P200TxE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 31, 2019 Optos Plc Ms. Rachel Reay Regulatory Specialist Queensferry House, Carnegie Campus, Enterprise Way Dunfermline, KY11 8GR GB Re: K190732 Trade/Device Name: P200TxE Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: June 18, 2019 Received: June 19, 2019 Dear Ms. Reay: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems. 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/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. for Bradley Cunningham, MSE, RAC Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K190732 Device Name P200TxE Indications for Use (Describe) The P200TxE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina, retinal layers, optic disc, choroido-scleral interface. It is indicated for producing highresolution, wide field, en-face reflectance images, auto fluorescence images, fluorescein angiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures. The system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions. Type of Use (Select one or both, as applicable) 図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 ## Optos Plc's P200TxE Optos Plc Queensferry House Carnegie Campus Enterprise Way, Dunfermline, Scotland, UK KY11 8GR | Phone: | 0044 1383 843300 | |----------------------|-----------------------------------------------------------------------------------------------------| | Facsimile: | 0044 1383 843333 | | Contact Person: | Rachel Reay, Regulatory Specialist (rreay@optos.com) | | Date Prepared: | 20th March 2019 | | Name of Device | P200TxE | | Common or Usual Name | Optical Coherence Tomographer and Scanning Laser Ophthalmoscope | | Classification Name | Scanning laser ophthalmoscope (21 CFR §866.1570) | | Regulatory Class | Class II | | Product Code | OBO/MYC | | Predicate Devices | Primary: P200TE 'Monaco' (Optos Plc K173707)<br>Secondary: P200DTx 'California' (Optos Plc K142897) | ## Device Description P200TxE is a desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography. The device is intended to be used by ophthalmic and optometry health care professionals, most commonly in a hospital environment. {4}------------------------------------------------ ## K190732 The P200TxE delivers images in the following image modes: - 0 Scanning Laser Ophthalmoscopy - o Red and green reflectance - o Green-pumped autofluorescence - Fluorescein Angiography o - o Indo-Cyanine Green Angiography - Optical Coherence Tomography . The P200TxE 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 P200TxE instrument uses green laser illumination to excite autofluorescence (AF) emission from the naturally occurring lipofuscin in the human fundus. The P200TxE 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 P200TxE instrument uses infrared swept-source laser illumination for optical coherence tomography allowing a depth profile of the reflectance of the human fundus to be recorded. The P200TxE instrument uses blue laser illumination to excite emission from Sodium Fluorescein dye which is injected into the patient's bloodstream in a separate medical procedure as part of a Fluorescein angiography (FA) examination. The P200TxE instrument uses Infra-red (IR) laser illumination to excite emission from Indocyanine Green dye which is injected into the patient's bloodstream in a separate medical procedure as part of an Indocyanine Green anqiography (ICG) examination. Images can be reviewed through OptosAdvance review software (K162039) either on the image server, or on individual review stations, or other DICOM compliant PACS viewers. ## Intended Use / Indications for Use, P200TxE The P200TxE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina, retinal lavers, optic disc, choroido-scleral interface. It is indicated for producing high-resolution, wide field, en-face reflectance images, auto fluorescence images, fluorescein anqiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures. The system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions. {5}------------------------------------------------ ## K190732 Summary of Technological Characteristics The P200TxE, like the P200TE and P200DTx, 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 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. The P200TxE refers to the scanhead component of the system, together with touchscreen and hand controller. It is supported by an image server, which delivers patient management and image storage, as well as interfacing with the business systems and hospital 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 PC's 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. Technological implementation of Fluorescein Angiography and Indocvanine Green Angiography imaging is identical between P200TxE and P200DTx. P200TxE incorporates a swept-source light source to divide wavelengths temporally, while the P200TE incorporates a superluminescent diode (SLD) light source and a splitter to divide wavelengths spatially. Though the methods used to divide wavelengths are different, both are based on optical interference principles, and both spectral domain and swept-source OCT are generally thought to fall under the umbrella classification of Fourier Domain OCT. OCT safety and effectiveness has been demonstrated through bench and clinical testing. ## Substantial Equivalence to predicate devices Both P200TxE and P200TE are non-contact scanning laser ophthalmoscope and optical coherence tomographers intended for in-vivo digital imaging of posterior ocular structures. In other words, the P200TxE has the same intended use its predicate device. Thus, the P200TxE satisfies the first criterion for a finding of substantial equivalence. The P200TxE has all the same indications for use as P200TE. Additionally it includes FA and ICG fluorescence angiography imaging functionality, present in the second predicate device, P200DTx. With the exception of the upgrade to the OCT engine described above, P200TxE contains all the operational components of both the P200TE and P200DTx. All three devices are operated by touchscreen and hand controller. GUIs are presented to the user with branding and presentation styles consistent across the Optos range of devices. A table comparing the key features of the subject and predicate devices is provided below: {6}------------------------------------------------ # K190732 510(k) Summary Substantial Equivalence Chart | Device | OPTOS P200TXE | OPTOS P200TE | OPTOS P200DTx | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)<br>Number | --- | K173707 | K142897 | | Indications For<br>Use | The P200TXE is a non-<br>contact scanning laser<br>ophthalmoscope and optical<br>coherence tomographer<br>intended for in-vivo digital<br>imaging of posterior ocular<br>structures, including the<br>vitro-retinal interface, retina,<br>retinal layers, optic disc,<br>choroid and choroido-scleral<br>interface. It is indicated for<br>producing high-resolution,<br>wide field, en-face<br>reflectance images, auto<br>fluorescence images,<br>fluorescein angiography<br>images, indocyanine green<br>angiography images, and<br>axial cross-sectional images<br>of the posterior ocular<br>structures.<br>The system enables<br>practitioners to capture multi-<br>modal images in support of<br>detection, investigation and<br>monitoring of retinal<br>conditions. | 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 P200DTx scanning laser<br>ophthalmoscope is indicated<br>for use as a widefield and<br>retinal 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<br>also indicated for use as a<br>widefield scanning laser<br>ophthalmoscope for viewing<br>choroidal circulation patterns<br>that are illuminated using<br>Indocyanine Green dye and<br>for aiding in both the<br>assessment of choroidal<br>circulation and in the<br>diagnosis of choroiditis or<br>choroidal diseases. | | Product Code | MYC, OBO | MYC, OBO | MYC | | Regulation<br>Number | 21 CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 | | Device<br>Classification | II | II | II | | Components | Scanhead<br>Headrest and chinrest<br>Powered Table (separate)<br>Computer | Scanhead<br>Headrest and chinrest<br>Powered Table (separate)<br>Computer | Scanhead<br>Headrest and chinrest<br>Powered Table (separate)<br>Computer | | SLO Technology characteristics | | | | | Light Source | Laser | Laser | Laser | | Wavelength<br>and Color of<br>Light | 488nm: blue<br>532nm: green<br>635nm: red<br>802nm: infra-red | 532nm: green<br>635nm: red | 488nm: blue<br>532nm: green<br>635nm: red<br>802nm: infra-red | | Laser Class | Class 1 to ISO 60825 | Class 1 to ISO 60825 | Class 1 to ISO 60825 | | Number<br>of<br>lasers<br>used<br>per Scan | 1 or 2 | 1 or 2 | 1 or 2 | | External<br>Field<br>of View | 120° | 120° | 120° | | Internal<br>Field<br>of View | 200° | 200° | 200° | | Wide Angle<br>Digitized<br>Image Size | 3900x3072 pixels | 3900x3072 pixels | 3900x3072 pixels | | Scan Patterns | 2 axis scanner | 2 axis scanner | 2 axis scanner | | Software | Embedded and Application | Embedded and Application | Embedded and Application | | OCT Technology characteristics | | | | | Method<br>of<br>Operation | SS-OCT<br>(Low coherence<br>interferometry with<br>wavelength sweeping<br>source) | SD-OCT<br>(Low coherence interferometry<br>with fixed source) | N/A | | Light Source | Swept source laser<br>Centre wavelength 1050 +/- 10 nm<br>With wavelength sweep<br>range - 100 nm<br>Tracking 802 nm laser | SLD 830nm Super<br>Luminescent Diode<br>SLD 828 to 837nm centre<br>wavelength with >15nm<br>FHWM bandwidth<br>782nm ±3nm: infra-red | N/A | | Scan Rate | 100,000 A-scans/s | 70,000 A-scans/s | N/A | | Scanner Type | Galvanometric mirror pair | Galvanometric mirror pair | N/A | | Light Source<br>Classification | Class 1 | Class 1 | N/A | | Lateral<br>Resolution | 20μm | 20μm | N/A | | Axial<br>Resolution | < 7µm | < 10μm | N/A | | Field of View | 48 degrees x 30 degrees<br>20 x 20 Navigated<br>(degrees within UWF<br>addressable image)<br>80 degree Extended OCT<br>Line | 40 degrees x 30 degrees | N/A | | Scan Patterns | Line<br>Volume | Line<br>Volume<br>Circle | N/A | | Depth Range<br>(in air) | >3.5mm | 2.5mm | N/A | | Acquisition<br>time | ≤3s | ≤2s | N/A | | Retinal<br>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>Touchscreen & Hand controller | Tabletop Scanner<br>Headrest and Chinrest<br>Touchscreen & Hand<br>controller | | Cleaning and<br>disinfection /<br>sterilization | Sterilization not required.<br>Clean/<br>disinfect contact points | Sterilization not required.<br>Clean/<br>disinfect contact points | Sterilization not required.<br>Clean/<br>disinfect contact points | | Safety<br>Features | Laser & SweptSource<br>shutdown on light source<br>overpower and/or<br>incorrect functioning of<br>scanning elements | Laser & SLD shutdown on light<br>source overpower and/or<br>incorrect functioning of<br>scanning elements | Laser shutdown on laser<br>overpower<br>and/or incorrect functioning of<br>scanning elements | | Software…