(81 days)
The ALLEGRO Oculyzer is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber and the lens of the eye.
To evaluate:
- . Corneal shape
- . Analyze condition of the lens (opaque crystalline lens)
- Analyze the anterior chamber angle ●
- Analyze the anterior chamber depth
- Analyze he volume of the anterior chamber ●
- Analyze the anterior and posterior cortical opacity .
- Analyze the location of the cataracts (nuclear, subcapsular and or cortical), using cross-lit . images with densitometry
- Corneal thickness .
The ALLEGRO Oculyzer Scheimpflug Camera is based on the Scheimpflug principle for slit lamp photography. The system is table mounted onloing powered by an external power supply. The system contains
(a) measuring devices including:
- illumination unit with LED's, 475nm wavelength UV-free to illuminate the . anterior segment of the eye,
- a CCD-Camera unit to take the Scheimpflug Images, .
- a CCD-Camera unit in the center for the fixation monitoring and internal . correction,
- a optical lens system to project the slit, .
- two infrared LED's to illuminate the pupil for fixation monitoring. .
(b) electrical devices, including:
- a memory board and a CPU and which stores and analyses the taken . images.
- a power supply board which prepares and controls the electrical conditions of . the ALLEGRO Oculyzer Scheimpflug system
- an electric motor for rotating .
- a communication board for transferring the images to external standard high . speed PC's (part of the device)
All the mentioned parts are mounted internal the system and the housing around separates this parts from any external illegal operation.
The measurement can be done in two different ways, depending of what you like to evaluate:
-
(c) Taking photos from one Camera position:
The Camera takes pictures from one fixed position as it is already well known from the common Scheimpflug Cameras. The intended use is to get information of the condition of the lens. -
(d) Taking photos from several positions:
The Camera rotates around the eye and takes up to 50 Scheimpflug Images from several positions. Every single picture has 500 measured true elevation points. So in the summary we get 25.000 measured true elevation points. The Scheimpflug Images taken during the examination are digitalized in the system. All Image Data are transferred to the external PC. When the examination is finished, the PC calculates a three dimensional mathematical model from which all additional information is derived.
The intention is to get information about
- anterior and posterior surface of the cornea, .
- . thickness of the cornea.
- chamber angle, volume and depth. .
The provided 510(k) summary for the ALLEGRO Oculyzer device explicitly states, "6. Performance Data None presented." This means the submission does not include acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The submission relies solely on substantial equivalence to a predicate device (Oculus Pentacam Scheimpflug Camera system - K030719) without presenting independent performance data.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.