAN System.

### Common/ Usual Name

This device is commonly known as a pager and an alarm display unit.

### Device Classification

Unclassified according to a review performed of the CDRH Manual - FDA 91-4246
Classification Names for Medical Devices and In Vitro Diagnostic Products, as well as the
Diogenes 510(k) Register and database.

### Performance Standards

Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission.

### Device Description and Intended Use

The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual’s attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of a pager.

### Conclusion

Validation test results indicate that the pager meets the requirements of its intended use. This information is secondary to the primary care provided. Primary care remains unchanged by the addition of a pager.

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