CER-S

CER-S is a software tool for analyzing, editing, reviewing, and reporting continuous ECG recordings to help clinicians diagnose cardiac rhythm disorders in adults and pediatric patients. It is intended for use in clinical and hospital settings by qualified medical personnel or trained professionals under clinician supervision, and does not provide automated interpretation or serve as the sole diagnostic tool.

CER-S is a Windows-based PC software (SaMD) operating as a Holter analyzer with modules for ECG beat detection and classification, rhythm analysis, arrhythmia detection, interactive viewing and editing, template management, and report generation in ISHNE and aECG HL7 XML formats. Key improvements over the predicate include enhanced usability, optional pacemaker analysis, optimized algorithms for beat and noise detection, and strengthened cybersecurity.

IEC 60601-2-47:2012, IEC 60601-2-25:2011 (ECG performance), IEC 62304:2015 (software development lifecycle), IEC 62366-1:2020 (usability engineering), and ISO 14971:2019 (risk management).

CER-S shares the same software type, patient population (adults and pediatrics), user groups (qualified medical personnel or trained professionals under supervision), indications for use, and environmental use as the predicate device K213861. Both are Windows-based Holter analyzers intended for rhythm disorder diagnosis. The technological improvements (enhanced usability, pacemaker analysis option, algorithm optimization, cybersecurity strengthening) represent enhancements that do not raise different safety or effectiveness questions, making the devices substantially equivalent for their common intended use.