Stethee Pro 1, Stethee Pro Software System
M3DICINE Pty Ltd.The Stethee Pro 1 is an electronic stethoscope designed for medical screening and diagnostic use. It detects and amplifies sounds from the heart, lungs, and other internal organs, and works with the Stethee Pro Software System to record, visualize, analyze, and share these sounds. This helps clinicians better assess patient heart and lung conditions through enhanced audio and data analysis tools.
Intended Use
The Stethee Pro 1 is an electronic stethoscope intended for screening and medical diagnostic purposes. It detects and amplifies sounds from the heart, lungs, arteries, veins, and other internal organs, with or without selective filters. It is used on any person undergoing physical assessment. The Stethee Pro 1 is intended for use with the Stethee Pro Software System, which enables recording, playback, visualization, analysis, management, and reporting of patient samples, and sharing data with authorized users.
Technology
The Stethee Pro 1 contains hardware including sensors and embedded software for sound capture, digital signal processing, volume control, haptic feedback, LED display, and wireless Bluetooth data transfer. Sounds are streamed to Bluetooth or wired headphones and to a mobile smart device where the Stethee Pro Software System software handles recording, playback, visualization as phonocardiographs and spectrograms, analysis using machine learning algorithms, and reporting. The software platform supports cloud services for data sharing and remote access.
Performance
Performance testing included bench, software verification and validation, and clinical validation against predicate and reference devices, confirming device functions as intended. The device complies with relevant safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2). The software complies with IEC 62304 standards. Wireless coexistence testing was also successfully conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/27/2019
9 months - 2
FDA Approval
10/9/2020
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