Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

K221320 · Nidek Co., Ltd. · OBO · Mar 30, 2023 · Ophthalmic

Device Facts

• Record ID: K221320
• Device Name: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
• Applicant: Nidek Co., Ltd.
• Product Code: OBO · Ophthalmic
• Decision Date: Mar 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of: · the retina, retinal nerve fiber layer, optic disc, and · the anterior chamber and cornea (when used with the optional anterior segment OCT adapter) and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices. Scanning Laser Ophthalmoscope Mirante [SLO Model] The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.

Device Story

Mirante is a computer-controlled, non-contact ophthalmic imaging system combining Fourier Domain Optical Coherence Tomography (OCT) and Scanning Laser Ophthalmoscope (SLO) functions. It uses a low-coherence interferometer and Michelson interferometer for OCT depth-resolved retinal/anterior segment imaging; SLO uses a confocal scanning laser system for flat-surface fundus imaging. Operated by clinicians in clinics, it captures images via resonant/galvanometer mirrors. Output is processed by NAVIS-EX software for storage, management, measurement, and display. The device aids healthcare providers in diagnosing and managing retinal, corneal, and anterior chamber diseases. Benefits include high-resolution, non-invasive visualization of ocular microstructures, facilitating clinical decision-making.

Clinical Evidence

Prospective, comparative clinical study (n=170) evaluated agreement and precision of Mirante vs. Avanti (OCT) and image quality vs. P200DTx (SLO). Populations included normal, glaucoma, retinal disease, and corneal disease subjects. Agreement performance goals met for ILM-RPE/BM and Disc Map RNFL thickness. Mirante demonstrated superior clinical utility and image quality for SLO Color, B-FAF, and G-FAF modes compared to P200DTx (p<0.0001). No device-related adverse events reported.

Technological Characteristics

Fourier Domain OCT (880nm) and Confocal SLO (488nm, 532nm, 670nm, 790nm). Features resonant/galvanometer scanning, 85,000 A-scan/sec rate, and 60°/110° fields of view. Software: NAVIS-EX (v1.11.0) for image management/processing. Connectivity: Networked via DICOM. Biocompatible skin-contacting materials per ISO 10993. Electrical safety per AAMI/ANSI ES60601-1; Laser safety per IEC 60825-1.

Indications for Use

Indicated for in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disc, anterior chamber, and cornea (with optional adapter) in patients requiring fundus, color, angiography, autofluorescence, or retro mode imaging as an aid in diagnosis and management of ocular diseases.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Avanti (K180660)
• P200DTx (K142897)
• Image Filing Software NAVIS-EX (K181345)

Reference Devices

• AFC-330 (K113451)
• SL-2000 (K163564)

Submission Summary (Full Text)

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March 30, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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.

Nidek Co., LTD. % Ryan Bouchard Official Correspondent Ora. Inc. 300 Brickstone Square Andover, Massachusetts 01810

Re: K221320

Trade/Device Name: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC, NFJ Dated: February 22, 2023 Received: February 24, 2023

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. 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.

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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 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-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 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-device-safety/medical-device-reportingmdr-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Elvin Y. I

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221320

#### Device Name

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

#### Indications for Use (Describe)

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]

The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:

· the retina, retinal nerve fiber layer, optic disc, and

· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)

and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Scanning Laser Ophthalmoscope Mirante [SLO Model]

The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> <span style="font-size: 10pt;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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#### 510(k)

#### Summary

#### K221320

This summary of the 510(k) premarket notification for the Nidek Mirante with NAVIS-EX Software is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### Owner Company name, address

NIDEK CO., LTD. 34-14 Meahama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Contact person: Tsutomu Sunada E-mail: Tsutomu Sunada(@nidek.co.jp

#### Contact/Application Correspondent

Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: [phone] Facsimile: [phone] E-mail: rbouchard(@oraclinical.com

#### Date Prepared

March 30, 2023

#### Name of Device - Mirante

Trade Name:

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX

Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

| Common Name: | Optical Coherence Tomography |
|----------------------------|-------------------------------------------|
| Classification Name: | Ophthalmoscope |
| Classification Regulation: | 21 CFR 886.1570 |
| Product Code: | OBO, MYC, NFJ |
| Predicate Devices | |
| Primary predicate: | Avanti (K180660) |
| Secondary predicate: | P200DTx: (K142897) |
| | Image Filing Software NAVIS-EX: (K181345) |

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#### OCT/SLO Device Description

The Nidek Mirante 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 Nidek Mirante 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.

The Nidek Mirante 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 Mirante utilizes Fourier spectroscopic imaging a Michelson interferometer. The interfering light of the reference light and the reflected light from the test eye obtained by the Michelson interferometer are spectrally divided by a diffraction grating and the signal is acquired by a line scan camera. The signal is inverse Fourier transformed to obtain the reflection intensity distribution in the depth direction of the patient's eve. The galvano mirror scans the imaging light in the XY direction to obtain a tomographic image.

The OCT scan patterns include the following:

Retinal Scan Patterns

- Macula Line
- Macula Cross
- Macula Map
- Macula Multi ●
- Macula Radial ●
- Disc Map
- Disc Radial .

Anterior Scan Patterns

- Cornea line
- Cornea cross ●
- Cornea radial
- ACA line ●

The Mirante includes scanning laser ophthalmoscope (SLO) functions as well as the OCT functions. The SLO component uses a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected by the hole mirror and the signal is obtained by the detector.

A resonant mirror and a galvanometer mirror placed in the imaging optical path scan the imaging light in the XY direction to obtain a flat surface image.

#### Indications for Use

#### Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]

The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NA VIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:

- · the retina, retinal nerve fiber layer, optic disc, and

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· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)

and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

#### Scanning Laser Ophthalmoscope Mirante [SLO Model]

The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

#### Statement of Substantial Equivalence

Nidek believes that the Nidek Mirante described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to legally marketed predicate devices. These are Class II medical devices and include the Avanti OCT cleared in K180660 and the OPTOS P200DTx cleared in K142897.

#### Optical coherence tomography (OCT)

The Mirante is substantially equivalent to the Avanti for the intended use for imaging and measurements of anterior and posterior ocular structures. The Mirante has virtually the same intended use as Avanti (K180660) with the exception that the Mirante does not include a normative database.

The principle of operation is identical in that both devices employ a non-invasive, non-contact low-coherence interferometry technique [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 anterior structures of the eye (i.e., cornea and retina, including the ganglion and retinal nerve fiber layers).

#### Scanning Laser Ophthalmoscope (SLO)

The Mirante is substantially equivalent to the OPTOS P200DTx for the intended use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. The Mirante has the same intended use as OPTOS P200DTx (K142897).

The principle of operation is identical in that both devices employ a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected light is reflected by the hole mirror and the signal is obtained by the detector.

There are minor differences in technological characteristics between the Mirante and the predicate devices that do not raise questions of safety or effectiveness.

#### Discussion

Bench testing has been performed to demonstrate that the Mirante device performs as intended and is substantially equivalent to the predicate devices, Avanti (K180660) and OPTOS P200DTx

(K142897), with respect to imaging and measurement of ocular structures. Both devices comply with recognized consensus standards regarding electrical safety, optical safety and biocompatibility. The system level testing with software version 1.22 was conducted with passing results.

Performance testing included OCT and SLO system testing, optical safety testing, and Usability testing. The performance testing demonstrated that the device satisfies the performance requirements specified for its intended use and is equivalent to the relevant performance characteristics of the comparative predicate device.

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Therefore, based on the same intended use and similar technological characteristics with substantial equivalence to the predicate devices confirmed with performance testing, the Mirante is technologically and functionally equivalent to the predicate devices, Avanti (K180660) and OPTOS P200DTx (K142897). The differences between the proposed device, Mirante, and the predicate devices are insignificant and do not raise new issues of safety or effectiveness of the device.

The Comparison Table of Technological Characteristics follows.

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| | Test Device | Primary Predicate Device | Secondary Predicate Device | Discussion | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Mirante SLO/OCT model with<br>NAVIS-EX | Avanti | P200DTx | | |
| 510(k) Number | | (K180660) | (K142897) | | |
| Classification, Product Code | Class II, HLI, OBO, MYC | Class II, HLI, OBO | Class II, MYC | Same | |
| Regulation number | 21CFR 886.1570 | 21 CFR 886.1570 | 21 CFR 886.1570 | Same | |
| | (Ophthalmoscope, AC-<br>Powered) | (Ophthalmoscope, AC-<br>Powered) | (Ophthalmoscope, AC-<br>Powered) | Same | |
| Applicant | Nidek Co., Ltd. | Optovue, Inc. | Optos, Plc | | |
| Indications for use | The Mirante SLO/OCT with<br>scanning laser ophthalmoscope<br>and optical coherence<br>tomography function and with<br>Image Filing Software NAVIS-<br>EX is a non-contact system for<br>imaging the fundus and for<br>axial cross sectional imaging of<br>ocular structures. It is indicated<br>for in vivo imaging and<br>measurement of:<br>• the retina, retinal nerve fiber<br>layer, optic disc, and<br>• the anterior chamber and<br>cornea (when used with the<br>optional anterior segment OCT<br>adapter)<br>and for color, angiography,<br>autofluorescence, and retro<br>mode imaging of the retina as<br>an aid in the diagnosis and<br>management. | The Avanti is an optical<br>coherence tomography system<br>intended for the in vivo<br>imaging, cross-sectional, and<br>three-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, corneal epithelia,<br>corneal stroma, pachymetry,<br>corneal power, and anterior<br>chamber of the eye. With the<br>integrated normative database,<br>Avanti is also a quantitative<br>tool for the comparison of<br>retina, retinal nerve fiber layer,<br>and optic disc measurements in<br>the human eye to a database of<br>a known normal subjects. It is<br>indicated for use as a<br>diagnostic device to aid in the<br>detection and management of<br>ocular diseases. | 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 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. | Similar - All devices support imaging of<br>the posterior and anterior segment of the<br>eye. The Mirante does not include an<br>integrated normative database.<br>The indications for use of the NAVIS-EX<br>have remained unchanged from the<br>indications for use of the previously<br>cleared NAVIS-EX. | |
| | | Test Device | Primary Predicate Device | Secondary Predicate Device | Discussion |
| | | The Image Filing Software<br>NAVIS-EX is a software<br>system intended for use to<br>store, manage, process,<br>measure, analyze and display<br>patient data and clinical<br>information from computerized<br>diagnostic instruments through<br>networks. It is intended to work<br>with compatible NIDEK<br>ophthalmic devices. | The Avanti with the AngioVue<br>software feature is indicated as<br>an aid in the visualization of<br>vascular structures of the retina<br>and choroid in normal subjects,<br>and in subjects with glaucoma<br>and retinal diseases. The<br>AngioAnalytics software<br>feature of AngioVue is<br>indicated for the measurement<br>of vascular density, the foveal<br>avascular zone, the thickness of<br>retinal layers, and nerve fiber<br>layer, and measurement of<br>optic disc parameters in normal<br>subjects, and in subjects with<br>glaucoma and retinal diseases. | - | - |
| OCT Function | | - | - | - | - |
| Principle | Retina cross-<br>sectional<br>observation and<br>image capture | Spectral domain OCT | Spectral domain OCT | - | Same for the predicate device. |
| | Anterior segment<br>cross-sectional<br>observation and<br>image capture | Spectral domain OCT | Spectral domain OCT | - | Same for the predicate device. |
| Light source wavelength | | 880 nm | 840 nm | - | Similar value<br>The difference does not result in any<br>difference in OCT image quality that can<br>affect diagnosis. Thus, the light source<br>wavelength is considered to be<br>substantially equivalent between the<br>Mirante and the predicate device. |
| | Scan rate (temporal resolution) | 85,000 A-Scan/sec | 70,000 A-Scan/sec | - | Similar<br>The higher scan rate for the Test device<br>does not affect the safety and efficacy as<br>compared to the predicate |
| | | Test Device | Primary Predicate Device | Secondary Predicate Device | Discussion |
| Resolution<br>(Optical<br>resolution) | Retina cross-<br>sectional image<br>capture | Retina cross-sectional<br>observation<br>Horizontal (X-Y) directions:<br>$20 \mu m$<br>Depth (Z) direction: $7 \mu m$ | Horizontal: $15 \mu m$ ( according<br>to brochure )<br>Depth: $5 \mu m$ | | Similar<br>The differences are not expected to affect<br>the safety or effectiveness of the device. |
| | Anterior segment<br>cross-sectional<br>observation and<br>image capture | Anterior segment cross-<br>sectional observation<br>(Optional)<br>Horizontal (X-Y) directions:<br>$30 \mu m$<br>Depth (Z) direction: $7 \mu m$ | Horizontal (X-Y) direction:<br>Unknown<br>Depth: $5 \mu m$ | | Similar depth<br>The horizontal resolution of the predicate<br>device is unknown., however, resolution<br>in the horizontal (X-Y) direction does not<br>substantially affect the device<br>effectiveness.<br>The differences are not expected to affect<br>the safety or effectiveness of the device |
| Angle of<br>view | Retina cross-<br>sectional image<br>capture | Scan width: 3 mm to 16.5 mm,<br>Scan depth: 2.1 mm | Scan width: 2 mm to 12 mm,<br>Scan depth: 2 mm to 3 mm | | Similar values<br>The scan width and scan depth are<br>considered to be substantially equivalent<br>between the Mirante and the predicate<br>device.…