Predicate Devices

Reference Devices

Not Found.

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes automated segmentation and comparison to a reference database using statistical cut-off values, but does not mention AI or ML.

Therapeutic

No
The device is described as an imaging and measurement tool for diagnosis and management of retinal conditions, not for treatment or therapy.

Diagnostic

Yes

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." The device also includes a "Reference Database that enables the results of OCT segmentation analysis to be compared to reference data" to flag parameters outside the normal range, further aiding in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states that the P200TE is a "desktop retinal imaging device" that performs "ultra-widefield scanning laser ophthalmoscopy and optical coherence tomography." It describes physical components like "ellipsoidal mirrors," "mirrored scanner," "laser or SLD," and "detectors," indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the P200TE is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: An IVD device is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
P200TE Function: The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is used for in-vivo viewing, digital imaging, and measurement of structures within the eye. It does not analyze samples taken from the body.

The device is used to directly image and measure structures within the living eye, which falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 measurement of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and non-mydriatic conditions.

P200TE 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 includes a Reference Database that enables the results of OCT segmentation analysis to be compared to reference data, including Full retinal thickness, Ganglion Cell Complex thickness, Retina Nerve Fiber Layer thickness and Optic Nerve Head metrics.

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

OBO, MYC

Device Description

The 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 images 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. A Reference Database enables the automatic annotation of OCT segmentation results to provide comparison to a known healthy population. Segmentation 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 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.

Images 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 retina, retinal nerve fiber layer, ganglion cell complex (GCC), and optic disc.

Indicated Patient Age Range

The Reference Database cohort had an age range of 22-84 years.

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 reference database of healthy eyes was created for measurement comparisons. In total, 879 eyes were enrolled in the study. For full retina thickness and GCC measurements, 860 eyes were included in the analysis. For RNFL and ONH measurements, data was divided into three groups based on disc size: 279 eyes for small optic discs ( 2.15 mm2). The age distribution was skewed toward older eyes with a mean age of 51 years old, with 56% of eyes over the age of 50. The cohort included good racial and ethnic diversity: 15% Hispanic, 16% Asian, 14% Black or African American, and 57% White. Data were analyzed with a non-parametric method to determine the 1%, 5%, 95%, and 99% cut-off values, with no overlap between intervals at 90% confidence.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing:
Technological implementation of SLO and OCT imaging is identical between the cleared P200TE and the submitted P200TE with RDB. No technological updates are included in this submission.
Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications, with no concerns raised in relation to key nonfunctional performance parameters.
Design Verification and Validation of the A10700 P200TE with RDB has been performed in support of this submission, including OCT non-functional performance parameters and functional parameters for the US Reference Database.
The P200TE is type tested in accordance with the following standards: IEC 60601-1:2015+A11:2021, IEC 60601-1-2:2014+A1:2020, IEC 60825-1:2007. Safety Calculations are also provided with reference to ANSI Z80.36-2021.
Software verification and validation has been conducted in accordance with QMS processes. All testing has passed with no additional safety or performance concerns raised.

Clinical Performance Testing:
A reference database of healthy eyes was created for measurement comparisons in order to flag parameters that fall outside the normal range. Standard cut-off values were chosen including the 1%, 5%, 95%, and 99% levels.

RNFL, GCC, and ONH Rim measurements: Values below 5% are ‘borderline’ (amber), and values below 1% are ‘outside normal limits’ (red).
ONH C/D parameters: Values above 95% are amber, and values above 99% are red.
FRT measurements: Values below 5% are light blue and values below 1% are dark blue, while values above 95% are amber and values above 99% are red.
The cut-off values were determined using a non-parametric analysis to reduce potential bias introduced when using standard parametric techniques due to their underlying assumptions. The reference database was split into 3 divisions for RNFL and ONH measurements based on optic disc size.
In total, 879 eyes were enrolled in the study. For full retina thickness and GCC measurements, the final number included in the analysis was 860 eyes. The RNFL and ONH measurements were divided into three groups based on disc size. For small optic disc area ( 2.15 mm2), 254 eyes for RNFL and 255 for ONH.
The age distribution was skewed toward older eyes with the mean age in the database of 51 years old (56% of eyes over 50). Racial and ethnic diversity: 15% Hispanic, 16% Asian, 14% Black or African American, and 57% White.
These data were analyzed with a non-parametric method to determine the 1%, 5%, 95%, and 99% cut off values, with no overlap between intervals at 90% confidence. These values were implemented into software for the device that alerts users when measurement values fall outside these cut-off limits.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Mean, Standard Deviation, Median, Minimum, Maximum, and Percentiles (1st, 5th, 95th, 99th) with 90% Confidence Intervals were reported for:

Full Retinal Thickness (Central Foveal, Superior Parafoveal, Temporal Parafoveal, Inferior Parafoveal, Nasal Parafoveal, Superior Perifoveal, Temporal Perifoveal, Inferior Perifoveal, Nasal Perifoveal thickness).
GCC thickness (Total Average, Superior Hemiretina, Inferior Hemiretina).
RNFL measurements (Average RNFL Thickness Over TSNIT Circle, Temporal Quadrant RNFL Over TSNIT Circle, Superior Quadrant RNFL Over TSNIT Circle, Inferior Quadrant RNFL Over TSNIT Circle, Nasal Quadrant RNFL Over TSNIT Circle) by optic disc size.
ONH measurements (ONH: C/D Vertical, ONH: C/D Horizontal, ONH: C/D Area, ONH: Rim Area) by optic disc size.

Predicate Device(s)

K121739, K231673

Reference Device(s)

Not Found.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found.

Regulation Number and Section

§ 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.

Summary

0

May 9, 2024

Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Optos Plc Graham Mcleod Senior Director of Regulatory Affairs Queensferry House, Carnegie Campus Enterprise Way Dunfermline, Fife KY11 8GR United Kingdom

Re: K233602

Trade/Device Name: P200te (a10700) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: March 28, 2024 Received: March 29, 2024

Dear Graham Mcleod:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Ng -S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

2

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Submission Number (if known)

K233602

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 measurement of posterior ocular structures, including the retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and nonmydriatic conditions.

P200TE 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 includes a Reference Database that enables the results of OCT segmentation analysis to be compared to reference data, including Full retinal thickness, Ganglion Cell Complex thickness, Retina Nerve Fiber Layer thickness and Optic Nerve Head metrics.

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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image contains text that appears to be a document header or title. The text includes "P200TE 510(k) Summary K233602" on the first line, which likely refers to a product model, a regulatory submission type (510(k)), and a reference or tracking number (K233602). The second line reads "Optos Plc", which is probably the name of the company or organization associated with the document.

Image /page/4/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, sans-serif font 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 | Graham McLeod
Sr. Director of Regulatory Affairs, Optos Plc
Tel: 0044 1383 843300
E-mail: RA@optos.com (preferred) |
| Secondary Correspondent | Rachel Reay
Sr. Regulatory Specialist, Optos Plc
Tel: 0044 1383 843300
E-mail: RA@optos.com (preferred) |
| Date Prepared | 25th March 2024 |

2. Subject Device

Device Trade Name	P200TE (A10700)
Common Name	Ophthalmoscope
Classification	Tomography, Optical Coherence
Regulatory Class	886.1570
Product Code	OBO, MYC

3. Legally Marketed Predicate Devices

Predicate #	K121739 (Primary)	K231673
Device Trade Name	iVue	P200TE (A10700)
Product Code	OBO, HLI	OBO, MYC

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Image /page/5/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left, followed by the word "optos" in a blue, sans-serif font. A registered trademark symbol is located to the upper right of the "s" in "optos". The eye symbol is a combination of light blue and dark blue colors.

4. Device Description

The 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 eve 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 images 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. A Reference Database enables the automatic annotation of OCT segmentation results to provide comparison to a known healthy population. Segmentation outcomes are recorded as annotations and support adjustment as deemed necessary by the clinician.

6

Image /page/6/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue, sans-serif font on the right. The eye symbol is a combination of light and dark blue shades, creating a sense of depth. The word "optos" is in a bold font, and there is a registered trademark symbol next to the "s".

P200TE automatic seqmentation provides comprehensive retinal and optic nerve head information, including:

. Full Retinal Thickness (FRT)
. Ganglion Cell Complex Thickness (GCC)
ONH 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.

Images 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 retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc under mydriatic and non-mydriatic conditions.

P200TE 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 includes a Reference Database that enables the results of OCT segmentation analysis to be compared to reference data, including Full retinal thickness, Ganglion Cell Complex thickness, Retina Nerve Fiber Layer thickness and Optic Nerve Head metrics.

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.

7

Image /page/7/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue letters on the right. A registered trademark symbol is located to the right of the "s" in "optos".

6. Substantial Equivalence to Predicate

Both P200TE and iVue are Spectral Domain optical coherence tomographers intended for in-vivo digital imaging of posterior ocular structures, with retinal laver boundary analysis, optic nerve head analysis and thickness maps. Both devices provide a reference database to allow comparison of measurements against a database of known subjects.

The updated P200TE has all the same indications for use as P200TE and alongside this introduces the opportunity for comparison to a reference database, present in the primary predicate device, iVue. In other words, the P200TE has the same intended use as its predicate devices, and thus satisfies the first criterion for a finding of substantial equivalence.

The Optos Reference Database (RDB) enables the automatic annotation of OCT segmentation results to provide comparison to a known healthy population cohort of 860 subjects across an age range 22-84 years, with an average age of 51. This is shown in terms of percentiles. Cut-off values of 1%, 5%, 95%, and 99% (determined with a nonparametric method) are used to color-code results to indicate where they fall in relation to database distribution. This is similar to iVue, which uses color-coded percentile categories to denote 'within normal', 'borderline', or 'outside normal' based on cut-off levels of 5% for 'borderline' and 1% for 'outside normal'.

The Optos RDB is partitioned into three strata, based on optic disc size as the prioritized covariate for RNFL and ONH RDB comparisons. It is non-parametric, with an age profile intended to mirror disease prevalence. These covariates are selected in line with the parameters used in the predicate iVue database.

Technological implementation of SLO and OCT imaging is identical between the cleared P200TE and this submission of the P200TE with RDB. No technological updates are included in this submission.

P200TE with segmentation and RDB is substantially equivalent to the previously cleared P200TE (K231673), and RDB functionality is also substantially equivalent to the Optovue iVue (K121739). Minor differences in RDB implementation do not present different questions of safety or effectiveness than the predicate device because there are no novel technological principles or applications introduced.

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Image /page/8/Picture/1 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue letters on the right. A small registered trademark symbol is located to the upper right of the word "optos".

Table 1: Substantial Equivalence Chart

| Device | OPTOS P200TE with
segmentation and RDB | Optovue iVue | OPTOS P200TE with
segmentation |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K233602 | K121739
(Primary predicate) | K231673 |
| Indications For
Use | The P200TE is a non-
contact scanning laser
ophthalmoscope and
optical coherence
tomographer. It is intended
for invivo 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.
P200TE 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 includes a
Reference Database that
enables the results of OCT
segmentation analysis to
be compared to reference
data, including Full retinal
thickness, Ganglion Cell
Complex thickness, Retina
Nerve Fiber Layer
thickness and Optic Nerve
Head metrics.
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 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. | 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. |
| Product Code | MYC, OBO | HLI, OBO | MYC, OBO |
| Regulation
Number | 21 CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 |
| Device
Classification | ll | ll | ll |
| Components | Scanhead
Headrest and chinrest
Powered Table
(separate)
Computer | Scanner
Computer
Control box
Footswitch (optional)
Joystick and chinrest | Scanhead
Headrest and chinrest
Powered Table
(separate)
Computer |
| | | assembly | |
| SLO Technology Characteristics | | | |
| Light Source | Laser | N/A | Laser |
| Wavelength
and Color of
Light | 532nm ±5nm: green
635nm ±5nm: red | N/A | 532nm ±5nm: green
635nm ±5nm: red |
| Laser Class | Class 1 to ISO 60825 | N/A | Class 1 to ISO 60825 |
| Number
of
lasers used
per Scan | 1 or 2 | N/A | 1 or 2 |
| External Field
of View | 120° | N/A | 120° |
| Internal Field
of View | 200° | N/A | 200° |
| Wide Angle
Digitized Image Size | 3900x3072 pixels | N/A | 3900x3072 pixels |
| Scan Patterns | 2 axis scanner | N/A | 2 axis scanner |
| Software | Embedded and
Application | N/A | Embedded and
Application |
| 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 830 nm to 850 nm
Super Luminescent
Diode | SLD 830-850nm
Super Luminescent
Diode
Nominal center
wavelength 840nm
50nm FHWM
bandwidth
782nm ±3nm: infra-red |
| Scan Rate | 70,000 A-scans/s | 25,000 A-Scans/s | 70,000 A-scans/s |
| Scanner Type | Galvanometric mirror pair | Lens based system | Galvanometric mirror
pair |
| Light Source
Classification | Class 1 | Class 1 | Class 1 |
| Transverse
Resolution | 20μm | 15μm | 20μm |
| Axial
Resolution | 2.15 mm2), the final number included in the RNFL analysis was 254, and the final number in the ONH analysis was 255.

The age distribution was skewed toward older eyes with the mean age in the database of 51 years old with 56% of eyes over the age of 50. There was good racial and ethnic diversity with 15% of patients Hispanic, 16% Asian, 14% Black or African American, and 57% White. The age distribution was intentionally skewed toward older eyes in order to better match the age distribution typically found in eye clinics and representing eves susceptible to agerelated eye diseases. Because of this, age-related corrections were not necessary for this database.

These data were analyzed with a non-parametric method to determine the 1%, 5%, 95%, and 99% cut off values, with no overlap between intervals at 90% confidence. These values were implemented into software for the device that alerts users when measurement values fall outside these cut-off limits. In this way, the reference database aids in the detection and management of ocular disease.

14

Image /page/14/Picture/0 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 made up of two curved shapes, one light blue and one dark blue, that form the outline of an eye. The word "optos" is written in a sans-serif font, and there is a registered trademark symbol after the "s".

OPT1089 Summary Tables

Table 3: Study demographic information

Baseline Characteristic	Statistic	Value
Age at Enrolment	N (population size)	879
	n (non-missing sample size)	879
	Mean	51.0
	Standard Deviation	15.39
	Median	53
	Minimum	22
	Maximum	84
Age Group N (%)	22-30	124 (14.1)
	31-40	97 (11.0)
	41-50	165 (18.8)
	51-60	232 (26.4)
	61-70	177 (20.1)
	71+	84 (9.6)
Sex N (%)	Female	543 (61.8)
	Male	335 (38.1)
	Unspecified	1 (0.1)
Ethnicity N (%)	Hispanic or Latino	128 (14.6)
	Non Hispanic or Latino	751 (85.4)
Race N (%)	American Indian / Alaska Native	1 (0.1)
	Asian	144 (16.4)
	Black or African American	122 (13.9)
	Native Hawaiian or Other Pacific Islander	11 (1.3)
	White	501 (57.0)
	Other	100 (11.4)

15

Image /page/15/Picture/0 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue on the right. The eye symbol is a combination of light blue and dark blue shapes, creating the impression of an eye. The word "optos" is written in a sans-serif font, with a small registered trademark symbol next to the "s".

P200TE 510(k) Summary K233602 Optos Plc

Table 4: Summary statistics and cut-off percentiles for Full Retinal Thickness measurements


Parameter	N
(population
size)	n (non-
missing
sample size)	Mean (95% CI of
Mean)	Standard
Deviation	Median (Min, Max)	1st percentile	5th percentile	95th percentile	99th percentile
Central Foveal
Thickness	879	860	247.04 (245.55,
248.52)	22.160	246.23 (183.82,
329.70)	195.74 (189.60,
199.07)	212.32 (208.39,
214.15)	283.34 (280.22,
288.51)	302.84 (300.76,
310.93)
Superior Parafoveal
Thickness	879	860	315.00 (314.00,
316.00)	14.998	314.81 (254.21,
361.60)	278.64 (277.01,
281.13)	290.54 (287.38,
292.30)	339.33 (337.97,
340.78)	351.57 (347.65,
354.03)
Temporal Parafoveal
Thickness	879	860	303.45 (302.47,
304.42)	14.585	303.28 (249.22,
350.19)	269.57 (262.19,
271.14)	279.39 (277.69,
280.71)	326.82 (324.75,
329.39)	338.66 (334.77,
341.17)
Inferior Parafoveal
Thickness	879	860	312.35 (311.35,
313.34)	14.814	312.28 (253.75,
359.73)	278.01 (271.74,
280.86)	287.24 (285.59,
288.11)	335.93 (334.38,
337.52)	348.59 (344.55,
351.81)
Nasal Parafoveal
Thickness	879	860	316.55 (315.49,
317.61)	15.815	316.97 (257.44,
364.37)	277.99 (272.89,
282.46)	289.85 (287.75,
292.50)	342.07 (340.34,
344.30)	354.37 (350.10,
358.87)
Superior Perifoveal
Thickness	879	860	278.54 (277.62,
279.46)	13.717	278.64 (227.52,
322.60)	244.80 (239.81,
248.65)	256.88 (255.46,
258.57)	300.63 (299.57,
303.68)	313.65 (308.92,
317.20)
Temporal Perifoveal
Thickness	879	860	260.50 (259.64,
261.35)	12.789	260.27 (214.64,
304.00)	230.24 (222.82,
235.42)	240.19 (238.76,
241.71)	281.03 (279.55,
283.25)	290.68 (288.88,
292.21)
Inferior Perifoveal
Thickness	879	860	265.08 (264.18,
265.98)	13.447	265.12 (217.70,
308.01)	234.08 (229.50,
236.15)	241.98 (241.20,
243.29)	286.98 (285.67,
289.82)	297.36 (294.27,
299.26)
Nasal Perifoveal
Thickness	879	860	291.78 (290.78,
292.78)	14.983	291.67 (234.72,
345.70)	255.73 (252.18,
259.22)	267.25 (265.56,
268.74)	316.25 (315.08,
317.63)	328.19 (326.46,
335.06)

Table 5: Summary statistics and cut-off percentiles for GCC thickness measurements


Parameter	N
(population
size)	n (non-
missing
sample size)	Mean (95% CI of
Mean)	Standard
Deviation	Median (Min, Max)	1st percentile	5th percentile	95th percentile	99th percentile
Total Average	879	860	108.03 (107.53,
108.53)	7.480	107.95 (82.67,
132.46)	88.01 (86.66,
90.71)	95.31 (93.67,
96.07)	120.45 (119.77,
121.24)	124.09 (122.74,
126.80)
Superior
Hemiretina	879	860	107.90 (107.39,
108.40)	7.539	107.81 (83.65,
133.04)	87.88 (85.93,
91.01)	95.65 (94.26,
96.48)	120.09 (119.04,
120.97)	124.37 (123.63,
126.71)
Inferior
Hemiretina	879	860	108.16 (107.62,
108.69)	8.003	108.16 (79.83,
131.87)	87.22 (84.41,
89.91)	94.20 (93.29,
95.26)	121.44 (120.54,
122.10)	125.07 (124.30,
125.55)

Table 6: Summary statistics and cut-off percentiles for RNFL measurements


Parameter	Optic
Disc
Size	N
(population
size)	n (non-
missing
sample size)	Mean (95% Cl
of Mean)	Standard
Deviation	Median (Min.
Max)	1st percentile	5th percentile	95th percentile	99th percentile
Average RNFL Thickness
Over TSNIT Circle	Small optic
disc	879	279	106.46 (105.17
107.74)	10.892	106.39 (69.03,
133.00)	80.21 (69.03
84.23)	88.75 (84.82)
90.29)	123.69 (122.12
127.36	131.50 (129.16.
133.00)
	Medium
optic disc	879	320	112.02 (110.82
113.22	10.905	112.49 (76.48)
150.30)	85.95 (76.48)
89.31)	95.04 (90.46)
96.57)	129.77 (126.84
135.14)	138.91 (136.22
150.30)
	Large optic
disc	879	254	113.85 (112.39)
115.30)	11.802	113.90 (81.54)
147.45)	84.94 (81.54
91.80)	94.69 (92.26)
96.93)	134.91 (130.76.
137.14)	141.23 (138.05.
147.45)
Temporal Quadrant RNFL
Over TSNIT Circle	Small optic
disc	879	279	86.02 (84.44
87.61)	13.458	84.08 (58.57
140.45)	60.43 (58.57
65.23)	68.10 (65.62.
69.06)	110.48 (107.24.
115.73)	125.88 (117.33)
140.45)
	Medium
optic disc	879	320	84.36 (83.11.
85.60)	11.325	83.79 (58.32)
122.78)	62.77 (58.32)
63.83)	67.70 (64.56)
69.64)	103.36 (102.25,
105.961	112.17 (109.71.
122.78)
	Large optic
disc	879	254	85.05 (83.68)
86.43)	11.095	83.14 (63.77
121.46)	64.13 (63.77
66.04)	69.33 (66.06)
71.12)	105.56 (101.74
108.42)	114.64 (108.49)
121.46)
Superior Quadrant RNFL
Over TSNIT Circle	Small optic
disc	879	279	123.65 (121.46,
125.83)	18.546	124.75 (70.59)
194.77)	76.32 (70.59)
86.63)	93.78 (87.35)
96.73)	154.85 (148.94
160.52)	169.49 (161.46.
194.77)
	Medium
optic disc	879	320	133.10 (131.25,
134.95)	16.802	133.63 (75.20,
191.32)	88.47 (75.20)
92.06)	106.40 (98.23,
110.09)	160.02 (156.25
167.04)	175.92 (167.98,
191.32)
	Large optic
disc	879	254	134.30 (132.13.
136.47)	17.534	133.70 (89.95)
180.56)	98.81 (89.95
101.16)	104.19 (101.29)
109.02)	165.15 (161.79.
170.74)	175.46 (171.56,
180.56)
Inferior Quadrant RNFL Over
TSNIT Circle	Small optic
disc	879	279	133.68 (131.54
135.82)	18.168	135.09 (57.76
178.33)	78.52 (57.76.
96.861	103.68 (97.59)
107.12)	162.16 (158.33
171.79)	175.59 (171.81,
178.33)
	Medium
optic disc	879	320	141.73 (139.84
143.63)	17.204	142.58 (90.98)
206.53)	97.91 (90.98)
101.85)	112.68 (106.12,
116.40)	168.23 (164.27
176.26)	185.34 (180.42
206.53)
	Large optic
disc	879	254	145.48 (143.15,
147.82)	18.907	145.37 (88.95)
198.32)	98.84 (88.95)
110.16)	113.91 (111.74.
118.11)	178.58 (171.76.
181.11)	190.48 (181.34.
198.32)
Nasal Quadrant RNFL Over
TSNIT Circle	Small optic
disc	879	279	82.49 (80.73.
84.26)	14.963	80.54 (46.51)
128.37)	51.13 (46.51)
57.55)	59.61 (58.03.
61.95)	109.27 (103.97
116.10)	124.93 (116.37)
128.37)

16

Image /page/16/Picture/0 description: The image shows the Optos logo. The logo consists of a stylized eye symbol on the left and the word "optos" in blue, sans-serif font on the right. A small registered trademark symbol is located to the upper right of the word "optos".


Parameter	Optic
Disc
Size	N
(population
size)	n (non-
missing
sample size)	Mean (95% Cl of
Mean)	Standard
Deviation	Median (Min.
Max)	1st percentile	5th percentile	95th percentile	99th percentile
ONH: C/D
Vertical	Small optic disc	879	284	0.376 (0.353,
0.399)	0.1981	0.409 (0.000,
0.773)	0.000 (0.000,
0.000)	0.000 (0.000,
0.000)	0.648 (0.616,
0.683)	0.709 (0.684,
0.773)
	Medium optic
disc	879	321	0.486 (0.466,
0.506)	0.1802	0.506 (0.000,
0.805)	0.000 (0.000,
0.000)	0.064 (0.000,
0.206)	0.736 (0.715,
0.759)	0.782 (0.769,
0.805)
	Large optic disc	879	255	0.550 (0.527,
0.572)	0.1844	0.590 (0.000,
0.821)	0.000 (0.000,
0.000)	0.102 (0.000,
0.235)	0.765 (0.741,
0.779)	0.797 (0.780,
0.821)
ONH: C/D
Horizontal	Small optic disc	879	284	0.354 (0.331,
0.376)	0.1919	0.396 (0.000,
0.731)	0.000 (0.000,
0.000)	0.000 (0.000,
0.000)	0.612 (0.598,
0.643)	0.683 (0.644,
0.731)
	Medium optic
disc	879	321	0.462 (0.443,
0.482)	0.1780	0.493 (0.000,
0.808)	0.000 (0.000,
0.000)	0.000 (0.000,
0.171)	0.694 (0.685,
0.707)	0.725 (0.711,
0.808)
	Large optic disc	879	255	0.531 (0.508,
0.554)	0.1889	0.572 (0.000,
0.888)	0.000 (0.000,
0.000)	0.102 (0.000,
0.206)	0.779 (0.751,
0.803)	0.835 (0.805,
0.888)
ONH: C/D Area	Small optic disc	879	284	0.171 (0.156,
0.185)	0.1246	0.169 (0.000,
0.513)	0.000 (0.000,
0.000)	0.000 (0.000,
0.000)	0.378 (0.369,
0.424)	0.494 (0.426,
0.513)
	Medium optic
disc	879	321	0.257 (0.241,
0.273)	0.1455	0.256 (0.000,
0.608)	0.000 (0.000,
0.000)	0.002 (0.000,
0.037)	0.501 (0.489,
0.517)	0.550 (0.540,
0.608)
	Large optic disc	879	255	0.327 (0.307,
0.347)	0.1624	0.331 (0.000,
0.736)	0.000 (0.000,
0.000)	0.011 (0.000,
0.042)	0.581 (0.556,
0.603)	0.623 (0.603,
0.736)
ONH: Rim Area	Small optic disc	879	284	1.270 (1.246,
1.295)	0.2102	1.259 (0.689,
1.758)	0.814 (0.689,
0.842)	0.933 (0.864,
0.971)	1.617 (1.608,
1.706)	1.738 (1.715,
1.758)
	Medium optic
disc	879	321	1.441 (1.410,
1.473)	0.2848	1.457 (0.704,
2.148)	0.870 (0.704,
0.906)	0.970 (0.921,
1.025)	1.915 (1.858,
1.998)	2.037 (2.019,
2.148)
	Large optic disc	879	255	1.633 (1.585,
1.681)	0.3880	1.610 (0.690,
2.587)	0.924 (0.690,
0.989)	1.040 (1.000,
1.092)	2.358 (2.274,
2.399)	2.545 (2.404,
2.587)

Table 7: Summary statistics and cut-off percentiles for ONH measurements

8. Conclusion

The existing and updated P200TE devices have the same intended use, technological characteristics and principles of operation, and similar indications. Additionally the updated P200TE incorporates the Reference Database functionality of the iVue.

Minor differences in Reference Database implementation do not present different questions of safety or effectiveness than the predicate devices as no novel technological principles or applications are introduced. Color-coding and covariate selection are in line with the iVue and functionality has been demonstrated clinically. Thus, the P200TE is substantially equivalent to the stated predicates.