(11 days)
Not Found
No
The summary describes standard OCT technology and image processing software, with no mention of AI or ML capabilities.
No
The device is used for imaging and aiding in assessment and management of diseases, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is described as "aiding in the assessment and management of various diseases of the posterior segment", which indicates a diagnostic function for conditions like age-related macula degeneration, diabetic retinopathy, and glaucoma by imaging the retina.
No
The device description explicitly states it is an "add-on to the Heidelberg Retina Angiograph (HRA 2)" and describes the physical process of acquiring images using light and optical interference, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an imaging system (Optical Coherence Tomography - OCT) used to image the retina and retinal structures in vivo (within the living body). It uses light to create cross-sectional images.
- Lack of Sample Analysis: There is no mention of analyzing biological samples taken from the patient. The device directly interacts with the patient's eye.
Therefore, while it is a medical device used for diagnosis and management of diseases, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.
Product codes
HLI, OBO
Device Description
The HRA 2 / OCT is an add-on to the Heidelberg Retina Angiograph (HRA 2). It is intended for the imaging of the retina and retinal structures.
With the additional HRA 2 / OCT it is possible to perform axial cross sectional images of the retina or 3-dimensional volume scans of the retina. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used. The intensity of the back-reflected light is measured and displayed as gray-values on a computer monitor.
The light sent to the probe interferes with the light that is back-reflected from the probe. The optical interference of both light beams is detected and the spectrum of the light is analyzed in an optical spectrometer. This technology is called spectral-domain optical coherence tomography (SD-OCT) or Fourier-domain OCT (FD-OCT).
The images acquired by the device can be displayed, edited and stored using the Heidelberg Eye Explorer Software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
retina and retinal structures, posterior segment, macula, retina nerve fiber layer, optic disk
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The HRA 2 / OCT has been tested according to IEC 60601-1 and IEC 60601-1-2, and was found to meet all requirements. The system is a laser product of Class 1 according to 21 CFR Part 1040 Section 1040.10 and IEC 60825-1:1993+A2:2001.
The evaluation of the device and comparison of acquired images resulted in substantial equivalence to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary of Safety and Effectiveness
Manufacturer and Submitter
| Company Name: | Heidelberg Engineering GmbH |
|---|---|
| Company Address: | Tiergartenstrasse 15 |
| 69121 Heidelberg, Germany | |
| phone: +49 / 6221 / 64 643 0 | |
| fax: +49 / 6221 / 64 63 62 | |
| Contact Person: | Dr. Gerhard Zinser |
| Date Summary Prepared: | September 11, 2006 |
Device
Trade/Device Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification Panel: Classification:
HRA 2 / OCT Heidelberg Retina Angiograph / Optical Coherence Tomograph Opthalmoscope, AC-powered 21 CR 886.1570 HLI Ophthalmic Class II device
Substantial Equivalence
The OCT add-on to the HRA 2 is substantially equivalent to the Carl Zeiss Ophtalmic Systems Inc. Humphrey Octical Coherence Tomographer 3, Humphrey OCT3, a 510 (k) cleared device ( K012727 ).
Device Description
The HRA 2 / OCT is an add-on to the Heidelberg Retina Angiograph (HRA 2). It is intended for the imaging of the retina and retinal structures.
With the additional HRA 2 / OCT it is possible to perform axial cross sectional images of the retina or 3-dimensional volume scans of the retina. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used. The intensity of the back-reflected light is measured and displayed as gray-values on a computer monitor.
The light sent to the probe interferes with the light that is back-reflected from the probe. The optical interference of both light beams is detected and the spectrum of the light is analyzed in an optical spectrometer. This technology is called spectral-domain optical coherence tomography (SD-OCT) or Fourier-domain OCT (FD-OCT).
The images acquired by the device can be displayed, edited and stored using the Heidelberg Eye Explorer Software.
OCT 3 1 2006
1
Intended Use
The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.
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Image /page/2/Picture/1 description: The image shows the words "HEIDELBERG" and "ENGINEERING" stacked vertically. The text is in a bold, sans-serif font and is black. The letters are slightly distorted, as if they were stretched vertically.
fechnological Characteristics Compared to Predicate Device
| Comparison items
k number | HRA 2 / OCT | OCT 3
K012727 | |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Indications for use | The OCT add-on to the HRA 2 is a device for the
optical imaging of posterior ocular structures. | The Humphrey OCT3 is a high resolution tomographic
device for the viewing and axial cross sectional imaging of
posterior ocular structures. | |
| | The Device uses Optical Low Coherence
Tomography technology for the axial cross
sectional imaging of the retina. | It is used for the in vivo imaging
and measurement of the retina, retina nerve fiber layer and
optic disk. It is intended for use as a diagnostic device to | |
| | The OCT add-on to the HRA 2 is intended for use
for the imaging of the retina and retinal structures,
and for aiding in the assessment and management
of various diseases of the posterior segment, such | aid in the detection and management of ocular diseases, | |
| | like age-related macula degeneration, diabetic
retinopathy, and glaucoma. | including but not limited to macular edema, central serous
retinopathy and glaucoma. | |
| Corneal contact | No | No | |
| Working distance cornea to
objective | Ca. 10 mm | No information | |
| Corneal contact sensing and
warning feature | No | No | |
| Pre-sterilized contact surface | No | No | |
| | HRA 2 / OCT | OCT 3 | |
| Comparison of similarities and differences continued:
Comparison items
k number | | K012727 | |
| Front surface area | 310 mm² | No information. | |
| Focus | Manually adjustable | Manually adjustable | |
| Focus adjustment range | Correction of patients refractive errors: -12 to +12
diopters | Correction of patients refractive errors: -12 to +12
diopters | |
| Alignment to patient | Device is adjusted horizontally and vertically while
the patient is sitting straight in front of the device. | Device is adjusted horizontally and vertically while the
patient is sitting straight in front of the device. | |
| Working position | The patient is sitting straight in front of the device.
The examiner is sitting opposite to the patient. | The patient is sitting straight in front of the device. The
examiner is sitting opposite to the patient. | |
| Optical setup | Frequency (Fourier) Domain OCT | Time Domain OCT | |
| Type of scanning aperture | Point scan. | Point scan. | |
| Scanning means | Galvanometric scanning motor. | Galvanometric scanning motor | |
| Light source | SLD, 870 nm, Class 1 | SLD 820 nm, Class 1 | |
| Optical resolution, lateral | 14 μm | 20 μm in tissue
(spot size in tissue) | |
| Optical resolution, depth | 6,9 μm |