(56 days)
The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems. The device can be used on adults and pediatrics.
The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device should not be used on infants weighing less than 10kg.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the Eko Model E5 System. It primarily outlines the regulatory approval of the device and its intended use. It does not contain information about specific acceptance criteria for device performance, the results of a study proving those criteria were met, or details about the study design (sample size, expert involvement, ground truth establishment, MRMC study, etc.).
Therefore, I cannot extract the requested information to describe the acceptance criteria and the study that proves the device meets them from the provided text.
To answer your request, I would need a different document, such as a summary of the clinical or performance testing conducted for the Eko Model E5 System, which would typically be included in the full 510(k) submission or a dedicated study report.
§ 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.