(64 days)
MAC-LAB System:
The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Medical Systems Information Technologies TRAM modules (K921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.
CardioLab EP System:
The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. 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, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.
The ComboLab System
The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.
The MAC-LAB / CardioLab EP and ComboLab systems do not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure.
The MAC-LAB System is a microprocessor based data acquisition system used during cardiac catheterization procedures. The MAC-LAB system, via various models of the GE Medical Systems Information Technologies TRAM module (K921669) and amplifier module, acquires patient data which may include surface ECG, invasive and non-invasive blood pressure, blood oxygen saturation via pulse oximetry, respiration, and temperature. The TRAM module is housed in a dedicated front end chassis called the remote acquisition case (RAC). The MAC-LAB System joins together the TRAM module and amplifier module with computer processors, software, high resolution display monitors, power supply, laser printer, keyboard and mouse. Digital data is transmitted, via cable, from the TRAM module and/or amplifier module 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 other information systems via LAN.
The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to acquire ECG, intracardiac signals, and pressure signals via amplifier module. Digital data is also acquired from other devices such as RF generators, fluoro video systems and the GE Medical Systems Information Technologies TRAM module. 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 computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN.
The product will be available in three configurations: CardioLab EP application only, MAC-LAB application only, or combination of both CardioLab EP and MAC-LAB applications. The 'CardioLab EP only' 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 combination of both CardioLab EP and MAC-LAB allows the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases).
The provided document is a 510(k) Summary for the GE Medical Systems Information Technologies MAC-LAB/CardioLab EP/ComboLab System from 2002. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific quantitative performance acceptance criteria through a detailed study comparing its performance to a defined ground truth.
Therefore, the document does not contain the specific information requested regarding acceptance criteria, a detailed study proving the device meets those criteria, or the methodology of such a study (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, or training set details).
Instead, the document focuses on demonstrating that the new device is as safe, as effective, and performs as well as predicate devices through:
- Technology Equivalence: Stating that the proposed system employs "the same functional technology as the predicate device."
- Compliance with Voluntary Standards: Mentioning that the systems comply with voluntary standards (details not provided in this excerpt).
- Quality Assurance Measures: Listing general quality assurance activities applied to development: requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.
The "Test Summary" section explicitly states: "The results of these measurements demonstrate that the MAC-LAB/CardioLab EP/ComboLab System are as safe, as effective, and perform as well as the predicate devices." This is a general statement of equivalency rather than a presentation of data against specific, quantifiable acceptance criteria.
In summary, none of the requested information (points 1-9) about acceptance criteria, study design, and performance metrics can be extracted directly from this 510(k) summary.
§ 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).