Intended Use

The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.

Technology

TipTraQ comprises a fingertip wearable sensor with PPG (green, red, infrared light sources and dual photodetectors) and integrated accelerometer and gyroscope to capture physiological waveform data; the data is analyzed in a cloud-based AI system to compute total sleep time, REM time, oxygen desaturation index, and apnea-hypopnea index for sleep apnea evaluation.

Performance

Performance testing included bench testing for pulse rate accuracy, extensive software verification and validation, electrical and electromagnetic safety testing, biocompatibility assessment per ISO standards, and clinical validations comprising SpO2 accuracy studies and comparison to polysomnography for sleep staging and apnea-hypopnea index measurement, demonstrating sensitivity and specificity of approximately 0.8-1.0 for diagnostic thresholds, supporting safety and effectiveness.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/15/2024

    3 months
  • 2

    FDA Approval

    2/3/2025

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