Search Results
Found 1 results
510(k) Data Aggregation
K Number
K182659Device Name
Galilei G6 Lens Professional
Manufacturer
SIS AG, Surgical Instrument Systems
Date Cleared
2019-07-25
(303 days)
Product Code
MXK, HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
SIS AG, Surgical Instrument Systems
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Galilei G6 Lens Professional) is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate:
- · Corneal shape
- · Pachymetry (corneal thickness)
- Position of the cornea relative to iris and lens
- · Anterior and posterior opacity
- · Anterior chamber angle
- · Anterior chamber depth
- · Volume of the anterior chamber
- · White-to-white distance
- · Pupil size
- · Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings)
- · Location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry
- · Condition of the lens (opaque crystalline lens)
- · Lens shape
- · Crystalline lens thickness
The Galilei G6 Lens Professional is designed to additionally evaluate:
• Axial length
The Galilei G6 Lens Professional) also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Device Description
The Galilei G6 Lens Professional is (in hardware and software) identical to the Galilei G4 Dual Scheimpflug Analyzer but features an additional biometry module (hardware and software) referred to as "EBR Accessory".
The Galilei G6 Lens Professional consists of the following functional units:
- Measurement Head Container for the cameras, light sources, monitor drivers and electron-● ics. The Placido disk and Dual-Scheimpflug imaging is integrated into the Measurement Head, which performs a 180-degree rotation during data acquisition.
- Main Monitor Display and navigation through the software, selection of functions. ●
- PC box Container of the power supply and the computer. Periphery (Main monitor, mouse ● and keyboard) is connected directly to the computer.
- . Elevation Table - Height-adjustable instrument table with locking wheels.
- EBR Accessory Container of the EBR main printed circuit board as well as the optical and ● mechanical components such as a scanner and a partial coherence interferometer used for biometry measurements. Mounted inside the PC box.
The GALILE! G6 device takes images of the anterior segment of the eye, which includes the cornea, iris, pupil, limbus, anterior chamber and crystalline lens. Topography and anterior segment tomography are calculated from those images.
A pair of slit light images are recorded simultaneously with two cameras placed at opposite sides at an angle of 45°. Due to the Scheimpflug principle, an angled orientation of the camera's sensor allows a sharp focus over the entire image in spite of the 45° recording angle.
The images are then analyzed and anterior cornea, anterior lens and iris surfaces are detected. This information is then used to reconstruct a three-dimensional model of the anterior chamber.
Twenty (20) concentric rings in the Placido are reflected on the anterior surface of the cornea and recorded by a top-view camera in the center of the measurement head. The sizes and shapes of the recorded rings are used to calculate the curvature of the anterior surface of the eye.
Both the Placido and Scheimpflug information are then merged to a single model of the eye.
The EBR Accessory enables the Galilei G6 to take an optical A-scan by means of partial coherence interferometry.
A beam of partial coherence infrared light is directed along the optical axis into the eye. Whenever it passes a transition between layers with different refractive indices (e.g., corneal surfaces, crystalline lens surfaces, retinal surfaces), a portion of the light is reflected back towards the reflected light is compared to a reference beam passing through a light path of adjustable optical length. The length of the reference arm is varied by a scanner.
When the optical lengths of sample arm and reference arm match to within the coherence length of the partial coherence light source, an interference peak is detected and the corresponding layer within the eye is deduced.
Ask a Question
Page 1 of 1