(203 days)
The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.
Their purpose of these devices is to vaporise an inhalable anaesthetic agent for which they have been calibrated and which is indicated on the labelling. They may be used for the induction and maintenance of a state of anaesthesia in humans during a medical procedure, usually involving a surgical operation. They may additionally be used for veterinary procedures.
The devices are calibrated for a specific anaesthetic agent and vaporisers for the following anaesthetic agents are available in the Vapamasta 6 range; Halothane, Enflurane, Isoflurane or Sevoflurane.
The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Vapamasta 6 Anaesthetic Vaporiser." This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter focuses on regulatory approval based on substantial equivalence, and it outlines the indications for use of the Vapamasta 6 Anaesthetic Vaporiser. It does not include the detailed performance study results that would typically address your request.
Therefore, I cannot provide the requested information based on the given text.
§ 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).