Who is the manufacturer of AS/3 COMPACT AIRWAY MODULE M-CAIOV?

Datex Medical Instrumentation, Inc. filed the 510(k) submission for AS/3 COMPACT AIRWAY MODULE M-CAIOV (K960490).

What is the FDA product code for AS/3 COMPACT AIRWAY MODULE M-CAIOV?

CBS. It is classified under 21 CFR 868.1620 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for AS/3 COMPACT AIRWAY MODULE M-CAIOV?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AS/3 COMPACT AIRWAY MODULE M-CAIOV?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AS/3 COMPACT AIRWAY MODULE M-CAIOV

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

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.

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

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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.