(91 days)
The Bio Z Cardio Profile Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters including: Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Pulse Wave Velocity (PWV), Oxygen Delivery Index (DO2l), Stroke Volume (SV), Stroke Index (SI), Cardiac Output (CO), Cardiac Index (CI), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Left Cardiac Work (LCW), Left Cardiac Work Index (LCWI), Velocity Index (VI), Acceleration Index (ACI), Heather Index (HI), Pre-Ejection Period (PEP), Left Ventricular Ejection Time (LVET), Thoracic Fluid Content (TFC), Thoracic Fluid Content Index (TFCI), Baseline Impedance (Zo), Total Arterial Compliance (TAC), Total Arterial Compliance Index (TACI), Systolic Time Ratio (STR), Systolic Time Ratio Index (STRI). The Bio Z Cardio Profile Hemodynamic Monitor is not intended to be used as a vital sign monitor.
The Bio Z Cardio Profile Hemodynamic Monitor is a data acquisition system that measures and processes ECG and impedance data. In combination with height, weight, age, and gender the hemodynamic parameters are calculated by the user software (Cardio Vascular Lab). Additional parameters are measured with the help of OEM modules (NIBP and SpO2) integrated in the device. The Bio Z Cardio Profile also allows the estimation of the Pulse Wave Velocity (PVVV). For this purpose the pressure cuff (NIBP) is placed on the upper leg. The ICG signal is used to define the opening of the aortic valve and the pressure cuff is used to determine the arrival of the pulse wave after leaving the heart. On this basis the propagation time of the pulse wave in the aorta can be estimated. Pulse Wave Velocity can be calculated when considering the distance between the heart and the pressure cuff placed on the upper leq. The Bio Z Cardio Profile measures SpO2 for the purpose of calculating Oxygen Delivery Index (DO2l). The SpO2 measurements are provided by an integrated OEM module, the Nellcor™ OxiMax™ NELL-1 ™ OEM pulse oximetry module (previously cleared on the Cheetah Reliant by the FDA (K103166)). The Nell-1 module measures functional oxygen saturation non-invasively via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsed blood flow. The Nell-1 module receives electrical signals from the sensor, which is then run through an algorithm to provide SpO2 values. Utilizing the Nell-1 OEM module, the Bio Z Cardio Profile is capable of measuring: Blood oxygen saturation (SpO2 via finger Oximeter) for use in calculating Oxygen Delivery Index (DO2l); using Oxygen Saturation (SpO2) data from Oximeter and Cardiac Index (CI) data from the ICG function. The Nell-1 module, as part of the Bio Z Cardio Profile, is intended for spot-check measurements of arterial blood oxygen saturation. The SpO2 measurement data is not available to view by the user; it is only used in the calculation of Oxygen Delivery Index (DO2)), which requires an additional ICG Cardiac Index (CI) measurement.
The provided text describes the Bio Z Cardio Profile Hemodynamic Monitor and its intended use, but it does not contain details about a specific study or acceptance criteria with reported performance data. It primarily focuses on the device's technical characteristics, regulatory classification, and establishment of substantial equivalence to predicate devices.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study, sample sizes, expert involvement, or adjudication methods, as this information is not present in the provided document.
The document is a 510(k) summary, which typically outlines the device and its equivalence to legally marketed predicates, but does not always include detailed performance study results that would fulfill all the requested criteria. Such detailed study results are usually found in the full 510(k) submission or separate clinical reports, which are not included here.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.