(135 days)
Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
Stethophone is an electronic stethoscope software application that operates on smartphones. Stethophone is designed for use by both healthcare professionals and home users.
Stethophone enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis.
Stethophone is designed to assist healthcare providers both in hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in cloud for later analysis. It also enables home users to record and send chest sounds to their physicians.
Stethophone is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare providers, while sound capturing can be performed by both healthcare providers and home users.
Key product features:
- Capturing chest sounds using the smartphone microphone:
- Real-time listening to chest sounds,
- Recording of chest sounds,
- Sending examinations to specialists for assessment
- Two modes of sound visualization: oscillogram and spectrogram, and
- Selection of three audio filters for listening:
- Bell: Traditional filter used for low frequency sounds,
- Diaphragm: Traditional filter used for higher frequency sounds of heart and lungs, and
- Starling: Filter for listening to the full frequency of chest sounds.
Collectively, these features enable a healthcare professional to examine and monitor patients, seek out second opinions from specialists, and use the device in a telemedicine context.
The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in the typical format expected for comprehensive regulatory submissions. The document is an FDA 510(k) summary, which provides a high-level overview.
However, based on the available text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Sparrow Acoustics Inc. submitted performance testing information in this 510(k) to demonstrate safety and efficacy of Stethophone, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination."
It also mentions the types of tests conducted: "Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving lay users and external medical specialists with auscultation experience."
Without the full performance testing report, specific numeric acceptance criteria and detailed reported performance cannot be provided in a table format. The summary only broadly states that the device "meets predetermined specifications and performs according to pre-specified acceptance criteria."
Here's an example of what such a table would look like if the specific data were available:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| [Specific metric, e.g., Frequency Response Accuracy (Bell Filter)] | [Specific measured value vs. accepted range, e.g., "Within +/- 3dB of target response across 25-300 Hz"] |
| [Specific metric, e.g., Amplification Gain Consistency] | [Specific measured value vs. accepted range, e.g., "Standard deviation of amplification gain 4 on a 5-point scale for clarity"] |
| [Specific metric, e.g., Repeatability (Inter-measurement variability)] | *[Specific statistical measure vs. accepted threshold, e.g., "Coefficient of Variation |
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.