(105 days)
The Sigma Delta 'T' vaporizer range is designed to attach to the back bar of an anaesthetic machine and deliver controlled concentrations of anaesthesia gasses into a fresh gas. The fresh gas is then delivered into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient. The Vaporizer is calibrated in Vol % of the fresh gas flow and is compensated for changes in both fresh gas flows and temperature changes within the specified range. The indicated use of the Sigma Delta 'T' has therefore not changed from that of the legally marketed device the Sigma Delta.
Anaesthetic Vaporizer
This document is a 510(k) premarket notification decision letter from the FDA for an "Anaesthetic Vaporizer." It does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging diagnostics. The device described is a traditional medical device (anesthetic vaporizer), not a software device that would typically have performance metrics like sensitivity, specificity, and a ground truth study.
Therefore, I cannot provide the requested information.
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).