Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary mentions "image processing" but does not explicitly mention AI, ML, or any related terms like deep learning or neural networks. The performance studies focus on agreement and precision of measurements, not on the performance of an AI/ML algorithm.

Therapeutic

No
The device is described as a system for imaging and measurement, indicated as an aid in diagnosis and management of ocular disease, not for treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis and management of adults having or suspected of having ocular disease." This indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description clearly states that the system includes the Nidek Optical Coherence Tomography RS-3000, which is a physical ophthalmic instrument (hardware) that acquires image data. The software (NAVIS-EX) is used for managing and processing the images acquired by the hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Nidek Optical Coherence Tomography RS-3000 is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the system is for "in vivo imaging and measurement of ocular structures" as an aid in the diagnosis and management of ocular disease. IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body).
Device Description: The description reinforces that it's an ophthalmic instrument for observing and analyzing the eye in a non-contact and non-invasive manner. This is consistent with an in vivo imaging device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or performing tests on samples taken from the body.

Therefore, the Nidek Optical Coherence Tomography RS-3000 is an in vivo imaging device used for ophthalmic diagnosis and management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function 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, and optic disc, and
. the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter),
as an aid in the diagnosis and management of adults having or suspected of having ocular disease.

Product codes

OBO

Device Description

The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX. is an ophthalmic instrument to observe and analyze the fundus, and the shape or the lesion of the retina in a non-contact and non-invasive manner. In addition, the anterior segment adapter attached over the objective lens of the main body enables non-invasive and noncontact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle. The image filing software NAVIS-EX permits management and various diagnoses of captured images. When the personal computer (PC) with the NAVIS-EX installed is connected to the RS-3000 through a cable, the image data acquired by the RS-3000 is transmitted. The software offers the functions such as filing, external 1/F, image processing.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), Confocal scanning laser ophthalmoscopy

Anatomical Site

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

Indicated Patient Age Range

adults

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 prospective clinical study was conducted at one clinical site located in the United States. A total of 89 subjects were enrolled to provide at least 80 evaluable eyes for the agreement measurements and at least 48 evaluable eyes for the precision and registration i measurements.
The subject eye groups consisted of the following four groups: (1) Normal Eyes; (2) Eyes with Retinal Disease; (3) Eyes with Glaucoma and (4) Eyes with Corneal Disease (including eyes having undergone keratorefractive surgery). All study eyes were evaluated for the agreement and device capability assessments of this study. The first 12 eyes that had completed the study of each of the four study eye populations enrolled were evaluated for the precision assessment of the study. The first 12 eyes of the normal, retinal disease and glaucoma study eye groups that had completed the study were evaluated for the registration assessment. If both eyes of a subject were eligible for the study, one eye was selected randomly for evaluation. Both eyes of the normal eye study group must have met all normal eligibility criteria to participate in the study. The order of device testing was randomized.
Three Nidek RS-3000 devices and three Optovue RTVue devices were used. Each RS-3000 device was paired with one RTVue device for a total of three RS-3000/RTVue device pairs. Each of the three device pairs was designated one, and only one, operator for a total of three operator and device pairs for the precision and registration scans acquired for this study. Each operator and device pair was considered one configuration for a total of three specific operator/device configurations. Study eyes evaluated for precision and registration assessments were equally distributed among the three operator/device configurations.

Agreement Assessment: Twenty study eyes from each eye group that completed the study were included in the agreement assessment. The first acceptable RS-3000 scan with follow-up off and the first acceptable RTVue scan were designated as the agreement scans. Scans were acquired to capture the clinical data points for each of the agreement primary clinical endpoints.

Precision Assessment: The first 12 study eyes that completed the study from each eye population within the agreement assessment cohort were designated for the precision assessment. Each operator/device configuration tested four of the 12 study eyes for each eye group. Three measurements from each device were taken of each eye. This is a nested design with three configurations, four eyes per configuration and three measurements per device per eye. All three RS-3000 and RTVve scans had the registration feature disabled (follow-up off). Scans were acquired to capture the clinical data points for each of the precision primary clinical endpoints.

RS-3000 Registration Assessment: The same three specific operator/device configurations used in the precision assessment were used for the registration assessment of the RS-3000. The same 12 study eyes from each eye group for the precision assessment (excluding the corneal disease group as the RS-3000 does not have a registration feature associated with the pachymetry measurement) were designated for the registration assessment. The third acceptable scan obtained in the precision assessment was designated as the "baseline" scan. Three additional scans with the registration feature enabled (follow-up on) were acquired following the baseline scan. Scans were acquired to capture the clinical data points for each of the registration primary clinical endpoints.

Device Capability Assessment: All study eyes from each subject group were included for the SLO Quality Assessment. Utilizing the single scan acquired for the agreement assessment with the RS-3000 (only), the quality of the SLO image for each study eve was assessed by a Reading Center.

Safety Assessment: Safety endpoints were defined as any adverse events identified during the clinical study. There were zero adverse events that occurred during this clinical study.

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

Agreement Assessment:
For the normal subjects, the RS-3000 measured an average of 16.2, 19.0, 17.8, and 18.4μm greater than the RTVue in four segments (nasal 2, temporal 2, superior 2 and inferior 2, respectively) for Total Retinal Thickness. For the retinal group, all nine segments showed agreement between the two devices for Total Retinal Thickness.
For the normal subjects, the RS-3000 measured an average of 20.0, 10.6, and 14.3um less than the RTVue in three segments (temporal 1, superior 1, and inferior 1. respectively) for Inner Retinal Thickness. For the retinal group, all eight segments showed agreement between the two devices for Inner Retinal Thickness.
For the normal subjects, the RS-3000 measured an average of 14.7 to 34.3um greater than the RTVue in all nine segments for Outer Retinal Thickness. For the retinal group, all but 1 segment showed agreement between the two devices for Outer Retinal Thickness.
For all subjects, in both the normal and glaucoma study groups, the RS-3000 showed agreement with the RTVue in all four quadrants and in the total mean for Retinal Nerve Fiber Layer Thickness.
For all subjects, in both the normal and glaucoma study groups, the RS-3000 showed agreement with the RTVue in all four parameters analyzed, C/D horizontal, C/D vertical, Disc area and Cup area for Optic Disc Analysis.
The RS-3000 measured an average of 13.4um higher than the RTVue for the measurement of central corneal thickness for the normal study group. In the corneal group, no significant differences in the measurement of central corneal thickness were found between the two devices.

Precision Results:
For the normal group, the repeatability limits (range: 2.8 to 7.393μm) and the reproducibility limits (range: 2.8 to 7.393µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (the repeatability limits and the reproducibility limits of RTVue have the same range: 6.313 to 17.746um) for Total Retinal Thickness. The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.761 to 6.55um).
For the normal group, the repeatability limits (range: 1.476 to 5.442um) and the reproducibility limits (range: 1.476 to 5.442µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (repeatability limit range: 3.461 to 10.601um; reproductbility limit range: 3.461 to 11.843um) for Inner Retinal Thickness. The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.034 to 5.280um).
For the normal group, the repeatability limits (range: 2.425 to 4.174 m) and the reproducibility limits (range: 2.425 to 5.032µm) of RS-3000 with follow-up off tended to be smaller than that of the RTVue (the repeatability limits and the reproducibility limits of RTVue have the same range: 7.961 to 12.531µm) in all segments for Outer Retinal Thickness. The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.139 to 4.252um}.
For the normal group, the repeatability and reproducibility limits were similar in all but 2 segments between the 2 settings of RS-3000 for G-Chart Thickness. The repeatability limits of the 2 inferior/temporal segments were greater in the off setting than the on setting.
For the normal group, the repeatability limits (range: 6.682 to 20.661um) and the reproducibility limits (range: 6.682 to 21.575um) of RS-3000 with follow-up off tended to be larger than that of the RTVue (the repeatability limit range: 3.508 to 8.516um; the reproducibility limit range: 3.508 to 14.148µm) for Retinal Nerve Fiber Layer. The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 8.043 to 16.413um).
For the normal group, the repeatability limits of RS-3000 with follow-up off (range: 0.058 to 0.478µm) tended to be larger in C/D horizontal, disc area and cup area, and smaller in C/D vertical than that of the RTVue (range: 0.073 to 0.196um) for Optic Disc Analysis. The reproducibility limits were similar between RS-3000 with follow-up off (range: 0.241 to 1.029µm) and RTVue (range: 0.238 to 1.039um), except for disc area in which the RS-3000 with follow-up off tended to be larger.
The repeatability limits of RS-3000 were larger than that of the RTVue in both the normal (8.15µm and 3.024um, respectively) and corneal groups (18.933um and 3.199um, respectively) for Central Corneal Thickness. The reproducibility limit of RS-3000 was larger than that of the RTVue in the normal group (31.336um and 3.024µm, respectively), but similar between the two devices in the corneal group (57.874µm and 53.963um, respectively).
There were zero adverse events that occurred during this clinical study.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Agreement: Mean Difference, 95% CI for Mean Difference, 95% LOA for Mean Difference
Precision: Repeatability SD, Repeatability Limit, Reproducibility SD, Reproducibility Limit, CV% based on Repeatability, CV% based on Reproducibility

Predicate Device(s)

K101505, K11505, K083291

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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

1. 510(K) SUMMARY

Date Prepared: March 14, 2013

MAR 1 4 2013

・・

1

SPONSOR/510(K) OWNER/ MANUFACTURER

Nidek Co., Ltd. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Telephone: +81-533-67-8901 Facsimile: +81-533-67-6628 Email: yoneji_mizuno@nidek.co.jp Establishment Registration Number: 8030392

OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281 Telephone: (440) 554-3706 Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com

COMMON/USUAL NAME

Optical Coherence Tomography

PROPRIETARY OR TRADE NAMES

RS-3000

1

K12/622

K121622 510{k) Summary

CLASSIFICATION INFORMATION

Classification Name: Medical Specialty: Device Class: Classification Panel: Product Codes:

Ophthalmoscope, A-C Powered Ophthalmic II Ophthalmic Device Panel ово

PRODUCT CODE: CLASSIFICATION / CFR TITLE

·OBO:

Class II § 21 CFR 886.1570

LEGALLY MARKETED PREDICATE DEVICE

Trade/Device Name: RTVue with Normative Database Applicant: Optovue 510{k} Premarket Notification number: K101505 Classification: Class II FDA Product Code: HLI Establishment Registration number: 3005950902 Trade/Device Name: RTVue CAM with Corneal Power Measurement Applicant: Optovue 510(k) Premarket Notification number: K11505 Classification: Class II FDA Product Code: OBO, MMQ Establishment Registration number: 3005950902 Trade/Device Name: Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Database Applicant: Carl Zeiss 510(k) Premarket Notification number: K083291 Classification: Class II FDA Product Code: HLI Establishment Registration number: 2918630

2

K121622

K121622 510{k) Summary

GENERAL DEVICE DESCRIPTION

The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX. is an ophthalmic instrument to observe and analyze the fundus, and the shape or the lesion of the retina in a non-contact and non-invasive manner. In addition, the anterior segment adapter attached over the objective lens of the main body enables non-invasive and noncontact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle. The image filing software NAVIS-EX permits management and various diagnoses of captured images. When the personal computer (PC) with the NAVIS-EX installed is connected to the RS-3000 through a cable, the image data acquired by the RS-3000 is transmitted. The software offers the functions such as filing, external 1/F, image processing.

INDICATIONS FOR USE - RS-3000

The Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function 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, and optic disc, and
. the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter),

as an aid in the diagnosis and management of adults having or suspected of having ocular disease.

3

K121622

K121622 510(k) Summary

DEVICE DESCRIPTION

Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, is an ophthalmic instrument to observe and analyze the fundus, and the shape or the lesion of the retina in a non-contact and non-invasive manner. In addition, the anterior segment adapter attached over the objective lens of the main body enables non-invasive and noncontact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle.

By using confocal laser scanning ophthalmoscopy with a 785nm near-infrared light source, the fundus image (hereinafter referred to as SLO image) is obtained; and by optical coherence tomography with an 880 nm infrared light, the cross-sectional image of the fundus (hereinafter referred to as OCT image) is obtained. '

The images captured using the RS-3000 allow observation of the fundus, and the shape, structure, and lesion of the patient's retina. In addition, the anterior segment adapter attached over the objective lens of the main body of the RS-3000 enables non-invasive and non-contact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle. The RS-3000 system is comprised of the following components: Main body, PC, PC monitor, Image Filing Software NAVIS-EX and isolation transformer. The NAVIS-EX software permits the management of various analyses of the captured images.

The image filing software NAVIS-EX permits management and various diagnoses of captured images. When the personal computer (PC) with the NAVIS-EX installed is connected to the RS-3000 through a cable, the image data acquired by the RS-3000 is transmitted. The software offers functions such as filing, external I/F, and Image processing. ﻟﻤﻤﻠﻜﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

SUBSTANTIAL EQUIVALENCE

The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, is similar in technological characteristics, performance and has the same intended use as the predicate device(s). Any differences in technological characteristics between the Nidek Optical Coherence Tomography RS-3000 with Image Filing Software NAVIS-EX and the predicate device do not raise any new questions of safety or effectiveness. Thus, the RS-3000 with Image Filing Software NAVIS-EX is substantially equivalent to the predicate device(s).

4

KI21622

5 •

K121622 510(k) Summary

COMPARISON TABLE OF TECHNOLOGICAL CHARACTERISTICS

Substantial Equivalence Comparison Table: RTVue
Feature	RS-3000 with NAVIS-EX	RTVue, CA
Manufacturer	NIDEK	Optovue
510(k) Number	K121622	K101505
Classification	886.1570	886.1570
Product Code	OBO	HLI
Intended Use
	The Nidek Optical Coherence
Tomography RS-3000 including
scanning laser ophthalmoscope
function 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, and optic disc, and
• the anterior chamber and
cornea (when used with the
optional auxiliary anterior
chamber adapter),
as an aid in the diagnosis and
management of adults having or
suspected of having ocular
disease.	The RTVue with Normative
Database is an optical
coherence tomography system
indicated for the in vivo
imaging and measurement of
the retina, retinal nerve fiber
layer, and optic disk as an aid
in the diagnosis and
management of retinal disease.
The RTVue with Normative
database 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 known normal subjects. It is
intended for use as a diagnostic
device to aid in the detection
and management of ocular
disease.
Performance Features
Measurement principle
Imaging of the
Fundus/Anterior
Segment	Confocal scanning laser
ophthalmoscopy for RS-3000	Near IR observation
Tomographic Imaging
of the
Fundus/Anterior
Segment	Spectral Domain OCT	Spectral Domain OCT
Scan rate (in OCT Image
capture)	53,000 A-Scan/s	26,000 A-Scan/s
Light source wavelength
Imaging of the
Fundus/Anterior
Segment	785 nm (Diode laser) for RS-
3000,	735 nm (LED)
Tomographic Imaging
of the
Fundus/Anterior
Segment	880 nm (SLD)	840 nm (SLD)

Imaging of the Fundus	25 µm (in the X and Y directions)
for RS-3000(SLO)	25 µm (in the X and Y
directions)
Tomographic Imaging
of the Fundus	20 µm (in the X and Y
directions), 7 µm (in the Z
direction)	15 µm (in the X and Y
directions), 5 µm (in the Z
direction)
Imaging of the
Anterior Segment	50 µm (in the X and Y directions)
for RS-3000(SLO)	70 µm (in the X and Y
directions)
Tomographic Imaging
of the Anterior
Segment	20 µm (in the X and Y
directions), 7 µm (in the Z
direction)	15 µm (in the X and Y
directions), 5 µm (in the Z
direction)
Minimum pupil
diameter required	φ2.5 mm	φ2.5mm
Focus range	-15 D to +10 D	-15 D to +20 D
Field of view
Imaging of the Fundus	40°× 30 °for RS-3000,	32°×22°
Tomographic Imaging
of the Fundus	Scan width:
3 mm to 9 mm
Scan depth:
2.1 mm	Scan width:
2 mm to 12 mm
Scan depth:
2 mm to 2.3 mm
Imaging of the
Anterior Segment	14 mm×12 mm	5.75mm×4.3mm / 12mm×8mm
Tomographic Imaging
of the Anterior
Segment	Scan width:
2 mm to 8 mm
Scan depth:
2.1 mm	Scan width:
1 mm to 3 mm
/ 2 mm to 6 mm
Scan depth:
1.96 mm / 2.3 mm
Measurement and Analysis
3D Volume Rendering	Yes	Yes
Retinal Thickness
measurement (Total/Inner
layer)	Yes	Yes
RNFL Thickness
measurement	Yes	Yes
Optic Disc analysis	Yes	Yes
Pachymetry	Yes	Yes
Angle analysis	Yes	Yes

5

6

K121622

6

K12/622

K121622 510(k) Summary

Substantial Equivalence Comparison Table: Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Database
Feature	RS-3000 with NAVIS-EX	Cirrus HD-OCT
Manufacturer	NIDEK	Carl Zeiss
510(k) Number	K121622	K083291
Classification	886.1570	886.1570
Product Code	OBO	OBO
Intended Use
	The Nidek Optical Coherence Tomography
RS-3000 including scanning laser
ophthalmoscope function 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, and optic disc, and the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter), as an aid in the diagnosis and management
of adults having or suspected of having
ocular disease.	The Cirrus™ HD-OCT is a non-contact, high
resolution tomographic and biomicroscopic
imaging device. It is indicated for in-vivo
viewing, axial cross-sectional, and three
dimensional imaging and measurement of
anterior and posterior ocular structures,
including cornea, retina, retinal fiber layer,
macula, and optic disc. The Cirrus HD-OCT
with Retinal Nerve Fiber Layer (RNFL) and
Macular Normative Database is a
quantitative tool for the comparison of
retinal nerve fiber layer and the macula in
the human retina to a database of known
normal subjects. It is intended for use as a
diagnostic device to aid in the detection and
management of ocular diseases including,
but not limited to, macular holes, cystoid
macular edema, diabetic retinopathy, age-
related macular degeneration, and
glaucoma.
Performance Features
Measurement
principle	Confocal scanning laser ophthalmoscopy	Confocal scanning laser ophthalmoscopy
Light source
wavelength	785 nm (Diode laser)	750 nm (SLD)
Optical power	320μW	20Hz
Field of view	40°x 30°	36°× 30°
Lateral resolution	25 μm	25 μm
Focus adjustment
range	-15D to +10D	-20D to +20D
Detector type	APD	Line CCD
External fixation lamp	Provided	Provided
Anterior segment
imaging	Yes	Yes

7

NON-CLINICAL PERFORMANCE SUMMARY

See Appendix 10 and Appendix 11 for supporting documentation regarding non-clinical performance testing.

The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, was evaluated according to the requirements of FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 62304, IEC 62366, ISO 15004-1, and ISO15004-2) and were found to meet the requirements of the applicable parts.

Bench testing of the repeatability and reproducibility of thickness measurement using the RS-3000 on a model eye was performed by multiple operators. Analysis of measurement errors in each result maintains sufficient accuracy with the device requirement specification of ± 5% accuracy of thickness measurements. As a result of this testing, the RS-3000 was found to maintain sufficient accuracy and to meet requirement specifications.

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8

K12/622

CLINICAL SUMMARY

A prospective clinical study was conducted at one clinical site located in the United States. A total of 89 subjects were enrolled to provide at least 80 evaluable eyes for the agreement measurements and at least 48 evaluable eyes for the precision and registration i measurements.

The specific objectives of the study were to:

a. assess the agreement of the measurements of Total Retinal Thickness [ILM-RPE], Inner Retinal Thickness [ILM-IPL/INL], Outer Retinal Thickness [IPL/INL-RPE], Retinal Nerve Fiber Layer (RNFL) Thickness, Optic Disc Analysis and Central Corneal Thickness between the Nidek OCT RS-3000 and the Optovue RTVue1 predicate device;
b. compare the quality of the Anterior Chamber Angle OCT image between the Nidek RS-3000 and the Optovue RTVue predicate device;
c. assess the precision of the Nidek RS-3000 and the Optovue RTVue with respect to the measurements of Total Retinal Thickness [ILM-RPE], G Chart [NFL+GCL+IPL] Thickness (RS-3000 only), Inner Retinal Thickness [ILM-IPL/INL], Outer Retinal Thickness [IPL/INL-RPE], RNFL Thickness, Optic Disc Analysis and Central Corneal Thickness;
d. compare the precision of the Nidek RS-3000 to the precision of the Optovue RTVue;
e. obtain a quality assessment of the SLO image of the RS-3000; and
assess the registration function of the RS-3000. ﺖ

The subject eye groups consisted of the following four groups: (1) Normal Eyes; (2) Eyes with Retinal Disease; (3) Eyes with Glaucoma and (4) Eyes with Corneal Disease (including eyes having undergone keratorefractive surgery). All study eyes were evaluated for the agreement and device capability assessments of this study. The first 12 eyes that had completed the study of each of the four study eye populations enrolled were evaluated for the precision assessment of the study. The first 12 eyes of the normal, retinal disease and glaucoma study eye groups that had completed the study were evaluated for the registration assessment. If both eyes of a subject were eligible for the study, one eye was selected randomly for evaluation. Both eyes of the normal eye study group must have met all normal eligibility criteria to participate in the study. The order of device testing was randomized.

Three Nidek RS-3000 devices and three Optovue RTVue devices were used. Each RS-3000 device was paired with one RTVue device for a total of three RS-3000/RTVue device pairs. Each of the three device pairs was designated one, and only one, operator for a total of three operator and device pairs for the precision and registration scans acquired for this study. Each operator and device pair was considered one configuration for a total of three

' The RTVue OCT is 510(k) cleared by the U.S. Food and Drug Administration and is commercially distributed in the United States; K101505.

9

10

specific operator/device configurations. Study eyes evaluated for precision and registration assessments were equally distributed among the three operator/device configurations.

Agreement Assessment: Twenty study eyes from each eye group that completed the study were included in the agreement assessment. The first acceptable RS-3000 scan with follow-up off and the first acceptable RTVue scan were designated as the agreement scans. Scans were acquired to capture the clinical data points for each of the agreement primary clinical endpoints.

Precision Assessment: The first 12 study eyes that completed the study from each eye population within the agreement assessment cohort were designated for the precision assessment. Each operator/device configuration tested four of the 12 study eyes for each eye group. Three measurements from each device were taken of each eye. This is a nested design with three configurations, four eyes per configuration and three measurements per device per eye. All three RS-3000 and RTVve scans had the registration feature disabled (follow-up off). Scans were acquired to capture the clinical data points for each of the precision primary clinical endpoints.

RS-3000 Registration Assessment: The same three specific operator/device configurations used in the precision assessment were used for the registration assessment of the RS-3000. The same 12 study eyes from each eye group for the precision assessment (excluding the corneal disease group as the RS-3000 does not have a registration feature associated with the pachymetry measurement) were designated for the registration assessment. The third acceptable scan obtained in the precision assessment was designated as the "baseline" scan. Three additional scans with the registration feature enabled (follow-up on) were acquired following the baseline scan. Scans were acquired to capture the clinical data points for each of the registration primary clinical endpoints.

Device Capability Assessment: All study eyes from each subject group were included for the SLO Quality Assessment. Utilizing the single scan acquired for the agreement assessment with the RS-3000 (only), the quality of the SLO image for each study eve was assessed by a Reading Center.

Safety Assessment: Safety endpoints were defined as any adverse events identified during the clinical study. There were zero adverse events that occurred during this clinical study.

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Clinical Endpoints:

| | Data points | RS-3000
and
RTVue | RS-
3000
only | Agreement | Precision | Registration [RS-
3000 only] |
|----------------------------|------------------------------------------------|-------------------------|---------------------|-----------|-----------|---------------------------------|
| Total Retinal
Thickness | 9 segments | X | | X | X | X |
| Inner Retinal
Thickness | RS-3000: 8
segments
RTVue: 9
segments | X | | X | X | X |
| Outer Retinal
Thickness | 9 segments | X | | X | X | X |
| RNFL | TSNI | X | | X | X | X |
| G Chart | 8 segments | X | X | X | X | X |
| Optic Disc
Analysis | C/D Ratio, Disc
Area, Cup Area | X | | X | X | X |
| Pachymetry | Central Corneal
Thickness | X | | X | | |
| Anterior
Chamber Image | Image
Assessment | X | | X | | |
| SLO Image | Image
Assessment | | X | | | |

Scan Patterns and Scan Parameters:

| | RS-3000 Scan Pattern :
Parameter | RTVue Scan Pattern : Parameter |
|-------------------------|-------------------------------------|----------------------------------------------------------------|
| Total Retinal Thickness | Macular Map : 6 x 6mm | EMM5 Scan: 6 x 6mm |
| Inner Retinal Thickness | | |
| Outer Retinal Thickness | | |
| G Chart | | Image: [scan] |
| SLO Image | | |
| RNFL | Disc Map :4.5 x 4.5mm | ONH Scan + 3D Disc Map : Radial
Scans 3.45mm Circular Scans |
| Optic Disc Analysis | | |
| Pachymetry | Corneal Radial : 6 x 6mm | Cam-L Pachymetry: 6mm Radial Scans
with Circle |
| Anterior Chamber Image | ACA Line : 4mm | CS-HD Angle : 4mm |

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Acceptability of Scans:

Study technicians were instructed to acquire the minimum number of "acceptable" required scans for agreement and precision analysis as dictated in the clinical study protocol. Reasons for not accepting a scan included: Poor SSI (Signal Strength Index), Poor Patient Cooperation, Device Malfunction, Ocular Obstruction, Eye Blink, Eye Movement and Scan Pattern Cut Off and Other.

For the Total Retinal Thickness scans, there are 7.1%, 32.2% and 4.7% unacceptable scans for RS-3000 with follow-up off, RS-3000 with follow-up on and RTVue, respectively. The most common reasons for unacceptable scans are scan pattern (5.6%, RS-3000 with followup off), others (22.6%, RS-3000 with follow-up on), and eye blink and other (1.9% each, RTVue). Twenty-four of the 26 other reasons for RS-3000 with follow-up on were indicated as not aligning with baseline. The Inner and Outer Retinal Thickness scans had very similar unacceptable rates.

For the G-chart scans, there are 7.1% and 22.9% unacceptable scans for RS-3000 with follow-up off and on, respectively. The most common reasons for unacceptable scans are scan pattern (5.1%, RS-3000 with follow-up off) and others (16.2%, RS-3000 with followup on). Sixteen of the 17 other reasons for RS-3000 with follow-up on were indicated as not aligning with baseline.

For the RNFL and Optic Disc scans, there are 14.2%, 29.4% and 5.6% unacceptable scans for RS-3000 with follow-up off, RS-3000 with follow-up on and RTVue, respectively. The most common reasons for unacceptable scans are scan pattern (5%, RS-3000 with followup off) and others (16:8%, RS-3000 with follow-up on and 3.7%, RTVue). Eighteen of the 20 other reasons for RS-3000 with follow-up on were indicated as not aligning with baseline.

For the Central Corneal Thickness scans, there are 27.7% and 4.6% unacceptable scans for RS-3000 and RTVue, respectively. The most common reasons for unacceptable scans are scan pattern (4.1%, RS-3000), and poor SSI (1.9%, RTVue).

For the Anterior Chamber scans, there are 40.7% and 2.2% unacceptable scans for RS-3000 and RTVue, respectively. The most common reasons for unacceptable scans are poor patient cooperation (26%, RS-3000), and poor SSI and eye blink (1.1% each, RTVue).

The RS-3000 unacceptable scan rates were:

lower in the normal group than the retinal group in retinal thickness scans (6% and . 9.4% for follow-up off, and 20.4% and 40.9% for follow-up on),
lower in the normal group than the glaucoma group in G-chart scans (2.5% and . 10.3% for follow-up off, and 20.4% and 25% for follow-up on),
lower in the normal group than the retinal group in RNFL scans (13% and 14.8% for . follow-up off", and 20.4% and 37.3% for follow-up on),

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lower in the normal group than the glaucoma group and the corneal group in Central Corneal Thickness scans (23%, 32.6% and 26.2%, respectively), and
. similar among the four eye groups (from 37.1% to 44.7%) in Anterior Chamber scans.

Agreement Results:

Total Retinal Thickness

Limit of agreement analysis of the total retinal thickness is summarized in tables 1 through 4 below. For the normal subjects, the RS-3000 measured an average of 16.2, 19.0, 17.8, and 18.4μm greater than the RTVue in four segments (nasal 2, temporal 2, superior 2 and inferior 2, respectively). For the retinal group, all nine segments showed agreement between the two devices.

Inner Retinal Thickness

Limit of agreement analysis of the inner retinal thickness is summarized n tables 1 through 4 below. For the normal subjects, the RS-3000 measured an average of 20.0, 10.6, and 14.3um less than the RTVue in three segments (temporal 1, superior 1, and inferior 1. respectively). For the retinal group, all eight segments showed agreement between the two devices.

Outer Retinal Thickness

Limit of agreement analysis of the total retinal thickness is summarized in tables 1 through 4 below. For the normal subjects, the RS-3000 measured an average of 14.7 to 34.3um greater than the RTVue in all nine segments. For the retinal group, all but 1 segment showed agreement between the two devices. The RS-3000 measured an average of 21.3um greater than the RTVue in the temporal segment 1.

Retinal Nerve Fiber Laver Thickness

Limit of agreement analysis of the retinal nerve fiber layer is summarized in tables 1 through 4 below. For all subjects, in both the normal and glaucoma study groups, the RS-3000 showed agreement with the RTVue in all four quadrants and in the total mean.

Optic Disc Analysis

Limit of agreement analysis of the optic disc analysis is summarized in tables 1 through 4 below. For all subjects, in both the normal and glaucoma study groups, the RS-3000 showed agreement with the RTVue in all four parameters analyzed, C/D horizontal, C/D vertical, Disc area and Cup area.

Central Corneal Thickness

The RS-3000 measured an average of 13.4um higher than the RTVue for the measurement of central corneal thickness for the normal study group. In the corneal group, no significant differences in the measurement of central corneal thickness were found between the two devices.

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| n Mean (SD) | RTVue
Mean (SD) | Difference
Mean (SD) | 95% CI for
Mean
Difference | 95% LOA
for Mean
Difference | |
|------------------------------------------|--- | Total Retinal Thickness (µm) | | Nasal 1 | 20 | Nasal 2 | 20 | Center | 20 | Temporal 1 | 20 | Temporal 2 | 20 | Superior 1 | 20 | Superior 2 | 20 | Inferior 1 | 20 | Inferior 2 | 20 | Inner Retinal Thickness (µm) | | Nasal 1 | 20 | Nasal 2 | 20 | Temporal 1 | 20 | Temporal 2 | 20 | Superior 1 | 20 | Superior 2 | 20 | Inferior 1 | 20 | Inferior 2 | 20 | Outer Retinal Thickness (µm) | | Nasal 1 | 20 | Nasal 2 | 20 | Center | 20 | Temporal 1 | 20 | Temporal 2 | 20 | Superior 1 | 20 | Superior 2 | 20 | Inferior 1 | 20 | Inferior 2 | 20 | Retinal Nerve Fiber Layer Thickness (µm) | | Superior | 20 | Temporal | 20 | Inferior | 20 | RS-3000
-------------------|--------------------|-------------------------|----------------------------------|-----------------------------------|-------------|
| | | | | |
| 307.9 (19.4) | 299.7 (22.0) | 8.2 (9.4) | 3.8, 12.6 | -10.5, 26.9 |
| 338.2 (19.2) | 322.0 (19.2) | 16.2 (6.1) | 13.3, 19.0 | 3.9, 28.4 |
| 266.9 (22.9) | 266.8 (21.9) | 0.1 (7.9) | -3.6, 3.8 | -15.6, 15.8 |
| 282.3 (17.0) | 280.0 (18.0) | 2.4 (11.9) | -3.2, 7.9 | -21.4, 26.1 |
| 322.6 (16.0) | 303.6 (18.8) | 19.0 (9.3) | 14.6, 23.3 | 0.4, 37.5 |
| 295.6 (19.8) | 282.3 (19.6) | 13.4 (9.1) | 9.1, 17.6 | -4.8, 31.5 |
| 336.0 (19.3) | 318.2 (17.3) | 17.8 (7.2) | 14.4, 21.2 | 3.3, 32.3 |
| 284.4 (16.6) | 283.7 (18.0) | 0.7 (8.0) | -3.1, 4.5 | -15.4, 16.8 |
| 333.6 (17.4) | 315.2 (17.2) | 18.4 (8.2) | 14.5, 22.3 | 1.9, 34.9 |
| | | | | |
| 111.5 (10.5) | 120.1 (12.2) | -8.7 (8.9) | -12.8, -4.5 | -26.4, 9.1 |
| 112.3 (8.4) | 130.6 (13.6) | -18.3 (11.5) | -23.7, -12.9 | -41.2, 4.6 |
| 86.6 (8.5) | 106.6 (8.4) | -20.0 (5.9) | -22.8, -17.2 | -31.9, -8.1 |
| 102.4 (6.1) | 114.1 (10.3) | -11.7 (8.3) | -15.5, -7.8 | -28.2, 4.9 |
| 97.5 (9.6) | 108.0 (8.4) | -10.6 (4.9) | -12.9, -8.2 | -20.4, -0.7 |
| 114.2 (9.3) | 127.2 (12.3) | -13.0 (12.0) | -18.6, -7.4 | -37.0, 11.0 |
| 97.0 (8.3) | 111.3 (9.4) | -14.3 (6.5) | -17.4, -11.2 | -27.4, -1.2 |
| 115.1 (8.5) | 125.8 (10.3) | -10.8 (7.6) | -14.3, -7.2 | -26.0, 4.5 |
| | | | | |
| 195.8 (11.6) | 179.6 (13.8) | 16.3 (7.0) | 13.0, 19.5 | 2.2, 30.3 |
| 225.4 (12.5) | 191.2 (15.1) | 34.3 (9.7) | 29.7, 38.8 | 14.8, 53.7 |
| 218.4 (15.3) | 185.2 (11.7) | 33.2 (7.0) | 29.9, 36.5 | 19.2, 47.2 |
| 195.5 (10.5) | 173.3 (12.6) | 22.2 (7.8) | 18.5, 25.8 | 6.5, 37.8 |
| 219.7 (11.0) | 189.5 (14.0) | 30.2 (8.6) | 26.1, 34.2 | 12.9, 47.4 |
| 197.5 (11.7) | 174.1 (13.5) | 23.5 (8.6) | 19.4, 27.5 | 6.3, 40.6 |
| 221.0 (12.5) | 191.0 (16.4) | 30.1 (11.9) | 24.5, 35.6 | 6.2, 53.9 |
| 186.9 (10.7) | 172.2 (11.4) | 14.7 (4.3) | 12.7, 16.7 | 6.2, 23.2 |
| 218.0 (12.4) | 189.8 (14.0) | 28.2 (7.1) | 24.9, 31.5 | -14.0, 42.4 |
| | | | | |
| 125.5 (16.5) | 116.8 (12.6) | 8.7 (10.7) | 3.7, 13.7 | -12.7, 30.1 |
| 63.2 (11.3) | 76.4 (8.5) | -13.2 (9.1) | -17.5, -9.0 | -31.4, 5.0 |
| 128.0 (14.3) | 127.4 (11.7) | 0.5 (7.1) | -2.8, 3.8 | -13.7, 14.7 |

Table 1: Mean Difference in Retinal Thickness, RNFL, Optic Disc and Central Corneal Thickness Between RS-3000 and RTVue . Subjects With Normal Eyes .

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| | n | RS-3000
Mean (SD) | RTVue
Mean (SD) | Difference
Mean (SD)1 | 95% CI for
Mean
Difference2 | 95% LOA
for Mean
Difference3 |
|--------------------------------|----|----------------------|--------------------|---------------------------|-----------------------------------|------------------------------------|
| Nasal | 20 | 84.1 (11.9) | 81.1 (8.7) | 3.0 (8.6) | -1.0, 7.0 | -14.2, 20.2 |
| Total Mean | 20 | 101.0 (10.3) | 100.4 (7.8) | 0.5 (4.6) | -1.6, 2.7 | -8.6, 9.7 |
| Optic Disc | | | | | | |
| C/D
Horizontal | 19 | 0.542 (0.148) | 0.687 (0.205) | -0.176
(0.124) | -0.236, -
0.116 | -0.425,
0.072 |
| C/D Vertical | 19 | 0.495 (0.128) | 0.585 (0.166) | -0.111
(0.071) | -0.145, -
0.077 | -0.253,
0.031 |
| Disc Area
(mm^2) | 20 | 2.134 (0.396) | 1.849 (0.339) | 0.285 (0.290) | 0.150, 0.420 | -0.294,
0.864 |
| Cup Area
(mm^2) | 19 | 0.643 (0.383) | 0.712 (0.515) | -0.106
(0.248) | -0.225,
0.014 | -0.601,
0.389 |
| Central Corneal Thickness (µm) | | | | | | |
| | 20 | 543.2 (28.5) | 529.8 (29.2) | 13.4 (6.6) | 10.3, 16.4 | 0.2, 26.5 |
| | n | RS-3000
Mean (SD) | RTVue
Mean (SD) | Difference
Mean (SD) ¹ | 95% CI for
Mean
Difference² | 95% LOA
for Mean
Difference³ |
| Total Retinal Thickness (µm) | | | | | | |
| Nasal 1 | 20 | 309.2 (31.9) | 296.8 (36.1) | 12.4 (18.7) | 3.6, 21.2 | -25.1, 49.9 |
| Nasal 2 | 20 | 327.8 (48.1) | 317.4 (47.8) | 10.4 (12.7) | 4.4, 16.4 | -15.1, 35.9 |
| Center | 20 | 280.1 (76.0) | 277.0 (70.1) | 3.1 (14.8) | -3.8, 10.0 | -26.6, 32.8 |
| Temporal 1 | 20 | 275.0 (19.9) | 269.5 (24.6) | 5.6 (9.6) | 1.0, 10.1 | -13.7, 24.8 |
| Temporal 2 | 20 | 308.9 (46.2) | 290.3 (45.3) | 18.6 (9.4) | 14.1, 23.0 | -0.3, 37.4 |
| Superior 1 | 20 | 290.6 (28.3) | 279.8 (31.9) | 10.8 (9.0) | 6.5, 15.0 | -7.2, 28.7 |
| Superior 2 | 20 | 323.0 (47.2) | 309.2 (46.2) | 13.8 (10.2) | 9.0, 18.6 | -6.6, 34.2 |
| Inferior 1 | 20 | 287.4 (30.7) | 284.1 (37.3) | 3.3 (10.3) | -1.5, 8.1 | -17.2, 23.8 |
| Inferior 2 | 20 | 327.9 (48.1) | 315.0 (52.0) | 13.0 (8.1) | 9.1, 16.8 | -3.3, 29.2 |
| Inner Retinal Thickness (µm) | | | | | | |
| Nasal 1 | 20 | 114.8 (20.9) | 115.6 (19.5) | -0.9 (14.7) | -7.7, 6.0 | -30.2, 28.5 |
| Nasal 2 | 20 | 110.7 (31.3) | 124.6 (26.9) | -14.0 (18.1) | -22.4, -5.5 | -50.1, 22.2 |
| Temporal 1 | 20 | 86.4 (12.0) | 102.9 (13.3) | -16.5 (9.3) | -20.8, -12.1 | -35.0, 2.1 |
| Temporal 2 | 20 | 103.6 (19.0) | 109.6 (20.1) | -6.0 (13.8) | -12.4, 0.4 | -33.5, 21.5 |
| Superior 1 | 20 | 100.2 (18.1) | 107.0 (16.3) | -6.9 (8.2) | -10.7, -3.0 | -23.2, 9.5 |
| Superior 2 | 20 | 111.5 (27.1) | 119.6 (21.4) | -8.2 (15.4) | -15.3, -1.0 | -38.9, 22.6 |
| Inferior 1 | 20 | 100.8 (21.2) | 109.3 (13.9) | -8.5 (14.0) | -15.0, -1.9 | -36.5, 19.6 |
| Inferior 2 | 20 | 120.0 (21.6) | 120.6 (21.7) | -0.6 (15.2) | -7.7, 6.6 | -31.0, 29.9 |
| Outer Retinal Thickness (µm) | | | | | | |
| Nasal 1 | 20 | 194.0 (15.3) | 181.2 (20.7) | 12.8 (16.6) | 5.0, 20.5 | -20.5, 46.0 |
| Nasal 2 | 20 | 216.8 (25.1) | 192.7 (25.3) | 24.1 (19.4) | 15.0, 33.2 | -14.6, 62.8 |
| Center | 20 | 210.9 (41.0) | 190.6 (53.5) | 20.4 (23.9) | 9.2, 31.5 | -27.4, 68.1 |
| Temporal 1 | 20 | 188.0 (13.9) | 166.7 (13.0) | 21.3 (9.5) | 16.9, 25.7 | 2.4, 40.2 |
| Temporal 2 | 20 | 204.8 (32.5) | 180.7 (27.9) | 24.1 (13.9) | 17.6, 30.6 | -3.7, 51.9 |
| Superior 1 | 20 | 189.8 (14.5) | 172.7 (16.9) | 17.2 (11.6) | 11.7, 22.6 | -6.0, 40.3 |
| Superior 2 | 20 | 210.9 (28.1) | 189.6 (28.8) | 21.4 (19.0) | 12.5, 30.2 | -16.7, 59.4 |
| Inferior 1 | 20 | 185.9 (11.5) | 174.9 (25.6) | 11.0 (16.5) | 3.3, 18.7 | -22.1, 44.1 |
| Inferior 2 | 20 | 207.3 (28.9) | 194.3 (34.9) | 13.0 (14.9) | 6.0, 19.9 | -16.8, 42.7 |

Data included are the first accepted scans from RS-3000 with follow-up off and the first accepted scans from RTVue.

1 Difference = RS-3000 - RTVue

2 95% confidence interval for mean difference based on t-distribution

3 95% limits of agreement = mean difference +/- 2 x difference SD

Program: LOA.sas (11DEC2012 20:56:34)

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K121622 510(k) Summary

Table 2: Mean Difference in Retinal Thickness Between RS-3000 and RTVue Subjects With Retinal Disease

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| | ﺘ | RS-3000
Mean (SD) | RTVue
Mean (SD) | Difference
Mean (SD) ! Difference2 Difference3 | 95% Cl for 95% LOA
Mean | for Mean | |
|------------------------------------------------------------------------------------------|---|----------------------|--------------------|---------------------------------------------------|----------------------------------|----------|--|
| Data included are the first accepted scans from RS-3000 with follow-up off and the first | | | | | | | |

accepted scans from RTVue.

1 Difference = RS-3000 - RTVue

2 95% confidence interval for mean difference based on t-distribution 3 95% limits of agreement = mean difference +/- 2 x difference SD

95 % limits of agreement = mean difference +/- 2 x difference

Program: LOA.sas (11DEC2012 20:56:34)

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| | | RS-3000
Mean (SD) | RTVue
Mean (SD) | Difference
Mean (SD)1 | 95% CI for
Mean Difference2 | 95% LOA
for Mean Difference3 |
|------------------|----|------------------------------------------|--------------------|--------------------------|--------------------------------|---------------------------------|
| | n | | | | | |
| | | Retinal Nerve Fiber Layer Thickness (µm) | | | | |
| Superior | 20 | 90.9 (26.0) | 86.3 (19.4) | 4.5 (9.3) | 0.2, 8.9 | -14.0, 23.1 |
| Temporal | 20 | 53.1 (14.0) | 65.8 (13.6) | -12.8 (9.7) | -17.3, -8.2 | -32.2, 6.6 |
| Inferior | 20 | 85.9 (27.4) | 91.4 (24.3) | -5.5 (8.3) | -9.4, -1.6 | -22.0, 11.0 |
| Nasal | 20 | 70.0 (22.8) | 66.1 (10.2) | 3.9 (18.3) | -4.7, 12.5 | -32.8, 40.6 |
| Total Mean | 20 | 75.7 (16.1) | 77.4 (13.5) | -1.8 (6.0) | -4.6, 1.1 | -13.8, 10.3 |
| | | | | | | |
| | | Optic Disc | | | | |
| C/D Horizontal | 20 | 0.783 (0.130) | 0.917 (0.129) | -0.134
(0.117) | -0.189, -
0.079 | -0.368,
0.100 |
| C/D Vertical | 20 | 0.762 (0.119) | 0.834 (0.133) | -0.073
(0.065) | -0.103, -
0.042 | -0.202,
0.057 |
| Disc Area (mm^2) | 20 | 2.195 (0.385) | 2.028 (0.362) | 0.167 (0.332) | 0.012, 0.322 | -0.497,
0.831 |
| Cup Area (mm^2) | 20 | 1.305 (0.443) | 1.434 (0.539) | -0.130
(0.394) | -0.314,
0.055 | -0.917,
0.658 |

Table 3: Mean Difference in RNFL and Optic Disc Between RS-3000 and RTVue Subjects With Glaucoma

Data included are the first accepted scans from RS-3000 with follow-up off and the first accepted scans from RTVue.

1 Difference = RS-3000 - RTVue

2 95% confidence interval for mean difference based on t-distribution 3 95% limits of agreement = mean difference +/- 2 x difference SD

Program: LOA.sas (11DEC2012 20:56:34)

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Table 4: Mean Difference in Central Corneal Thickness Between RS-3000 and RTVue Subjects With Corneal Disease

| n | RS-3000
Mean (SD) | RTVue
Mean (SD) | Difference
Mean (SD)1 | 95% CI for
Mean
Difference2 | 95% LOA
for Mean
Difference3 |
|--------------------------------|----------------------|--------------------|--------------------------|-----------------------------------|------------------------------------|
| Central Corneal Thickness (μm) | | | | | |
| 20 | 520.8 (63.8) | 508.1 (63.2) | 12.8 (8.0) | 9.0, 16.5 | -3.2, 28.7 |

Data included are the first accepted scans from RS-3000 with follow-up off and the first accepted scans from RTVue.

1 Difference = RS-3000 ~ RTVue

2 95% confidence interval for mean difference based on t-distribution

3 95% limits of agreement = mean difference +/- 2 x difference SD

Program: LOA.sas (11DEC2012 20:56:34)

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Precision Results:

Total Retinal Thickness

Repeatability and reproducibility of the total retinal thickness are summarized in tables 5 through 11 below.

For the normal group, the repeatability limits (range: 2.8 to 7.393μm) and the reproducibility limits (range: 2.8 to 7.393µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (the repeatability limits and the reproducibility limits of RTVue have the same range: 6.313 to 17.746um). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.761 to 6.55um).

For the retinal group, the repeatability limits of RS-3000 with follow-up off (range: 6.049 to 32.453um) tended to be larger than or similar to that of the RTVue (range: 5.522 to 17.511um). However, there was no clear pattern in the reproducibility limits between the two study devices (range: 6.049 to 32.453um for RS-3000 Off, 6.031 to 17.511um for RTVue). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 4.62 to 27.403um).

Inner Retinal Thickness

Repeatability and reproducibility of the inner retinal thickness are summarized in tables 5 through 11 below.

For the normal group, the repeatability limits (range: 1.476 to 5.442um) and the reproducibility limits (range: 1.476 to 5.442µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (repeatability limit range: 3.461 to 10.601um; reproductbility limit range: 3.461 to 11.843um). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.034 to 5.280um).

For the retinal group, the repeatability limits (range: 5.176 to 14.162µm) and the reproducibility limits (range: 5.176 to 14.162µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (repeatability limit range: 6.433 to 18.397μm; reproducibility limit range: 8.056 to 20.9um). The repeatability limits and the reproducibility limits of RS-3000 with follow-up off tended to be larger or similar to that of the RS-3000 with follow-up on (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 3.365 to 18.026pm).

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Outer Retinal Thickness

Repeatability and reproducibility of the outer retinal thickness are summarized in tables 5 through 11 below

For the normal group, the repeatability limits (range: 2.425 to 4.174 m) and the reproducibility limits (range: 2.425 to 5.032µm) of RS-3000 with follow-up off tended to be smaller than that of the RTVue (the repeatability limits and the reproducibility limits of RTVue have the same range: 7.961 to 12.531µm) in all segments. The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.139 to 4.252um}.

For the retinal group, the repeatability limits of RS-3000 with follow-up off frange: 4.961 to 23.653μm) tended to be smaller than or similar to that of the RTVue (range: 7.865 to 20.293μm). The reproducibility limits of RS-3000 with follow-up off (range: 4.961 to 25.459µm) tended to be smaller in the superior and inferior segments than that of RTVue (range: 7.865 to 20.293μm), and there was no clear pattern in the other segments. The repeatability limits and the reproducibility limits of RS-3000 with follow-up off tended to be larger than or similar to that of the RS-3000 with follow-up on (repeatability range: 3.30 to 16.755μm and reproducibility range: 3.30 to 23.312μm).

G Chart

Repeatability and reproducibility of the G-chart thickness are summarized in table 5 through 11 below.

For the normal group, the repeatability and reproducibility limits were similar in all but 2 segments between the 2 settings of RS-3000 (repeatability limit range: 1.807 to 6.209um for the off setting and 1.807 to 4.501um for the on setting; the reproducibility limits had the same range as the repeatability limits). The repeatability limits of the 2 inferior/temporal segments were greater in the off setting than the on setting.

For the glaucoma group, the repeatability and reproducibility limits of the off setting tended to be greater than or similar to that of the on setting (repeatability limit range: 3.333 to 16.858µm for the off setting and 1.924 to 19.281 um for the on setting; reproducibility limit range: 6.616 to 28.245 um for the off setting and 1.924 to 29.736um for the on setting).

Retinal Nerve Fiber Laver

Repeatability and reproducibility of the retinal nerve fiber layer thickness are summarized in tables 5 through 11 below.

For the normal group, the repeatability limits (range: 6.682 to 20.661um) and the reproducibility limits (range: 6.682 to 21.575um) of RS-3000 with follow-up off tended to be larger than that of the RTVue (the repeatability limit range: 3.508 to 8.516um; the reproducibility limit range: 3.508 to 14.148µm). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 8.043 to 16.413um)

21

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For the glaucoma group, the repeatability limits of RS-3000 with follow-up off (range: 11.122 to 32.506um) tended to be larger than that of the RTVue (range: 3.67 to 10.291 um). The repeatability limits of the off setting were greater than or similar to the on setting (range: 7.525 to 20.766um). However, there is no clear pattern in the reproducibility limits between the RS-3000 with follow-up off (range: 15.591 to 46.568um) and RTVue (range: 6.533 to 26.092um). The reproducibility limits were similar between the two settings of RS-3000 (range of the on setting: 10.139 to 52.57um).

Optic Disc Analysis

Repeatability and reproducibility of the optic disc are summarized in tables 5 through 11 below.

For the normal group, the repeatability limits of RS-3000 with follow-up off (range: 0.058 to 0.478µm) tended to be larger in C/D horizontal, disc area and cup area, and smaller in C/D vertical than that of the RTVue (range: 0.073 to 0.196um). The reproducibility limits were similar between RS-3000 with follow-up off (range: 0.241 to 1.029µm) and RTVue (range: 0.238 to 1.039um), except for disc area in which the RS-3000 with follow-up off tended to be larger. The repeatability limits {range of on setting: 0.065 to 0.388μm) and the reproducibility limits {range of on setting: 0.211 to 1.092µm) were similar between the two settings of RS-3000, except for C/D horizontal in which the repeatability limit of the off setting tended to be larger than that of the on setting.

For the glaucoma group, the repeatability limits of RS-3000 with follow-up off (range: 0.087 to 0.318um) tended to be smaller in C/D horizontal and larger in disc area than that of the RTVue (range: 0.117 to 0.413µm). The two devices had similar repeatability limits in C/D vertical and cup area. The reproducibility limits of RS-3000 with follow-up off (range: 0.087 to 0.775um) tended to be smaller in C/D horizontal, C/D vertical and cup area, and larger in disc area than that of RTVue (range: 0.186 to 0.455um). The repeatability and reproducibility limits of the off setting were smaller than or similar to the on setting {repeatability limit range: 0.132 to 0.422um; reproducibility limit range: 0.132 to 0.918um).

Central Corneal Thickness

The repeatability limits of RS-3000 were larger than that of the RTVue in both the normal (8.15µm and 3.024um, respectively) and corneal groups (18.933um and 3.199um, respectively). The reproducibility limit of RS-3000 was larger than that of the RTVue in the normal group (31.336um and 3.024µm, respectively), but similar between the two devices in the corneal group (57.874µm and 53.963um, respectively).

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Table 5: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring Retinal Thickness, G-Chart Thickness, RNFL, Optic Disc and Central Corneal Thickness Subjects With Normal Eyes

		Repeatability		Reproducibility		CV%
	n	SD	Limit	SD	Limit	Based on
Repeatability	Based on
Reproducibility
Total Retinal Thickness (µm)
Nasal 1	12	1.642	4.596	1.642	4.596	0.531	0.531
Nasal 2	12	1.537	4.302	1.537	4.302	0.450	0.450
Center	12	2.641	7.393	2.641	7.393	0.992	0.992
Temporal 1	12	2.115	5.921	2.115	5.921	0.746	0.746
Temporal 2	12	1.000	2.800	1.000	2.800	0.309	0.309
Superior 1	12	1.354	3.791	1.354	3.791	0.459	0.459
Superior 2	12	1.518	4.252	1.518	4.252	0.448	0.448
Inferior 1	12	2.230	6.244	2.230	6.244	0.781	0.781
Inferior 2	12	1.344	3.762	1.344	3.762	0.401	0.401
Inner Retinal Thickness (µm)
Nasal 1	12	0.898	2.513	0.898	2.513	0.798	0.798
Nasal 2	12	1.700	4.759	1.700	4.759	1.481	1.481
Temporal 1	12	1.394	3.905	1.394	3.905	1.599	1.599
Temporal 2	12	1.179	3.300	1.179	3.300	1.150	1.150
Superior 1	12	0.527	1.476	0.527	1.476	0.540	0.540
Superior 2	12	1.564	4.378	1.564	4.378	1.341	1.341
Inferior 1	12	1.179	3.300	1.179	3.300	1.211	1.211
Inferior 2	12	1.944	5.442	1.944	5.442	1.681	1.681
Outer Retinal Thickness (µm)
Nasal 1	12	1.130	3.165	1.130	3.165	0.577	0.577
Nasal 2	12	0.898	2.513	0.898	2.513	0.397	0.397
Center	12	1.434	4.015	1.434	4.015	0.655	0.655
Temporal 1	12	0.866	2.425	0.866	2.425	0.442	0.442
Temporal 2	12	1.054	2.952	1.054	2.952	0.478	0.478
Superior 1	12	0.866	2.425	0.866	2.425	0.440	0.440
Superior 2	12	1.027	2.877	1.027	2.877	0.464	0.464
Inferior 1	12	1.106	3.096	1.797	5.032	0.589	0.957
Inferior 2	12	1.491	4.174	1.491	4.174	0.681	0.681
G Chart Thickness (µm)
Superior/Nasal 1	12	0.646	1.807	0.646	1.807	0.598	0.598
		Repeatability		Reproducibility		CV%
	n	SD	Limit	SD	Limit	Based on Repeatability	Based on Reproducibility
Superior/Nasal 2	12	1.958	5.482	1.958	5.482	1.673	1.673
Superior/Temporal 1	12	0.957	2.681	0.957	2.681	1.085	1.085
Superior/Temporal 2	12	1.555	4.353	1.555	4.353	1.432	1.432
Inferior/Nasal 1	12	0.898	2.513	0.898	2.513	0.836	0.836
Inferior/Nasal 2	12	1.667	4.667	1.667	4.667	1.449	1.449
Inferior/Temporal 1	12	1.528	4.277	1.528	4.277	1.676	1.676
Inferior/Temporal 2	12	2.217	6.209	2.217	6.209	2.034	2.034
Retinal Nerve Fiber Layer Thickness (µm)
Superior	12	7.379	20.661	7.379	20.661	5.746	5.746
Temporal	12	4.381	12.267	4.381	12.267	7.070	7.070
Inferior	12	4.014	11.239	4.014	11.239	3.055	3.055
Nasal	12	6.593	18.461	7.705	21.575	8.063	9.422
Total Mean	12	2.386	6.682	2.386	6.682	2.347	2.347
Optic Disc
C/D Horizontal	12	0.050	0.141	0.123	0.344	9.302	22.701
C/D Vertical	12	0.021	0.058	0.086	0.241	4.184	17.325
Disc Area (mm^2)	12	0.171	0.478	0.365	1.023	7.598	16.251
Cup Area (mm^2)	12	0.055	0.155	0.368	1.029	8.112	53.949
Central Corneal Thickness (µm)
	12	2.911	8.150	11.191	31.336	0.529	2.035
	n	Repeatability		Reproducibility		CV%
		SD	Limit	SD	Limit	Based on Repeatability	Based on Reproducibility
Total Retinal Thickness (µm)
Nasal 1	12	1.787	5.005	1.787	5.005	0.578	0.578
Nasal 2	12	1.434	4.014	1.434	4.014	0.420	0.420
Center	12	2.339	6.550	2.339	6.550	0.872	0.872
Temporal 1	12	1.658	4.643	1.658	4.643	0.583	0.583
Temporal 2	12	1.641	4.596	1.641	4.596	0.507	0.507
Superior 1	12	1.143	3.199	1.143	3.199	0.388	0.388
Superior 2	12	1.354	3.791	1.354	3.791	0.400	0.400
Inferior 1	12	1.764	4.939	1.764	4.939	0.615	0.615
Inferior 2	12	0.986	2.761	0.986	2.761	0.294	0.294
Inner Retinal Thickness (µm)
Nasal 1	12	0.727	2.034	0.727	2.034	0.643	0.643
Nasal 2	12	1.886	5.280	1.886	5.280	1.634	1.634
Temporal 1	12	1.054	2.952	1.054	2.952	1.205	1.205
Temporal 2	12	1.106	3.096	1.106	3.096	1.077	1.077
Superior 1	12	0.745	2.087	0.745	2.087	0.763	0.763
Superior 2	12	1.344	3.763	1.344	3.763	1.148	1.148
Inferior 1	12	0.913	2.556	0.913	2.556	0.935	0.935
Inferior 2	12	1.333	3.733	1.333	3.733	1.160	1.160
Outer Retinal Thickness (µm)
Nasal 1	12	1.518	4.252	1.518	4.252	0.776	0.776
Nasal 2	12	0.943	2.640	0.943	2.640	0.418	0.418
Center	12	1.225	3.429	1.225	3.429	0.558	0.558
Temporal 1	12	0.882	2.469	0.882	2.469	0.449	0.449
Temporal 2	12	1.093	3.060	1.093	3.060	0.495	0.495
Superior 1	12	0.764	2.139	0.764	2.139	0.388	0.388
Superior 2	12	1.080	3.024	1.080	3.024	0.488	0.488
Inferior 1	12	1.202	3.365	1.202	3.365	0.637	0.637
Inferior 2	12	1.118	3.130	1.118	3.130	0.510	0.510
G Chart Thickness (µm)
Superior/Nasal 1	12	0.646	1.807	0.646	1.807	0.596	0.596
	n	Repeatability		Reproducibility		CV%
		SD	Limit	SD	Limit	Based on
Repeatability	Based on
Reproducibility
Superior/Nasal 2	12	1.581	4.427	1.581	4.427	1.343	1.343
Superior/Temporal 1	12	1.000	2.800	1.000	2.800	1.130	1.130
Superior/Temporal 2	12	1.118	3.130	1.118	3.130	1.023	1.023
Inferior/Nasal 1	12	0.799	2.238	0.799	2.238	0.743	0.743
Inferior/Nasal 2	12	1.607	4.501	1.607	4.501	1.400	1.400
Inferior/Temporal 1	12	0.882	2.469	0.882	2.469	0.963	0.963
Inferior/Temporal 2	12	1.213	3.397	1.213	3.397	1.119	1.119
Retinal Nerve Fiber Layer Thickness ( $\mu$ m)
Superior	12	5.862	16.413	5.862	16.413	4.578	4.578
Temporal	12	3.508	9.822	3.508	9.822	5.529	5.529
Inferior	12	4.696	13.150	4.696	13.150	3.604	3.604
Nasal	12	5.006	14.017	5.006	14.017	6.268	6.268
Total Mean	12	2.872	8.043	2.872	8.043	2.835	2.835
Optic Disc
C/D Horizontal	12	0.035	0.097	0.096	0.270	6.674	18.511
C/D Vertical	12	0.023	0.065	0.075	0.211	4.738	15.328
Disc Area (mm^2)	12	0.138	0.388	0.390	1.092	6.220	17.527
Cup Area (mm^2)	12	0.059	0.164	0.322	0.902	9.151	50.283
		Repeatability		Reproducibility		CV%
	n	SD	Limit	SD	Limit	Based on
Repeatability	Based on
Reproducibility
Total Retinal Thickness (µm)
Nasal 1	12	10.127	28.356	10.127	28.356	3.233	3.233
Nasal 2	12	7.145	20.007	7.145	20.007	2.144	2.144
Center	12	4.106	11.497	4.106	11.497	1.391	1.391
Temporal 1	12	11.590	32.453	11.590	32.453	4.151	4.151
Temporal 2	12	2.708	7.583	2.708	7.583	0.846	0.846
Superior 1	12	2.160	6.049	2.160	6.049	0.732	0.732
Superior 2	12	3.232	9.049	3.232	9.049	0.957	0.957
Inferior 1	12	2.698	7.554	2.698	7.554	0.940	0.940
Inferior 2	12	3.253	9.109	3.253	9.109	0.977	0.977
Inner Retinal Thickness (µm)
Nasal 1	12	5.058	14.162	5.058	14.162	4.331	4.331
Nasal 2	12	4.857	13.598	4.857	13.598	4.303	4.303
Temporal 1	12	3.375	9.449	3.375	9.449	3.757	3.757
Temporal 2	12	3.041	8.516	3.041	8.516	2.807	2.807
Superior 1	12	2.021	5.658	2.021	5.658	1.934	1.934
Superior 2	12	3.460	9.688	3.460	9.688	2.949	2.949
Inferior 1	12	1.849	5.176	1.849	5.176	1.823	1.823
Inferior 2	12	2.934	8.217	2.934	8.217	2.392	2.392
Outer Retinal Thickness (µm)
Nasal 1	12	7.165	20.061	7.165	20.061	3.657	3.657
Nasal 2	12	7.057	19.760	9.093	25.459	3.209	4.134
Center	12	4.113	11.517	4.113	11.517	1.843	1.843
Temporal 1	12	8.448	23.653	8.448	23.653	4.470	4.470
Temporal 2	12	4.010	11.229	4.010	11.229	1.898	1.898
Superior 1	12	1.772	4.961	1.772	4.961	0.933	0.933
Superior 2	12	2.949	8.256	2.949	8.256	1.343	1.343
Inferior 1	12	1.871	5.239	1.871	5.239	1.011	1.011
Inferior 2	12	3.167	8.867	3.167	8.867	1.510	1.510

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K121622 510(k) Summary

All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes

Repeatability SD = Square root of the residual variance

Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance

CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD

Repeatability limit = 2.8 x Repeatability SD

Reproducibility limit = 2.8 x Reproducibility SD

Program: RR.sas (11DEC2012 20:58:33)

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Table 6: RS-3000 with Follow-up On: Repeatability and Reproducibility in Measuring Retinal Thickness, G-Chart Thickness, RNFL and Optic Disc Subjects With Normal Eyes

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K121622 510{k) Summary

All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance

Repeatability SD = Square root of the residual variance

Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance

CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the

repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD

Reproducibility limit = 2.8 x Reproducibility SD

Program: RR.sas (11DEC2012 20:58:33)

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.

Table 7: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring Retinal Thickness Subjects With Retinal Disease

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	Repeatability			Reproducibility		CV%
	n	SD	Limit	SD	Limit	Based on
Repeatability	Based on
Reproducibility
All statistics are estimated from a nested ANOVA model with random effects
operator/device and eyes within operator/device using all accepted scans.
n = Number of eyes
	n	Repeatability		Reproducibility		CV%
		SD	Limit	SD	Limit	Based on
Repeatability	Based on
Reproducibility
Total Retinal Thickness (um)
Nasal 1	12	5.984	16.755	5.984	16.755	1.907	1.907
Nasal 2	12	8.033	22.492	8.033	22.492	2.399	2.399
Center	12	5.250	14.699	5.250	14.699	1.767	1.767
Temporal 1	12	9.787	27.403	9.787	27.403	3.508	3.508
Temporal 2	12	2.774	7.767	2.774	7.767	0.868	0.868
Superior 1	12	1.650	4.620	1.650	4.620	0.558	0.558
Superior 2	12	2.455	6.874	2.455	6.874	0.722	0.722
Inferior 1	12	2.533	7.093	2.533	7.093	0.882	0.882
Inferior 2	12	2.088	5.847	2.088	5.847	0.632	0.632
Inner Retinal Thickness (µm)
Nasal 1	12	1.202	3.365	1.202	3.365	1.031	1.031
Nasal 2	12	6.438	18.026	6.438	18.026	5.654	5.654
Temporal 1	12	4.580	12.823	4.580	12.823	5.122	5.122
Temporal 2	12	2.764	7.739	2.764	7.739	2.555	2.555
Superior 1	12	1.667	4.667	1.667	4.667	1.583	1.583
Superior 2	12	1.443	4.042	1.443	4.042	1.217	1.217
Inferior 1	12	2.211	6.191	2.211	6.191	2.168	2.168
Inferior 2	12	1.555	4.353	1.555	4.353	1.284	1.284
Outer Retinal Thickness (µm)
Nasal 1	12	5.984	16.755	8.326	23.312	3.040	4.230
Nasal 2	12	4.890	13.693	5.412	15.153	2.218	2.455
Center	12	3.136	8.780	3.136	8.780	1.405	1.405
Temporal 1	12	5.354	14.992	5.354	14.992	2.834	2.834
Temporal 2	12	3.100	8.681	3.100	8.681	1.469	1.469
Superior 1	12	1.247	3.492	1.247	3.492	0.657	0.657
Superior 2	12	2.603	7.290	2.603	7.290	1.180	1.180
Inferior 1	12	1.179	3.300	1.179	3.300	0.638	0.638
Inferior 2	12	2.345	6.567	2.345	6.567	1.122	1.122

.

residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD

Reproducibility limit = 2.8 x Reproducibility SD

Program: RR.sas (11DEC2012 20:58:33)

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Table 8: RS-3000 with Follow-up On: Repeatability and Reproducibility in Measuring Retinal Thickness Subjects With Retinal Disease

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30

All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD

Reproducibility limit = 2.8 x Reproducibility SD

Program: RR.sas (11DEC2012 20:58:33)

30

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Table 9: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring G-Chart Thickness, RNFL and Optic Disc Subjects With Glaucoma

		Repeatability		Reproducibility		CV%
	n	SD	Limit	SD	Limit	Based on
Repeatability	Based on
Reproducibility
G Chart Thickness (µm)
Superior/Nasal 1	12	1.258	3.523	10.088	28.245	1.456	11.673
Superior/Nasal 2	12	2.517	7.047	2.517	7.047	2.609	2.609
Superior/Tempor
al 1	12	1.787	5.004	2.912	8.153	2.567	4.181
Superior/Tempor
al 2	12	2.363	6.616	2.363	6.616	2.681	2.681
Inferior/Nasal 1	12	1.190	3.333	9.991	27.974	1.480	12.419
Inferior/Nasal 2	12	4.916	13.765	6.738	18.867	5.251	7.198
Inferior/Tempora
11	12	2.718	7.611	5.130	14.365	4.079	7.699
Inferior/Tempora
12	12	6.021	16.858	6.021	16.858	6.972	6.972
Retinal Nerve Fiber Layer Thickness (µm)
Superior	12	5.568	15.591	5.568	15.591	6.629	6.629
Temporal	12	4.964	13.899	5.781	16.185	9.405	10.953
Inferior	12	6.039	16.910	6.039	16.910	7.531	7.531
Nasal	12	11.609	32.506	16.631	46.568	17.769	25.456
Total Mean	12	3.972	11.122	6.370	17.837	5.586	8.958
Optic Disc
C/D Horizontal	12	0.056	0.158	0.056	0.158	6.925	6.925
C/D Vertical	12	0.031	0.087	0.031	0.087	4.039	4.039
Disc Area (mm^2)	12	0.096	0.269	0.277	0.775	4.505	12.971
Cup Area (mm^2)	12	0.114	0.318	0.114	0.318	8.409	8.409

.

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32

All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance

CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD

Repeatability limit = 2.8 x Repeatability SD

Reproducibility limit = 2.8 x Reproducibility SD

Program: RR.sas (11DEC2012 20:58:33)

32

K121622

33 Table 10: RS-3000 with Follow-up On: Repeatability and Reproducibility in Measuring G-Chart Thickness, RNFL and Optic Disc Subjects With Glaucoma

		Repeatability		Reproducibility		CV%
	n	SD	Limit	SD	Limit	Based on Repeatability	Based on Reproducibility
G Chart Thickness (µm)
Superior/Nasal 1	12	1.624	4.549	10.121	28.338	1.868	11.640
Superior/Nasal 2	12	6.886	19.281	8.994	25.183	6.999	9.141
Superior/Temporal 1	12	1.691	4.736	1.691	4.736	2.423	2.423
Superior/Temporal 2	12	2.427	6.795	2.427	6.795	2.739	2.739
Inferior/Nasal 1	12	1.225	3.429	10.620	29.736	1.508	13.080
Inferior/Nasal 2	12	4.173	11.685	6.041	16.916	4.429	6.412
Inferior/Temporal 11	12	0.687	1.924	0.687	1.924	1.015	1.015
Inferior/Temporal 12	12	3.902	10.924	3.902	10.924	4.526	4.526
Retinal Nerve Fiber Layer Thickness (µm)
Superior	12	7.416	20.766	7.416	20.766	9.020	9.020
Temporal	12	3.621	10.139	3.621	10.139	7.386	7.386
Inferior	12	6.654	18.632	7.337	20.543	8.648	9.535
Nasal	12	5.972	16.722	18.775	52.570	9.534	29.973
Total Mean	12	2.687	7.525	6.364	17.820	3.934	9.318
Optic Disc
C/D Horizontal	12	0.047	0.132	0.047	0.132	5.849	5.849
C/D Vertical	12	0.055	0.155	0.055	0.155	7.142	7.142
Disc Area (mm^2)	12	0.149	0.417	0.328	0.918	7.136	15.717
Cup Area (mm^2)	12	0.151	0.422	0.151	0.422	11.323	11.323

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K12/622

K121622 510(k) Summary

All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD

Reproducibility limit = 2.8 x Reproducibility SD

Program: RR.sas (11DEC2012 20:58:33)

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K12/622

35

Table 11: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring Central Corneal Thickness Subjects With Corneal Disease

	Repeatability		Reproducibility		CV%
	n	SD	Limit	SD	Limit	Based on
Repeatability	Based on
Reproducibility
Central Corneal Thickness (μm)	12	6.762	18.933	20.669	57.874	1.283	3.922

All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eves Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD

Program: RR.sas (11DEC2012 20:58:33)

CONCLUSIONS

In summary, Nidek Co., Ltd., is of the opinion that the Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, does not introduce any new potential safety risks, are as effective, and perform as well as the predicate device(s).

WARNING: Clinical studies indicate that measurements of retinal layer thickness for central corneal thickness] performed by the RS-3000 sometimes differs from those of OCT devices made by other manufacturers, due to differences in segmentation software. Measurements made on different devices are not interchangeable.

35

Image /page/35/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Nidek Co., Ltd. % Ms. Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281

Re: K121622 Trade/Device Name: RS-3000 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC Powered Regulatory Class: Class II Product Code: OBO Dated: March 4, 2013 Received: March 7, 2013

Dear Ms. Sattler:

This letter corrects our substantially equivalent letter of March 14, 2013.

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

MAR 1 5 2013

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

36

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Deborah Liftalls -S

for Malvina B. Eydelman, M.D. Director Division of Opthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

37

INDICATIONS FOR USE STATEMENT: RS-3000

510(k) Number (if known): K121622

Device Name: RS-3000

Indications for Use:

The Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a noncontact 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, and optic disc, and
AND/OR
. the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter),
as an aid in the diagnosis and management of adults having or suspected of having ocular disease.

Prescription Use _ X __ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles Chiang 2013.03 1413.56:57 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K121622