Canon OCT-A1

{0}------------------------------------------------ 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 24, 2019 Canon Inc. % Ryan Bouchard VP, Medical Devices Ora. Inc. 300 Brickstone Square Andover, MA 01810 # Re: K182942 Trade/Device Name: Canon OCT-A1 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HLI Dated: June 17, 2019 Received: June 18, 2019 # Dear Ryan Bouchard: 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. 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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. 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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 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182942 Device Name Canon OCT-A1 Indications for Use (Describe) The Canon OCT-A1 is an optical coherence tomography system indicated for the in-vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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 Canon OCT-A1 K182942 is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ### Owner Company name, address a. Canon Inc. 9-1, Imaikami-cho Nakahara-ku. Kawasaki Kanagawa 211-8501 Japan Contact person: Tatsuya Yamazaki #### b. Contact/Application Correspondent Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard@oraclinical.com ### Date Prepared C. July 24, 2019 #### d. Name of Device | Trade Name: | Canon OCT-A1 *- | |----------------------------|-------------------------------| | Common Names: | Optical Coherence Tomography | | Classification Name: | Tomography, optical coherence | | Classification Regulation: | 21 CFR 886.1570 | | Product Code: | OBO | | 510(k) Number: | K182942 | #### Predicate Device e. Optovue RTVue XR OCT Avanti with Normative Database (K153080) ### f. Device Description The Canon OCT-A1 *- is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The OCT-A1 is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. {4}------------------------------------------------ *: "Al" stands for the "Automatic-1" which means the first Canon OCT with the automatic alignment and adjustment feature. The OCT-A1 uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds. The OCT-A1 quantifies numerous ocular structures. The various retinal layers or structures, which are imaged or measured, include the following: 1) The internal limiting membrane (ILM) 2) The retinal nerve fiber layer (RNFL) 3) The NFL+GCL+IPL thickness 4) The retinal pigment epithelium (RPE) 5) Bruch's membrane (BM) 6) The full retina thickness ### Indications for Use g. The Canon OCT-A1 is an optical coherence tomography system indicated for the invivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician. #### h. Statement of Substantial Equivalence Canon, Inc. believes that the Canon OCT-A1 described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Optovue RTVue XR OCT cleared in K153080. {5}------------------------------------------------ | Feature | Canon OCT-A1 | RTVue XR OCT (K153080) | |----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Canon Inc. | Optovue, Inc. | | Classification | 886.1570 | 886.1570 | | Product Code | OBO | HLI, OBO | | Indications for use | The Canon OCT-A1 is an optical<br>coherence tomography system indicated<br>for the in-vivo imaging and measurement<br>of the retina, retinal nerve fiber layer, and<br>optic disc as a tool and an aid in the<br>diagnosis and management of retinal<br>diseases by a clinician. | The RTVue XR OCT Avanti with<br>Normative Database is an optical<br>coherence tomography system indicated<br>for the in vivo imaging and measurement<br>of the retina, retinal nerve fiber layer, and<br>optic disc as a tool and aid in the<br>diagnosis and management of retinal<br>diseases by a clinician.<br><br>The RTVue XR OCT Avanti with<br>Normative Database is also a quantitative<br>tool for the comparison of retina, retinal<br>nerve fiber layer, and optic disc<br>measurements in the human eye to a<br>database of known normal subjects. It is<br>intended for use as a diagnostic device to<br>aid in the detection and management of<br>ocular diseases.<br><br>The RTVue XR OCT Avanti with<br>AngioVue™ software is indicated as an<br>aid in the visualization of vascular<br>structures of the retina and choroid. | | Technological Characteristics: OCT | | | | Imaging | Spectral Domain OCT | Spectral Domain OCT | | Scan Rate | 70,000 A-Scan/s | 70,000 A-Scan/s | | Light Source | | | | -Wave Length | 860 nm (SLD) | 840 nm (SLD) | | -Power Output | 7.5 mW | Unknown | | -Continuous/Pulsed | Pulsed | Unknown | | -Pulse Durations | 100μs | Unknown | | Field of View | Scan width: 3 mm to 10 mm<br>Scan depth: 2 mm | Scan width: 2 mm to 12 mm<br>Scan depth: 2 to 3 mm | | Optical Resolution | 20µm (in the X and Y directions), 3.4 µm<br>(in the Z direction) | 15µm (in the X and Y directions), 5 µm<br>(in the Z direction) | | Exposure Power at<br>Pupil | 893 μW | ≤750 μW | | Feature | Canon OCT-A1 | RTVue XR OCT (K153080) | | Technological Characteristics: SLO | | | | Imaging | Near IR observation (Confocal laser scanning) | Near IR observation | | Light Source | | | | -Wavelength | 780 nm (LD) | 735 nm (LED) | | -Power Output | 30mW | Unknown | | -Continuous/Pulsed | Pulsed | Unknown | | -Pulse Durations | 41ns | Unknown | | Field of View | 45° x 34° | 32° x 22° | | Optical Resolution | 25µm (in the X and Y directions) | 25µm (in the X and Y directions) | | Technological Characteristics: Light for Anterior Segment Adjustment | | | | Wavelength | 970 nm | Unknown | | Power output | 5.5mW | Unknown | | Continuous/Pulsed | Continuous | Unknown | | Pulse Durations | - | Unknown | | Technological Characteristics: Internal Fixation Lamp | | | | Wavelength | 590 nm | Unknown | | Power output | 2.8mW | Unknown | | Continuous/Pulsed | Pulsed | Unknown | | Pulse Durations | 260.ns | Unknown | | Technological Characteristics: External Fixation Lamp | | | | Wavelength | 460 nm | Unknown | | Power output | 2.32 ed | Unknown | | Continuous/Pulsed | Continuous | Unknown | | Pulse Durations | - | Unknown | | Technological Characteristics: Others | | | | Minimum Pupil Diameter Required | φ 3.0 mm | φ 2.5 mm | | Focus Range | - 18 D to +15 D | - 15 D to +12 D | {6}------------------------------------------------ {7}------------------------------------------------ | Feature | Canon OCT-A1 | RTVue XR OCT (K153080) | |---------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Measurement and Analysis | | | | Imaging of the<br>Fundus | SLO | SLO | | Retinal Thickness Measurement | | | | -Total | ILM to RPE | VRI to RPE | | -Inner | No | VRI to IPL | | -Outer | No | RPE to IPL | | GCC Thickness<br>(NFL+GCL+IPL<br>Thickness) | Yes | Yes | | - S - I difference | No | Yes | | - Focal loss volume | No | Yes | | - Global loss<br>volume | No | Yes | | RNFL Thickness<br>Measurement | Along the circumference of a circle of<br>3.45 mm diameter which is targeted<br>around the ONH | Along the circumference of a circle of<br>3.45 mm diameter which is targeted<br>around the ONH | | Optic Disc Analysis | | | | -Disc area | Yes | Yes | | -Rim area | Yes | Yes | | -Cup area | No | Yes | | -Cup volume | Yes | Yes | | -Rim volume | Yes | Yes | | -Nerve head<br>volume | No | Yes | | -C/D area | Yes | Yes | | -C/D vertical | Yes | Yes | | -C/D horizontal | Yes | Yes | | -R/D minimum | Yes | No | Both the Canon OCT-A1 and the Optovue XR OCT are OCT devices. The principle of operation is identical in that both devices employ a non-invasive, non-contact lowcoherence interferometry technique [specifically, spectral domain optical coherence tomography (SD-OCT)] to generate high-resolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the posterior structures of the eye (i.e., retina, including the ganglion and retinal nerve fiber layers. There are minor differences in technological characteristics between the Canon OCT-A1 and the predicate device for the OCT including wavelength, size of field of view, optical {8}------------------------------------------------ resolution, and exposure power at pupil. There are also minor differences in technological characteristics between the Canon OCT-A1 and the predicate device for the SLO including wavelength and field of view. There are also differences related to minimum pupil diameter required for measurement and focus range. Regarding measurement and analysis, the retinal thickness measurement methodology differs between the Canon OCT-A1 and the predicate device. There are also differences in the optic disc analysis. Performance testing including both bench testing and clinical testing demonstrated substantial equivalence. Therefore, based on the same intended use and similar technological characteristics with substantial equivalence to the predicate device confirmed with performance testing, the Canon OCT-A1 is technologically and functionally equivalent to the predicate device, RTVue XR OCT (K153080). The differences between the proposed device, OCT-A1, and the predicate device are insignificant and do not raise new issues of safety or effectiveness of the device. The Canon OCT-A1 is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent. #### i. Performance Testing Canon, Inc. performed bench tests to ensure safety and effectiveness and to demonstrate substantial equivalence of the OCT-A1 to the predicate device. A list of testing conducted included: - · Scan Speed - · Transverse and Depth Resolution - Field of View/Angle of View - · Scan Depth - · Testing to the Standards Electrical Safety: AAMI/ANSI ES60601-1 Electromagnetic Compatibility: IEC 60601-1-2 Safety of Laser Products: IEC 60825-1 Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 Ophthalmic Instruments: ISO 15004-1, ISO 15004-2 Optical Radiation Hazard Analysis: ANSI Z80.36-2016. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern-. The software verification and validation was conducted in two stages, one which included bench testing based on proper recognition of layer and quantitative measurement of thickness or area. The second stage of the software validation was performed by involving human eyes in a clinical evaluation. Clinical Testing: A clinical study was conducted to demonstrate substantial equivalence of the Canon OCT-A1 (OCT-HS-100) in comparison with Optovue RTVue Avanti. The repeatability and reproducibility were evaluated for the measurements of: Full retinal {9}------------------------------------------------ thickness: Retinal nerve fiber layer (RNFL) thickness: Ganglion cell complex (GCC) thickness; and Optic nerve head (ONH) The main objective of the clinical study was to assess agreement and precision of the Canon OCT-A1 (OCT-HS-100) in comparison with the Optovue RTVue Avanti. The study was a prospective comparative, randomized, single center study conducted in the US to gather agreement and precision data in at least 99 evaluable eyes, approximately 33 eligible subjects in each of the study subject groups: normal subjects; subjects with glaucoma; and subjects with retinal disease. The primary inclusion criteria for all groups included: Male or female subjects from 18 vears of age or older who have full legal capacity to volunteer on the date the informed consent is signed; Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date; Subjects who agree to participate in the study In addition each of the groups had inclusion criteria associated with the specific group. Normal Group: - . Subjects with normal eye examinations (without pathology) in one or both eyes on the date of the study visit as observed with a +90 Diopter Fundus Lens; - Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or . better in the normal eye(s) Glaucoma Group: - . Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s) - with a current BSCVA of 20/40 or better in the glaucoma study eve(s) ● - . History of visual field defects within the previous two (2) months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage Retinal Disease Group: - Subjects with a current BSCVA of 20/400 or better in the retinal disease study eve(s) . at the study visit - Subjects diagnosed with retinal pathology including but not limited to: Non . Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six (6) months, who exhibit structural lesions in the study eye - Subjects diagnosed with retinal pathology including but not limited to: Neovascular . Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six (6) months, who exhibit vascular and/or ischemic lesions in the study eye. The exclusion criteria was similar for all groups and included: - Subjects unable to tolerate ophthalmic imaging; - Subjects with ocular media not sufficiently clear to obtain acceptable OCT images; . - . Subjects with a history of leukemia, dementia or multiple sclerosis. {10}------------------------------------------------ - . Subject has a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study Group specific exclusion criteria included: - . Normal Group: Subjects with any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the studv visit: - . Retinal Disease Group: Subjects with glaucoma in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit Three Canon OCT-A1 devices and 3 Optovue RTVue Avanti devices were used. Each Canon OCT-A1 device was paired with 1 of the Optovue RTVue Avanti devices. One device operator was assigned to each device pair to create 3 distinct operator/device configurations. Device operators and investigators were masked to the automated results of segmentation. This study included 125 subjects with 37 in the normal group, 37 in the glaucoma group, and 38 in the retinal disease group. The study included two main analyses: 1) analysis of agreement and 2) analysis of precision. In the effectiveness population, the mean (SD) age was 39.1 (15.28) years for the normal eve subjects. 71.6 (8.78) years for the glaucoma eve subjects. 62.1 (15.11) years for the retinal disease eye subjects, 53.5 (17.38) years for the FFA normal eye subjects, and 59.3 (14.73) years FFA retinal disease eve subjects. The overall mean age of all subjects was 57.5 (18.67) years. Sixty-one females and 64 males participated (48.8% and 51.2%, respectively), and the majority of subjects were white 92 (73.6%) and not Hispanic or Latino 101 (80.8%). # Analysis of Agreement Summary # Full Retinal Thickness (FRT) The normal population showed Canon Macula 3D scans tended to have higher FRTs by about 10 to 30 um depending on the parameter with mean differences ranging from 12.56 to 29.95 um. The glaucoma population showed Canon Macula 3D scans tended to have higher FRTs by about 15 to 30 um depending on the parameter with mean differences ranging from 15.42 to 29.39 um. The retinal disease population showed Canon Macula 3D scans tended to have higher FRTs by about 15 to 25 um depending on the parameter with mean differences ranging from 12.52 to 24.46 um. See Table 1 for the mean differences and 95% Limits of Agreement (LOA). Some of the 95% LOAs were fairly wide, as seen in Table 1. {11}------------------------------------------------ The differences shown between the Canon and the Optovue devices are largely because the two devices use different bands in the RPE as the outer of the retina. Optovue uses the 2nd hyper reflective band (upper border of RPE) as an outer border of the retina and the Canon uses the 3th hyper reflective band (lower border of RPE) as an outer border of the retina. In addition, the diameter of the outer section of the grid for the Canon OCT-A1 is 6mm whereas the Optovue uses a 5mm diameter. FRT is summarized in Table 1. | Subject Population<br>Comparable<br>Parameter | Canon OCT-A1<br>Mean (SD) | Optovue<br>Avanti<br>RTVue<br>Mean (SD) | Mean<br>Difference<br>(SD) | 95% CI for Mean<br>Difference | 95% LOA<br>for<br>Differences | |-----------------------------------------------|---------------------------|-----------------------------------------|----------------------------|-------------------------------|-------------------------------| | All Configurations | | | | | | | Normal – N | 37 | 37 | | | | | Central (µm) | 267.20 (19.396) | 248.89 (18.222) | 18.32 (5.056) | (16.69, 19.95) | (8.20, 28.43) | | Para Inferior (µm) | 339.95 (15.682) | 310.00 (16.159) | 29.95 (6.066) | (28.00, 31.91) | (17.82, 42.09) | | Para Nasal (µm) | 344.05 (17.430) | 315.30 (18.034) | 28.75 (7.179) | (26.44, 31.06) | (14.39, 43.11) | | Para Superior (µm) | 343.27 (18.369) | 314.62 (18.160) | 28.65 (7.468) | (26.25, 31.06) | (13.72, 43.59) | | Para Temporal (µm) | 329.85 (16.339) | 301.92 (16.948) | 27.93 (6.769) | (25.75, 30.11) | (14.39, 41.47) | | Peri Inferior (µm) | 285.94 (13.608) | 273.38 (13.303) | 12.56 (7.029) | (10.30, 14.83) | (-1.49, 26.62) | | Peri Nasal (µm) | 314.45 (18.170) | 296.76 (16.744) | 17.69 (6.606) | (15.56, 19.82) | (4.48, 30.90) | | Peri Superior (µm)…