(91 days)
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Datex AS/3TM Anesthesia Monitor,AS/3TM Compact Monitor
No
The description focuses on standard gas analysis and measurement techniques (infrared photometer, paramagnetic oxygen sensor, pneumotachometer, pressure transducer) and does not mention any AI or ML components.
No
The device is described as a monitor that measures concentrations of various gases and identifies anesthetic agents in respiratory gases. This is a diagnostic function, not a therapeutic one.
No
The device measures physiological parameters (CO2, N2O, O2, anesthetic agent concentration, airway pressure, and volume) and identifies anesthetic agents. While this information is crucial for monitoring patient status during anesthesia, the description focuses on measurement and monitoring, not on diagnosing a disease or condition. It provides data for clinicians to interpret, but the device itself does not make a diagnosis.
No
The device description explicitly details hardware components such as an infrared photometer, paramagnetic oxygen sensor, pneumotachometer type transducer, and pressure transducer, indicating it is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes gases within the airway, which are directly involved in respiration and are not samples taken from the body for analysis outside of the physiological process.
- The device measures physiological parameters directly related to respiration (CO2, O2, N2O, anesthetic agents, airway pressure, volume, respiratory rate). These are in-vivo measurements, not in-vitro analysis of a sample.
- The intended use and device description clearly indicate monitoring of respiratory gases and mechanics during anesthesia and recovery. This is a real-time, in-vivo monitoring function.
Therefore, the AS/3M Compact Airway Module M-CAiOV is a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The AS/31M Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3TM Anesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
Product codes
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Device Description
The AS/3TM Compact Airway Module M-CAiOV is a part of the modular anesthesia monitoring system AS/3TM. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Datex AS/3TM Airway Module G-AiOV
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1620 Halothane gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the word "Datex" in white letters on a black, rounded rectangle. The font is bold and sans-serif. The word is centered in the rectangle.
¥960490
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
510(k) SUMMARY
Contact person: Rauno Ruoho
PRODUCT NAMES
AS/3TM Compact Airway Module M-CAiOV Device name: Airway gas, pressure and volume measurement device Common name:
DESCRIPTION OF THE DEVICE
The AS/3TM Compact Airway Module M-CAiOV is a part of the modular anesthesia monitoring system AS/3TM. 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/31M Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3TM Anesthesia Monitor or in the AS/3TM 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/3TM Compact Airway Module connected to the AS/3TM Frame is substantially equivalent in safety and effectiveness to Datex AS/3TM 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.