(71 days)
Not Found
No
The summary mentions "automatic segmentation" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe the training or testing of such algorithms. The performance study focuses on agreement and precision compared to a predicate device, not on the performance metrics typically associated with AI/ML diagnostic algorithms (e.g., sensitivity, specificity, AUC).
No.
The device is used for imaging and analysis to aid in detection, diagnosis, documentation, and management of retinal health and diseases, rather than providing direct therapy or treatment.
Yes
Explanation: The "Intended Use/Indications for Use" section explicitly states that the P200TE is "indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina." This directly indicates its role as a diagnostic device.
No
The device description explicitly states it is a "desktop retinal imaging device" and describes physical components like lasers, mirrors, scanners, and detectors, indicating it is a hardware device with integrated software.
Based on the provided information, the P200TE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- P200TE Function: The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It performs in-vivo viewing, imaging, and analysis of structures within the eye. It does not analyze samples taken from the body.
The device is clearly intended for direct examination and imaging of the eye's internal structures, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions.
It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.
The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.
Product codes (comma separated list FDA assigned to the subject device)
OBO
Device Description
P200TE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and optical coherence tomography. Ultra-widefield images can be captured in less than half a second. The device is intended to be used by ophthalmic and optometry health care professionals.
The P200TE delivers images in the following image modes:
- Scanning Laser Ophthalmoscopy
- Reflectance imaging
- Autofluorescence imaging
- Optical Coherence Tomography
The P200TE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths.
The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus.
The P200TE instrument uses a broadband near-infrared (N-IR) super-luminescent diode (SLD) light source for optical coherence tomography allowing a depth profile of the reflectance of the fundus to be recorded. The P200TE instrument uses N-IR laser illumination for reflectance imaging simultaneously with OCT imaging. Reflectance images are used to track eye position during OCT imaging and are not available to the user.
The P200TE images the eye via two ellipsoidal mirrors arranged so that a focal point of one of the mirrors coincides with a focal point of the other mirror; a mirrored scanner is also located at this common focal point. The pupil of the subject's eye is placed at one of the other focal points. A second mirrored scanner is located at the remaining focal point; a laser or SLD reflected off this scanner is relayed onto the second scanner by the first ellipsoidal mirror and from there is reflected through the pupil and into the eye by the second ellipsoidal mirror. The second scanning element is different for OCT and SLO imaging. The energy reflected back from the retina, or emitted by fluorophores, returns through the same path to the detectors; the imaqes are generated from the captured detector data.
P200TE OCT images are automatically segmented to identify and annotate retinal layers and structures, enabling practitioners to efficiently assess retinal structures in support of detecting, monitoring and documentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician.
P200TE automatic segmentation provides comprehensive retinal and optic nerve head information, including:
- Full Retinal Thickness (FRT)
- Ganglion Cell Complex Thickness (GCC)
- ONH Cup and Disc Analysis
- ONH Nerve Fiber Layer Thickness
The P200TE refers to the scan head component of the system, together with touchscreen and hand controller. The device is supported by an image server which delivers patient management and image storage, as well as interfacing with the business systems and Electronic Medical Record systems.
The images are captured by the scan head under operator control and then automatically saved to the image server that uses a database structure to hold the images and patient information. For subsequent image review, a number of viewing PCs are connected remotely or via a local area network to the image server. The patient records and images are then accessible in a distributed format suited to the physical layout of the eye-care practice.
lmages can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other compatible PACS viewers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanning Laser Ophthalmoscopy (SLO), Optical Coherence Tomography (OCT)
Anatomical Site
Posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, retina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmic and optometry health care professionals.
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
A total of 106 subjects were enrolled: with 35 subjects without ovular pathology, 35 with glaucoma, and 35 with retina pathology. One subject was withdrawn because they did not meet the inclusion criteria. Mean age for all subjects was 46.8 years with a range from 22 to 75 years of age. Mean age for the normal group was 36 years with a range from 23 to 59 years of age, mean age for the glaucoma group was 61.7 years with a range from 37 to 75, and mean age of the retina group was 42.4 with a range from 22 to 74. There were 44 male subjects (41.5%) and 62 female subjects (58.5%). There were 12 Asian subjects (11.3%), 39 White subjects (36.8%), and 54 Black subjects (50.9%) with 1 other (0.9%).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Study Type: Design Verification, Non-functional performance testing.
- Sample Size: Not specified.
- Key Results: The functional and system level testing showed that the system met the defined specifications with no concerns raised in relation to key non-functional performance parameters. Tests included Spatial performance (Lateral range; Lateral resolution; Axial range; Axial resolution), Sensitivity (Signal-to-Noise ratio, depth attenuation), and Auxiliary Functions. All testing passed with no additional safety or performance concerns raised.
Clinical Performance Testing:
- Study Type: Prospective, single-site, 3 x 3 crossed study.
- Sample Size: 106 subjects (35 without ocular pathology, 35 with glaucoma, 35 with retinal pathology). One subject withdrawn (resulting in 105 subjects for analysis).
- Key Results:
- Repeatability and reproducibility were determined, and agreement between the P200TE and iVue was evaluated with Bland Altman and Deming Regression analysis.
- Performance goals for agreement were met for all FRT, RNFL, and ONH parameters for all groups.
- Agreement performance goals were not met for GCC due to the iVue GCC grid being shifted 1 mm temporally from the fovea, leading to a thinner layer measurement in that peripheral region.
- Performance goals for precision were met for all parameters and all groups.
- The P200TE had lower variability than the iVue in 96% of parameters for repeatability and 94% of parameters for reproducibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Repeatability (SD, Limit (Ratio), CV%) and Reproducibility (SD, Limit (Ratio), CV%) for Full Retinal Thickness (FRT), Retinal Nerve Fiber Layer (RNFL) Averaged Thickness, GCC thickness, and Optic Nerve Head (ONH) Measurements.
Examples from tables:
- Full Retinal Thickness (FRT) - Normal Group:
- Fovea Thickness (μm): Repeatability CV% = 0.91%, Reproducibility CV% = 1.13%
- Superior Inner (μm): Repeatability CV% = 0.53%, Reproducibility CV% = 0.64%
- Retinal Nerve Fiber Layer (RNFL) Averaged Thickness - Normal Group:
- Temporal (µm): Repeatability CV% = 2.50%, Reproducibility CV% = 3.26%
- Average RNFL (µm): Repeatability CV% = 1.13%, Reproducibility CV% = 1.47%
- GCC thickness - Normal Group:
- Superior Average (µm): Repeatability CV% = 0.88%, Reproducibility CV% = 1.26%
- Inner Retina Average (µm): Repeatability CV% = 0.77%, Reproducibility CV% = 1.06%
- Optic Nerve Head (ONH) Measurements - Normal Group:
- C/D Horizontal Ratio: Repeatability CV% = 6.88%, Reproducibility CV% = 7.96%
- Disk Area (mm2): Repeatability CV% = 3.56%, Reproducibility CV% = 4.75%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
August 18, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Optos Plc Rachel Reay Senior Regulatory Affairs Specialist Queensferry House, Carnegie Campus Enterprise Way Dunfermline, Fife KY11 8GR United Kingdom
Re: K231673
Trade/Device Name: P200te (a10700) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: June 7, 2023 Received: June 8, 2023
Dear Rachel Reay:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elvin Y. Na -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
P200TE (A10700)
Indications for Use (Describe)
The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions.
It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.
The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye on the left and the word "optos" in blue letters on the right. A registered trademark symbol is located to the upper right of the word "optos".
510(k) Summary
1. Contact Details
| Applicant | Optos Plc
Queensferry House
Carnegie Campus
Enterprise Way
Dunfermline, Fife
Scotland, UK
KY11 8GR |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Rachel Reay
Sr. Regulatory Affairs Specialist, Optos Plc
Tel: 0044 1383 843300
E-mail: RA@optos.com (preferred) |
| Date Prepared | July 24th 2023 |
2. Subject Device
| Device Trade Name | P200TE (A10700) |
|---|---|
| Common Name | Ophthalmoscope |
| Classification | Tomography, Optical Coherence |
| Regulatory Class | 886.1570 |
| Product Code | OBO |
3. Legally Marketed Predicate Devices
| Predicate # | K173707 | K121739 |
|---|---|---|
| Device Trade Name | P200TE (A10700) | iVue |
| Product Code | OBO | OBO |
4
Image /page/4/Picture/1 description: The image contains the logo for Optos. The logo features a stylized eye symbol on the left, followed by the word "optos" in a bold, sans-serif font. A registered trademark symbol is placed to the upper right of the word "optos".
4. Device Description
P200TE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and optical coherence tomography. Ultra-widefield images can be captured in less than half a second. The device is intended to be used by ophthalmic and optometry health care professionals.
The P200TE delivers images in the following image modes:
- Scanning Laser Ophthalmoscopy
- . Reflectance imaging
- Autofluorescence imaging
- . Optical Coherence Tomography
The P200TE instrument uses red and green laser illumination for reflectance imaging, enabling it to image pathology throughout the layers of the retina, from the sensory retina and nerve fiber layer, through the retinal pigment epithelium (RPE) and down to the choroid. The image can be separated to present the distinct retinal sub-structures associated with the individual imaging wavelengths.
The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus.
The P200TE instrument uses a broadband near-infrared (N-IR) super-luminescent diode (SLD) light source for optical coherence tomography allowing a depth profile of the reflectance of the fundus to be recorded. The P200TE instrument uses N-IR laser illumination for reflectance imaging simultaneously with OCT imaging. Reflectance images are used to track eye position during OCT imaging and are not available to the user.
The P200TE images the eye via two ellipsoidal mirrors arranged so that a focal point of one of the mirrors coincides with a focal point of the other mirror; a mirrored scanner is also located at this common focal point. The pupil of the subject's eye is placed at one of the other focal points. A second mirrored scanner is located at the remaining focal point; a laser or SLD reflected off this scanner is relayed onto the second scanner by the first ellipsoidal mirror and from there is reflected through the pupil and into the eye by the second ellipsoidal mirror. The second scanning element is different for OCT and SLO imaging. The energy reflected back from the retina, or emitted by fluorophores, returns through the same path to the detectors; the imaqes are generated from the captured detector data.
P200TE OCT images are automatically segmented to identify and annotate retinal layers and structures, enabling practitioners to efficiently assess retinal structures in support of detecting, monitoring and documentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician.
5
P200TE 510(k) Summary Optos Plc K231673
Image /page/5/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye on the left and the word "optos" in blue letters on the right. The eye is light blue and gray, and the word "optos" is in a bold, sans-serif font. There is a registered trademark symbol to the right of the word "optos".
P200TE automatic segmentation provides comprehensive retinal and optic nerve head information, including:
- . Full Retinal Thickness (FRT)
- . Ganglion Cell Complex Thickness (GCC)
- . ONH Cup and Disc Analysis
- . ONH Nerve Fiber Layer Thickness
The P200TE refers to the scan head component of the system, together with touchscreen and hand controller. The device is supported by an image server which delivers patient management and image storage, as well as interfacing with the business systems and Electronic Medical Record systems.
The images are captured by the scan head under operator control and then automatically saved to the image server that uses a database structure to hold the images and patient information. For subsequent image review, a number of viewing PCs are connected remotely or via a local area network to the image server. The patient records and images are then accessible in a distributed format suited to the physical layout of the eye-care practice.
lmages can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other compatible PACS viewers.
5. Indications for Use
The P200TE is a non- contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and non-mydriatic conditions.
It is indicated for producing high resolution, ultra- widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.
The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.
6. Substantial Equivalence to Predicate
The updated P200TE has all the same indications for use as P200TE and alongside this introduces the capability to produce retinal layer boundary analysis, optic nerve head analysis and thickness maps, present in the second predicate device, iVue. In other words, the P200TE has the same intended use its predicate devices, and thus satisfies the first criterion for a finding of substantial equivalence.
Both P200TE and iVue are Spectral Domain optical coherence tomographers intended for in- vivo digital imaging and measurement of posterior ocular structures, with retinal layer boundary analysis, optic nerve head analysis and thickness maps.
6
Image /page/6/Picture/0 description: The image contains the logo for Optos, a company specializing in retinal imaging technology. The logo features a stylized eye symbol in light blue on the left, followed by the company name "optos" in dark blue. A registered trademark symbol is located to the upper right of the company name.
Technological implementation of SLO and OCT imaging is identical between the cleared P200TE and the submitted P200TE with segmentation. Both the current and updated devices are operated by touchscreen and hand controller. GUls are presented to the user with branding and presentation styles consistent across the Optos range of devices.
Technological implementation of OCT imaging in the iVue is comparable to the P200TE in that both systems operate via a superluminescent diode (SLD) light source of equivalent wavelengths and a splitter to divide wavelengths spatially, based on optical interference principles and under the umbrella classification of Fourier Domain OCT.
P200TE with segmentation is substantially equivalent to the previously cleared P200TE, and segmentation functionality is also substantially equivalent to the Optovue iVue. Minor differences in segmentation implementation do not present different questions of safety or effectiveness than the predicate device because there are no novel technological principles or applications introduced.
| Device | OPTOS P200TE with
segmentation | OPTOS P200TE | Optovue iVue |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | --- | K173707 | K121739 |
| Indications
For Use | The P200TE is a non-
contact scanning laser
ophthalmoscope and optical
coherence tomographer. It
is intended for in-vivo
viewing, digital imaging,
and analysis of posterior
ocular structures, including
the retina, retinal nerve fiber
layer, ganglion cell complex
(GCC) and optic disc, under
mydriatic and non-mydriatic
conditions.
It is indicated for producing
high resolution, ultra-
widefield, en face
reflectance images,
autofluorescence images,
axial cross-sectional
images, three-dimensional
images, retinal layer
boundary analysis, optic
nerve head analysis and
thickness maps.
The P200TE is indicated for
use as a device to aid in the
detection, diagnosis,
documentation and
management of retinal
health and diseases that
manifest in the retina. | The P200TE is a non-
contact scanning laser
ophthalmoscope and
optical coherence
tomographer intended for
in-vivo viewing and digital
imaging of posterior
ocular structures,
including the retina,
retinal nerve fiber layer
and optic disc. It is
indicated for producing
high-resolution, widefield,
en face reflectance
images, autofluorescence
images, and axial, cross-
sectional images of the
posterior ocular
structures. | The iVue is a non-contact,
high resolution tomographic
imaging device. It is
intended for in vivo imaging,
axial cross-sectional, and
three-dimensional imaging
and measurement of
anterior and posterior
ocular structures, including
retina, retinal nerve fiber
layer, ganglion cell complex
(GCC), optic disc, cornea,
and anterior chamber of the
eye. The iVue with
Normative Database is a
quantitative tool for the
comparison of retina, retinal
nerve fiber layer, ganglion
cell complex, and optic disc
measurements to a
database of known normal
subjects.
The iVue with Normative
Database is indicated for
use as a device to aid in the
diagnosis, documentation,
and management of ocular
health and diseases in the
adult population. |
| Product
Code | MYC, OBO | MYC, OBO | HLI, OBO |
| Regulation
Number | 21 CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 |
| Device
Classification | II | II | II |
| Components | Scanhead
Headrest and chinrest
Powered Table
(separate)
Computer | Scanhead
Headrest and chinrest
Powered Table
(separate)
Computer | Scanner
Computer
Control box
Footswitch (optional)
Joystick and chinrest
assembly |
| | SLO Technology characteristics | | |
| Light Source | Laser | Laser | N/A |
| Wavelength
and Color of
Light | 532nm ±5nm: green
635nm ±5nm: red | 532nm ±5nm: green
635nm ±5nm: red | N/A |
| Laser Class | Class 1 to ISO 60825 | Class 1 to ISO 60825 | N/A |
| Number of
lasers used
per Scan | 1 or 2 | 1 or 2 | N/A |
| External Field
of View | 120° | 120° | N/A |
| Internal Field
of View | 200° | 200° | N/A |
| Wide Angle
Digitized
Image Size | 3900x3072 pixels | 3900x3072 pixels | N/A |
| Scan
Patterns | 2 axis scanner | 2 axis scanner | N/A |
| Software | Embedded and
Application | Embedded and
Application | N/A |
| | OCT Technology characteristics | | |
| Method of
Operation | Spectral Domain OCT | Spectral Domain OCT | Spectral Domain OCT |
| Light Source | SLD 830-850nm
Super Luminescent
Diode
Nominal center
wavelength 840nm
50nm FHWM
bandwidth
782nm ±3nm: infra-red | SLD 830nm Super
Luminescent Diode
SLD 828 to 837nm
center wavelength with
15nm FHWM
bandwidth
782nm ±3nm: infra-red | SLD 830 nm to 850 nm
Super Luminescent
Diode |
| Scan Rate | 70,000 A-scans/s | 70,000 A-scans/s | 25,000 A-Scans/s |
| Scanner
Type | Galvanometric mirror
pair | Galvanometric mirror
pair | Lens based system |
| Light Source
Classification | Class 1 | Class 1 | Class 1 |
| Transverse
Resolution | 20µm | 20µm | 15µm |
| Axial
Resolution |