Solo Pace Control

The Solo Pace Control is an external cardiac pacemaker pulse generator designed for temporary single-chamber pacing in clinical environments, primarily for interventional cardiology procedures. It is used with a cardiac pacing lead system to provide short-term demand pacing for conditions including complete heart block, bradycardia, and cardiac complications during procedures, with continuous patient monitoring required.

Solo Pace Control provides sensing and pacing functions similar to the predicate Medtronic 5392 but with a simplified design including only features necessary for single-chamber pacing in the catheterization laboratory. Key differences include AC main power with battery backup, bed-mountable form factor, assistive operational workflow stages (pacing capture check, rapid pacing, control pacing, back-up pacing), Bluetooth-enabled remote control capability, and pre-sets organized around interventional structural heart procedures.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-4-2 (immunity), IEC 60601-2-31 (external pacemaker safety and performance), ANSI C63.27-2001 and AAMI C63.270-2021 (wireless coexistence evaluation), plus system and subsystem verification testing, software validation, cybersecurity risk management, and design validation with clinical users.

Both devices are external pulse generators for temporary cardiac pacing in clinical environments using the same regulatory classification and product code. Although Solo Pace Control is simplified for interventional cardiology and adds Bluetooth remote control and workflow-specific presets, these design differences represent non-fundamental modifications that do not introduce new safety or performance risks. Performance testing met specified acceptance criteria across all standard electrical safety, EMC, wireless, and pacemaker-specific tests, demonstrating the simplified design and new features do not raise new safety or effectiveness issues compared to the predicate.