Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard OCT/SLO imaging system and image filing software. There is no mention of AI, ML, deep learning, or any related terms in the intended use, device description, or performance studies. The performance studies focus on agreement and precision metrics, not AI/ML performance metrics like AUC or standalone performance of an algorithm.

Therapeutic

No

Explanation: The device is described as an imaging and measurement system for diagnosis and management, not for treatment or therapy. It aids in diagnosis and management by providing imaging and measurement data.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in the diagnosis and management" of conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details hardware components like a scanning laser ophthalmoscope, optical coherence tomography system, interferometer, diffraction grating, line scan camera, galvano mirror, resonant mirror, and detector. While it includes software (Image Filing Software NAVIS-EX), it is an integral part of a larger hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, the Nidek Mirante SLO/OCT and Mirante SLO devices are not IVDs (In Vitro Diagnostics).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Mirante devices are described as non-contact systems for imaging and measuring ocular structures in vivo (within the living body). They use light (OCT and SLO) to visualize and quantify tissues in the eye.
Intended Use: The intended use clearly states "in vivo imaging and measurement" and "imaging of the retina as an aid in the diagnosis and management." This involves direct interaction with the patient's eye, not analysis of samples taken from the body.
Device Description: The description details how the device scans the eye using light and analyzes the reflected light to create images and measurements. This is a form of medical imaging, not in vitro testing.

While the device is used as an "aid in the diagnosis and management," this is a common function of many medical devices that are not IVDs. The key distinction is whether the analysis is performed on a sample outside the body (in vitro) or directly within the body (in vivo).

Therefore, the Nidek Mirante SLO/OCT and Mirante SLO are considered medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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 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. It is intended to work with compatible NIDEK ophthalmic devices.

Product codes (comma separated list FDA assigned to the subject device)

OBO, MYC, NFJ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Scanning Laser Ophthalmoscope (SLO) and Optical Coherence Tomography (OCT)

Anatomical Site

fundus, ocular structures, retina, retinal nerve fiber layer, optic disc, anterior chamber, cornea

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A total of 170 subjects were enrolled in the study and included in the Safety Analysis Set and Full Analysis Set. This included:

45 subjects in the Normal group,
46 subjects in the Glaucoma group, ●
47 subjects in the Retinal Disease group, and ●
32 subjects in the Corneal Disease group. .

Of those, three subjects in the Glaucoma group discontinued due to a major protocol deviation of inclusion/exclusion and randomization category. A total of 167 subjects completed the study.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Performance: A prospective, comparative clinical study was conducted in compliance with 21 CFR parts 50, 56, and 812 at one clinical site in the United States. The primary purpose of the clinical study was to assess agreement and precision of the Nidek Mirante OCT in comparison with Avanti OCT and to assess image quality of Nidek Mirante OCT Anterior Chamber Angle image compared to Avanti. Additionally, the Nidek Mirante SLO image quality was compared to the OPTOS P200DTx. The secondary purpose was to evaluate any adverse event found during the clinical study.

Agreement Analyses: Mirante / Avanti Analyses:

[ILM-RPE/BM] and Disc Map RNFL Thickness: Agreement performance goals were met for all parameters and each individual population. Mean differences between Mirante and Avanti scans (Mirante – Avanti) were higher for Mirante device for all populations for [ILM-RPE/BM] Thickness, and higher for most parameters for Disc Map RNFL Thickness (except TSNIT Temporal). Mirante is likely thicker by around 10-20 µm than Avanti for [ILM-RPE/BM] Thickness due to a difference in the definition of the lower line, and likely thicker by around 10 µm for Disc Map RNFL Thickness due to segmentation algorithm differences.
Disc Map Optic Disc analysis: Agreement performance goals were met for all parameters and each individual population. Mirante scans had lower values for Horizontal C/D Ratio and Vertical Cup-to-Disc (C/D) Ratio and higher values for Disc Area and Cup Area for All Subjects population.
Cornea Radial CCT analysis: Agreement performance goals were not met for the Normal and Corneal Disease populations for the CCT parameter. Mirante scans showed higher mean differences than Avanti, attributed to definition differences in upper and lower lines. Mirante is thicker by around 15 um than Avanti.

Precision Analyses: Mirante / Avanti Analyses:

[ILM-RPE/BM] Thickness: Mirante device met precision performance goals for all parameters and each group (Normal, Glaucoma, and Retinal Disease) for repeatability.
Disc Map RNFL Thickness: Mirante device met most precision performance goals, with acceptable variation among all parameters in the Normal population, and all but one TSNIT Nasal and one TSNIT Temporal parameter in the Glaucoma population for repeatability.
Disc Map Optic Disc: Mirante device met most precision performance goals, with acceptable variation among all parameters for repeatability in the Normal and Glaucoma populations, except for cup area in both populations.
Cornea Radial CCT: Mirante device met precision performance goals for all parameters and all populations for repeatability.

Precision Analyses: Mirante Only Analyses:

Macula Trace: Both Mirante settings met precision performance goals, with acceptable variation for all parameters and each population for repeatability.
Disc Trace RNFL Thickness and Disc Trace Optic Disc: Both Mirante settings did not meet performance goals for some parameters in Normal and Glaucoma populations.
Cornea Radial CCT: Both Mirante settings met precision performance goals, with acceptable variation for all parameters and each population for repeatability.

Image Quality:

SLO Color Fundus analysis: Mirante provided better clinical utility and overall quality in comparison to P200DTx (p

Regulation Number and Section

§ 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.

Summary

0

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.

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: (978) 332-9574 Facsimile: (978) 689-0020 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

5

· 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.

6

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.

7

	Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
Device Name	Mirante SLO/OCT model with
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-
Powered)	(Ophthalmoscope, AC-
Powered)	(Ophthalmoscope, AC-
Powered)	Same
Applicant	Nidek Co., Ltd.	Optovue, Inc.	Optos, Plc
Indications for use	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 Avanti is an optical
coherence tomography system
intended for the in vivo
imaging, cross-sectional, and
three-dimensional imaging and
measurement of anterior and
posterior ocular structures,
including retina, retinal nerve
fiber layer, ganglion cell
complex (GCC), optic disc,
cornea, corneal epithelia,
corneal stroma, pachymetry,
corneal power, and anterior
chamber of the eye. With the
integrated normative database,
Avanti is also a quantitative
tool for the comparison of
retina, retinal nerve fiber layer,
and optic disc measurements in
the human eye to a database of
a known normal subjects. It is
indicated for use as a
diagnostic device to aid in the
detection and management of
ocular diseases.	The P200DTx scanning laser
ophthalmoscope is indicated
for 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. It is also
indicated for use as a widefield
scanning laser ophthalmoscope
for viewing choroidal
circulation patterns that are
illuminated using Indocyanine
Green dye and for aiding in
both the assessment of
choroidal circulation and in the
diagnosis of choroiditis or
choroidal diseases.	Similar - All devices support imaging of
the posterior and anterior segment of the
eye. The Mirante does not include an
integrated normative database.
The indications for use of the NAVIS-EX
have remained unchanged from the
indications for use of the previously
cleared NAVIS-EX.
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
		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.	The Avanti with the AngioVue
software feature is indicated as
an aid in the visualization of
vascular structures of the retina
and choroid in normal subjects,
and in subjects with glaucoma
and retinal diseases. The
AngioAnalytics software
feature of AngioVue is
indicated for the measurement
of vascular density, the foveal
avascular zone, the thickness of
retinal layers, and nerve fiber
layer, and measurement of
optic disc parameters in normal
subjects, and in subjects with
glaucoma and retinal diseases.	-	-
OCT Function		-	-	-	-
Principle	Retina cross-
sectional
observation and
image capture	Spectral domain OCT	Spectral domain OCT	-	Same for the predicate device.
	Anterior segment
cross-sectional
observation and
image capture	Spectral domain OCT	Spectral domain OCT	-	Same for the predicate device.
Light source wavelength		880 nm	840 nm	-	Similar value
The difference does not result in any
difference in OCT image quality that can
affect diagnosis. Thus, the light source
wavelength is considered to be
substantially equivalent between the
Mirante and the predicate device.
	Scan rate (temporal resolution)	85,000 A-Scan/sec	70,000 A-Scan/sec	-	Similar
The higher scan rate for the Test device
does not affect the safety and efficacy as
compared to the predicate
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
Resolution
(Optical
resolution)	Retina cross-
sectional image
capture	Retina cross-sectional
observation
Horizontal (X-Y) directions:
$20 \mu m$
Depth (Z) direction: $7 \mu m$	Horizontal: $15 \mu m$ ( according
to brochure )
Depth: $5 \mu m$		Similar
The differences are not expected to affect
the safety or effectiveness of the device.
	Anterior segment
cross-sectional
observation and
image capture	Anterior segment cross-
sectional observation
(Optional)
Horizontal (X-Y) directions:
$30 \mu m$
Depth (Z) direction: $7 \mu m$	Horizontal (X-Y) direction:
Unknown
Depth: $5 \mu m$		Similar depth
The horizontal resolution of the predicate
device is unknown., however, resolution
in the horizontal (X-Y) direction does not
substantially affect the device
effectiveness.
The differences are not expected to affect
the safety or effectiveness of the device
Angle of
view	Retina cross-
sectional image
capture	Scan width: 3 mm to 16.5 mm,
Scan depth: 2.1 mm	Scan width: 2 mm to 12 mm,
Scan depth: 2 mm to 3 mm		Similar values
The scan width and scan depth are
considered to be substantially equivalent
between the Mirante and the predicate
device.
	Anterior segment
cross-sectional
image capture	Scan width: 2 to 8 mm,
Scan depth: 2.1 mm	12 mm × 8 mm (Field of view)
Maximum of 2.3mm
(according to Operator's
Manual)		Similar values
The scan width and scan depth are
considered to be substantially equivalent
between the Mirante and the predicate
device.
Display
resolution	Retina cross-
sectional image
capture	Horizontal (X-Y) directions: 3
$\mu$ m/pixel
Depth (Z) direction 4 $\mu$ m/pixel	unknown		predicate information unknown
	Anterior segment
cross-sectional
image capture	Horizontal (X-Y) directions 2
$\mu$ m/pixel
Depth (Z) direction 4 $\mu$ m/pixel	unknown		Because the length per pixel of the
Mirante is smaller than the optical
resolution, this only contributes to the
fineness of the depicted structures and the
amount of information obtained for
diagnosis remains unchanged. Therefore,
this is not considered to be an issue for
safety or effectiveness for the Mirante.
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
Required pupil diameter		2.5 mm in diameter (3 mm in diameter or larger is recommended.)	2.3 mm		Similar values
The required pupil diameter is considered
to be substantially equivalent between the
Mirante and the predicate OCT device.
Sensitivity		Regular, Fine, Ultrafine	unknown		The predicate information is unknown

The [Fine] or [Ultra Fine] setting may
allow capturing of proper cross sectional
(OCT) images even though only OCT
images with lower quality were captured
for the eye with the [Regular] setting".
The provision of the [Fine] or [Ultra
Fine] setting does not improve the
effectiveness. The increase in the status
of target eyes that Mirante can deliver the
basic performance (or capture the OCT
images) will act to reduce the risk of
misdiagnosis due to insufficient
information, and will raise no new safety
concerns. |
| OCT Scan
Pattern | Retinal scan
pattern | Macula Line | Line | | Similar functions

Horizontal direction: 32 lp/mm
Vertical direction: 50 lp/mm
50% Image height : 25 lp/mm | | Unknown | Mirante is considered to have the minimum resolving power required for fundus cameras. Thus, Mirante is considered to have substantially equivalent resolving power compared to fundus imaging devices on the market. | |
| | 95% Image height: 16 lp/mm
Wide angle (Optional)
Center:
Horizontal direction: 17.5 lp/mm
Vertical direction: 28 lp/mm
50% Image height: 11 lp/mm
95% Image height: 5.4 lp/mm | | | | |
| HD on/off | Available | | None | The HD on/off function for reducing noises contributes to the convenience, not to the effectiveness. The presence of this function does not substantially affect the safety and effectiveness of the Mirante. | |
| Angle of view | Regular angle: 60°
Wide angle (Optional): 110° | | 148° x 115° (external to eye) | The predicate devices have different references for the angel of view. This does not indicate a safety or efficacy issue with the test device
Both the Mirante and the predicate device obtain equivalent information that is essentially necessary for diagnosis. Thus, the angle of view is considered to be substantially equivalent between the Mirante and the predicate device. | |
| Required pupil diameter | Regular angle: 3.3 mm in diameter
Wide angle (Optional): 3.3 mm in diameter | | 2 mm | Similar requirements. No safety or efficacy impact. | |
| (Fundus surface imaging function) | | | | | |
| Mode | IR (refraction of Infrared light)
FA (fluorescein angiography using blue light) | | Red Free
FA | Similar modes.
The test device has an I/R mode that is not present in the predicate. | |
| | | Test Device | Primary Predicate Device | Secondary Predicate Device | Discussion |
| | | ICG (indocyanine green
angiography using infrared
light) | - | ICG | These differences are not expected to
have an impact on the device safety or
efficacy. The differences in SLO modes |
| | | FAF(fundus autofluorescence
using blue or green light) | - | FAF | are considered not to affect the safety
and effectiveness. |
| | | Color (using blue, green, and
red light) | - | Color | |
| | | Retro (This mode is to capture
the image of retina that is
illuminated from behind by
infrared light scattered by
choroid. This is a kind of
Retro illumination method.) | - | - | |
| Image size | - | 4096 × 4096, 2048 × 2048,
1536×1536, 1024×1024, 768
× 768, 512× 512 | - | Optomap plus: 3900 pixels (W)
x 3072 pixels (H)
Optomap: 2600 pixels (W) x
2048 pixels (H) | Similar
Mirante has both lower and higher pixel
patterns than the predicate device. |
| | | | | | Thus, the resolution is considered to be
substantially equivalent between the
Mirante and the predicate device. |
| Panorama | - | Yes | unknown | - | predicate information unknown |
| | | | | | The function allows Mirante to captures
images for panorama image composition
for viewing so that NAVIS-EX overlaps
and composes multiple fundus images
captured at different angles. This function
increases the convenience, but does not
increase the amount of information. This
function is considered not to affect the
safety and effectiveness. |
| Others | - | | | | |
| Focus range/Focus compensation | | - 15D to +15D ( V.D.=12 ) | - 15D to +12D | -12D to +7D | Similar
The differences do not affect the safety
and effectiveness in clinical use. |
| Working
distance | Fundus surface /
Anterior segment | 19.0 mm ±1mm (between
objective lens and cornea) | Fundus Imager: 22 mm | Unknown | Similar |
| | | Test Device | Primary Predicate Device | Secondary Predicate Device | Discussion |
| | front imaging
function | Wide Angle (Optional): 9.0
mm ±1mm or more | Corneal Imager: 13 mm | | These specifications are related to
convenience in image capture but do not
affect the safety and effectiveness. |
| | OCT | 19.0 mm ±1mm (between
objective lens and cornea) | 22 mm | | |
| | | 15.4 mm ±1 mm (Anterior
segment cross-sectional image
capture) | | | |
| Movement
range | Main body
(vertical
movement) | 30 mm | 25 mm | Unknown | |
| | Main body
(horizontal | Forward and backward: 165
mm | X: 100 mm | Unknown | |
| | movement) | Left and right: 110 mm | Y: 85 mm | | |
| | Chinrest (vertical
movement) | 80 mm | 65 mm | Unknown | |
| Dimensions
and weight | Main Body | [SLO/OCT model] | 380 (W) × 524 (D) × 499 to
531(H) mm | 550(W) x 550(D) x 608 to
632(H) mm | |
| | | 345 (W) × 548 (D) × 527 to
557 (H) mm (Image capturing
unit)
23 kg (Image capturing unit) | 34kg | 34 kg | |
| | | 203 (W) × 424 (D) × 438 (H)
mm (Control box) | | | |
| | | 20 kg (Control box) | | | |
| | | [SLO model] | | | |
| | | 345 (W) × 548 (D) × 527 to
557 (H) mm (Image capturing
unit) | | | |
| | | 22 kg (Image capturing unit) | | | |
| | | 203 (W) × 424 (D) × 438 (H)
mm (Control box) | | | |
| | | 16 kg (Control box) | | | |
| | Isolation
Transformer | 130 (W) × 220 (D) × 125 (H)
mm | 142(W) × 564(D) × 239(H)
mm | | |
| | | 7.0 kg | 15kg | | |
| | Computer | 177 (W) × 480 (D) × 426 (H)
mm | 210(W) × 477(D) × 430(H)
mm | | |
| | | 19 kg (Computer) | 18kg | | |
| | | 508 (W) × 56 (D) × 325 (H)
mm | (without monitor) | | |
| | | Test Device | Primary Predicate Device | Secondary Predicate Device | Discussion |
| Power supply
specifications | Main Body | 4.0 kg (Computer monitor) | AC110VAC and 230VAC,
1.8A, 50/60Hz | 100-240Vac, 50/60Hz | |
| | Isolation
Transformer | AC100V-240V150VA,
50/60Hz | AC110-240 VAC,
1.8A, 50/60Hz | | |
| | Computer | AC100V1000VA, 50/60Hz | unknown | | |
| | | 400 W (Computer) | | | |
| | | 27 W (Computer monitor) | | | |
| Others | Auto shot | Yes (OCT) | None | Yes | Similar |
| | Eye Tracer | Yes | Yes | Unknown | Same |
| | Color Fundus
image capture
mode | Pseudo Color | None | Pseudo Color | Similar |
| | External fixation
lamp | Yes | Yes | None | Same |
| Appearance | | Image: Optical device | Image: Optical device | Image: Optical device | |

Table 1: Comparison Table of Technological Characteristics – Mirante

8

9

10

11

12

13

14

15

16

With regards to the technical differences between the Mirante, the RTVue XR Avanti and the P200DTx in the Comparison Table above the clinical and non-clinical testing demonstrates that the differences do not raise any new questions about safety and effectiveness. Summaries of the non-clinical testing are provided in the following sections.

The following are the differences in measurement and analysis between the devices:

Substantial Equivalence Discussion for the Nidek Mirante per the 510(k) Decision-Making Flowchart

Are the predicate device(s) legally marketed? Q1.
Yes, the predicate device Avanti OCT was cleared in K180660 and the OPTOS P200DTx SLO was cleared in K142897.
1. Do the devices have the same intended use?
  Yes, the Mirante OCT/SLO has the same intended use as the predicate devices except that the Mirante does not include a normative database. Both Mirante and Avanti are ophthalmic imaging devices for viewing the fundus and anterior segment structures using optical coherence tomography. Avanti is provided with a normative database, while Mirante is not. Absence of the normative database that is a useful tool in diagnosis after fundus image capture does not impair the functions as an ophthalmic imaging device.
Q3. Do the devices have the same technological characteristics?
No, based on the information available the Mirante has different technological characteristics when compared to the Avanti OCT.

No, based on the information available the Mirante has different technological characteristics when compared to the OPTOS P200DTx SLO.

The differences in OCT that are found are include:

Light source wavelength:
The difference in interference signal emission that is ascribed to the difference in wavelength (40 nm) does not result in any difference in OCT image quality that can affect the diagnosis, considering that resolution of OCT in the Z (depth) direction is on the order of micrometer. Thus, the light source wavelength is considered to be substantially equivalent between the Mirante and the predicate device.
Scan rate (temporal resolution):
The Mirante has a higher scan rate 85,000 A-scan/second versus 70,000 A-scan/second. The higher scan rate results in the time for scanning of 1.54 seconds at 85000 A-scan/sec versus 1.87 seconds at 70,000 A-scan/sec resulting in a difference of less than 0.4 seconds when A-Scan is set to 1024 and B-Scan is set to 128. The slightly decreased imaging time with the Mirante is considered to be substantially equivalent to the predicate device.
Resolution (Optical resolution):
(a) Retina cross-sectional image capture. The Mirante has a lower optical resolution in the horizontal (X-Y ) direction, but the reduced resolution of 20 um does not decrease the essential information for diagnosis.

Resolution in the depth (Z) direction was verified to be less than or equal to 7 um. The actual measured values ranged from 6.62 to 6.94 um in air and from 4.78 to 5.01 um when converted to

17

the values in the eye. This means that the resolution in the Z direction is approximately 5 um in the eye, which is equivalent to the resolution in the depth (Z) direction of the predicate device.

Thus, the resolution in the depth direction is considered to be substantially equivalent between the Mirante and the predicate device.

(b) Anterior segment cross-sectional observation and image capture. The horizontal resolution of the predicate device is unknown, however, resolution in the horizontal (X-Y) direction does not substantially affect the device effectiveness.

Resolution for the Mirante in the depth (Z) direction was verified to be less than or equal to 7 um. The actual measured values ranged from 6.89 to 6.98 um in air and from 4.98 to 5.04 um when converted to the values in the eye. This means that the resolution in the Z direction is approximately 5 µm in the eye, which is equivalent to the resolution in the depth (Z) direction of the predicate device. Thus, the resolution in the depth direction is considered to be substantially equivalent between the Mirante and the predicate device.

. Angle of View:
(a) Retina cross-sectional image capture. The Mirante has a wider scan width than the predicate device, but the wider scan width does not substantially increase the effectiveness. The Mirante has a shorter scan depth than the predicate device by 0.9 mm. The depth of 2.1 mm corresponds to more than 5 times the thickness of the retina, which is a sufficient scan depth for diagnosis and the difference does not decrease the substantial effectiveness. Thus, the scan width and scan depth are considered to be substantially equivalent between the Mirante and the predicate device.

(b) Anterior segment cross-sectional image capture. Mirante has a shorter scan width but the width is sufficient for capturing in one image a range from a cornea center to a corneal peripheral part or from the corneal limbus to the proximity of pupillary edge at the iris that is an important part for diagnosis, and the difference between Mirante and the predicate device does not decrease the substantial effectiveness.

The Mirante has a shorter scan depth than Avanti by 0.2 mm. The depth of 0.2 mm is about 4 times as thick as the cornea and is sufficient for measuring the anterior chamber angle, and the difference does not decrease the substantial effectiveness. Thus, the scan width and scan depth are considered to be substantially equivalent between the Mirante and the predicate device.

Display resolution:
The predicate information for this point is unknown. Because the length per pixel of the Mirante is smaller than the optical resolution, this only contributes to the fineness of the depicted structures and the amount of information obtained for diagnosis remains unchanged. Therefore, this is not considered to be an issue for safety or effectiveness for the Mirante.
. Required pupil diameter:
Although the required pupil diameter of Mirante is larger than that of Avanti, it is assumed that the pupils of most of the patients would be larger than the required pupil diameter under the intended environment. An OCT is intended to be used in a darkened room or half-darkened room and pupils open to an average of 3.24 mm under illumination of 4.00 lux and 4.05 mm under illumination of 0.40 lux. Thus, the required pupil diameter is considered to be substantially equivalent between the Mirante and the predicate OCT device.
. Sensitivity: predicate information for this function is unknown.
[Regular] "OCT Sensitivity" performs high-speed image capture with standard OCT sensitivity, while [Fine] or [Ultra Fine] setting allows a Signal Strength Index (SSI) value higher than that

18

obtained respectively with [Regular] or [Fine] by increasing the OCT sensitivity. The [Fine] or [Ultra Fine] setting may allow capturing of proper cross sectional (OCT) images even though only OCT images with lower quality were captured for the eye with the [Regular] setting.

There are cases where the device does not fully exert its basic performance to capture proper OCT images. Using the [Fine] or [Ultra Fine] setting covers those cases to some extent. In other words, using those settings expands the range where the device fully exerts its effectiveness.

Thus, the provision of the [Fine] or [Ultra Fine] setting does not improve the effectiveness. The increase in the status of target eyes that Mirante can deliver the basic performance (or capture the OCT images) will act to reduce the risk of misdiagnosis due to insufficient information, and will raise no new safety concerns.

OCT Scan Patterns: ●
Although scan patterns are slightly different in terms of names and variations, both the Mirante and the predicate device have similar scan patterns.
Anterior Segment Imaging Function: .
The anterior segment imaging function acquires images used to show the position to which the anterior segment OCT image corresponds, and any essential difference lies in the presence or absence of this function itself; detailed specifications do not affect the essence of this function. Thus, the difference in principle is considered not to cause substantial differences between the Mirante and the predicate device.

The differences in SLO that are found are minor and include:

. Light source wavelength:
Red and infrared wavelengths are different between Mirante and the predicate device. Theoretically, different wavelengths reach different depths in structure but do not cause differences in observation for images related to diagnosis. Although chromatic aberration is also different between the Mirante and the predicate device, this is corrected respectively during color composition and alignment, and also does not cause differences in observation for images related to diagnosis. Thus, the difference in wavelengths is considered not to cause substantial differences between the Mirante and the predicate device.
Resolving Power:
The predicate device resolving power is unknown. The Mirante is considered to have the minimum resolving power required for fundus cameras such as previously cleared AFC-330 (K113451), taking into account the reduction associated with the increased angle of view:

There are no international standards, guidelines, or other official criteria applicable to the optical performance of fundus SLOs. For this reason, NIDEK referred to the requirements for resolving power in ISO 10940:2009 for fundus cameras that are also fundus imaging devices to verify the specifications for resolving power in SLO bench testing provided in Appendix 8 1 34.

ISO 10940:2009, Section 4.2 requires the following resolving power:

Angle of view >30

Center ≧ 60 lp/mm

Center ≥ 40 lp/mm

Periphery ≥ 25 lp/mm

In addition, in general, it is clear that optical performance deteriorates as the angle of view

19

increases.

NIDEK assumed that the above criteria in ISO 10940:2009 to be the minimum requirement for the angle of view of 30°.

In consideration that optical performance decreases as the angle of view increases and based on assumption that the resolving power is inversely proportional to the angle of view for the above criteria in the standard, and the value obtained by multiplying the inverse of the angle of view is assumed to be the criteria of resolving power that corresponds to the angle of view for fundus SLOs.

Based on this assumption, the criteria of resolving power with a normal angle of view of 60° for Mirante are calculated as follows:

Center: 60 lp/mm x 30/60 = 30 lp/mm

Middle: 40 lp/mm x 30/60 = 20 lp/mm

Periphery: 25 lp/mm×30/60 = 12.5 lp/mm

The resolving powers of Mirante with the normal angle of view of Mirante meet the criteria as described on the left:

The criteria of resolving power with a wider angle of 110° for Mirante are calculated as follows:

Center: 60 lp/mm×30/110=16.4 lp/mm

Middle: 40 lp/mm×30/110=10.9 lp/mm

Periphery: 25 lp/mm×30/110=6.8 lp/mm

The resolving powers of the Mirante with a wider angle of view meet the criteria for the center and middle areas meet the criteria as described on the left, while it does not slightly meet the criterion for the periphery.

The eyeball is spherical, and the wider the angle of view, the greater the distortion in the periphery.

With an angle of view of 110°, the periphery is close to the equatorial plane and distortion is close to the maximum. Although the resolution in the periphery may not meet the criterion, this is considered to have no significant impact.

Thus, Mirante is considered to have substantially equivalent resolving power compared to fundus imaging devices on the market.

HD on/off:
This is available for the Mirante but not available for the predicate. The HD on/off function for reducing noises contributes to the convenience, not to the effectiveness. This function is not necessarily essential if a high-quality image is obtained at a time. The presence of this function does not substantially affect the safety and effectiveness of the Mirante.
Angle of View:
Mirante has a smaller angle of view than the predicate device both in normal image capture and wide-field image capture. However, both the Mirante and the predicate device have a 110 to 220degree ultra-wide angle field of view that is defined as an image of the far periphery of the retina, including the anterior edge of the vortex vein ampulla and beyond. Both the Mirante and the predicate device obtain equivalent information that is essentially necessary for diagnosis. Thus, the angle of view is considered to be substantially equivalent between the Mirante and the

20

predicate device.

Required pupil diameter:
Although the required pupil diameter of Mirante is larger than that of the predicate device, it is assumed that the pupils of most of the patients would be larger than the required pupil diameter under the intended environment. An SLO is intended to be used in a darkened room or halfdarkened room and pupils open to an average of 3.24 mm under illumination of 4.00 lux and 4.05 mm under illumination of 0.40 lux. Thus, the required pupil diameter is considered to be substantially equivalent between the Mirante and the predicate OCT device.
. Mode:
Both Mirante and the predicate device have color imaging and fluorescence imaging functions. Although Mirante has infrared light (IR) imaging and retro mode imaging functions, but from a diagnostic standpoint, the information provided by IR images does not essentially exceed that of color SLO images. However, it is essentially a high-contrast monochromatic imaging mode. The retro mode imaging differs from the other imaging modes in its principle; the mode specializes in contrast enhancement and is essentially a high-contrast monochromatic imaging mode.

The differences in SLO modes are considered not to affect the safety and effectiveness.

. Image Size:
Mirante has both lower and higher pixel patterns than the predicate device.

With the setting of 4096 × 4096 pixels for the Mirante, which is a higher pixel number than Optomap plus of the predicate device, the length per pixel is approximately 3.25 um, which is a smaller scale than the resolution. For this reason, smooth and "easy-to-see" images are obtained whose contribution is limited to the convenience because the fineness of the structures that can be depicted remains unchanged and the amount of obtained information for diagnosis remains unchanged. Thus, the resolution is considered to be substantially equivalent between the Mirante and the predicate device.

Panorama:
Whether the predicate device is provided with this function is unknown. The function allows Mirante to capture images for panorama image composition for viewing so that NAVIS-EX overlaps and composes multiple fundus images captured at different angles. The function is equivalent to displaying multiple images captured at different angles at a time. This function increases the convenience but does not increase the amount of information. The presence or absence of this function is considered not to affect the safety and effectiveness.
Focus range/Focus compensation:
Diopter correction compensates for the refractive errors of the patient's eye. Mirante has a wider range of focus for patients, and can target the patients with wider range of refractive errors but this does not affect the safety and effectiveness in clinical use.
Working distance: .
These specifications are related to convenience in image capture but do not affect the safety and effectiveness of the device.

Therefore, the minor differences between the subject device and the predicate devices do not raise new questions of safety or effectiveness. The Nidek Mirante is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent.

Conclusion

21

The Nidek Mirante SLO/OCT has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. A substantial equivalence chart comparing the similarities and differences between the subject device and its predicate device demonstrates substantial equivalence.

Mirante SLO only

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 device OPTOS P200DTx (K142897) with respect to imaging and measurement of ocular structures 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 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.

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

The Comparison Table of Technological Characteristics follows.

22

	Test Device	Predicate Device	Discussion
Device Name	Mirante SLO with NAVIS-EX	P200DTx
510(k) Number		(K142897)
Classification, Product Code	ClassII, HLI, OBO, MYC	ClassII, MYC	Same
Regulation number	21CFR 886.1570	21 CFR 886.1570	Same
	(Ophthalmoscope, AC-Powered)	(Ophthalmoscope, AC-Powered)	Same
Applicant	Nidek Co., Ltd.	Optos, Plc
Intended Use	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.	The P200DTx scanning laser
ophthalmoscope is indicated for 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. It is also indicated for use as a
widefield scanning laser
ophthalmoscope for viewing choroidal
circulation patterns that are
illuminated using Indocyanine Green
dye and for aiding in both the
assessment of choroidal circulation
and in the diagnosis of choroiditis or
choroidal diseases.	Similar
SLO Function
Principle	SLO: Confocal laser scanning method	SLO: Confocal laser scanning method	Same
Light source wavelength	Blue: 488 nm	Blue: 488 nm	The test device has similar light source wavelengths compared
to the predicate device.
	Green: 532 nm	Green: 532 nm
	Red: 670 nm	Red: 635 nm	The difference in wavelengths is considered not to cause
substantial differences between the Mirante and the predicate
	IR (Infrared): 790 nm	IR (Infrared): 802 nm	device.
Resolving power	Regular angle	Unknown	Mirante is considered to have the minimum resolving power
	Center:

Horizontal direction: 32 lp/mm
Vertical direction: 50 lp/mm | Resolving power | required for fundus cameras. Thus, Mirante is considered to
have substantially equivalent resolving power compared to
fundus imaging devices on the market. | |
| | 50% Image height: 25 lp/mm | | | |
| | 95% Image height: 16 lp/mm | | | |
| | Wide angle (Optional) | | | |
| | Test Device | Predicate Device | Discussion | |
| | Center:
Horizontal direction: 17.5 lp/mm
Vertical direction: 28 lp/mm | | | |
| | 50% Image height: 11 lp/mm | | | |
| | 95% Image height: 5.4 lp/mm | | | |
| HD on/off | Available | None | The HD on/off function for reducing noises contributes to the
convenience, not to the effectiveness. The presence of this
function does not substantially affect the safety and
effectiveness of the Mirante. | |
| Angle of view | Regular angle: 60° | 148° x 115° (external to eye) | The predicate devices have different references for the angel
of view. This does not indicate a safety or efficacy issue with
the test device | |
| | Wide angle (Optional): 110° | | Both the Mirante and the predicate device obtain equivalent
information that is essentially necessary for diagnosis. Thus,
the angle of view is considered to be substantially equivalent
between the Mirante and the predicate device. | |
| Required pupil diameter | Regular angle: 3.3 mm in diameter | 2mm | Similar requirements. No safety or efficacy impact. | |
| (Fundus surface imaging function) | Wide angle (Optional): 3.3 mm in
diameter | | | |
| Mode | | Red Free | Similar modes. | |
| | IR (refraction of Infrared light) | | The test device has an I/R mode that is not present in the
predicate. These differences are not expected to have an | |
| | FA(fluorescein angiography using
blue light) | FA | impact on the device safety or efficacy. The differences in
SLO modes are considered not to affect the safety and | |
| | ICG (indocyanine green angiography
using infrared light) | ICG | effectiveness. | |
| | FAF(fundus autofluorescence using
blue or green light) | FAF | | |
| | Color (using blue, green, and red
light) | Color | | |
| | Retro (This mode is to capture the
image of retina that is illuminated
from behind by infrared light scattered
by choroid. This is a kind of
retroillumination method.) | | | |
| | | Test Device | Predicate Device | Discussion |
| Image size | | 4096 × 4096, 2048 × 2048, 1536 ×
1536, 1024 × 1024, 768 × 768, 512 ×
512 | Optomap plus: 3900 pixels (W) x
3072 pixels (H)
Optomap: 2600 pixels (W) x 2048
pixels (H) | Similar
Mirante has both lower and higher pixel patterns than the
predicate device.
Thus, the resolution is considered to be substantially
equivalent between the Mirante and the predicate device. |
| Panorama | | Yes | | predicate information unknown
The function allows Mirante to captures images for panorama
image composition for viewing so that NAVIS-EX overlaps
and composes multiple fundus images captured at different
angles. This function increases the convenience, but does not
increase the amount of information. This function is
considered not to affect the safety and effectiveness. |
| Others | | | | |
| Focus range/Focus compensation | | - 15D to +15D ( V.D.=12 ) | -12D to +7D | Similar
The differences do not affect the safety and effectiveness in
clinical use. |
| Working
distance | Fundus surface / Anterior
segment front imaging
function | 19.0 mm ±1mm (between objective
lens and cornea)
Wide Angle (Optional): 9.0 mm
±1mm or more | Unknown | predicate information unknown
These specifications are related to convenience in image
capture but does not affect the safety and effectiveness. |
| Movement
range | Main body (vertical
movement) | 30 mm | Unknown | |
| Main body (horizontal
movement) | | Forward and backward: 165 mm
Left and right: 110 mm | Unknown | |
| | Chinrest (vertical
movement) | 80 mm | Unknown | |
| Dimensions and Main Body
weight | | [SLO/OCT model]
345 (W) × 548 (D) × 527 to 557 (H)
mm (Image capturing unit)
23 kg (Image capturing unit)
203 (W) × 424 (D) × 438 (H) mm
(Control box)
20 kg (Control box)
[SLO model] | 550(W) × 550(D) × 608 to 632(H)
mm
34 kg | |
| | | Test Device | Predicate Device | Discussion |
| | | 345 (W) × 548 (D) × 527 to 557 (H) mm (Image capturing unit) | | |
| | | 22 kg (Image capturing unit) | | |
| | | 203 (W) × 424 (D) × 438 (H) mm
(Control box) | | |
| | | 16 kg (Control box) | | |
| | Isolation Transformer | 130 (W) × 220 (D) × 125 (H) mm | | |
| | | 7.0 kg | | |
| | Computer | 177 (W) × 480 (D) × 426 (H) mm | | |
| | | 19 kg (Computer) | | |
| | | 508 (W) × 56 (D) × 325 (H) mm | | |
| | | 4.0 kg (Computer monitor) | | |
| Power supply | Main Body | AC100V-240V150VA, 50/60Hz | 100-240Vac, 50/60Hz | |
| specifications | Isolation Transformer | AC100V1000VA, 50/60Hz | | |
| | Computer | 400 W (Computer) | | |
| | | 27 W (Computer monitor) | | |
| Others | Auto shot | Yes (OCT) | Yes | Similar |
| | Eye Tracer | Yes | Unknown | predicate information unknown |
| | Color Fundus image
capture mode | Pseudo Color | Pseudo Color | Similar |
| | External fixation lamp | Yes | None | Same |
| Appearance | | Image: Optical device | Image: Optical device | |

Table 2: Comparison Table of Technological Characteristics – Mirante SLO

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With regards to the technical differences between the Mirante, the Avanti and the P200DTx in the Comparison Table above the clinical and non-clinical testing demonstrates that the differences do not raise any new questions about safety and effectiveness.

Substantial Equivalence Discussion for the Nidek Mirante per the 510(k) Decision-Making Flowchart

Q1. Are the predicate device(s) legally marketed?
Yes, the predicate device Avanti OCT was cleared in K180660 and the OPTOS P200DTx SLO was cleared in K142897.
Q2. Do the devices have the same intended use?
Yes, the Mirante OCT/SLO has the same intended use as the predicate devices except that the Mirante does not include a normative database.
Q3. Do the devices have the same technological characteristics?
No. based on the information available the Mirante has different technological characteristics when compared to the OPTOS P200DTx SLO. The differences found are minor and are summarized in Section 9.1.3 above.

However, the minor differences between the subject device and the predicate device do not raise new questions of safety or effectiveness. The Nidek Mirante is as safe and effective as its predicate device, and thus, may be considered substantially equivalent.

1.1.1.1. Conclusion

The Nidek Mirante has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. A substantial equivalence chart comparing the similarities and differences between the subject device and its predicate device demonstrates substantial equivalence.

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.

Performance testing, including both bench testing and clinical testing, demonstrate substantial equivalence.

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, RTVue XR Avanti (K180660) and OPTOS P200DTx (K142897). The differences between the proposed device, Mirante, and the predicate device are insignificant and do not raise new issues of safety or effectiveness of the Nidek Mirante is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent.

Performance Testing

The Mirante has been verified for performance and functionality to assure conformance to the requirements for its

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basic intended use.

The Mirante's compliance to electrical safety, light safety and biocompatibility has been established. The software development lifecycle and the associated verification activities have no unresolved major or critical bugs. A list of testing conducted included:

Medical electrical equipment Part 1: General requirements for basic safety and essential . performance: AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
. Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests: IEC 60601-1-2:2014
. Medical device software - Software life cycle processes: IEC 62304: Edition 1.1 2015-06
Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]: IEC 62366-1: Edition 1.0 2015-02
American National Standard for Ophthalmics Light Hazard Protection for Ophthalmic ● Instruments: ANSI Z80.36-2016
. Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]: IEC 60825-1: Edition 2.0 2007-03
. Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments: ISO 15004-1: First edition 2006-06-01
Health software - Part 1: General requirements for product safety: IEC 82304-1 Edition 1.0 2016-10

The biocompatibility of the skin contacting materials was previously established for the SL-2000 (K163564) and the materials are identical to those previously approved.

Software documentation has been prepared and submitted for a "moderate" Level of Concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The device software was verified and validated to support the proposed indications for use according to IEC 62304:2015 Medical device software life cycle processes and FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

Risk Analvsis

The device and the device software have been assessed to make sure all the risks were sufficiently mitigated according to the intended use. Identification of the associated hazards has been performed in order to evaluate, estimate and control the associated risks in accordance with EN ISO 14971 Application of risk analysis to medical devices.

Clinical Performance

Clinical performance testing was conducted to demonstrate substantial equivalence. A prospective, comparative clinical study was conducted in compliance with 21 CFR parts 50, 56, and 812 at one clinical site in the United States. The clinical testing was not subject to the regulations under 21 CFR 56.104 or 56.105. The primary purpose of the clinical study was to assess agreement and precision of the Nidek Mirante OCT in comparison with Avantı OCT and to assess image quality of Nidek Mirante OCT Anterior Chamber Angle image compared to Avanti. Additionally, the Nidek Mirante SLO image quality was compared to the OPTOS P200DTx. The secondary purpose was to evaluate any adverse event found during the clinical study.

Subject Disposition:

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A total of 170 subjects were enrolled in the study and included in the Safety Analysis Set and Full Analysis Set. This included:

45 subjects in the Normal group,
46 subjects in the Glaucoma group, ●
47 subjects in the Retinal Disease group, and ●
32 subjects in the Corneal Disease group. .

Of those, three subjects in the Glaucoma group discontinued due to a major protocol deviation of inclusion/exclusion and randomization category. A total of 167 subjects completed the study.

Demography and Baseline Characteristics:

The mean (standard deviation [SD]) age in the Full Analysis Set was:

44.9 (15.36) years for the normal eye subjects, ●
65.1 (9.20) years for the Glaucoma subjects,
69.7 (11.23) years for the Retinal Disease subjects, and ●
55.4 (15.09) years for the Corneal Disease subjects.

The overall mean age for all subjects was 59.2 (16.05) years, with the majority of subjects aged