(72 days)
The indications for use for the Gas Module II include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the "Datascope Corp. Patient Monitoring Division Gas Module II". This document confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
However, a 510(k) clearance letter does not typically contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria, nor does it include the methodology details requested in your prompt. These details are usually found in the 510(k) submission itself (which is not this document) or in supporting documentation provided by the manufacturer.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This statement is key – it indicates that the clearance is based on substantial equivalence, not necessarily on new studies proving acceptance criteria for novel performance claims.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the full 510(k) submission for K974903, which would contain the performance summary and supporting studies.
§ 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).