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.

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.

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.

AI/ML Overview

The provided text describes the P200TE device, a non-contact scanning laser ophthalmoscope and optical coherence tomographer. The primary purpose of the submission K233602 is to introduce a Reference Database (RDB) feature to the previously cleared P200TE, enabling the comparison of OCT segmentation analysis results to a known healthy population.

The acceptance criteria for the P200TE with the Reference Database are not explicitly stated in a quantitative table format with pass/fail metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Optovue iVue and previous P200TE) by showing that the updated P200TE has the same intended use, technological characteristics, principles of operation, and similar indications. The "acceptance criteria" are implied to be centered around the clinical performance testing of the Reference Database, specifically its ability to establish reliable cut-off values for various retinal and optic nerve head measurements based on a healthy cohort, and the effective color-coding of results for interpretation.

Here's an attempt to structure the information based on the provided text, inferring acceptance criteria from the study's design and reported results:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Acceptance Criteria (Inferred from Study Design)	Reported Device Performance (Summary Statistics and Percentiles)
Reference Database (RDB) Establishment: Ability to define statistically sound cut-off values (1%, 5%, 95%, 99%) for various OCT measurements to differentiate "normal" from "borderline" or "outside normal" based on a healthy population. These cut-offs must be suitable for color-coding.	Full Retinal Thickness (FRT) Measurements: - Central Foveal Thickness: Mean 247.04, 1st %ile: 195.74, 5th %ile: 212.32, 95th %ile: 283.34, 99th %ile: 302.84. - Superior Parafoveal Thickness: Mean 315.00, 1st %ile: 278.64, 5th %ile: 290.54, 95th %ile: 339.33, 99th %ile: 351.57. - And similar detailed statistics for Temporal, Inferior, Nasal Parafoveal, and Perifoveal thicknesses (see Table 4). Color-coding implemented: Values below 5% light blue, below 1% dark blue; values above 95% amber, above 99% red.
Ganglion Cell Complex (GCC) Thickness Measurements: Ability to define statistically sound cut-off values for GCC measurements to differentiate "normal" from "borderline" or "outside normal."	GCC Thickness Measurements: - Total Average: Mean 108.03, 1st %ile: 88.01, 5th %ile: 95.31, 95th %ile: 120.45, 99th %ile: 124.09. - Superior Hemiretina: Mean 107.90, 1st %ile: 87.88, 5th %ile: 95.65, 95th %ile: 120.09, 99th %ile: 124.37. - Inferior Hemiretina: Mean 108.16, 1st %ile: 87.22, 5th %ile: 94.20, 95th %ile: 121.44, 99th %ile: 125.07. Color-coding implemented: Values below 5% amber, below 1% red.
Retinal Nerve Fiber Layer (RNFL) Measurements: Ability to define statistically sound cut-off values for RNFL measurements, considering optic disc size, to differentiate "normal" from "borderline" or "outside normal."	RNFL Measurements (stratified by optic disc size): - Average RNFL, Temporal, Superior, Inferior, and Nasal Quadrant RNFL over TSNIT Circle (see Table 6 for detailed percentiles and means for Small, Medium, and Large optic disc groups). Color-coding implemented: Values below 5% amber, below 1% red.
Optic Nerve Head (ONH) Analysis: Ability to define statistically sound cut-off values for ONH parameters (C/D Vertical, C/D Horizontal, C/D Area, Rim Area), considering optic disc size, to differentiate "normal" from "borderline" or "outside normal."	ONH Measurements (stratified by optic disc size): - C/D Vertical, C/D Horizontal, C/D Area, Rim Area (see Table 7 for detailed percentiles and means for Small, Medium, and Large optic disc groups). Color-coding implemented: Values above 95% amber, above 99% red.
Non-clinical Performance: Device meets defined functional and non-functional specifications. Compliance with relevant electrical, laser, and EMC standards. Software verification and validation.	Non-clinical system testing showed the system met defined specifications, with no concerns. Type tested in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, and ANSI Z80.36-2021. Software V&V conducted according to QMS processes. All testing passed with no additional safety or performance concerns.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 860 eyes for full retina thickness and GCC measurements. For RNFL and ONH measurements, the sample was stratified by optic disc size:
- Small optic disc (< 1.76 mm2): 279 eyes for RNFL, 284 eyes for ONH.
- Medium optic disc (1.76 mm2 - 2.15 mm2): 320 eyes for RNFL, 321 eyes for ONH.
- Large optic disc (> 2.15 mm2): 254 eyes for RNFL, 255 eyes for ONH.
- Overall, 879 eyes were enrolled in the study.
Data Provenance: The document does not explicitly state the country of origin. It describes the age distribution as "skewed toward older eyes...to better match the age distribution typically found in eye clinics," implying a focus on a patient population that would likely use the device. It also mentions "good racial and ethnic diversity" (15% Hispanic, 16% Asian, 14% Black or African American, and 57% White), which suggests a US-based or diverse multinational cohort. The study was prospective in the sense that it established a reference database from healthy eyes for future comparison, effectively a one-time data collection for the database.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The ground truth for the reference database was established by collecting data from "healthy eyes." The criteria for defining an eye as "healthy" for inclusion in the reference database are not detailed (e.g., based on clinical examination by ophthalmologists, absence of specific diseases).

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. The study describes the creation of a "reference database of healthy eyes" and the use of "non-parametric analysis to determine the 1%, 5%, 95%, and 99% cut off values." This suggests a statistical approach to defining "normalcy" from the collected data, rather than individual case adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance and the establishment of a reference database for interpretation by human users, not on the improvement of human readers with AI assistance beyond providing a data comparison tool. The device provides "automatic segmentation" but the core of the submission (K233602) is the RDB facilitating comparison guidance, not an AI-assisted diagnostic workflow assessment involving human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, the study evaluated the standalone performance of the algorithm's segmentation and RDB comparison feature by establishing the statistical distribution and cut-offs from a healthy population. The "clinical performance testing" section primarily details the generation of these normative values and their statistical validity. The device performs "automatic segmentation," and the RDB then compares these segmented measurements to a normative dataset. The study does not describe a human-in-the-loop performance study for this specific submission's purpose (adding the RDB).

7. The Type of Ground Truth Used

The ground truth for the Reference Database was derived from clinical data collected from a cohort of "healthy eyes." The specific criteria for "healthy" status and whether this involved expert consensus, clinical outcomes, or other methods are not detailed. It is explicitly stated that the "age distribution was intentionally skewed toward older eyes... Because of this, age-related corrections were not necessary for this database," suggesting the definition of "healthy" for each age group was considered stable across the cohort.

8. The Sample Size for the Training Set

The document refers to the data collected as the basis for the "reference database." This dataset of 879 eyes (with 860 eyes analyzed for FRT and GCC, and stratified numbers for RNFL and ONH based on disc size) effectively serves as the "training set" or "normative dataset" from which the cut-off percentiles were derived.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the "training set" (the healthy reference database) was established through a clinical study that enrolled "healthy eyes." The data from these eyes were then used in a non-parametric statistical analysis to determine the 1st, 5th, 95th, and 99th percentile cut-off values for various OCT measurements. The document states, "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." For RNFL and ONH measurements, the database was further partitioned into three strata based on optic disc size to account for its influence. This statistical derivation from a healthy population defines the "ground truth" for the RDB's comparative function.

Summary

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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"

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(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

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

Enclosure

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Indications for Use

Submission Number (if known)

K233602

Device Name

P200TE (A10700)

Indications for Use (Describe)

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 PlcQueensferry HouseCarnegie CampusEnterprise WayDunfermline, FifeScotland, UKKY11 8GR
Primary Correspondent	Graham McLeodSr. Director of Regulatory Affairs, Optos PlcTel: 0044 1383 843300E-mail: RA@optos.com (preferred)
Secondary Correspondent	Rachel ReaySr. Regulatory Specialist, Optos PlcTel: 0044 1383 843300E-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 delivers images in the following image modes:

. Scanning Laser Ophthalmoscopy
. Reflectance imaging
. Autofluorescence imaging
. Optical Coherence Tomography

The P200TE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the fundus.

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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

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.

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.

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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 withsegmentation and RDB	Optovue iVue	OPTOS P200TE withsegmentation
510(k)Number	K233602	K121739(Primary predicate)	K231673
Indications ForUse	The P200TE is a non-contact scanning laserophthalmoscope andoptical coherencetomographer. It is intendedfor invivo viewing, digitalimaging, and measurementof posterior ocularstructures, including theretina, retinal nerve fiberlayer, ganglion cellcomplex (GCC) and opticdisc under mydriatic andnon-mydriatic conditions.P200TE is indicated forproducing high resolution,ultra-widefield, en facereflectance images,autofluorescence images,axial cross-sectionalimages, three-dimensionalimages, retinal layerboundary analysis, opticnerve head analysis andthickness maps.The P200TE includes aReference Database thatenables the results of OCTsegmentation analysis tobe compared to referencedata, including Full retinalthickness, Ganglion CellComplex thickness, RetinaNerve Fiber Layerthickness and Optic NerveHead metrics.The P200TE is indicated foruse as a device to aid in thedetection, diagnosis,documentation andmanagement of retinalhealth and diseases thatmanifest in the retina.	The iVue is a non-contact,high resolution tomographicimaging device. It is intendedfor in vivo imaging, axialcross-sectional, and three-dimensional imaging andmeasurement of anterior andposterior ocular structures,including retina, retinal nervefiber layer, ganglion cellcomplex (GCC), optic disc,cornea, and anterior chamberof the eye. The iVue withNormative Database is aquantitative tool for thecomparison of retina, retinalnerve fiber layer, ganglioncell complex, and optic discmeasurements to a databaseof known normal subjects.The iVue with NormativeDatabase is indicated for useas a device to aid in thediagnosis, documentation,and management of ocularhealth and diseases in theadult population.	The P200TE is a non-contact scanning laserophthalmoscope andoptical coherencetomographer. It isintended for in-vivoviewing, digital imaging,and analysis of posteriorocular structures,including the retina, retinalnerve fiber layer, ganglioncell complex (GCC) andoptic disc, under mydriaticand non-mydriaticconditions.It is indicated forproducing high resolution,ultra-widefield, en facereflectance images,autofluorescence images,axial cross-sectionalimages, three-dimensionalimages, retinal layerboundary analysis, opticnerve head analysis andthickness maps.The P200TE is indicatedfor use as a device to aidin the detection,diagnosis, documentationand management ofretinal health anddiseases that manifest inthe retina.
Product Code	MYC, OBO	HLI, OBO	MYC, OBO
RegulationNumber	21 CFR 886.1570	21 CFR 886.1570	21 CFR 886.1570
DeviceClassification	ll	ll	ll
Components	ScanheadHeadrest and chinrestPowered Table(separate)Computer	ScannerComputerControl boxFootswitch (optional)Joystick and chinrest	ScanheadHeadrest and chinrestPowered Table(separate)Computer
		assembly
SLO Technology Characteristics
Light Source	Laser	N/A	Laser
Wavelengthand Color ofLight	532nm ±5nm: green635nm ±5nm: red	N/A	532nm ±5nm: green635nm ±5nm: red
Laser Class	Class 1 to ISO 60825	N/A	Class 1 to ISO 60825
Numberoflasers usedper Scan	1 or 2	N/A	1 or 2
External Fieldof View	120°	N/A	120°
Internal Fieldof View	200°	N/A	200°
Wide AngleDigitized Image Size	3900x3072 pixels	N/A	3900x3072 pixels
Scan Patterns	2 axis scanner	N/A	2 axis scanner
Software	Embedded andApplication	N/A	Embedded andApplication
OCT Technology Characteristics
Method ofOperation	Spectral Domain OCT	Spectral Domain OCT	Spectral Domain OCT
Light Source	SLD 830-850nm SuperLuminescent DiodeNominal centerwavelength 840nm 50nmFHWM bandwidth782nm ±3nm: infra-red	SLD 830 nm to 850 nmSuper LuminescentDiode	SLD 830-850nmSuper LuminescentDiodeNominal centerwavelength 840nm50nm FHWMbandwidth782nm ±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 mirrorpair
Light SourceClassification	Class 1	Class 1	Class 1
TransverseResolution	20μm	15μm	20μm
AxialResolution	< 7µm	5µm	< 7µm
Transversescan range	5.28 mm to 12 mm	2 mm to 12 mm	5.28 mm to 12 mm
Scan Patterns	LineVolumeCircle	LineVolumeCircle	LineVolumeCircle
Depth Range(in tissue)	2.3mm	2.3mm	2.3mm
Acquisitiontime	≤2s	≤2s	≤2s
RetinalTracking	Yes	No	Yes

Ergonomics	Tabletop ScannerHeadrest and ChinrestTouchscreen & Handcontroller	Tabletop ScannerComputerControl boxFootswitch (optional)Joystick and chinrestassembly
Cleaning anddisinfection /sterilization	Sterilization not required.Clean/disinfect contact points	Sterilization notrequired. Clean/disinfect contact points
SafetyFeatures	Laser & SLD shutdown onlight source overpowerand/orincorrect functioning ofscanning elements	Halt to operation forstatus abnormality
Software	Embedded andApplication	Embedded andApplication
OperatingSystem	Linux (SLO)Windows (Application &OCT)	32 or 64 bit WindowsXP Pro. Ed./Win 7
OCT Analysis
Retinal Thickness
FullRetinalThickness	9 sector ETDRS	9 sector ETDRS
GCCThickness	Averaged;Fovea-centeredHemifields	Averaged;Temporally OffsetHemifields
Optic Disc Analysis
RNFLperipapillary	Averaged, Quads, TSNIT	Averaged, quads,TSNIT
Disc area	Yes	Yes
Rim area	Yes - reference planemodel	Yes - fixed offsetmodel
C/D area	Yes	Yes
C/D horizontalratio	Yes	Yes
C/Dverticalratio	Yes	Yes
OCT Reference Database
Method	Non-Parametricbased reference database	Regression basednormative database
Cohort	860 subjects, age range22-84 years	458 subjects, agerange 18-82 years
RDBPresentationScheme	Cut-off values of 1%,5%, 95%, and 99% areused to color-coderesults	Cut-off values of 1%,5%, 95%, and 99%are used to color-coderesults

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P200TE 510(k) Summary K233602 Optos Plc

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Table 2: The physical principles of operation for each modality, consistent with the predicate device P200TE

Modality	Imaging mode	Physicalprinciple	Output	Use scenario
Reflectanceimaging(SLO)	Optomap UWFcomposite Red /Green retinalimagingOptomap/Optomapplus resolutionmodes	Point by pointmapping ofreflected lightintensity frommulti-channellaser incidenton retina.	2D image ofthe retina.	To enable UWFvisualization andquantitative assessment ofthe retina, choroid, opticnerve head and nerve fiberlayer when viewed in acompatible DICOM viewer.
Fluorescenceimaging(SLO)	Optomap UWFAuto-Fluorescence(AF) imagingOptomap/Optomapplus resolutionmodes	Point by pointmapping offluorescencelight intensityfrom multi-channel laserincident onretina.	2D image ofthe retina.AF relies onnaturalfluorophorespresent inretina.	To enable UWFvisualization andquantitative assessment ofthe health of the cells whenviewed in a compatibleDICOM viewer. Areas ofHypo and Hyperfluorescence are used bypractitioners to assess themetabolism of the eye.
OpticalCoherenceTomography(OCT)	Central PosteriorOCT Imaging	Point by pointmapping ofback-scatteredlight intensity,resolved in theaxial directionthroughcoherencegating.Coherencegating isachievedthrough low-coherenceinterferometry.Low coherencelight is incidenton the retina foraxial mapping.	2D axial crosssection (B-scan) or 3Dvolume (C-scan) of retina.Providesstructuralinformation ofretina in theaxial andtransversedirection	To support investigation ofanomalies found in the SLORG or AF, and to broadlyassess the health at theMacula and through theONH.Providing 3D structuralinformation in the macularand ONH regions, throughsingle scans or acombination ofscans.For use inconjunction with Red-Greenand Auto FluorescenceSLO images to assess eyehealth

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Image /page/12/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 a combination of light blue and dark blue, with the dark blue forming the pupil. There is a registered trademark symbol next to the "s" in "optos".

7. Summary of Studies

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 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
. IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1.2: General requirements for safety - collateral standard: Electromagnetic compatibility -Requirements and tests
. IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification and requirements

Safety Calculations are also provided with reference to ANSI Z80.36-2021 Ophthalmics -Light Hazard Protection for Ophthalmic Instruments.

Sterility, Shelf-Life, Biocompatibility and Animal Testing was not required for this submission.

Software verification and validation has been conducted in accordance with QMS processes and documentation has been provided with this submission.

All testing has passed with no additional safety or performance concerns raised.

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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. Measurements within the 5-95% are considered 'within normal limits' and colored green for easy interpretation.

. RNFL. GCC. and ONH Rim measurements: Values below the 5% are considered 'borderline' and colored amber for easy interpretation, and values below the 1% are considered 'outside normal limits' and colored red.
. ONH C/D parameters: Values above the 95% level are colored amber and values above the 99% level are colored red.
FRT measurements: Values below 5% are colored light blue and values below 1% ● are colored dark blue while values above the 95% level are colored amber and values above the 99% level are colored 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. The small, medium, and large optic disc groups were used to take into account the influence of disc size on these measurements.

In total. 879 eves 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 (due to the large effect of optic disc size on these measurements). For eyes with small optic disc area < 1.76 mm2), the final number included in the RNFL analysis was 279, and the final number in the ONH analysis was 284. For eyes with medium optic discs (disc area between 1.76 mm2 and 2.15 mm2), the final number included in the RNFL analysis was 320, and the final number in the ONH analysis was 321. For eyes with large optic discs (disc area > 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.

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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)

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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

						Percentiles and 90% Cls
Parameter	N(populationsize)	n (non-missingsample size)	Mean (95% CI ofMean)	StandardDeviation	Median (Min, Max)	1st percentile	5th percentile	95th percentile	99th percentile
Central FovealThickness	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 ParafovealThickness	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 ParafovealThickness	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 ParafovealThickness	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 ParafovealThickness	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 PerifovealThickness	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 PerifovealThickness	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 PerifovealThickness	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 PerifovealThickness	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

						Percentiles and 90% Cls
Parameter	N(populationsize)	n (non-missingsample size)	Mean (95% CI ofMean)	StandardDeviation	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)
SuperiorHemiretina	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)
InferiorHemiretina	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

							Percentiles and 90% Cls
Parameter	OpticDiscSize	N(populationsize)	n (non-missingsample size)	Mean (95% Clof Mean)	StandardDeviation	Median (Min.Max)	1st percentile	5th percentile	95th percentile	99th percentile
Average RNFL ThicknessOver TSNIT Circle	Small opticdisc	879	279	106.46 (105.17107.74)	10.892	106.39 (69.03,133.00)	80.21 (69.0384.23)	88.75 (84.82)90.29)	123.69 (122.12127.36	131.50 (129.16.133.00)
	Mediumoptic disc	879	320	112.02 (110.82113.22	10.905	112.49 (76.48)150.30)	85.95 (76.48)89.31)	95.04 (90.46)96.57)	129.77 (126.84135.14)	138.91 (136.22150.30)
	Large opticdisc	879	254	113.85 (112.39)115.30)	11.802	113.90 (81.54)147.45)	84.94 (81.5491.80)	94.69 (92.26)96.93)	134.91 (130.76.137.14)	141.23 (138.05.147.45)
Temporal Quadrant RNFLOver TSNIT Circle	Small opticdisc	879	279	86.02 (84.4487.61)	13.458	84.08 (58.57140.45)	60.43 (58.5765.23)	68.10 (65.62.69.06)	110.48 (107.24.115.73)	125.88 (117.33)140.45)
	Mediumoptic 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 opticdisc	879	254	85.05 (83.68)86.43)	11.095	83.14 (63.77121.46)	64.13 (63.7766.04)	69.33 (66.06)71.12)	105.56 (101.74108.42)	114.64 (108.49)121.46)
Superior Quadrant RNFLOver TSNIT Circle	Small opticdisc	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 (148.94160.52)	169.49 (161.46.194.77)
	Mediumoptic 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 (156.25167.04)	175.92 (167.98,191.32)
	Large opticdisc	879	254	134.30 (132.13.136.47)	17.534	133.70 (89.95)180.56)	98.81 (89.95101.16)	104.19 (101.29)109.02)	165.15 (161.79.170.74)	175.46 (171.56,180.56)
Inferior Quadrant RNFL OverTSNIT Circle	Small opticdisc	879	279	133.68 (131.54135.82)	18.168	135.09 (57.76178.33)	78.52 (57.76.96.861	103.68 (97.59)107.12)	162.16 (158.33171.79)	175.59 (171.81,178.33)
	Mediumoptic disc	879	320	141.73 (139.84143.63)	17.204	142.58 (90.98)206.53)	97.91 (90.98)101.85)	112.68 (106.12,116.40)	168.23 (164.27176.26)	185.34 (180.42206.53)
	Large opticdisc	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 OverTSNIT Circle	Small opticdisc	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 (103.97116.10)	124.93 (116.37)128.37)

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							Percentiles and 90% Cls
Parameter	OpticDiscSize	N(populationsize)	n (non-missingsample size)	Mean (95% Cl ofMean)	StandardDeviation	Median (Min.Max)	1st percentile	5th percentile	95th percentile	99th percentile
ONH: C/DVertical	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 opticdisc	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/DHorizontal	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 opticdisc	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 opticdisc	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 opticdisc	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.

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.