Lumify Diagnostic Ultrasound System

The Lumify Diagnostic Ultrasound System is a mobile, software-controlled medical device that acquires and displays high-resolution ultrasound images in B-mode (2D), Color Doppler, Pulsed Wave Doppler, Combined, and M-modes. It runs on iOS and Android devices and is indicated for diagnostic ultrasound imaging and fluid flow analysis across multiple clinical applications including fetal/obstetric, abdominal, gynecological, cardiac, musculoskeletal, and transvaginal imaging. The device is designed for use by trained healthcare professionals in clinical settings.

The subject device adds the C9-4ec endocavitary curved linear transducer and a Fertility Package to the existing Lumify system. The C9-4ec is similar to the predicate C9-4v but includes transvaginal clinical indication and improved fertility measurement features: two-distance diameter measurement (versus single-distance on reference devices), mean diameter calculation per follicle, and capacity to measure up to 15 labeled follicles per ovary (versus 10 for Affiniti and 8 for ClearVue). No changes were made to core ultrasound modes or device operation principles.

IEC 62304 (medical device software lifecycle), IEC 62366-1 (usability engineering), ISO 14971 (risk management), IEC 60601-1 (medical electrical equipment safety), IEC 60601-2-37 (ultrasonic equipment requirements), IEC 60601-1-2 4.1 (electromagnetic disturbances), IEC 62359 (thermal and mechanical indices), and ISO 10993-1 (biological evaluation).

Substantial equivalence is established because the C9-4ec transducer shares identical design (endocavitary curved linear construction) and indications with reference devices (C9-4v on Affiniti and ClearVue systems), and the Fertility Package measurements are enhancements of established functionality already cleared on those systems. Transvaginal indication, though new to Lumify, is well-established on reference predicates. Non-clinical testing confirmed all acceptance criteria were met, no new risks were introduced, and the device's fundamental scientific technology and performance are unchanged from the predicate, supporting a determination that proposed modifications do not raise new questions of safety or effectiveness.