(86 days)
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, cross-sectional images of the posterior ocular structures.
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 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 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 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.
The provided text focuses on establishing substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance metrics. However, it does describe a clinical study conducted to demonstrate the device's similarity to its predicate for qualitative clinical use.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for device performance. Instead, the "acceptance criteria" for the study were implicitly tied to demonstrating non-inferiority and similarity in image quality for qualitative clinical use compared to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image quality for qualitative clinical use is similar between P200TE and Spectral OCT/SLO. | - Wilcoxon signed-rank test analyses showed non-inferiority for image quality between P200TE and Spectral OCT/SLO. - Linearly weighted Cohen's kappa analyses showed adequate inter-grader agreement in scoring. - Results "showed that the image quality for purposes of qualitative clinical use are similar between the P200TE and the Spectral OCT/SLO." |
| Compliance with recognized consensus standards (Non-Clinical) | - P200TE complied with ISO 15004-2:2007 (Light hazard protection), IEC60825-1 (Safety of Laser Products), and IEC 62366 (Usability engineering). - Results of bench testing demonstrated compliance with relevant recognized consensus standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 35 participants (32 study eyes).
- Data Provenance: Prospective, observational study at a single U.S. clinical site.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three independent, masked graders.
- Qualifications of Experts: The document does not specify the exact qualifications (e.g., "radiologist with 10 years of experience"). However, they were referred to as "graders" at a "third-party reading center" and "qualitatively evaluated the images based on pre-specified grading criteria... for qualitative clinical use," suggesting they were likely ophthalmologists, optometrists, or trained image graders with expertise in ocular imaging.
4. Adjudication Method for the Test Set
- The document states that "three independent, masked graders qualitatively evaluated the images." It then notes that "The grading results from the two devices were then compared using one-tailed Wilcoxon signed-rank test analyses... and linearly weighted Cohen's kappa analyses."
- The use of "independent" graders and the subsequent statistical comparison (including inter-grader agreement with kappa) suggests a consensus or comparison approach, rather than a strict 2+1 or 3+1 adjudication rule where disagreements are explicitly resolved by a third party. The primary goal was to assess agreement and similarity across graders and between devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Yes, a form of MRMC study was conducted. Three independent graders evaluated images from both the P200TE and the predicate device (Spectral OCT/SLO) across multiple cases (32 study eyes from 35 participants).
- Effect Size of Human Readers' Improvement with AI vs. without AI Assistance: This information is not applicable/not provided. The study described is a comparison of two imaging devices (P200TE vs. Spectral OCT/SLO) in terms of image quality for qualitative clinical use, not an AI-assisted interpretation study. The P200TE is an imaging device, not an AI algorithm designed to improve human reading.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable/not provided. The P200TE is an ophthalmoscope and optical coherence tomographer, a diagnostic imaging device. Its performance is assessed in terms of image quality for human interpretation, not as a standalone algorithm performing automated detection or diagnosis.
7. Type of Ground Truth Used
- The ground truth for the qualitative evaluation of image quality was established by expert assessment/consensus based on "pre-specified grading criteria... based on the presence or absence of clinically relevant structures and anatomic boundaries and on the overall image clarity necessary for qualitative clinical use."
- The "truth" for the study was not about disease presence (e.g., pathology, outcomes data) but rather the quality of the images produced by the device as judged by experts.
8. Sample Size for the Training Set
- Not provided/not applicable. The P200TE is an imaging device (hardware and embedded software) for image acquisition, not an AI model that requires a training set of images for learning. The document describes clinical validation of the device's output, not the development of a trained algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not provided/not applicable. As mentioned above, this device is not an AI model that underwent a training phase on a labeled dataset. The study focused on validating the image quality of the P200TE compared to its predicate for human interpretation.
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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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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
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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) |
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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
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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
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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)Number | K173707 | K080460 | K142897 |
| IndicationsFor Use | The P200TE is a non-contactscanning laserophthalmoscope and opticalcoherence tomographerintended for in-vivo viewingand digital imaging ofposterior ocular structures,including the retina, retinalnerve fiber layer and opticdisc. It is indicated forproducing high-resolution,widefield, en face reflectanceimages, autofluorescenceimages, and axial, cross-sectional images of theposterior ocular structures. | The Spectral OCT/SLO is anon-contact, high-resolutionnon-invasive tomographic andconfocal imaging device.It is indicated for in vivoviewing, axial cross-sectional,and three-dimensionalimaging and measurement ofposterior ocular structuresincluding: retina, macula,retina nerve fibre layer andoptic disk. It is used as adiagnostic device to aid in thedetection and management ofocular diseases affecting theposterior segment of the eye.In addition, cornea, sclera andconjunctiva can be imagedwith the system by changingthe focal position. | The P200DTx scanning laserophthalmoscope is indicated foruse as a widefield and retinalfluorescence andautofluorescence imagingophthalmoscope to aid in thediagnosis and monitoring ofdiseases and disorders thatmanifest in the retina. It is alsoindicated for use as a widefieldscanning laser ophthalmoscopefor viewing choroidalcirculation patterns that areilluminated using IndocyanineGreen dye and for aiding inboth the assessment ofchoroidal circulation and in thediagnosis of choroiditis orchoroidal diseases. |
| Product Code | HLI, OBO | OBO | MYC |
| RegulationNumber | 21 CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 |
| DeviceClassification | II | II | II |
| Components | Scan headHeadrest and chinrestPowered Table (separate)Computer | Scan headHeadrest and chinrestPowered Table Computer | ScanheadHeadrest and chinrestPowered Table (separate)Computer |
| ComplianceStandards | ANSI/AAMI ES60601-1, -1-2, ISO 15004-2, IEC60825-1 | IEC 60601-1, -1-2, ISO 10993 | IEC 60601-1, -1-2, ISO 10993, ISO 15004-2, IEC60825 |
| SLO Technology Characteristics | |||
| Light Source | Laser | N/A | Laser |
| Wavelength andColor of Light | 532nm: green635nm: red | N/A | 488nm: blue532nm: green635nm: red802nm: infra-red |
| Laser Class | Class 1 to ISO 60825 | N/A | Class 1 to ISO 60825 |
| Number oflasers used perScan | 1 or 2 | N/A | 1 or 2 |
| External Field ofView | 120° | N/A | 120° |
| Internal Field ofView | 200° | N/A | 200° |
| Wide AngleDigitizedImage 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 ofOperation | SD-OCT(Low coherenceinterferometry with fixedsource) | SD-OCT(Low coherenceinterferometry with fixedsource) | N/A |
| Light Source | SLD 830nm SuperLuminescent Diode782nm: infra-red | SLD 830nm SuperLuminescent Diode782nm: 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 SourceClassification | Class 1 | Class 1 | N/A |
| Optical Power | ≤ 750µW at Cornea | ≤ 750µW at Cornea | N/A |
| LateralResolution | 20μm | 20μm | N/A |
| Axial Resolution | < 10μm | < 10μm | N/A |
| Field of View | 12mm x 9mm (40 degrees x30 degrees) | 9mm x 9mm (30 degrees x 30degrees) | N/A |
| Scan Patterns | Line ScanRaster ScanRetina Topography ScanOptic Nerve HeadTopography Scan | Line ScanRaster ScanRetina Topography ScanOptic Nerve Head TopographyScan | N/A |
| Optic Nerve Head RNFLRing Scan | Optic Nerve Head RNFL RingScan | ||
| Radial Scan | |||
| Quantitativeparameters | None | Retinal thickness analysisNerve Fibre thickness analysisOptic Nerve Head analysis | N/A |
| Depth Range (inair) | 2.5mm | 1.7 -2.3mm | N/A |
| Scan Pixels | Axial (depth) 1024Lateral 1024 | Axial (depth) 1024Lateral 1024 | N/A |
| Acquisition time | ≤2s | ≤2s | N/A |
| Retinal Tracking | Yes | Yes | N/A |
| General | |||
| Ergonomics | Tabletop ScannerHeadrest and ChinrestTouchscreen & Handcontroller | Tabletop ScannerHeadrest and ChinrestComputer | Tabletop ScannerHeadrest and ChinrestTouchscreen & Handcontroller |
| Cleaning anddisinfection/sterilization | Sterilization not required.Clean/disinfect contactpoints | Sterilization not required.Clean/disinfect contact points | Sterilization not required.Clean/disinfect contactpoints |
| Safety Features | Laser & SLD shutdown onlight source overpowerand/or incorrect functioningof scanning elements | SLD shutdown on light sourceoverpower and/or incorrectfunctioning of scanningelements | Laser shutdown on laseroverpower and/or incorrectfunctioning of scanningelements |
| Software | Embedded and Application | Embedded and Application | Embedded and Application |
| OperatingSystem | Linux (SLO)Windows 7 (Application &OCT) | Windows XP (Application andOCT) | Linux |
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The optical coherence tomographer features of the P200TE are similar to the primary predicate Spectral OCT/SLO but there are minor differences. Importantly, the light sources in both devices are identical. The Spectral OCT/SLO can produce 27,000 Ascans/s while the P200TE is capable of 70,000 A-scans/s due to a change in software. The change in software also removes the ability to provide numerical measurements from the machine. The field of view difference 9mm x 9mm x 9mm is minor and due to the software change. The difference in depth range 1.7 to 2.3mm vs. 2.5mm is due to the change in software.
The scanning laser ophthalmoscope features of the P200TE are similar to the secondary predicate Optos P200DTx but there are minor differences. The P200TE has removed the functionality of the Fluorescein Angiography and ICG which used a 488nm blue light source and 802nm infra-red light source in the predicate device. The P200TE can still provide Red/Green Reflectance and Auto Fluorescence. Field of view and other characteristics are all the same.
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Performance data was provided which showed that the P200TE complied with recognized consensus standards as did the predicate devices. The P200TE and the predicate devices are substantially equivalent.
PERFORMANCE DATA
Non-Clinical
In addition to electrical safety and software testing performed on the device. the following bench performance testing was conducted in order to support substantial equivalence:
- ISO 15004-2:2007 Ophthalmic Instruments Fundamental ● requirements and test methods - Part 2: Light hazard protection
- IEC60825-1 Safety of Laser Products; ●
- IEC 62366: Application of usability engineering to medical devices. ●
Results of the bench testing demonstrated that the Optos P200TE complies with the relevant recognized consensus standards.
Clinical
A prospective, observational study at a single US clinical site was conducted. 35 participants age 18 or older were enrolled and assigned to one of three sub-groups. "normal" (no ocular pathology), "glaucoma," (with existing diagnosis of glaucoma of various severities), or "retinal disease" (those with a variety of retinal conditions, including, but not limited to, age-related macular degeneration, diabetic retinopathy, diabetic macular edema, macular hole, epiretinal membrane). 32 study eves were imaged with the P200TE device and the Spectral OCT/SLO device in a randomized order. The scan patterns used were Line Scan, RNFL scan, ONH Topography, Retina Topography, and Raster scan. Images were reviewed for various imaging artifacts. Images were then compiled and submitted to a thirdparty reading center (outside of the US) where three independent, masked graders qualitatively evaluated the images based on pre-specified grading criteria. These criteria were based on the presence or absence of clinically relevant structures and anatomic boundaries and on the overall image clarity necessary for qualitative clinical use. Grading results from the two devices were then compared using onetailed Wilcoxon signed-rank test analyses for a non-inferiority hypothesis and linearly weighted Cohen's kappa analyses. The grading results were found to be similar between the two devices. The kappa analyses show adequate inter-grader agreement in scoring. These results showed that the image quality for purposes of qualitative clinical use are similar between the P200TE and the Spectral OCT/SLO, and support a determination of substantial equivalence.
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CONCLUSIONS
The Optos P200TE has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicates. The minor differences between the subject device and the predicate devices do not raise new questions of safety or effectiveness. Therefore, the Optos P200TE is substantially equivalent to the Spectral OCT/SLO
§ 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.