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The SAFERsleep System is a software-based product intended for use by an anesthetist to assist in the safe administration and record keeping of drugs used during an anesthetic procedure.

The SAFERsleep System provides an integrated method of information collection and documentation on drugs administered and concurrent anesthetic monitor data. The system also includes ease of use features to reduce the possibility of errors in drug administration.

The SAFERsleep System is a medical device with two primary functions: to aggregate and report data on the events, anesthesia drugs, physiological parameters, and physiological reactions related to a patient undergoing anesthesia as well as to provide a visual and auditory feedback system on the anesthesia drugs selected to be administered. The visual and auditory feedback system reinforces the existing process of checking these drugs prior to administration.

Users of the SAFERsleep System will benefit from the visual and auditory feedback of the SAFERsleep System by swiping a bar-coded syringe across the SAFERsleep System bar-code scanner prior to administering anesthetic medication. In addition, the identity of the scanned anesthetic medication will be recorded automatically and integrated into an automated anesthesia record. The SAFERsleep System will visibly flash on a computer screen the name of the drug, the international color code for the drug, and simultaneously state the drug name over the sound system of the host PC. This functionality is designed to assist anesthetic practitioners in reducing drug administration error.

Data is input to the SAFERsleep System directly from anesthetic monitors, which are connected to the patient. Additional input mechanisms have been provided (a.) to enable data input from other anesthesia equipment (for example, consciousness monitors) and (b.) to enable user entry of anesthetic drugs, events, patient data, administrative data, other clinical data and the use of specific items of equipment (such as endotracheal tubes or intravenous lines, for example). The aggregation of data from these various sources enables the formation of an automated anesthesia record and reduces the burden of manual recording keeping by the anesthetist.

The provided text does not contain information about acceptance criteria or the study that proves the device meets them. The document is a 510(k) summary for the SAFERsleep System, which focuses on device description, indications for use, substantial equivalence to predicate devices, and regulatory classification. It does not include details on performance studies, test sets, ground truth establishment, or expert evaluations.

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