AS/3 CARDIAC OUTPUT & SVO2 MODULE

K961063 · Datex Medical Instrumentation, Inc. · DQK · May 31, 1996 · Cardiovascular

Device Facts

• Record ID: K961063
• Device Name: AS/3 CARDIAC OUTPUT & SVO2 MODULE
• Applicant: Datex Medical Instrumentation, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: May 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The AS/3™ COPSv module is intended to be used in the Datex AS/3™ Anaesthesia Monitor or in the AS/3™ Compact Monitor in anesthesia department, in intensive care department etc.

Device Story

AS/3™ COPSv Module; modular component for Datex AS/3™ Anaesthesia/Compact Monitors. Inputs: thermodilution signals for C.O./REF; spectrophotometric data for SvO2; invasive pressure signals. Processing: licensed Baxter Edwards algorithms for C.O., REF, and SvO2 calculations. Output: real-time hemodynamic parameters displayed on monitor. Used in anesthesia/ICU by clinicians. Benefits: continuous hemodynamic monitoring to guide clinical decision-making.

Clinical Evidence

No clinical data provided; device relies on established thermodilution and spectrophotometric measurement techniques licensed from Baxter Edwards.

Technological Characteristics

Modular anesthesia monitoring component. Thermodilution technique for C.O./REF; spectrophotometric technique for SvO2. Hardware/software for C.O. and invasive pressure identical to K922876. Integrated measurement algorithms.

Indications for Use

Indicated for patients requiring cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2), and invasive pressure monitoring in anesthesia or intensive care settings.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• COP module (K922876)

Submission Summary (Full Text)

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Datex

510(k) SUMMARY

K961063

15.03.96

MAY 31 1996

Datex-Engström Division

Instrumentarium Corp.

P.O. Box 446

FIN-00101 Helsinki

Finland

Tel: [phone]

Fax: [phone]

Contact person: Rauno Ruoho

## PRODUCT NAMES

Device name: AS/3™ Cardiac Output and SvO2 Module

Common name: Cardiac Output and SvO2 Measurement Device

## DESCRIPTION OF THE DEVICE

The AS/3™ COPSv Module is a parts of the modular anesthesia monitoring system AS/3™. It provides cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2) and invasive measurement of patient.

The AS/3™ COPSv module is intended to be used in the Datex AS/3™ Anaesthesia Monitor or in the AS/3™ Compact Monitor in anesthesia department, in intensive care department etc.

The hardware of all parameter measurement is in the M-COPSv module. The software for all measurement algorithm is in the M-COPSv module. C.O. and REF measurements are based on the thermodilution technique. SvO2 is measured utilizing a spectrophotometric technique. C.O., REF and SvO2 measurement algorithm are licensed from Baxter Edwards. The hardware and software for cardiac output and invasive pressure measurements of the COPSv module is exactly same as in the COP module (File K922876).