P200TE (A10700)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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<br>Queensferry House<br>Carnegie Campus<br>Enterprise Way<br>Dunfermline, Fife<br>Scotland, UK<br>KY11 8GR | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Primary Correspondent | Graham McLeod<br>Sr. Director of Regulatory Affairs, Optos Plc<br>Tel: 0044 1383 843300<br>E-mail: RA@optos.com (preferred) | | Secondary Correspondent | Rachel Reay<br>Sr. Regulatory Specialist, Optos Plc<br>Tel: 0044 1383 843300<br>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 | {5}------------------------------------------------ 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. {8}------------------------------------------------ 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<br>segmentation and RDB | Optovue iVue | OPTOS P200TE with<br>segmentation | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)<br>Number | K233602 | K121739<br>(Primary predicate) | K231673 | | Indications For<br>Use | The P200TE is a non-<br>contact scanning laser<br>ophthalmoscope and<br>optical coherence<br>tomographer. It is intended<br>for invivo viewing, digital<br>imaging, and measurement<br>of posterior ocular<br>structures, including the<br>retina, retinal nerve fiber<br>layer, ganglion cell<br>complex (GCC) and optic<br>disc under mydriatic and<br>non-mydriatic conditions.<br>P200TE is indicated for<br>producing high resolution,<br>ultra-widefield, en face<br>reflectance images,<br>autofluorescence images,<br>axial cross-sectional<br>images, three-dimensional<br>images, retinal layer<br>boundary analysis, optic<br>nerve head analysis and<br>thickness maps.<br>The P200TE includes a<br>Reference Database that<br>enables the results of OCT<br>segmentation analysis to<br>be compared to reference<br>data, including Full retinal<br>thickness, Ganglion Cell<br>Complex thickness, Retina<br>Nerve Fiber Layer<br>thickness and Optic Nerve<br>Head metrics.<br>The P200TE is indicated for<br>use as a device to aid in the<br>detection, diagnosis,<br>documentation and<br>management of retinal<br>health and diseases that<br>manifest in the retina. | The iVue is a non-contact,<br>high resolution tomographic<br>imaging device. It is intended<br>for in vivo imaging, axial<br>cross-sectional, and three-<br>dimensional imaging and<br>measurement of anterior and<br>posterior ocular structures,<br>including retina, retinal nerve<br>fiber layer, ganglion cell<br>complex (GCC), optic disc,<br>cornea, and anterior chamber<br>of the eye. The iVue with<br>Normative Database is a<br>quantitative tool for the<br>comparison of retina, retinal<br>nerve fiber layer, ganglion<br>cell complex, and optic disc<br>measurements to a database<br>of known normal subjects.<br>The iVue with Normative<br>Database is indicated for use<br>as a device to aid in the<br>diagnosis, documentation,<br>and management of ocular<br>health and diseases in the<br>adult population. | The P200TE is a non-<br>contact scanning laser<br>ophthalmoscope and<br>optical coherence<br>tomographer. It is<br>intended for in-vivo<br>viewing, digital imaging,<br>and analysis of posterior<br>ocular structures,<br>including the retina, retinal<br>nerve fiber layer, ganglion<br>cell complex (GCC) and<br>optic disc, under mydriatic<br>and non-mydriatic<br>conditions.<br>It is indicated for<br>producing high resolution,<br>ultra-widefield, en face<br>reflectance images,<br>autofluorescence images,<br>axial cross-sectional<br>images, three-dimensional<br>images, retinal layer<br>boundary analysis, optic<br>nerve head analysis and<br>thickness maps.<br>The P200TE is indicated<br>for use as a device to aid<br>in the detection,<br>diagnosis, documentation<br>and management of<br>retinal health and<br>diseases that manifest in<br>the retina. | | Product Code | MYC, OBO | HLI, OBO | MYC, OBO | | Regulation<br>Number | 21 CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 | | Device<br>Classification | ll | ll | ll | | Components | Scanhead<br>Headrest and chinrest<br>Powered Table<br>(separate)<br>Computer | Scanner<br>Computer<br>Control box<br>Footswitch (optional)<br>Joystick and chinrest | Scanhead<br>Headrest and chinrest<br>Powered Table<br>(separate)<br>Computer | | | | assembly | | | SLO Technology Characteristics | | | | | Light Source | Laser | N/A | Laser | | Wavelength<br>and Color of<br>Light | 532nm ±5nm: green<br>635nm ±5nm: red | N/A | 532nm ±5nm: green<br>635nm ±5nm: red | | Laser Class | Class 1 to ISO 60825 | N/A | Class 1 to ISO 60825 | | Number<br>of<br>lasers used<br>per Scan | 1 or 2 | N/A | 1 or 2 | | External Field<br>of View | 120° | N/A | 120° | | Internal Field<br>of View | 200° | N/A | 200° | | Wide Angle<br>Digitized Image Size | 3900x3072 pixels | N/A | 3900x3072 pixels | | Scan Patterns | 2 axis scanner | N/A | 2 axis scanner | | Software | Embedded and<br>Application | N/A | Embedded and<br>Application | | OCT Technology Characteristics | | | | | Method of<br>Operation | Spectral Domain OCT | Spectral Domain OCT | Spectral Domain OCT | | Light Source | SLD 830-850nm Super<br>Luminescent Diode<br>Nominal center<br>wavelength 840nm 50nm<br>FHWM bandwidth<br>782nm ±3nm: infra-red…