Anterion

The ANTERION is a non-contact ophthalmic imaging device using swept-source OCT technology to visualize and measure the anterior segment of the eye, including corneal thickness (epithelial and stromal), anterior chamber parameters (width, depth, volume, angle), lens thickness, and axial length. The device consists of hardware with integrated forehead/chin rest and software with four apps (Imaging, Cornea, Cataract, Metrics) for different measurement and analysis functions.

The subject device is identical to the predicate (K230897) in main technology (swept-source OCT at 1310 nm), supporting technologies (infrared camera), optical specifications (axial/lateral resolution, scan patterns, A-scan rate), and all four software apps. The primary difference is the addition of an Epithelial Thickness Module within the Cornea App, which provides new measurements of corneal epithelial and stromal thickness via separate licensing. Only maintenance-level hardware assembly changes were implemented with no impact on device performance.

IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 and IEC TR 60601-4-2:2016 (electromagnetic compatibility), IEC 60825-1:2007 and ANSI Z80.36:2016 (laser safety), ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-18:2005 (biocompatibility), ISO 10993-1:2018 (biocompatibility assessment), and ISO 14971:2019 (risk assessment).

Substantial equivalence is established because the subject device maintains identical intended use and data acquisition modes as the predicate, utilizes the same OCT and infrared imaging technologies, and has equivalent optical and scanning specifications. Although the Epithelial Thickness Module is a new software feature, it does not alter the data acquisition process, imaging technologies, or core indications for use. Clinical study B-2020-1 demonstrates that epithelial thickness measurements from the subject device have precision (repeatability and reproducibility) comparable to or better than the Cirrus HD-OCT 5000 predicate across normal and abnormal cornea populations, with acceptable systematic measurement differences attributable to different scan strategies. Non-clinical testing confirms the device meets applicable electrical safety, EMC, and laser safety standards. No adverse events were reported.