← Product Code [CBS](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS) · K960490 # AS/3 COMPACT AIRWAY MODULE M-CAIOV (K960490) _Datex Medical Instrumentation, Inc. · CBS · May 3, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K960490 ## Device Facts - **Applicant:** Datex Medical Instrumentation, Inc. - **Product Code:** [CBS](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS.md) - **Decision Date:** May 3, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1620 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K960490](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K960490) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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