(22 days)
The MAC 800 is a portable ECG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.
The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes.
The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode.
The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.
Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional.
The arrhythmia detection portion of the MAC 800 is provided to the customer for the convenience of automatic documentation.
The MAC 800 is used under the direct supervision of a licensed healthcare practitioner.
Contraindications:
The MAC 800 is not designed to provide alarms for arrhythmia detection.
The device is not suitable for intra cardiac application.
It is not intended for use:
- As a vital signs physiological monitor; or
- For use during patient transport.
The MAC 800 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. The MAC 800 will provide, in resting ECG mode, ECG quality information using the hookup advisor. The hookup advisor advises users of poor lead quality based on noise measurement. It can be upgraded to provide options such as ECG measurement and interpretation with 12SL. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. Multiple QT correction formulas including Bazett, Framingham and Fridericia will be available as a user selectable option. Clinical Trials Data Guard and audit trail options are also available.
The MAC 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, an integrated 7" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non real time reports. The device can print the resting ECG report via the external laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to PDF file on SD card as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 can be used as a portable unit.
The provided 510(k) summary for the GE Healthcare MAC 800 Resting ECG Analysis System does not contain acceptance criteria or a study proving that the device meets such criteria.
Instead, the submission states:
- "The subject of this premarket submission, MAC 800 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." (Page 3)
- "GE Healthcare considers the MAC 800 Resting ECG Analysis System to be as safe, as effective, and performance is substantially equivalent to the predicate device." (Page 3)
The document focuses on demonstrating substantial equivalence to a predicate device (K081437, MAC 1600 ECG Analysis System) through non-clinical testing and similarity in technology, rather than presenting a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested information, as it is not present in the given text.
If this were a different kind of submission (e.g., a De Novo application or a submission for a novel device), it would typically include a detailed clinical study plan, acceptance criteria, and performance results. However, for a 510(k) submission asserting substantial equivalence, especially for a device type like an electrocardiograph, demonstrating equivalence to an already legally marketed device often suffices without new clinical studies.
§ 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).