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The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

The SensiLase™ PAD 3000 (SensiLase™) Skin Perfusion Pressure System provides measurements of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR). Both measurements may be clinically applied to assess perfusion. Both the SPP and PVR measurements are features of the predicate PV2000 device. The same methods arc applied for measurement of SPP and PVR as the predicate PV2000. The SPP measurement is performed by applying a pressure cuff capable of occluding skin blood flow (perfusion). The pressure cuff is inflated until the skin perfusion, as detected by a Laser Scnsor Assembly (LSA) underneath the cuff, is determined to be near zero or significantly reduced. The pressure is released until an increase in skin perfusion is determined. The cuff pressure when the skin perfusion increases is the SPP value. SPP is a test used to evaluate peripheral microcirculation. The measurement of the pulse volume recording (PVR) waveform is a measure of the pulsatile pressure amplitude resulting from a partially inflated cuff encircling the limb. The PVR is used as a more direct measurement of arterial blockage. The test output is a printout of the waveform, which is interpreted by a vascular specialist. The clinical application and interpretation of the Perfusion , SPP measurements and interpretation of the PVR Waveform is the same as the predicate PV2000.

The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.

The CapnoProbe A System provides a measurement of Sublingual pCO2 (SL CO2). The CapnoProbe A consists of a Disposable Sensor, Instrument, Fiber Optic Interconnect Cable and Calibration Fluid. The Disposable Sensor contains a fiber optic pCO- sensor and temperature sensor. The Disposable Sensor is placed under the tongue for a measurement of pCO2 and temperature. The Disposable Sensor connects to the fiber optic interconnect cable. The fiber optic interconnect cable connects to a software modified ABG Module. The instrument is a software modified Optical CAM and ABO Module. The softwaremodified instruments measures SL CO2 and temperature, displaying SL CO2. The instrument is dedicated to the function as programmed by the software. The instruments are referred to as a CapnoProbe A Monitor and a CapnoProbe A Module. Prior to use the CapnoProbe A System with disposable pCO2 sensor is calibrated with provided tonometered saline. The saline calibration fluid is the same as the predicate SensiCath System initialization fluid.

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.

The Olympus System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients with a pre-existing 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.

It is the intention of Optical Sensors Incorporated (OSI) to introduce into commercial distribution an Olympus Critical Care Monitoring System (Olympus System). The Olympus System supports modules and sensors used in monitoring critical parameters at the patient bedside. The module and sensor referenced in this submission are the cleared-to-market arterial blood gas module (ABG Module) and SensiCath optical sensor unit (SensiCath Sensor). When the Olympus System includes an ABG Module and SensiCath Sensor, monitoring of arterial blood gas at the point-of-care is accomplished. The Olympus System has three main components: - 1. an optical arterial blood gas sensor, hereafter referred to as the SensiCath Sensor. - 2. a module, the Arterial Blood Gas (ABG) Module, hereafter referred to as the ABG Module and, - 3. an operator interface (display, control knob) with electrical and mechanical support for the ABG Module, hereafter referred to as the Olympus Monitor.