(23 days)
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:
- · viewing the posterior segment of the eye, including two- and three-dimensional imaging
- · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
- · fundus imaging
· fluorescence imaging (fluorescein angiography, indocyanine green angiography, SPECTRALIS HRA+OCT, SPECTRALIS HRA) - · autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
- · performing measurements of ocular anatomy and ocular lesions.
The device is indicated as an aid in the detection and management of various ocular diseases, including:
- age-related macular degeneration
- macular edema
- · diabetic retinopathy
- · retinal and choroidal vascular diseases
- glaucoma
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)
The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laserscanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.
A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.
Because of discontinuation of device components, the following changes have been applied to the device:
- . Replacement of the OCT line camera in the spectrometer with an equivalent camera from the same manufacturer, and comparable specifications;
- . Update of the digital device interface from Thunderbolt to Thunderbolt 2;
- With the update of the TDI, the device complies with electromagnetic compatibility standard IEC 60601-1-2 Edition 4.0.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | According to AAMI / ANSI ES60601-1:2005 Edition 3.1 | All tests passed, and the device was found to comply |
| Electromagnetic Compatibility | According to IEC 60601-1-2 Edition 4.0 | All tests passed, and the device was found to comply |
| Laser Safety Analysis | According to IEC 60825-1:2007 | The total accessible emission under all circumstances is below the accessible emission limit for a Class I laser product. |
| System and software validation and verification | According to 21 CFR 820.30 and AAMI / ANSI / IEC 62304:2006 | All tests passed, and the device performed according to the requirements |
| Bench testing: OCT Sensitivity | Sensitivity ≥ 95 dB, with variation |
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.