SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE

K952912 · Spacelabs Medical, Inc. · DSI · Apr 2, 1997 · Cardiovascular

Device Facts

• Record ID: K952912
• Device Name: SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
• Applicant: Spacelabs Medical, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a SpaceLabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are detected. The SpaceLabs Medical Integrated Multi-Parameter Module is also intended for use as a non-invasive blood pressure system, a pulse oximeter, and a monitor of respiratory effort.

Device Story

Module acquires, processes, and displays ECG vectors, respiratory effort, NIBP, and SpO2; utilizes standard ECG electrodes, NIBP cuffs, and SpO2 sensors. Operates exclusively with SpaceLabs Medical PCMS monitor; clinician controls setup and alarm limits via menu. ECG electrodes measure body surface electrical activity; NIBP uses conventional inflatable cuff; SpO2 uses photoelectric pulse oximetry. Device provides real-time monitoring and audible/visible alarms for arrhythmias and ST segment deviations. Used in clinical settings by healthcare professionals to support patient monitoring and clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and energy source similarities to predicate devices.

Technological Characteristics

Multi-parameter module for ECG, NIBP, SpO2, and respiratory effort. Uses standard surface electrodes, inflatable cuffs, and photoelectric sensors. Energy source and materials are consistent with predicate devices. Integrated with PCMS monitor for processing and display.

Indications for Use

Indicated for adult and neonatal patient populations in all clinical settings. Not intended for home use. Used for ECG monitoring, arrhythmia detection (PVC, V-fib, asystole, tachycardia, etc.), ST segment deviation detection, non-invasive blood pressure measurement, pulse oximetry, and respiratory effort monitoring.

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 90352 PC Scout Expansion Housing (K945429)
• SpaceLabs Medical 90492 ECG Module (K942058)
• SpaceLabs Medical 90478 Telemetry Receiver (K922510)
• SpaceLabs Medical 90553 NIBP Monitor (K941167)
• Nellcor N-180 pulse oximeter (K913695)
• SpaceLabs Medical 90489 SpO2 Module (K901209)
• Hewlett Packard CMS and M1175A (K882609, K900032)
• Marquette Transcope System (K900598)

Submission Summary (Full Text)

{0}

APR - 2 1997

# 510(k) Summary

## SpaceLabs Medical Integrated Multi-Parameter Module K952912

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 Integrated Multi-Parameter Module Classification:
SpaceLabs Medical Integrated Multi-Parameter Module is classified under *Arrhythmia Detector and Alarm (No. 74DSI)* which has been classified as a Class III device, in accordance to 21 CFR 870.1025.

SpaceLabs Medical Integrated Multi-Parameter Module is also classified under *Noninvasive Blood Pressure Measurement System (No. 74DXN)* which has been classified as a Class II device, in accordance to 21 CFR 870.1130.

SpaceLabs Medical Integrated Multi-Parameter Module is also classified under *Oximeter (No. 74DQA)* which has been classified as a Class II device, in accordance to 21 CFR 870.2700.

3. Predicate Devices:
a. SpaceLabs Medical 90352 PC Scout Expansion Housing, as described in K945429.
b. SpaceLabs Medical 90492 ECG Module, as described in K942058;
c. SpaceLabs Medical 90478 Telemetry Receiver, as described in K922510;
d. SpaceLabs Medical 90553 NIBP Monitor, as described in K941167;
e. Nellcor N-180 pulse oximeter, as described in K913695;
f. SpaceLabs Medical 90489 SpO2 Module, as described in K901209;
g. Hewlett Packard CMS and M1175A, as described in K882609 and K900032; and
h. Marquette Transcope System, as described in K900598.

8

{1}

4. The SpaceLabs Medical Integrated Multi-Parameter Module is designed to acquire, process, and display electro-cardiogram vectors (ECG), respiratory effort, non-invasive blood pressure (NIBP), and pulse oximetric oxygen saturation (SpO2) using standard ECG electrodes, NIBP cuffs, and SpO2 sensors and be exclusively used with the SpaceLabs Medical Integrated Multi-Parameter Module along with the PCMS Monitor. Operation, set-up, and alarm limit settings are all controlled by simple menu choices via the PCMS Monitor.

5. The SpaceLabs Medical Integrated Multi-Parameter Module is designed to acquire, process and display up to two ECG vectors and the respiratory effort signal using standard ECG electrodes plus one channel of noninvasive blood pressure and one channel of pulse oximetry.

The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a SpaceLabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are detected.

The SpaceLabs Medical Integrated Multi-Parameter Module is also intended for use as a non-invasive blood pressure system, a pulse oximeter, and a monitor of respiratory effort.

The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use on both adult and neonatal patient populations in all clinical settings. The SpaceLabs Medical Integrated Multi-Parameter Module is not intended for home use. The intended uses of this device are substantially equivalent to its predicate devices.

6. The SpaceLabs Medical Integrated Multi-Parameter Module provides multiple lead ECG monitoring 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.

Non-invasive blood pressure measurements are acquired through a conventional inflatable cuff mechanism that is considered to be standard of care. The SpO2 channel is designed to noninvasively and continuously monitor functional oxygen saturation by the standard photoelectric pulse oximetric technique.

The design, material used, and energy source are similar to its predicate devices.