K960490 · Datex Medical Instrumentation, Inc. · CBS · May 3, 1996 · Anesthesiology
Device Facts
Record ID
K960490
Device Name
AS/3 COMPACT AIRWAY MODULE M-CAIOV
Applicant
Datex Medical Instrumentation, Inc.
Product Code
CBS · Anesthesiology
Decision Date
May 3, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.1620
Device Class
Class 2
Indications for Use
The AS/3™ Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3™ Anesthesia Monitor or in the AS/3™ Compact Monitor in anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
Device Story
Modular airway monitoring component for Datex AS/3™ anesthesia systems; measures CO2, N2O, O2, and anesthetic agent (AA) concentrations; identifies AA (halothane, enflurane, isoflurane, desflurane, sevoflurane); measures airway pressure and volume. Inputs: sampled respiratory gases via infrared photometer and paramagnetic O2 sensor; airway flow/pressure via pneumotachometer transducer. Outputs: real-time gas concentrations, respiratory rate (derived from CO2), pressure, and volume data displayed on host monitor. Used in OR/PACU by clinicians to monitor patient ventilation and anesthetic depth; facilitates clinical decision-making regarding anesthesia delivery and respiratory support.
Clinical Evidence
Bench testing only. Comparative performance verification conducted between M-CAiOV and predicate G-AiOV. Both modules measured gas and spirometry parameters simultaneously; results confirmed performance within specifications and substantial equivalence.
Technological Characteristics
Modular airway gas/pressure/volume monitor. Sensing: infrared photometer (CO2, N2O, AA), paramagnetic sensor (O2), pneumotachometer (flow), pressure transducer (airway pressure). Connectivity: proprietary interface for Datex AS/3™ monitor frames. Software: embedded firmware for signal processing and parameter derivation.
Indications for Use
Indicated for patients requiring respiratory gas, pressure, and volume monitoring during anesthesia in OR or PACU settings.
Regulatory Classification
Identification
A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.
Predicate Devices
Datex AS/3™ Airway Module G-AiOV
Submission Summary (Full Text)
{0}
Datex
510(k) SUMMARY
k960490
31 January, 1996
MAY - 3 1996
Datex-Engström Division
Instrumentarium Corp.
P.O. Box 446
FIN-00101 Helsinki
Finland
Tel: +358 0 39411
Fax: +358 0 1463310
Contact person: Rauno Ruoho
## PRODUCT NAMES
Device name: AS/3™ Compact Airway Module M-CAiOV
Common name: Airway gas, pressure and volume measurement device
## DESCRIPTION OF THE DEVICE
The AS/3™ Compact Airway Module M-CAiOV is a part of the modular anesthesia monitoring system AS/3™. It measures carbon dioxide (CO₂), nitrous oxide (N₂O), oxygen (O₂) and anesthetic agent concentration (AA) of respiratory gases. The Airway Module also identifies anesthetic agent (ID) and measures airway pressure and volume (pV).
The sampled gases are analyzed by an infrared photometer and a paramagnetic oxygen sensor. Respiratory rate is derived from the CO₂ signal. The anesthetic agents (halothane, enflurane, isoflurane, desflurane and sevoflurane) are identified from the sampled gases with infrared technique. Airway gas flow is measured with the aid of a pneumotachometer type transducer and airway pressure is measured from the same adapter by means of a pressure transducer.
## INTENDED USE
The AS/3™ Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3™ Anesthesia Monitor or in the AS/3™ Compact Monitor in anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
## SUBSTANTIAL EQUIVALENCE
In terms of overall functions and parameters measured, the AS/3™ Compact Airway Module connected to the AS/3™ Frame is substantially equivalent in safety and effectiveness to Datex AS/3™ Airway Module G-AiOV.
All measured parameters are the same as in previously approved G-AiOV Airway Module. The sensors are redesigned. CO2 and N2O are measured with infrared absorption with the same wavelengths as before. Anesthetic agents are measured with the same technique but
{1}
at a different wavelength as earlier. Oxygen sensor measurement principle is the same as before, only the sensor is redesigned. Spirometry measurement principle is the same as earlier with the same pressure sensors.
Both gas measurement and spirometry measurement accuracy's were verified with both Compact Airway Module M-CAiOV and Airway Module G-AiOV at the same time. The results showed that both performed within specifications and the results were substantially equivalent.
