P200TE

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February 28, 2018 Optos plc Geoff Fatzinger VP of Global Regulatory Affairs Oueensferry House, Carnegie Business Campus, Dunfermline, KY118GR Gb Re: K173707 Trade/Device Name: P200TE Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HLI, MYC Dated: November 29, 2017 Received: December 4, 2017 Dear Geoff Fatzinger: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely yours, # Bradley S. Cunningham -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173707 Device Name P200TE Indications for Use (Describe) The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retinal nerve fiber layer and optic disc. It is indicated for producing high-resolution, widefield, en face reflectance images, autofluorescence images, and axial, crosssectional images of the posterior ocular structures. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {3}------------------------------------------------ #### 510(k) Summary This summary of the 510(k) premarket notification for the Optos P200TE is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR\$807.92. Date Prepared: February 20, 2018 ### SPONSOR/ 510(k) OWNER/ MANUFACTURER Optos plc Queensferry House Carnegie Campus Enterprise Way Dunfermline Scotland KY11 8GR United Kingdom ### CONTACT PERSON Geoff Fatzinger Optos plc Vice President of Regulatory Ph - +44 (0)7741 312633 Email - gfatzinger@optos.com # NAME OF DEVICE Model Number: P200TE Classification Name: Tomography, Optical Coherence Ophthalmoscope ### DEVICE CLASSIFICATION Class II A/C Powered Ophthalmoscope # PRODUCT CODE: CLASSIFICATION / CFR TITLE OBO, HLI / 21 CFR 886.1570 ### PREDICATE DEVICES Primary Predicate: Optos Spectral OCT/SLO (K080460) Secondary Predicate: Optos P200DTx (K142897) # INDICATIONS FOR USE The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular {4}------------------------------------------------ structures, including the retina, retinal nerve fiber layer and optic disc. It is indicated for producing high-resolution, widefield, en face reflectance images, autofluorescence images, and axial, cross-sectional images of the posterior ocular structures. # PRODUCT DESCRIPTION The P200TE is based on Scanning Laser Ophthalmoscope (SLO) technology which scans in two dimensions over the retina. Light reflected from the retina is detected and transformed into a digital image. Images may be stored and subsequently reviewed. The P200TE allows images to be captured in the following imaging modes: - · Reflectance imaging - Autofluorescence imaging - · Optical coherence tomography imaging 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 laver, 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 human fundus. The P200TE instrument uses infrared laser illumination for reflectance imaging simultaneously with OCT imaging. Infra-red reflectance images are used to track eye position during OCT imaging and are not available to the user. The P200TE instrument uses infrared superluminescent diode (SLD) illumination for optical coherence tomography allowing a depth profile of the reflectance of the human fundus to be recorded. 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 {5}------------------------------------------------ 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. This is operationally installed to be networked with computer peripherals and proprietary software that facilitate the storage, management and viewing of the retinal images. 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 PC's are connected 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. #### SUBSTANTIAL EQUIVALENCE The company's P200TE is substantially equivalent to the Optos Spectral OCT/SLO cleared in K080460 with additional equivalence to the Optos P200DTx cleared in K142897. As explained in more detail below, the P200TE has the same intended use and similar principles of operation and technological characteristics as the previously cleared predicate devices. See the table below for a substantial equivalence chart comparing the relevant similarities and differences between the P200TE and its predicates: | Device | OPTOS P200TE | Primary: Spectral OCT/SLO | Secondary: OPTOS P200DTx | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)<br>Number | K173707 | K080460 | K142897 | | Indications<br>For Use | The P200TE is a non-contact<br>scanning laser<br>ophthalmoscope and optical<br>coherence tomographer<br>intended for in-vivo viewing<br>and digital imaging of<br>posterior ocular structures,<br>including the retina, retinal<br>nerve fiber layer and optic<br>disc. It is indicated for<br>producing high-resolution,<br>widefield, en face reflectance<br>images, autofluorescence<br>images, and axial, cross-<br>sectional images of the<br>posterior ocular structures. | The Spectral OCT/SLO is a<br>non-contact, high-resolution<br>non-invasive tomographic and<br>confocal imaging device.<br>It is indicated for in vivo<br>viewing, axial cross-sectional,<br>and three-dimensional<br>imaging and measurement of<br>posterior ocular structures<br>including: retina, macula,<br>retina nerve fibre layer and<br>optic disk. It is used as a<br>diagnostic device to aid in the<br>detection and management of<br>ocular diseases affecting the<br>posterior segment of the eye.<br>In addition, cornea, sclera and<br>conjunctiva can be imaged<br>with the system by changing<br>the focal position. | The P200DTx scanning laser<br>ophthalmoscope is indicated for<br>use as a widefield and retinal<br>fluorescence and<br>autofluorescence imaging<br>ophthalmoscope to aid in the<br>diagnosis and monitoring of<br>diseases and disorders that<br>manifest in the retina. It is also<br>indicated for use as a widefield<br>scanning laser ophthalmoscope<br>for viewing choroidal<br>circulation patterns that are<br>illuminated using Indocyanine<br>Green dye and for aiding in<br>both the assessment of<br>choroidal circulation and in the<br>diagnosis of choroiditis or<br>choroidal diseases. | | Product Code | HLI, OBO | OBO | MYC | | Regulation<br>Number | 21 CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 | | Device<br>Classification | II | II | II | | Components | Scan head<br>Headrest and chinrest<br>Powered Table (separate)<br>Computer | Scan head<br>Headrest and chinrest<br>Powered Table Computer | Scanhead<br>Headrest and chinrest<br>Powered Table (separate)<br>Computer | | Compliance<br>Standards | ANSI/AAMI ES60601-1, -<br>1-2, ISO 15004-2, IEC<br>60825-1 | IEC 60601-1, -1-2, ISO 10993 | IEC 60601-1, -1-2, ISO 10993, ISO 15004-2, IEC<br>60825 | | SLO Technology Characteristics | | | | | Light Source | Laser | N/A | Laser | | Wavelength and<br>Color of Light | 532nm: green<br>635nm: red | N/A | 488nm: blue<br>532nm: green<br>635nm: red<br>802nm: infra-red | | Laser Class | Class 1 to ISO 60825 | N/A | Class 1 to ISO 60825 | | Number of<br>lasers used per<br>Scan | 1 or 2 | N/A | 1 or 2 | | External Field of<br>View | 120° | N/A | 120° | | Internal Field of<br>View | 200° | N/A | 200° | | Wide Angle<br>Digitized<br>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<br>Operation | SD-OCT<br>(Low coherence<br>interferometry with fixed<br>source) | SD-OCT<br>(Low coherence<br>interferometry with fixed<br>source) | N/A | | Light Source | SLD 830nm Super<br>Luminescent Diode<br>782nm: infra-red | SLD 830nm Super<br>Luminescent Diode<br>782nm: infra-red | N/A | | Scan Rate | 70,000 A-scans/s | up to 27,000 A-scan/s | N/A | | Scanner Type | Galvanometric mirror pair | Galvanometric mirror pair | N/A | | Light Source<br>Classification | Class 1 | Class 1 | N/A | | Optical Power | ≤ 750µW at Cornea | ≤ 750µW at Cornea | N/A | | Lateral<br>Resolution | 20μm | 20μm | N/A | | Axial Resolution | < 10μm | < 10μm | N/A | | Field of View | 12mm x 9mm (40 degrees x<br>30 degrees) | 9mm x 9mm (30 degrees x 30<br>degrees) | N/A | | Scan Patterns | Line Scan<br>Raster Scan<br>Retina Topography Scan<br>Optic Nerve Head<br>Topography Scan | Line Scan<br>Raster Scan<br>Retina Topography Scan<br>Optic Nerve Head Topography<br>Scan | N/A | | | | | | | | Optic Nerve Head RNFL<br>Ring Scan | Optic Nerve Head RNFL Ring<br>Scan | | | | | Radial Scan | | | Quantitative<br>parameters | None | Retinal thickness analysis<br>Nerve Fibre thickness analysis<br>Optic Nerve Head analysis | N/A | | Depth Range (in<br>air) | 2.5mm | 1.7 -2.3mm | N/A | | Scan Pixels | Axial (depth) 1024<br>Lateral 1024 | Axial (depth) 1024<br>Lateral 1024 | N/A | | Acquisition time | ≤2s | ≤2s | N/A | | Retinal Tracking | Yes | Yes | N/A | | General | | | | | Ergonomics | Tabletop Scanner<br>Headrest and Chinrest<br>Touchscreen & Hand<br>controller | Tabletop Scanner<br>Headrest and Chinrest<br>Computer | Tabletop Scanner<br>Headrest and Chinrest<br>Touchscreen & Hand<br>controller | | Cleaning and<br>disinfection/<br>sterilization | Sterilization not required.<br>Clean/disinfect contact<br>points | Sterilization not required.<br>Clean/disinfect contact points…