(266 days)
The eMurmur ID software system is a decision support device for the healthcare provider (the user) in the evaluation of patient heart sounds. eMurmur ID is used to record, display, analyze, and store the acoustic signal of the heart, recorded by means of an electronic stethoscope. The automated analysis will identify specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and absence of a heart murmur.
eMurmur ID is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur ID are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.
eMurmur ID is a software system comprised of the following components:
- The eMurmur ID Backend, running on a server environment, hosts the eMurmur ID Heart Sound Analysis Algorithm, an encrypted database for archiving patient and user information, and an application programming interface (API) for communication with the web portal and mobile application.
- The eMurmur ID Mobile App, which runs on a mobile device. The app permits the following activities:
a. Electronic recording of heart sound signals via a compatible electronic stethoscope, the Littmann 3200
b. Visual and acoustic playback of heart and lung sounds
c. Capturing patient information
d. Transferring data to and from the eMurmur ID backend through a secure connection
e. Displaying heart sound analysis results - The eMurmur ID Web Portal, which provides the following functionalities:
a. Capturing and editing patient information
b. Displaying and editing patient encounters including heart sound analysis results
c. Visual and acoustic playback of heart and lung sounds
d. Downloading reports (PDF) and heart and lung sound recordings
e. Transferring data to and from the eMurmur ID backend through a secure connection
The acquisition of the acoustic data is carried out by the FDA-cleared off-the-shelf electronic stethoscope Littmann 3200 by 3M (MN, USA) (K083903).
For heart sounds to be analyzed by the heart sound analysis algorithm, a 20 second digital recording of the patient's heart sounds and the patient's date of birth are required. Heart sounds are recorded using the compatible, FDA-cleared, off-the-shelf electronic stethoscope Littmann 3200. The heart sounds are transmitted via Bluetooth to a mobile device running the eMurmur ID mobile app. The app then stores and sends the recorded data to the eMurmur ID backend for analysis. The results of the heart sound analysis are returned to the app within a few seconds, where they are displayed to the user together with the heart sound recording. The user can utilize the heart sound analysis results and the acoustic and visual representation of the heart sound recordings as decision support data in their decision-making process regarding the presence and type of a heart murmur.
Here's a detailed breakdown of the acceptance criteria and study information for the eMurmur ID device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for eMurmur ID were defined relative to a predicate device (SensiCardiac, the predecessor to SensiCardiac Mobi). The primary hypothesis was that eMurmur ID would perform "not worse than" the predicate device in distinguishing between AHA Class I (pathologic murmurs) and AHA Class III heart sounds (innocent murmurs and/or no murmurs) with respect to sensitivity and specificity.
| Metric | Acceptance Criteria (Not worse than SensiCardiac) | Reported eMurmur ID Performance (95% CI) | Reported SensiCardiac Performance (95% CI) | p-value (eMurmur ID vs. SensiCardiac) |
|---|---|---|---|---|
| Sensitivity | ≥ 58.3%* | 85.0% (72.9%-92.5%) | 58.3% (44.9%-70.7%) | 0.0014 (Significantly better) |
| Specificity | ≥ 58.3%* | 86.7% (74.9%-93.7%) | 58.3% (44.9%-70.7%) | 0.0009 (Significantly better) |
| Accuracy | ≥ 58.3%* | 85.8% (78.0%-91.3%) | 58.3% (49.0%-67.2%) |
§ 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.