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U.S. Department of Health and Human Services

Product Classification

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Device software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents
Definition The software feature is indicated for use with the anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The software feature is indicated for adult patients, 18 years of age and older. The anesthesia system and the software feature are intended for prescription use only.
Physical State Software medical device intended to work with anesthesia gas machine. User interfaces are on the anesthesia gas machine touch screen display.
Technical Method The software feature is an optional feature which allows the clinician to directly set the desired target End Tidal Oxygen (EtO2) and End Tidal Anesthetic Agent (EtAA) on the host anesthesia machine. The software feature utilizes breath-by-breath measurements from the respiratory gas module and interfaces with the anesthesia machine to titrate the electronic gas mixer and electronic anesthetic agent vaporizer to help achieve and maintain the target end tidal concentrations set by the clinician.
Target Area Breathing gas pathway.
Review Panel Anesthesiology
Product CodeQSF
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible