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The Cardiometrics FloWire 300 Doppler Guide Wire and the Cardiometrics FloWire XT 300 Doppler Guide Wires are intended for use in all blood vessels, including both coronary and peripheral arteries, to measure blood flow velocities during diagnostic angiography and/or interventional procedures. The FloWire may be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood flow velocity measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary or peripheral artery disease.

The FloWire 300/ FloWire XT 300 Doppler Guide Wire is a steerable guide wire with a ultrasound transducer mounted in a housing at the tip of the radiopaque tip coil. The FloWire 300/ FloWire XT 300 utilizes a coaxial design, has a nominal outer diameter of .014" throughout the entire length of the guide wire, and is approximately 300 cm in length. The FloWire 300/ FloWire XT 300 is constructed from a core wire, tapered at the distal end. Two different taper configurations are available, one is for the standard FloWire 300 Doppler Guide Wire, while the second configuration is for the FloWire XT 300 Doppler Guide Wire. The FloWire XT 300 Doppler Guide Wire has increased column strength in the distal segment of the wire just proximal to the tip of the wire, while retaining the floppy characteristics of the tip itself; the increased column strength provides additional support for tracking interventional devices, such as atherectorny devices, lasers and stents. External to the core wire is a hypotube, proximal and tip coils, and the transducer housing. The hypotube extends from the conductive bands at the proximal end of the FloWire 300/FloWire XT 300 Doppler Guide Wire to the proximal coil. The distal tip is available in three different stiffnesses: floppy or flex. In addition, the FloWire 300/FloWire XT 300 Doppler Guide Wire is coated to provide lubricity for tracking interventional devices, such as balloon dilatation catheters. The FloWire 300/FloWire XT 300 Doppler Guide Wire connects to the FloMap/FloMap II Instrument via the Rotary Connector Cable and Patient Cable.

The Cardiometrics WaveWire/WaveMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The WaveWire may be used to guide the positioning of balloon dilatation catheters, as well as other interventional devices such as atherectomy devices, lasers and stents. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary and/or peripheral artery disease.

The Cardiometrics WaveWire Pressure Wire is a steerable guide wire designed to perform real-time invasive pressure measurements in the vasculature. The WaveWire has a nominal outer diameter of either .014" or .018" and is 175 cm in length. It has a 3 cm . shapeable radiopaque tip coil that is available in three different stiffnesses: floppy. flex and firm. The WaveWire XT Pressure Wire design provides increased column strength in the distal segment of the wire just proximal to the guide wire while retaining the floppy characteristics of the tip itself: the increased column strength supports certain interventional devices (Note: All other characteristics of the WaveWire XT Pressure Wire are the same as the non-XT WaveWire). A miniature pressure transducer is mounted at the junction of the radiopaque tip coil and the radiolucent proximal coil. The WaveWire Pressure Wire is connected to the WaveMap Pressure Instrument via a rotary connector cable and patient cable. Each rotary connector cable includes an identification memory chip containing the calibration constants for the pressure transducer. In addition, the WaveWire Pressure Guide Wire is designed to be compatible with the Cordis CINCH® extension system. The WaveMap Pressure Instrument is intended for use only with the WaveWire Pressure Wire. The WaveMap is a microcomputer controlled instrument which processes the information from the transducer mounted in the WaveWire to produce real-time blood pressure measurements. The WaveMap provides digital readouts of mean aortic pressure from a guide catheter, mean WaveWire pressure, and a calculated parameter, such as gradient or fractional flow reserve (FFR). The WaveMap also supplies an analog output of the WaveWire pressure for display on a conventional physiologic monitoring system or strip chart recorder.

The FloWire Doppler Guide Wires and the FloMap Ultrasound Instrument measure blood velocities in peripheral and coronary arteries. The FloWire/FloMap System are intended for use in conjunction with diagnostic procedures such as peripheral and coronary angiography and for interventional procedures such as balloon angioplasty, as well as other interventional procedures which utilize a guide wire in the peripheral and coronary vasculature. The SmartWire Doppler Guide Wire and SmartMap Ultrasound Instrument are intended for use in the cerebral vasculature to measure blood flow velocities during diagnostic angiography and/or any interventional procedures.

This 510(k) Notification is being submitted for modifications to the tip mounted transducer of Cardiometrics Doppler Guide Wires (both FloWire and SmartWire Doppler Guide Wires). The transducer modifications allow the beam width to increase from 28° to 35° and allow the Doppler Guide Wires to all function at 12 MHz. Previously, the .014" Doppler Guide Wire functioned at 15 MHz and the .018" Doppler Guide Wire functioned at 12 MHz. This modified transducer will be more efficient with a higher signal to noise ratio with the wider beam width will allow for easier signal acquisition by the user when positioning the Doppler Guide Wire in the vessel. The currently marketed FloWire and SmartWire Doppler Guide Wires have the mechanical properties of other floppy steerable guide wires with the addition of a tip mounted ultrasound Doppler transducer. FloWire and SmartWire Doppler Guide Wires connect to a Rotary Connector Cable which is supplied with each guide wire. The Rotary Connector Cable in turn connects to the Patient Cable which connects to the Cardiometrics FloMap Ultrasound Instrument. The FloMap Instrument incorporates the electronics and software required to process the Doppler ultrasound signals in real time, displaying blood flow velocity measurements and spectral patterns on the instrument monitor. Blood flow velocity measurements are obtained using the FloWire and SmartWire Doppler Guide Wires to provide hemodynamic information in diagnostic and/or interventional procedures.