Edema Guard Monitor (EGM) CardioSet-001

The Edema Guard Monitor (EGM) CardioSet-001 is a battery-powered, non-invasive impedance monitor that measures changes in fluid status by applying low-amplitude, high-frequency electrical current to the body and measuring electrical impedance. It is intended for monitoring and managing patients with fluid management problems, heart failure, or coronary artery disease in both inpatient and outpatient settings under physician direction, as an adjunct to standard clinical assessment.

Both subject and predicate devices measure lung bioimpedance using skin electrodes at 100 kHz frequency with similar current amplitude and are battery-powered with local software control. The subject device uses six electrodes (3 front, 3 back) with positioning templates and is compatible with any standard ECG electrode, whereas the predicate uses only 2 specific disposable silver/silver chloride electrodes above and below the breastbone. Both display output on a console or device display.

Not stated in this summary.

The indications for use of the subject device are a subset of the predicate device's cleared indications, satisfying the first requirement for substantial equivalence. Both devices employ identical lung bioimpedance measurement technology to monitor pulmonary congestion via skin electrodes. Although the subject device uses six electrodes rather than two and accommodates standard ECG electrodes instead of proprietary ones, bench, animal, and clinical testing demonstrated that these differences provide equivalent or better lung fluid content calculation without raising different safety and effectiveness questions. The technological differences were implemented to overcome sensitivity challenges in bioimpedance measurement rather than to change fundamental operation or intended use.