(119 days)
The Mac-Lab System is intended for use in a catheterization and related cardiovascular specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record cardiovascular data from adult and pediatric patients undergoing cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure and procedural information and optional intracardiac electrocardiogram (IECG). Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices. The Mac-Lab System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during procedure. The Mac-Lab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
The CardioLab EP System is intended for use in an electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record electrophysiological data from adult and pediatric patients under going electrophysiological studies. Data includes: ECG, pressure, and intracardiac electrocardiogram (IECG) waveforms, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, invasive and noninvasive blood pressure, and procedural information. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab EP System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
The ComboLab System is the combination of the both the Mac-Lab and CardioLab EP systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related speciality laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab EP System, although only one may be used at a time.
The Mac-Lab System is a microprocessor based data acquisition system used during cath procedures to monitor, calculate and record physiological data from pediatric or adult patients. Data may be entered manually or acquired via an interfaced GE Medical Systems Information Technologies acquisition device, such as: TRAM module (K011000), EtCO2 module (K904789), CardioLab Amplifier Module (K910307), DASH 3000/4000 Monitor (K001359), Solar 8000M Monitor (K993757), MUSE cardiovascular system (K992637) or other peripheral interface. Data includes: ECG, pressure, respiration intracardiac electrocardiograms (IECG), and SpO2 waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, EtCO2, hemodynamic measurements, invasive and noninvasive blood pressure, temperature, and procedural information. The Mac-Lab joins together the acquisition devices with computer processors, software, highresolution display monitors, power supply, printers, keyboard and mouse. Digital data is transmitted, via cable, from the acquisition devices to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to the CardioLink INW server and other networked hospital information systems.
The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to monitor, calculate and record physiological data from pediatric or adult patients. Data may be entered manually or acquired via an interfaced GE Medical Systems Information Technologies acquisition device, such as: CardioLab Amplifier Module (K910307), TRAM module (K011000), EtCO2 module (K904789), DASH 3000/4000 Monitor (K001359), Solar 8000M Monitor (K993757), MUSE cardiovascular system (K992637) or other peripheral interface, such as RF generators and fluoro video Data includes: ECG. intracardiac pressure waveforms, heart rate, pulse electrocardiograms (IECG), and oximetry (SpO2), respiration rate, EtCO2, invasive and noninvasive blood pressure, temperature, and procedural information. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer via fiber optic cable. The CardioLab joins together the acquisition devices with computer processors, software, high-resolution display monitors, power supply, printers, Digital data is transmitted, via cable, from the keyboard and mouse. acquisition devices to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to the CardioLink INW server and other networked hospital information systems.
The product will be available in three configurations: CardioLab EP application only, Mac-Lab application only, or a combination of both CardioLab EP and Mac-Lab applications. The 'CardioLab EP only's configuration only allows the user to run the CardioLab EP mode. The 'Mac-Lab only' configuration only allows the user to run the Mac-Lab mode. The ComboLab configuration is the combination of both CardioLab EP and Mac-Lab modes, though only one mode may be used at a time (CardioLab EP for electrophysiological lab cases and Mac-Lab for catheterization lab cases).
Here's a breakdown of the acceptance criteria and study information for the Mac-Lab/CardioLab EP/ComboLab System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "The Mac-Lab/CardioLab EP/ComboLab System is as safe, as effective, and performs as well as the predicate device." (K032577) |
| Compliance with Voluntary Standards | "The Mac-Lab/CardioLab EP/ComboLab System complies with the voluntary standards as detailed in Section 9 of this submission." |
| Quality Assurance Measures | Applied: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level Testing (Module verification), Clinical Use Validation, Integration Testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental Testing. Outcomes: Demonstrated equivalence in safety, effectiveness, and performance to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a specific sample size for a test set in the context of validating algorithm performance or diagnostic accuracy. The testing mentioned (Unit-level, Integration, Final Acceptance, Performance, Safety, Environmental) seems to focus on the system's functional and safety aspects, rather than a clinical accuracy study with a defined test set.
- Sample Size: Not specified for performance validation of algorithms or diagnostic accuracy.
- Data Provenance: Not specified. The mention of "Clinical Use Validation" suggests some form of clinical data was involved, but details like country of origin or retrospective/prospective nature are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. The submission references "Clinical Use Validation" but does not detail how ground truth was established or if experts were involved in a diagnostic accuracy assessment for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on demonstrating equivalence to a predicate device via functional and safety testing.
- Effect Size: Not applicable, as no MRMC study was reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device described is a data acquisition and display system for physiological data, not an AI or algorithm-driven diagnostic tool that would typically have a "standalone" performance assessment in the absence of a human. Its function is to "monitor, calculate and/or record" data. Therefore, a standalone algorithm performance study, as typically understood for AI devices, was not conducted or reported. The validation focused on the system's ability to accurately acquire, process, and display physiological data, which inherently involves human interpretation.
7. Type of Ground Truth Used
The text does not specify a "ground truth" in the context of diagnostic accuracy. Given the nature of the device (data acquisition, monitoring, calculation, and recording of physiological parameters), the "ground truth" would likely be the accurate and verifiable physiological signals and measurements themselves, rather than a diagnostic outcome (like pathology or a physician's final diagnosis). The system derives physiological parameters (diastolic/systolic BP, heart rate, cycle length) from signal data but doesn't perform diagnostic analysis or have arrhythmia detection capabilities.
8. Sample Size for the Training Set
The text does not mention a training set size. This type of device, which is primarily a data acquisition and display system based on well-established physiological monitoring principles, would not typically involve "training" in the machine learning sense. Its functionality is based on predefined algorithms for processing signals, not learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned or implied for this type of device.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).