AeviceMD

The AeviceMD is a wearable electronic stethoscope system designed to acquire, record, and store lung sounds from pediatric patients aged 3 years and above in clinical or non-clinical settings. The device consists of a sensor patch worn on the chest, a docking station gateway, cloud platform, and mobile/web apps that allow clinicians to playback, review, and analyze recorded sounds for comparison with earlier patient data.

The AeviceMD has very similar technological characteristics to its predicate and reference devices, including the same frequency range for sound capture, Bluetooth connectivity for data transmission, ability to record and playback sounds, data transfer to compatible computing platforms (mobile app and web portal for HCP), reusable design, and wearable configuration.

ISO 10993-5:2009 and ISO 10993-10:2010 for biocompatibility; IEC 60601-1:2005 (with amendments) and EN 60601-1-2:2015 for electrical safety and EMC; IEC 60601-1-11:2015 for home healthcare use; IEC 60601-1-6:2010 for usability; ANSI AAMI IEC 62366-1:2015 for usability engineering; ANSI AAMI IEC 62304:2006/A1:2016 for software lifecycle; ISO 14971:2019 for risk management; plus non-clinical frequency response, stethoscope performance, human factors, shipping, and cleaning validation tests.

The subject device is substantially equivalent because it shares the same intended function (longitudinal recording and playback of lung sounds for clinician review), similar technological design (same frequency range, mobile/web connectivity, reusable, wearable), and comparable indications for use as the predicate device K223382. The key difference—expansion to pediatric patients aged 3+ years versus adults only—is supported by the reference device (Eko CORE) demonstrating safe and effective performance in pediatric populations. All three devices operate on the same fundamental principles of electronic auscultation sound acquisition and storage.