(70 days)
The purpose and function of the ICG mode of the C3 ICG is to monitor Cardiac Output through the use of Impedance Cardiography (ICG) in adult Males and Fernales.
When not being used for ICG, the C3 ICG can monitor and display continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2;), respiration rate, temperature and carbon dioxide (CO2) on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics.
The purpose of the LIFEGARD™ ICG is to non invasively monitor Cardiac Output using Impedance Cardiography (ICG) on adult Males and Females and provide continuous ECG, heart rate, non-invasive blood pressure (NIBP), on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics.
The C3 ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters when in the ICG mode. The hemodynamic parameters include: Acceleration Index (ACI), Cardiac Index (CI), Cardiac Output (CO), Ejection Time Ratio (ETR), Ejection Velocity Index (EVI), Heart Rate (HR), Heather Index (HI), Left Cardiac Work Index (LCWI), Left-ventricular Ejection Time (LVET), Pre-ejection Period (PEP), Stroke Index (SI), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Systolic Time Ratio (STR), Thoracic Fluid Content (TFC), Thoracic Fluid Volume Index (TFI), Velocity Index (VI). The Impedance Cardiography (ICG) function of the C3 ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
When not in the ICG mode, the C3 ICG is intended to provide continuous ECG, heart rate, noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpOz), respiration rate, temperature and carbon dioxide (CO2) on Adult and Pediatric patients within a hospital or facility providing patient care.
The LIFEGARD™ ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters. The hemodynamic parameters include: Acceleration Index (ACI), Blood Pressure (built-in NIBP), Cardiac Index (CI), Cardiac Output (CO), Heart Rate (HR), Left Cardiac Work Index (LCWI), Left-ventricular Ejection Time (LVET), Pre-ejection Period (PEP), Stroke Index (SI), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Systolic Time Ratio (STR), Thoracic Fluid Content (TFC), Velocity Index (VI). The LIFEGARD™ ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
The C3 ICG is a compact, lightweight device for measuring, processing, printing, and displaying information derived from six physiological measurements: Electrocardiogram (ECG), Pulse Oximetry (SpO2), Temperature, Blood pressure (NIBP), End-tidal CO2 (EtCO2), and Impedance Cardiograph (ICG). An internal thermal printer records waveforms, hemodynamic parameters and tabular trends on a 50-mm wide strip chart. The C3 ICG is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator.
The LIFEGARD™ ICG Patient Monitor is a compact, lightweight device for measuring, processing, storing, and displaying information derived from six physiological measurements: Electrocardiogram (ECG), Blood pressure (NIBP). A thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart. The LIFEGARD™ ICG monitor is powered by internal sealed lead-acid batteries.
The provided 510(k) summary for the Analogic Corporation C3 ICG and LIFEGARD™ ICG Hemodynamic Monitors is a premarket notification for a Class II medical device, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical trial to establish new performance claims. Therefore, the information provided for acceptance criteria and study details will reflect this regulatory pathway.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial's primary outcome measures. Instead, the submission describes a comparison study to demonstrate substantial equivalence of the ICG (Impedance Cardiography) parameter to the predicate device, Cardiodynamics BioZ (K974725). The objective was to show that the hemodynamic monitoring performance is "substantially equivalent."
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Clinical Testing) |
|---|---|
| Hemodynamic monitoring performance of ICG module is substantially equivalent to the predicate device (Cardiodynamics BioZ). | The clinical testing performed at the University of Mississippi Medical Center, comparing the C3 ICG to the Cardiodynamics BioZ predicate device, concluded that the hemodynamic monitoring performance of the C3 ICG and LIFEGARD™ ICG (which has essentially identical ICG circuitry as C3 ICG) is "substantially equivalent" to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 84 patients were sampled. Of these, 75 were readable and met Analogic's protocol. 6 were unreadable, and 3 had abnormal EVI (Ejection Velocity Index). The results from patients with abnormal EVI were included for completeness. The final effective sample size for analysis is 75 patients.
- Data Provenance: The study was conducted at the University of Mississippi Medical Center, indicating US-based data. The study was prospective, as it involved an "IRB approved protocol."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the use of "experts" to establish a ground truth in the traditional sense of consensus reading or interpretation for the ICG data. Instead, the ground truth was inherently established by the predicate device itself (Cardiodynamics BioZ), against which the new device's measurements were compared. The clinical study aimed to show agreement between the new device's ICG readings and those of the predicate device. Therefore, the "ground truth" was derived from the measurements of the established, legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable for this type of comparison study. The study directly compared measurements obtained from the novel device against those obtained from the predicate device. There was no mention of an adjudication process for discrepancies between readers or devices, as the goal was agreement with the predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted as described in the provided summary. The study was a direct comparison of device measurements against a predicate, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the study described is a standalone performance comparison. The C3 ICG (and by extension the LIFEGARD™ ICG through bench testing) was compared directly to the predicate device (Cardiodynamics BioZ) in its ability to measure hemodynamic parameters. The focus was on the agreement of the device's outputs, implying an "algorithm only" or device-only performance evaluation, as ICG technology fundamentally involves automated calculation of parameters from electrical signals.
7. The Type of Ground Truth Used
The "ground truth" was established by the measurements provided by the legally marketed predicate device, Cardiodynamics BioZ (K974725). The study aimed to demonstrate that the C3 ICG's hemodynamic parameter measurements were "substantially equivalent" to those produced by the predicate device.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning (e.g., for an AI algorithm). Impedance Cardiography relies on established physiological models and signal processing, rather than typical supervised learning that requires large labeled training datasets in the same way as, for example, image classification AI. The design of the ICG function was stated to be "substantially equivalent" to the predicate, implying a similar underlying method.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for an AI algorithm is mentioned, this question is not directly applicable. The underlying principles and algorithms for the ICG parameter are presented as being derived from or substantially equivalent to those of the predicate device.
§ 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.