(259 days)
Zilia Ocular is a non-contact imaging device for capturing, displaying and storing images of the retina under mydriatic conditions.
Zilia Ocular is intended for use as an aid to clinicians in the evaluation and documentation of ocular health.
The Zilia Ocular Fundus Camera (Zilia Ocular FC) is a non-contact, stand-alone device designed to image the eye fundus.
The device includes a base, a head support, an onboard computer with a 15.6'' touch-screen display and an optical head. A joystick, situated at the base of the device, controls the movements of the optical head to enable adequate positioning. The touch-screen display also includes a user interface allowing the user to control the device and acquire and display patient data and images.
The Zilia Ocular FC uses near-infrared (NIR) light-emitting diodes (LEDs) as illumination during alignment to the patient's pupil, and a white LED during focusing and imaging of the eye fundus. The region of the eye fundus being imaged can be modified by changing or moving the fixation target. The images are saved and stored on the onboard computer.
The dimensions of the Zilia Ocular FC are 620 mm (L) by 360 mm (W) by 500 mm (H) and it weighs about 32 kg.
The provided document is a 510(k) Summary for the Zilia Ocular Fundus Camera (Zilia Ocular FC). It describes the device, its intended use, and performance testing conducted to demonstrate substantial equivalence to predicate and reference devices.
However, the document does not contain specific acceptance criteria, reported device performance data against those criteria, or the details of a clinical study (such as sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance).
The document explicitly states: "Clinical Performance Data: This section is not applicable because clinical data was not provided for this 510(k) submission."
Therefore, I cannot provide the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 based on the provided text. The submission relied on non-clinical performance testing (electrical safety, EMC, recognized standards, risk management, biocompatibility, processing of healthcare products, software evaluation, and usability) to demonstrate substantial equivalence, rather than clinical performance data.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.