Tyto Stethoscope (G3)

The Tyto Stethoscope (G3) is an electronic stethoscope that captures heart and lung sounds from patients and transmits the recordings over an IP network to clinicians for remote review. It is intended for use by lay users (age 18+) in non-clinical settings to record auscultation sounds, which are then analyzed by healthcare professionals for medical diagnostic purposes.

The G3 uses the same embedded acoustic piezoelectric sensor, frequency range (20–3500 Hz), and filtering logic as the predicate device. Minor hardware differences include a new chipset (due to component discontinuation), removal of an audio jack, and a smaller display (2" vs 2.4"). Software updates include new firmware to support the hardware, user interface refinements, and AI-enabled algorithms for heart rate calculation and recording quality feedback.

IEC 60601-1 Edition 3.2, IEC 60601-1-11 Edition 2.1, IEC 60601-1-2 Edition 4.1, IEC TR 60601-4-2 Edition 1.0, ISO 10993-1:2018, ISO 14971:2019, ISO 17664:2021, AAMI TIR12:2020, and AAMI ST98:2022.

The G3 has identical intended use, the same regulatory classification (Class II), and substantially similar technological design to the predicate Tyto Stethoscope (K181612). The minor hardware and software modifications do not introduce new safety or effectiveness concerns and do not alter core functionality or user workflow. Performance testing—including heart rate algorithm validation (100% accuracy), comparative performance evaluation, and quality assessment—confirms equivalent performance to the predicate.