SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION

K962970 · Spacelabs Medical, Inc. · DSI · Mar 25, 1997 · Cardiovascular

Device Facts

• Record ID: K962970
• Device Name: SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
• Applicant: Spacelabs Medical, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a software-only option added to the 90492 module software, and is designed to acquire, analyze and display up to twelve ECG vectors in a standard diagnostic ECG analysis format and to work exclusively within the SpaceLabs Medical 90492 12-lead ECG module. The SpaceLabs Medical Model 90492 ECG module is designed to acquire, process and display up to twelve ECG leads and one respiratory effort signal using standard ECG electrodes. The twelve ECG leads consist of the standard twelve ECG leads, I, II, III, aVR, aVL, aVF, V1 - V6. The 90492 ECG module is used to monitor patients in the operating room, recovery rooms, intensive care units, in the emergency room, in research settings, or other units where additional ECG leads are desired.

Device Story

Software-only upgrade for SpaceLabs 90492 ECG module; acquires 12-lead ECG signals via standard surface electrodes. Uses Mortara Instruments diagnostic ECG algorithm (object code) to analyze cardiac cycles and beat-to-beat variability. Operates within SpaceLabs Patient Care Management System (PCMS). Clinicians place electrodes; system processes signals via digital filters; displays analog waveforms and diagnostic analysis. Output assists clinicians in rhythm determination and detection of abnormal/life-threatening cardiac events. Benefits include integrated diagnostic capability within existing monitoring workflow.

Clinical Evidence

Bench testing only. System underwent extensive safety and performance testing to ensure compliance with functional requirements and industry safety standards. No clinical trial data presented.

Technological Characteristics

Software-only option for 90492 ECG module. Uses standard ECG electrodes and shielded leadwires. Signal processing includes digital filtering to remove noise. Algorithm is provided as object code from Mortara Instruments. Operates within the SpaceLabs PCMS environment.

Indications for Use

Indicated for patients requiring continuous electrocardiographic monitoring and diagnostic ECG analysis in clinical settings including OR, recovery, ICU, ER, and research units.

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

• SpaceLabs Medical 12 Lead ECG Module (K942058)
• Mortara Instrument ELI300 (K933143)

Reference Devices

• Mortara Instruments ELI 100 (K920627)
• Mortara Instruments ELI 200 (K920626A)

Submission Summary (Full Text)

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MAR 25 1997
K962970

SpaceLabs Medical

15220 N.E. 40th Street
P.O. Box 97013
Redmond, Washington 98073-9713
206-882-3700

# 510(k) Summary

## SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option

1. Submitter's Name: SpaceLabs Medical Inc.
15220 N.E. 40th Street
Redmond, WA 98073
Telephone: [phone]
Facsimile: [phone]

2. Name of Device: SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option
Classification: Arrhythmia Detector and Alarm; 21 CFR 870.1025

3. Predicate Device(s):
The SpaceLabs Medical 12 Lead Diagnostic ECG Analysis Option is a modification to the existing SpaceLabs Medical 12 Lead ECG Module, as described in K942058. As a result of a business relationship between Mortara Instruments and SpaceLabs Medical, the diagnostic ECG algorithm used in the Diagnostic ECG Analysis Option are identical to those found in the Mortara Instrument ELI300, as described in K933143.

4. The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a software-only option added to the 90492 module software, and is designed to acquire, analyze and display up to twelve ECG vectors in a standard diagnostic ECG analysis format and to work exclusively within the SpaceLabs Medical 90492 12-lead ECG module. The diagnostic analysis algorithm is that used in the Mortara Instruments ELI 100 (K920627), ELI 200 (K920626A) and ELI 300 (K933143) and is provided by Mortara Instruments as object code. There is no additional hardware required for this option.

The SpaceLabs Medical Model 90492 ECG module is designed to acquire, process and display up to twelve ECG leads and one respiratory effort signal using standard ECG electrodes. The twelve ECG leads consist of the standard

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twelve ECG leads, I, II, III, aVR, aVL, aVF, V1 - V6. The 90492 ECG module is used to monitor patients in the operating room, recovery rooms, intensive care units, in the emergency room, in research settings, or other units where additional ECG leads are desired.

ECG data is displayed as an analog moving waveform or as various static waveforms. The analog ECG is passed through digital filters to eliminate unwanted signals. Standard ECG electrodes are used to interface the patient to the 90492 ECG module. Clinicians will position the electrodes in the customary locations. The electrodes are connected to shielded leadwires which are connected to a shielded cable. The cable is connected to the front of the 90492 module.

5. The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option provides a means for performing diagnostic ECG analysis in conjunction with the monitoring functions of the SpaceLabs Medical Model 90492 ECG module. Diagnostic ECG analyzes detailed ECG waveforms in each cardiac cycle and the beat-to-beat variability in order to determine the cardiac rhythm. When used in conjunction with a SpaceLabs Medical Patient Care Management System (PCMS) monitor the SpaceLabs Medical Model 90492 ECG module provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events.

6. The SpaceLabs Medical Model 90492 ECG module with the 12 Lead Diagnostic ECG Analysis Option provides multiple lead monitoring and ECG analysis from electrodes placed on the body surface. Electrical activity of the heart is measured via multiple electrodes placed at various locations on the patient's body. The design, material used, and energy source are similar to its predicate devices.

7. The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option has been subjected to extensive safety and performance testing. Final testing for the system includes various bench and performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have been performed to ensure the device complies to all applicable industry and safety standards.

In conclusion, the SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is as safe and effective as the predicate device and raises no new issues.

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