TipTraQ (TTQ001)

TipTraQ is a wearable fingertip device intended to aid in sleep apnea evaluation and diagnosis for adult patients suspected of sleep apnea in both home and clinical settings. It combines a photoplethysmography (PPG) sensor, accelerometer, mobile app, and cloud-based AI analysis to measure physiological parameters including oxygen saturation, pulse rate, sleep stages, and respiratory event indices (AHI, ODI).

TipTraQ uses PPG (red, infrared, green light sources) and accelerometer sensors worn on the fingertip, with cloud-based analysis. The primary predicate NightOwl uses PAT (pulse arrival time) and accelerometer data, also cloud-based. Key differences: TipTraQ measures green-channel PPG (predicate uses only red/infrared); TipTraQ calculates sleep stages (Wake, REM, NREM) and Total REM Time, which NightOwl does not; TipTraQ presents results to patients only after HCP confirmation, while NightOwl presents no patient results. Both devices use similar AASM-based AHI algorithms (1A and 1B rules).

ISO 80601-2-61:2019 (pulse oximetry bench testing); IEC 60601-1:2020, IEC 60601-1-2:2014+AMD1:2021, IEC 60601-1-11:2020 (electrical safety, EMC, home healthcare environment); IEC 62133-2:2017 (lithium battery safety); ISO 10993-1:2018 (biocompatibility); FDA guidance on pulse oximeter 510(k)s and device software functions.

TipTraQ and NightOwl share the same intended use (sleep apnea evaluation aid), target population (adults ≥22 years), prescription-only status, and operational setting (home/clinical with clinical interpretation). Both use fingertip wearable sensors, wireless data transfer, and cloud-based analysis with identical AHI algorithms (AASM 1A and 1B rules). Clinical validation data show TipTraQ's AHI performance (sensitivity/specificity at cutoffs 5, 15, 30) is comparable to or exceeds NightOwl's published performance. SpO2 accuracy (Arms 1.41) and pulse rate accuracy meet predefined acceptance criteria. The minor differences—green-channel PPG addition, sleep stage calculation, and patient-result presentation gating—do not alter fundamental safety or effectiveness compared to the predicate.