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For the ICG function: The BioZ Rx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: Heart Rate (HR) Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP) Mean Arterial Blood Pressure (MAP) Stroke Index (SI) Stroke Volume (SV) Cardiac Index (CI) Cardiac Output (CO) Systemic Vascular Resistance (SVR) Systemic Vascular Resistance Index (SVRI) Left Cardiac Work (LCW) Acceleration Index (ACI) Velocity Index/Index of Contractility (VI, IC) Thoracic Fluid Content (TFC) Thoracic Fluid Content Index (TFCI) Systolic Time Ratio (STR) Systolic Time Ratio Index (STRI) Pre-Ejection Period (PEP) Left Ventricular Ejection Time (LVET) Total Arterial Compliance (TAC) Total Arterial Compliance Index (TACI) Left Stroke Work Index (LSWI) Heather Index (HI) Q-C Interval (QC) Left Cardiac Work Index (LCWI) Systemic Stroke Resistance Index (SSRI/SSVRI) Base Impedance (TFI or Za) Electrocardiogram (ECG) For the optional 12-lead ECG function: Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to ruleout causes for symptoms.

This submission for the BioZ Rx covers a PC platform/printer/cart change and user software modifications compared to the predicate BioZ Dx System (K070156 and K051228), which is a noninvasive impedance cardiography (ICG) device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance. The BioZ Rx measures this change in impedance by injecting a high frequency, low amplitude alternating electrical current through the thorax between a pair of sensors placed on the neck and another pair placed on the mid-axillary line at the xiphoid process level. By detecting and measuring the change in thoracic impedance as a function of time, the BioZ Rx is able to calculate stroke volume, cardiac output and many other hemodynamic parameters. The device additionally includes the capability of performing a standard 12-Lead ECG test using previously cleared Welch/Allyn software and USB patient interface accessories (K052158 and K962854). All ICG signal processing and parameter measurements and calculations are identical to predicate device. Those tasks are performed within the ICG Patient Interface Module (PIM) which is essentially unchanged from the predicate device.

For the ICG function: The BioZ Dx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: Heart Rate (HR) Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP) Mean Arterial Blood Pressure (MAP) Stroke Index (SI) Stroke Volume (SV) Cardiac Index (CI) Cardiac Output (CO) Systemic Vascular Resistance (SVR) Systemic Vascular Resistance Index (SVRI) Left Cardiac Work (LCW) Acceleration Index (ACI) Velocity Index or Index of Contractility (VI, IC) Thoracic Fluid Content (TFC) Base Impedance (TFI or Zo) Thoracic Fluid Content Index (TFCI) Systolic Time Ratio (STR) Systolic Time Ratio Index (STRI) Pre-Ejection Period (PEP) Left Ventricular Ejection Time (LVET) Total Arterial Compliance (TAC) Total Arterial Compliance Index (TACI) Left Stroke Work Index (LSWI) Heather Index (HI) Q-C Interval (QC) Left Cardiac Work Index (LCWI) Electrocardiograph (ECG) Systemic Stroke Resistance Index (SSRI or SSVRI) End Diastolic Volume (EDV) End Diastolic Index (EDI) For the optional 12-lead ECG function: Where the clinician decides to evaluate the electrocardiogram of adult and pediatric as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to ruleout causes for symptoms.

This submission covers Version 4.0b5 of the BioZ Dx System Software for the BioZ Dx (K051228), which is a noninvasive impedance cardiography (ICG) device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance. The BioZ Dx measures this change in impedance by injecting a high frequency, low amplitude alternating electrical current through the thorax between a pair of sensors placed on the neck and another pair placed on the mid-axillary line at the xiphoid process level. By detecting and measuring the change in thoracic impedance as a function of time, the BioZ Dx is able to calculate stroke volume, cardiac output and many other hemodynamic parameters. The device additionally includes the capability of performing a standard 12-Lead ECG test. The modified BioZ Dx software and firmware applies the same functions and scientific concepts as the predicate devices. Additional parameters have been added in this release that exists in the predicate devices, and a small number of routine software bugs were corrected with this release.

For the ICG function (from K041294): The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: ECG Cardiac Output Thoracic Fluid Content Left Vent. Ejection Time End Diastolic Volume Systemic Vascular Resistance Left Cardiac Work Pre-Ejection Period Heart Rate Acceleration Index Index of Contractility Mean Blood Pressure Diastolic Blood Pressure Systolic Time Ratio End diastolic Index Cardiac Index Stroke Volume Systolic Blood Pressure For the optional 12-lead ECG function (from K031422): Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

The new product is the combination of two individually 510(k) cleared devices onto a single device platform. Both predicate devices presently use the identical common platform (CPU, display, printer, operating system) in their separate forms. The submission covers the changes necessary to the two predicate devices to allow co-residency of the Philips ECG PIM and its application software and the CardioDynamics ICG PIM and its application software into a single device. The new product combines the ECG functionality of the existing Philips PageWriter Trim III Cardiograph and the ICG functionality of the existing BioZDx monitor and allows switching between ECG and ICG applications. The ECG PIM is identical to PageWriter Trim Product including Philips' original product labeling and manuals. The PageWriter Trim application was modified by Philips to add an "Exit to ICG" function button and a common HIPPA-compliant timeout screen and password compatible with the existing CardioDynamics ICG application. The CardioDynamics application was modified to have an "Exit to ECG" button, and a "home" screen which allows initial selection of one of the two applications.

The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: ECG, Cardiac Output, Thoracic Fluid Content, Left Vent. Ejection Time, End Diastolic Volume, Systemic Vascular Resistance, PressureLeft Cardiac Work, Diastolic Blood Pressure, Pre-Ejection Period, Heart Rate, Acceleration Index, Index of Contractility, Mean Blood Pressure, Systolic Time Ratio, End diastolic Index, Cardiac Index, Stroke Volume, Systolic Blood Pressure.

The BioZDx Hemodynamic Monitor is a portable device for use in the hospital, outpatient and clinical settings. It noninvasively measures a patient's hemodynamic parameters using Impedance Cardiography (ICG) by attaching 8 electrodes to the patient, injecting a minimal current, and reading the returning voltage waveform. It utilizes proprietary DSP electronic circuitry and software incorporating formulas and algorithms to calculate various hemodynamic parameters based on patient inputs (gender, body frame size, height, weight, age, blood pressure) and measured ICG signals. The device includes a built-in printer for reports and an improved patient cable.

The BioZtect Sensor and BioZtect Cable are used with the GE Medical Systems Solar ICG (Impedance Cardiography) Module (K010164) and are intended to monitor and display a patient's hemodynamic parameters. The following are parameters that are available, to be used as needed by the ICG Module: Acceleration Index, Cardiac Output, Cardiac Index, ECG, End Diastolic Volume, End Diastolic Index, Heart Rate, Index of Contractility, Indexed Systemic Vascular Diastone Indon, Indexed Left Cardiac Work, Left Cardiac Work, Left Ventricular Ejection Time, Pre-Ejection Period, Stroke Volume, Stroke Index, Systolic Time Ratio, Systemic Vascular Resistance, Thoracic Fluid Content, Respiration Rate, Velocity Index

The ICG Module with accessories BioZtect Sensor and BioZtect Cable are substantially equivalent to the predicate BioZ.com System in terms of design, intended use and principle of operation, having minimally modified these accessories. Both systems are for use in the hospital, outpatient and clinical settings. The intended use is to noninvasively measure a patient's hemodynamic parameters using Impedance Cardiography (ICG). Monitoring is accomplished by attaching 8 electrodes to the patient (two on each side of the neck and thorax), injecting a minimal current through the upper electrodes, and reading the returning voltage waveform from the inner electrodes. The ICG Module utilizes CardioDynamics' proprietary DSP electronic circuitry and software, incorporating formulas and algorithms to calculate the various hemodynamic parameters. The user inputs patient parameters into the ICG Module, including patient gender, body frame size, height, weight, age and blood pressure. The module then utilizes these parameters and measures the ICG signals to determine the hemodynamic properties of that particular patient. Both the predicate BioZ.com System and the ICG Module with accessories BioZtect Sensor and BioZtect Cable utilize a computer-based system. Each system contains the following: 1. BioZ or ICG Module a) CardioDynamics' proprietary DSP hardware and Patient Interface Circuitry b) CardioDynamics proprietary DSP firmware and user software 2. BioZtect Sensors 3. BioZtect Patient Cable

The BioZ.com Hemodynamic Monitor is intended to monitor a patient's hemodynamic parameters. These parameters include: ECG, Heart Rate, Pre-ejection Period, Left Ventricular Ejection Time, Systolic Time Ratio, Stroke Volume, Cardiac Output, Cardiac Index, Systemic Vascular Resistance, End Diastolic Volume, End Diastolic Index, Index of Contractility, Acceleration Index, Left Cardiac Work, Thoracic Fluid Content, Respiration Rate.

The BioZ.com System is a self-contained computer-based product utilizing the same CardioDynamics proprietary DSP circuitry and software as its predicate device. It consists of an Instrument (containing DSP and Patient Interface Circuitry, Intel 80X86 Processor Board, DSP firmware and user software, power supply, built-in flat-panel screen, keyboard/keypad, power cord), Patient Cable, and Electrodes/Transducers. It is portable and can operate from AC power or an internal rechargeable battery. It uses thoracic electrical bioimpedance (TEB) by attaching 8 electrodes to the patient and injecting a minimal current to measure hemodynamic parameters.

The BioZ System was designed to monitor a patients hemodynamic parameters. These include ECG, HR, PEP, LVET, STR, SV, SI, CO, CI, SVR. SVRI, EDV, EDI, IC, ACI, LCW and TFC.

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