LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)

The LUX-Dx II and LUX-Dx II+ are insertable cardiac monitors (ICMs) designed to monitor and record subcutaneous electrocardiograms (S-ECG) for clinical evaluation and diagnosis of cardiac arrhythmias. The devices are indicated for patients with known heart conditions at risk of abnormal heart rhythms or symptoms suggesting arrhythmia (dizziness, palpitations, syncope, chest pain, shortness of breath), and specifically for atrial fibrillation monitoring in previously diagnosed or treated patients.

The devices are identical to the predicate in all fundamental characteristics: titanium body with titanium nitride electrodes, 1.2 cc volume, 3-gram mass, lithium-manganese dioxide battery (3-year longevity), parylene coating, MR conditional (1.5T and 3T), sterilized via ethylene oxide, and wireless telemetry using Bluetooth Low Energy, cellular, and Wi-Fi. Detection algorithms include atrial fibrillation, tachycardia, bradycardia, pause, atrial tachycardia, and premature ventricular contraction.

Not stated in this summary.

Substantial equivalence is established because the proposed devices are identical in device name, regulatory classification (Class II, MXD product code, 21 CFR 870.1025), intended use, physical design, materials, dimensions, power source, sterilization method, accessories, detection algorithms, and communication systems. The only difference is clarifying language in the indication for use regarding atrial fibrillation monitoring and patient population characterization, which does not alter intended use or introduce new or increased risks. All technological characteristics and system components remain functionally identical to the predicate device K231328.