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The modified SensiCath Sensor, when used as part of the Point-of-Care Blood gas Monitor System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients requiring an arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated. The intended use of the modified SensiCath Sensor is the same as the predicate SensiCath Sensor.

It is the intention of Optical Sensors Incorporated (OSI) and Marquette Electronics Incorporated (MEI) to introduce into commercial distribution a modification to the SensiCath Arterial Blood Gas Sensor. The modified sensor has a longer useful life and allows a greater number of ABG measurements. The modified sensor is substantially equivalent to the SensiCath Sensor presented in the SensiCath™ Point-of-Care Blood Gas Monitor System which received Food and Drug Administration (FDA) clearance to market, 510(k) K95 1094. The modified SensiCath Sensor operates with the SensiCath Point-of-Care Blood Gas Monitor System, just as the predicate SensiCath Sensor. As with the predicate sensor, the modified SensiCath Sensor measures blood gas parameters of partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2) and the blood's hydrogen ion concentration, (pH). The modified SensiCath Sensor is manufactured and sterilized by Optical Sensors Incorporated, as is the predicate SensiCath Sensor.