Assert-IQ (DM5100)

The Assert-IQ™ 4 ICM (model DM5100) is an insertable cardiac monitor system that monitors and diagnoses patients with unexplained cardiac symptoms (dizziness, palpitations, chest pain, syncope, shortness of breath) and those at risk for arrhythmias like bradycardia, tachycardia, and atrial fibrillation. It is inserted subcutaneously in the left pectoral region and has not been tested for pediatric use.

The DM5100 features patient-initiated and automated EGM triggering for arrhythmia detection, remote monitoring and programming, PVC burden and AF burden trending, and a 1D activity sensor (identical to DM5000). It uses the same battery as DM5500 but is configured for 4-year longevity (versus 6 years in DM5500 and 3 years in DM5000). Hardware and firmware are identical to DM5500.

ISO 11135 (EO sterilization with SAL 10⁻⁶ requirement), FDA Section 524B(b)(1) and 524B(b)(3) for cybersecurity compliance. MRI testing leveraged from predicate for 1.5T and 3T conditional compatibility.

The DM5100 is substantially equivalent to predicate K251221 because it shares the same fundamental design, mechanism of action, and indications for use. All design verification testing confirmed it meets specifications and performs equivalently to predicate models. Mechanical testing, usability, biocompatibility, sterilization, and MRI compatibility were leveraged from cleared predicate models, and no new or different safety/effectiveness questions were raised.