(25 days)
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:
- BioZ or ICG Module
a) CardioDynamics' proprietary DSP hardware and Patient Interface Circuitry
b) CardioDynamics proprietary DSP firmware and user software
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BioZtect Sensors
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BioZtect Patient Cable
This 510(k) submission (K011797) is for modifications to accessories (BioZtect Sensor and BioZtect Cable) used with the GE Medical Systems Solar ICG Module, and it asserts substantial equivalence to a predicate device. As such, it does not include a study demonstrating the device meets acceptance criteria in the way a de novo or PMA submission might.
Instead, the submission focuses on demonstrating that the modified accessories do not introduce new questions of safety or effectiveness compared to the existing predicate device. The core of the argument for substantial equivalence is that the changes are minimal and do not alter the fundamental design, intended use, or principle of operation.
Therefore, the requested information elements related to specific performance metrics and studies (acceptance criteria, sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
The document primarily states:
- Substantial Equivalence: The modified BioZtect Sensor and BioZtect Cable are substantially equivalent to the predicate CardioDynamics BioZtect Sensor and BioZtect Cable within the BioZ.com System (predicate K001100).
- Reason for Submission (for predicate accessories):
- Sensor: Modifications to electrode shape, material, gel, thickness, and snap size.
- Cable: Modifications to leadwire connector size, change style of module connector, addition of series inductors for each conductor, and addition of identification integrated circuit.
- Intended Use: Noninvasively measure a patient's hemodynamic parameters using Impedance Cardiography (ICG).
- Principle of Operation: Attaching 8 electrodes, injecting minimal current through upper electrodes, and reading returning voltage waveform from inner electrodes. The ICG Module uses DSP electronic circuitry and software to calculate hemodynamic parameters based on patient inputs and ICG signals.
In summary, there is no detailed performance study presented in this 510(k) summary that would provide the quantitative information requested. The acceptance is based on the argument that the modifications are minor and the device's performance is assumed to be equivalent to the predicate device whose performance would have been established previously.
§ 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.