P200TE (A10700)

K231673 · Optos Plc. · OBO · Aug 18, 2023 · Ophthalmic

Device Facts

• Record ID: K231673
• Device Name: P200TE (A10700)
• Applicant: Optos Plc.
• Product Code: OBO · Ophthalmic
• Decision Date: Aug 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended 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.

Device Story

P200TE is a desktop retinal imaging device combining ultra-widefield scanning laser ophthalmoscopy (SLO) and spectral domain optical coherence tomography (OCT). SLO uses red (635nm) and green (532nm) lasers for reflectance and autofluorescence imaging; OCT uses a near-infrared (840nm) super-luminescent diode. Device captures images via two ellipsoidal mirrors and galvanometric scanners. Operated by ophthalmic/optometry professionals via touchscreen and hand controller. System includes an image server for storage and management; images reviewed on remote PCs via OptosAdvance software. Automated segmentation algorithms identify retinal layers and structures, providing thickness maps (FRT, GCC, RNFL) and optic nerve head (ONH) analysis. Output aids clinicians in detecting, diagnosing, and managing retinal diseases. Benefits include high-resolution, wide-field visualization and quantitative structural assessment of the posterior eye.

Clinical Evidence

Prospective, single-site study (N=106; 35 normal, 35 glaucoma, 35 retinal pathology). Evaluated repeatability and reproducibility of FRT, RNFL, GCC, and ONH measurements using a 3x3 crossed study design (3 devices, 3 operators). P200TE showed excellent agreement with iVue predicate. Precision goals met for all parameters; P200TE demonstrated lower variability than iVue in 96% of repeatability and 94% of reproducibility metrics. GCC agreement goals were not met due to differences in scan location (iVue grid shifted 1mm temporally).

Technological Characteristics

Desktop scanner; Spectral Domain OCT (840nm SLD) and SLO (532nm/635nm lasers). Galvanometric mirror pair scanning. Class 1 laser/SLD. Dimensions: 200° internal FOV. Connectivity: Networked image server, DICOM-compatible. Software: Linux (SLO), Windows (OCT/Application). Sterilization: Not required; clean/disinfect contact points. Safety: Automatic light source shutdown on malfunction.

Indications for Use

Indicated for in-vivo viewing, digital imaging, and analysis of posterior ocular structures (retina, retinal nerve fiber layer, ganglion cell complex, optic disc) in patients under mydriatic and non-mydriatic conditions. Aids in detection, diagnosis, documentation, and management of retinal health and diseases.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• P200TE (a10700) (K173707)
• iVue (K121739)

Reference Devices

• OptosAdvance review software (K162039)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

Submission Number (if known)

K231673

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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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<br>Queensferry House<br>Carnegie Campus<br>Enterprise Way<br>Dunfermline, Fife<br>Scotland, UK<br>KY11 8GR |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Primary Correspondent | Rachel Reay<br>Sr. Regulatory Affairs Specialist, Optos Plc<br>Tel: [phone]<br>E-mail: [e-mail] (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 |

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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.

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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.

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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<br>segmentation | OPTOS P200TE | Optovue iVue |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | --- | K173707 | K121739 |
| Indications<br>For Use | The P200TE is a non-<br>contact scanning laser<br>ophthalmoscope and optical<br>coherence tomographer. It<br>is intended for in-vivo<br>viewing, digital imaging,<br>and analysis of posterior<br>ocular structures, including<br>the retina, retinal nerve fiber<br>layer, ganglion cell complex<br>(GCC) and optic disc, under<br>mydriatic and non-mydriatic<br>conditions.<br>It is indicated for producing<br>high resolution, ultra-<br>widefield, en face<br>reflectance images,<br>autofluorescence images,<br>axial cross-sectional<br>images, three-dimensional<br>images, retinal layer<br>boundary analysis, optic<br>nerve head analysis and<br>thickness maps.<br>The P200TE is indicated for<br>use as a device to aid in the<br>detection, diagnosis,<br>documentation and<br>management of retinal<br>health and diseases that<br>manifest in the retina. | The P200TE is a non-<br>contact scanning laser<br>ophthalmoscope and<br>optical coherence<br>tomographer intended for<br>in-vivo viewing and digital<br>imaging of posterior<br>ocular structures,<br>including the retina,<br>retinal nerve fiber layer<br>and optic disc. It is<br>indicated for producing<br>high-resolution, widefield,<br>en face reflectance<br>images, autofluorescence<br>images, and axial, cross-<br>sectional images of the<br>posterior ocular<br>structures. | The iVue is a non-contact,<br>high resolution tomographic<br>imaging device. It is<br>intended for in vivo imaging,<br>axial cross-sectional, and<br>three-dimensional imaging<br>and measurement of<br>anterior and posterior<br>ocular structures, including<br>retina, retinal nerve fiber<br>layer, ganglion cell complex<br>(GCC), optic disc, cornea,<br>and anterior chamber of the<br>eye. The iVue with<br>Normative Database is a<br>quantitative tool for the<br>comparison of retina, retinal<br>nerve fiber layer, ganglion<br>cell complex, and optic disc<br>measurements to a<br>database of known normal<br>subjects.<br>The iVue with Normative<br>Database is indicated for<br>use as a device to aid in the<br>diagnosis, documentation,<br>and management of ocular<br>health and diseases in the<br>adult population. |
| Product<br>Code | MYC, OBO | MYC, OBO | HLI, OBO |
| Regulation<br>Number | 21 CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 |
| Device<br>Classification | II | II | II |
| Components | Scanhead<br>Headrest and chinrest<br>Powered Table<br>(separate)<br>Computer | Scanhead<br>Headrest and chinrest<br>Powered Table<br>(separate)<br>Computer | Scanner<br>Computer<br>Control box<br>Footswitch (optional)<br>Joystick and chinrest<br>assembly |
| | SLO Technology characteristics | | |
| Light Source | Laser | Laser | N/A |
| Wavelength<br>and Color of<br>Light | 532nm ±5nm: green<br>635nm ±5nm: red | 532nm ±5nm: green<br>635nm ±5nm: red | N/A |
| Laser Class | Class 1 to ISO 60825 | Class 1 to ISO 60825 | N/A |
| Number of<br>lasers used<br>per Scan | 1 or 2 | 1 or 2 | N/A |
| External Field<br>of View | 120° | 120° | N/A |
| Internal Field<br>of View | 200° | 200° | N/A |
| Wide Angle<br>Digitized<br>Image Size | 3900x3072 pixels | 3900x3072 pixels | N/A |
| Scan<br>Patterns | 2 axis scanner | 2 axis scanner | N/A |
| Software | Embedded and<br>Application | Embedded and<br>Application | N/A |
| | OCT Technology characteristics | | |
| Method of<br>Operation | Spectral Domain OCT | Spectral Domain OCT | Spectral Domain OCT |
| Light Source | SLD 830-850nm<br>Super Luminescent<br>Diode<br>Nominal center<br>wavelength 840nm<br>50nm FHWM<br>bandwidth<br>782nm ±3nm: infra-red | SLD 830nm Super<br>Luminescent Diode<br>SLD 828 to 837nm<br>center wavelength with<br>>15nm FHWM<br>bandwidth<br>782nm ±3nm: infra-red | SLD 830 nm to 850 nm<br>Super Luminescent<br>Diode |
| Scan Rate | 70,000 A-scans/s | 70,000 A-scans/s | 25,000 A-Scans/s |
| Scanner<br>Type | Galvanometric mirror<br>pair | Galvanometric mirror<br>pair | Lens based system |
| Light Source<br>Classification | Class 1 | Class 1 | Class 1 |
| Transverse<br>Resolution | 20µm | 20µm | 15µm |
| Axial<br>Resolution | < 7µm | < 10µm | 5µm |
| Transverse<br>scan range | 5.28 mm to 12 mm | 6 mm to 12 mm | 2 mm to 12 mm |
| Scan<br>Patterns | Line<br>Volume<br>Circle | Line<br>Volume<br>Circle | Line<br>Volume<br>Circle |
| | | | |
| Depth Range<br>(in tissue) | 2.3mm…