Lumify Diagnostic Ultrasound System

The Lumify Diagnostic Ultrasound System is a mobile ultrasound device that acquires and displays diagnostic ultrasound images in B-mode (2D), Color Doppler, Pulsed Wave Doppler, Combined (B+Color), and M-modes. The Lung Application 3 software adds two features: pleural line assessment (classifying pleural lines as normal or irregular) and lung view quality assessment (determining adequacy of ultrasound frames for clinical interpretation). It is intended for use by healthcare professionals in clinical settings to assist in evaluations of adult patients with various pulmonary conditions.

The subject device adds software-only functionality for pleural line classification and lung view quality assessment using machine learning algorithms, whereas the predicate device featured a B-lines tool for detecting and classifying B-lines as merged or not merged. Both operate on the same hardware (C5-2, S4-1, L12-4 transducers), provide cineloop-level reporting by averaging frame results, and allow manual adjustment of software results. The core system software architecture and intended use remain unchanged.

The device complies with FDA's ultrasound guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, February 21, 2023.' No specific ISO, IEC, or ASTM standards are cited in the submission, though the document notes that hardware testing (such as IEC 60601-1, IEC 60601-2-37) was not required since the change is software-based only.

Substantial equivalence is demonstrated because the subject device uses the same fundamental ultrasound imaging technology, indications for use, modes of operation, transducers, and user environment as the predicate (K223771). The added Lung Application 3 features operate on similar principles (frame-level display and cineloop-level reporting) to the predicate's B-lines tool. Non-clinical performance testing showed both algorithms achieved substantial agreement with ground truth (lung view quality kappa 0.67, pleural line kappa 0.66), meeting predefined acceptance criteria. The changes do not introduce new risks or alter the system's core functionality, and no new questions of safety or effectiveness are raised.