3nethra neo HD FA; 3nethra neo HD

The 3nethra neo HD FA and 3nethra neo HD are handheld wide-angle fundus imaging systems for neonatal screening. They acquire, display, store, and transmit images of the posterior and anterior eye surfaces to document ocular diseases in infants, particularly retinopathy of prematurity (ROP). The devices provide image acquisition only and do not perform pathological analysis or diagnosis.

Both subject devices use white and blue LED light sources with software-controlled motorized blue filters and operate at AC 100–240 V, 50/60 Hz. The 3nethra neo HD FA includes a fluorescence angiography (FFA) module with blue light source and green filters; the 3nethra neo HD lacks this feature. Both achieve 150-degree field of view compared to the predicate's 120 degrees, and output images in PNG/JPEG/DCM formats. Both comply with IEC 60601-1 and IEC 60601-1-2 safety standards.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), ISO 15004-2 (ophthalmic instruments fundamental requirements and test methods), and ANSI Z80.36 (light safety for ophthalmic instruments). Testing demonstrated Group 1 instrument classification compliance.

The subject devices are substantially equivalent because their intended use, design methodology, and operating principles are identical to the primary predicate (3nethra neo, K183059), which is a device manufactured by the same applicant. The FFA capability in the HD FA variant mirrors the reference device (RetCam 3, K102859), which includes fluorescence angiography. All key technological characteristics—light sources, power supply, imaging formats, and safety compliance—match or exceed predicate specifications. Bench testing confirms electrical safety and EMC compliance, and clinical image quality comparison to the RetCam 3 demonstrated comparable performance. The patient-contact surface is identical to the primary predicate, eliminating biocompatibility concerns.