(16 days)
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediation populations. Dasio systems don't display, and record clock. Sie and all gr 3, 6, 12, or 15 lead ECG's, 12 lead can be upgraded to provide merpretive analysis, vootor loops, and resolution signal averaging of Sollware analysis options of the electrocardiogram. Transmission and QRS and I wave portions of and from a central ECG cardiovascular information system is optional.
The MAC 5000 is intended to be used under the direct supervision of a The MAC 5000 is michaou to be be as a loss and a hospital or medical professional's facility.
The MAC 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The system consists of two basic components: the processing unit and the patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.
The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The MAC 5000 system acquires ECG data using a modular patient data acquisition device called the CAM14 (K991735). By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5000 delivers 12 or 15 lead ECG's on fullsize reports with alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, integrated thermal writer and removable data storage.
Additionally, the MAC 5000 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.
The provided document (K042177) is a 510(k) summary for the GE MAC 5000 ECG Analysis System. It states that the device is substantially equivalent to predicate devices but does not contain specific acceptance criteria, performance data, or details of a study proving the device meets acceptance criteria.
The 510(k) summary mentions "Test Summary" and lists various types of testing performed (Risk Analysis, Technical Reviews, Design Reviews, Code Inspections, Unit level Testing, Integration Testing, Final Acceptance Testing, Performance Testing, Safety Testing). However, it explicitly states: "The results of these measurements demonstrated that the MAC 5000 is as safe, as effective, and performs as well as the predicate devices." This is a general statement of equivalency, not a presentation of specific acceptance criteria or quantitative performance data.
Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them, along with the specified details, because this information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for the new device.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).