Comparative Performance Analysis of Excitus AS Portable Suction Device Prototype
1.SCOPE.This research project processes experimental testing and characterization of suction devices for Excitus AS by Dr. R. Lyle Hood of the Mechanical Engineering Department at the University of Texas at San Antonio (UTSA) and Robert De Lorenzo of the Emergency Medicine Department at the University of Texas Health Science Center in San Antonio. The proposed costs are outlined in the Budget and Project Summary section entitled ???BUDGET JUSTIFICATION FOR PHASES 1 & 2.??? 2.REQUIREMENTS 2.1Service: UTSA is responsible for providing characterization of the Excitus AS suction device prototype and comparative performance against substantially equivalent devices already approved by the United States Food and Drug Administration. This includes (1) Air and liquid evacuation flowrate testing with calibrated equipment for the Excitus AS prototype and substantially equivalent units. This will be conducted in laboratory benchtop setups and from within human manikin models designed to simulate patient airways. (2) Summary report of findings for internal use. and a quality abstract for public dissemination. 2.2 Deliverables. The summary report will include experimental descriptions. all results and findings. and expert opinions from Dr. Hood and Dr. De Lorenzo on the adherence of the Excitus AS prototype to current standards and analysis of the device???s substantial equivalency with regards to United States regulatory agencies. 3. PERIOD OF PERFORMANCE. The official period of performance for this work will be February 1st. 2020 through July 31st. 2020. The report will be delivered no later than August 31th. 2020.