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The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The proposed OptoMonitor 3 includes the display of ARi/TIARi adjunctive hemodynamic indicators when compared to the approved OptoMonitor 3 with a fully integrated TAVI software update cleared via K213854.

The ACIST RXi System is indicated for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.

The current RXi system obtains intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The RXi measures intravascular pressure in a hyperemic state following administration of adenosine as fractional flow reserve (FFR). The proposed software update for the RXi system adds a diastolic pressure ratio (dPR), which measures intravascular pressure in a non-hyperemic (resting) state. Both current and proposed ACIST RXi Systems are used in conjunction with the Navvus Catheter. The proposed RXi System console containing embedded software that provides the main user interface. The system is used with the Navvus catheter which contains a pressure sensor for acquisition of pressure distal (Pd) to a lesion. The proximal aortic pressure (Pa) is acquired via an interface to a third-party hemodynamic system. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) using hyperemic agents and/or nonhyperemic indices of diastolic pressure ratio (dPR) and PdPa for physiological assessment of ischemic stenotic lesions. Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion while inducing hyperemia. dPR is a measure of the diastolic portion of the hemodynamic waveform and can be used by the physician to perform a physiologic assessment without inducing hyperemia in the patient.

The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The TruWave Disposable Pressure Transducer is a sterile, single-use device that is used to monitor intravascular, intracranial, and intrauterine pressures. The pressure transducer has a straight, flow-through design across the pressure sensor, and is available with or without the integral flush device. The pressure sensor is a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A transparent fluid path with an integral stopcock at one end and an integral flush device (either 3mL or 30mL) at the other end encloses the sensor. The enclosure of the TruWave Disposable Pressure Transducer has a pathway for air to enter the housing and acts as a vent. A disposable cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to the pressure transducer housing interfaces with an Edwards Lifesciences reusable cable that is specifically wired for the monitor being used. The TruWave Disposable Pressure Transducer can be mounted on the patient's arm using an arm strap or it may be mounted on an IV pole in a holder. The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems.

To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

The proposed OptoMonitor 3 and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires. The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). The device is a non-sterile, non-patient contact device.

To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires. The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019). The device is a non-sterile, non-patient contact device.

The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.

Comet™ II is a coronary and peripheral quidewire with a pressure sensor mounted approximately 3 cm proximally to the distal end of the straight tip. The optical pressure sensor is integrated within the distal region of a 0.014" quidewire to measure blood pressure gradient changes across coronary and peripheral lesions during endovascular procedures. The tip is radiopaque to help with guidewire placement and shapeable by the user. The guidewire is attached to an optical cable through a detachable connector. The optical cable has a connector on the proximal end for interface with an ancillary Boston Scientific signal processing module. When connected to the signal-processing module, a Boston Scientific iLab Polaris™ Multi-Modality Guidance System displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure. A torque device is preloaded onto the proximal end of the wire. The pressure guidewire, optical cable, and torque device are all connected in the single use sterilized packaging. The intended use of Comet II remains within the scope of the predicate intended use.

To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and or any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessels.

The proposed OptoMonitor is a software upgrade that includes software modifications allowing for the calculation of dPR index, and revised labeling relevant to this change. This device and its components are considered accessories to catheter pressure transducers and are intended for use with leqally marketed catheters. The OptoMonitor with the new dPR calculation is an upgraded version of the software embedded in the previously cleared OptoMonitor's Display Unit. The OptoMonitor comprises the exact same hardware as cleared version with most of the software remaining unchanged, except for the display unit software which in addition to the current calculation of Fractional Flow Reserve (FFR), the upgraded version will also calculate the diastolic pressure ratio (dPR). dPR is a resting index which consists in calculating the ratio of Pd and Pa over the diastolic portion of the heart beat cycle. dPR is a resting index for the diagnostic of the severity of stenosis equivalent to iFR (instantaneous wave-Free Ratio). IFR calculates the ratio of Pd and Pa over 75% of the diastolic portion. The OptoMonitor is composed of 3 parts: The Hybrid Cable Unit (HCU), the Signal Conditioner Unit (SCU) and the Display Unit (DU). There are no changes to the device hardware (HCU and SCU) from device system cleared under K142598. The device is a non-sterile, non-patient contact device.

Zurich Pressure Guidewire System is indicated to measure physiological parameters in the coronary and peripheral blood vessels and in the heart. Zurich Pressure Guidewire System is also indicated to direct a catheter through a blood vessel.

The Zurich Pressure Guidewire System Model 100™ ("Zurich Pressure Guidewire System") consists of a 0.014" (0.36 mm) diameter, 180 cm long Interventional Guidewire with a high fidelity sensor located immediately beyond the 3 cm shapeable radiopaque tip and a uniquely paired Portable Display. The signals from the sensor can be used to measure blood pressures and calculate Fractional Flow Reserve (FFR). The Guidewire is connected to the Portable Display via the Handle. The distal end has hydrophilic coating. The Portable Display also has an AO Cable that may be used to connect to the Zurich Medical Accessory Cable for AO pressure signal.

The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The Edwards Lifesciences Pressure Monitoring kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave disposable pressure transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.

The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).