Noxturnal Web

Noxturnal Web is a web-based software tool used by physicians to analyze and manually score sleep study recordings for diagnostic evaluation of sleep and respiratory-related sleep disorders in adults 18 years and older. The software displays physiological signals, generates reports with customizable comments, and supports multiple visualization layouts to help clinicians assess sleep quality and identify sleep-disordered breathing events.

Noxturnal Web v2.0 is a web-based software operating in the cloud with Windows or Mac OS, performing manual scoring of sleep studies including sleep staging, arousal detection, respiratory events, leg movements, and AHI calculation following AASM standards. It analyzes EEG, EOG, EMG, ECG, airflow, chest/abdomen movements, oxygen saturation, and body position data—identical in functionality to the predicate v1.0 device, with the addition of supporting patient age 18-21 years using adult AASM scoring rules.

Software verification and validation testing per IEC 62304 Edition 1.1 (medical device software lifecycle); design controls per ISO 13485 clause 7.3; risk management per ANSI AAMI ISO 14971:2019; cybersecurity per ANSI AAMI SW96:2023 and IEC 82304-1; and usability per ANSI AAMI IEC 62366-1:2015+AMD1:2020. AASM Manual for the Scoring of Sleep and Associated Events was used as the standard of reference.

Noxturnal Web v2.0 shares the same intended use, indications, functionalities, and technical characteristics as the predicate Noxturnal Web v1.0 (K241288), with the only difference being expanded patient population to include ages 18-21 years using validated adult AASM scoring rules—a change that does not present new or modified risks. Comprehensive software verification/validation and performance testing confirm the device meets requirements and is as safe and effective as the predicate device, presenting no new questions of safety and effectiveness.