MAC 7 Resting ECG Analysis System

The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph that acquires, analyzes, displays, and records ECG signals from surface electrodes in 3, 6, 12, or 15 lead configurations. It provides interpretive analysis and can print or transmit ECG data to a central clinical information system. It is intended for use by trained operators under direct supervision of a licensed healthcare practitioner in hospitals or medical facilities for both adult and pediatric populations.

The proposed device employs the same fundamental design, construction, and operating principles as the predicate MAC 7 (K203786). Key differences include: support for 15 channels instead of 12, expanded frequency response of 0.04–300 Hz (with 0.04–150 Hz as default), configurable HD Pace pacemaker detection, updated 12SL algorithm (v24 vs v23.1), added chest lead reversal detection capability, support for prior ECG download and review, and network printer capability. These enhancements maintain core functionality without altering safety or performance.

The device complies with voluntary consensus standard ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] and its relevant collateral and particular standards.

The MAC 7 is substantially equivalent to the predicate MAC 7 (K203786) because it uses identical fundamental technology, design, and operating principles for ECG acquisition, analysis, and recording. All modifications—such as increased channel support, enhanced lead reversal detection using a previously-cleared algorithm (12SL v24), configurable pacemaker detection, and additional software features—do not alter the core safety profile or intended clinical use. The device maintains alignment with adult and pediatric indications, contraindications, and patient populations as the predicate and reference devices.