NIDEK RS-3000

K121622 · Nidek Co., Ltd. · OBO · Mar 14, 2013 · Ophthalmic

Device Facts

• Record ID: K121622
• Device Name: NIDEK RS-3000
• Applicant: Nidek Co., Ltd.
• Product Code: OBO · Ophthalmic
• Decision Date: Mar 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

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.

Device Story

The RS-3000 is an ophthalmic instrument for non-contact, non-invasive observation and analysis of the fundus and anterior segment. It utilizes confocal laser scanning ophthalmoscopy (785nm near-infrared) for fundus images (SLO) and spectral domain optical coherence tomography (880nm infrared) for cross-sectional images (OCT). An optional anterior segment adapter enables corneal and anterior chamber angle observation. The system includes a main body, PC, monitor, and NAVIS-EX software. Operated by clinicians in a clinic setting, the device transmits acquired image data to the PC for filing, analysis, and image processing. The software provides quantitative measurements of retinal thickness, RNFL, and optic disc parameters. These outputs assist healthcare providers in diagnosing and managing ocular diseases, such as glaucoma and retinal conditions, by providing objective structural data.

Clinical Evidence

Prospective clinical study at one U.S. site with 89 subjects (Normal, Retinal Disease, Glaucoma, Corneal Disease). Evaluated agreement and precision of retinal thickness, RNFL, optic disc, and corneal measurements against the RTVue predicate. Agreement was assessed via limits of agreement analysis; precision was assessed using a nested ANOVA design. Results showed agreement in most parameters, though absolute values differed between devices due to segmentation software differences. No adverse events occurred. Bench testing confirmed repeatability and reproducibility within ±5% accuracy.

Technological Characteristics

Spectral Domain OCT; Confocal scanning laser ophthalmoscopy. Light sources: 785 nm (diode laser) for SLO, 880 nm (SLD) for OCT. Connectivity: PC-based with NAVIS-EX software via cable. Components: Main body, PC, monitor, isolation transformer. Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 62304, IEC 62366, ISO 15004-1, ISO 15004-2.

Indications for Use

Indicated for in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disc, anterior chamber, and cornea in adults having or suspected of having ocular disease. Used as an aid in diagnosis and management.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• RTVue with Normative Database (K101505)
• RTVue CAM with Corneal Power Measurement (K11505)
• Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Database (K083291)

Submission Summary (Full Text)

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### 1. 510(K) SUMMARY

Date Prepared: March 14, 2013

MAR 1 4 2013

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### SPONSOR/510(K) OWNER/ MANUFACTURER

Nidek Co., Ltd. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Telephone: [phone] Facsimile: [phone] Email: [e-mail] Establishment Registration Number: 8030392

### OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281 Telephone: [phone] Facsimile: [phone] E-mail: [e-mail]

### COMMON/USUAL NAME

Optical Coherence Tomography

### PROPRIETARY OR TRADE NAMES

RS-3000

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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

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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.

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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).

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# 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<br>Tomography RS-3000 including<br>scanning laser ophthalmoscope<br>function with Image Filing<br>Software NAVIS-EX is a non-<br>contact system for imaging the<br>fundus and for axial cross<br>sectional imaging of ocular<br>structures. It is indicated for in<br>vivo imaging and measurement<br>of:<br>• the retina, retinal nerve fiber<br>layer, and optic disc, and<br>• the anterior chamber and<br>cornea (when used with the<br>optional auxiliary anterior<br>chamber adapter),<br>as an aid in the diagnosis and<br>management of adults having or<br>suspected of having ocular<br>disease. | The RTVue with Normative<br>Database is an optical<br>coherence tomography system<br>indicated for the in vivo<br>imaging and measurement of<br>the retina, retinal nerve fiber<br>layer, and optic disk as an aid<br>in the diagnosis and<br>management of retinal disease.<br>The RTVue with Normative<br>database is also a quantitative<br>tool for the comparison of<br>retina, retinal nerve fiber layer,<br>and optic disc measurements<br>in the human eye to a database<br>of known normal subjects. It is<br>intended for use as a diagnostic<br>device to aid in the detection<br>and management of ocular<br>disease. |
| Performance Features | | |
| Measurement principle | | |
| Imaging of the<br>Fundus/Anterior<br>Segment | Confocal scanning laser<br>ophthalmoscopy for RS-3000 | Near IR observation |
| Tomographic Imaging<br>of the<br>Fundus/Anterior<br>Segment | Spectral Domain OCT | Spectral Domain OCT |
| Scan rate (in OCT Image<br>capture) | 53,000 A-Scan/s | 26,000 A-Scan/s |
| Light source wavelength | | |
| Imaging of the<br>Fundus/Anterior<br>Segment | 785 nm (Diode laser) for RS-<br>3000, | 735 nm (LED) |
| Tomographic Imaging<br>of the<br>Fundus/Anterior<br>Segment | 880 nm (SLD) | 840 nm (SLD) |
| | | |
| Imaging of the Fundus | 25 µm (in the X and Y directions)<br>for RS-3000(SLO) | 25 µm (in the X and Y<br>directions) |
| Tomographic Imaging<br>of the Fundus | 20 µm (in the X and Y<br>directions), 7 µm (in the Z<br>direction) | 15 µm (in the X and Y<br>directions), 5 µm (in the Z<br>direction) |
| Imaging of the<br>Anterior Segment | 50 µm (in the X and Y directions)<br>for RS-3000(SLO) | 70 µm (in the X and Y<br>directions) |
| Tomographic Imaging<br>of the Anterior<br>Segment | 20 µm (in the X and Y<br>directions), 7 µm (in the Z<br>direction) | 15 µm (in the X and Y<br>directions), 5 µm (in the Z<br>direction) |
| Minimum pupil<br>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<br>of the Fundus | Scan width:<br>3 mm to 9 mm<br>Scan depth:<br>2.1 mm | Scan width:<br>2 mm to 12 mm<br>Scan depth:<br>2 mm to 2.3 mm |
| Imaging of the<br>Anterior Segment | 14 mm×12 mm | 5.75mm×4.3mm / 12mm×8mm |
| Tomographic Imaging<br>of the Anterior<br>Segment | Scan width:<br>2 mm to 8 mm<br>Scan depth:<br>2.1 mm | Scan width:<br>1 mm to 3 mm<br>/ 2 mm to 6 mm<br>Scan depth:<br>1.96 mm / 2.3 mm |
| Measurement and Analysis | | |
| 3D Volume Rendering | Yes | Yes |
| Retinal Thickness<br>measurement (Total/Inner<br>layer) | Yes | Yes |
| RNFL Thickness<br>measurement | Yes | Yes |
| Optic Disc analysis | Yes | Yes |
| Pachymetry | Yes | Yes |
| Angle analysis | Yes | Yes |

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K121622

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# 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<br>RS-3000 including scanning laser<br>ophthalmoscope function with Image Filing<br>Software NAVIS-EX is a non-contact system<br>for imaging the fundus and for axial cross<br>sectional imaging of ocular structures. It is<br>indicated for in vivo imaging and<br>measurement of:<br>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<br>of adults having or suspected of having<br>ocular disease. | The Cirrus™ HD-OCT is a non-contact, high<br>resolution tomographic and biomicroscopic<br>imaging device. It is indicated for in-vivo<br>viewing, axial cross-sectional, and three<br>dimensional imaging and measurement of<br>anterior and posterior ocular structures,<br>including cornea, retina, retinal fiber layer,<br>macula, and optic disc. The Cirrus HD-OCT<br>with Retinal Nerve Fiber Layer (RNFL) and<br>Macular Normative Database is a<br>quantitative tool for the comparison of<br>retinal nerve fiber layer and the macula in<br>the human retina to a database of known<br>normal subjects. It is intended for use as a<br>diagnostic device to aid in the detection and<br>management of ocular diseases including,<br>but not limited to, macular holes, cystoid<br>macular edema, diabetic retinopathy, age-<br>related macular degeneration, and<br>glaucoma. |
| Performance Features | | |
| Measurement<br>principle | Confocal scanning laser ophthalmoscopy | Confocal scanning laser ophthalmoscopy |
| Light source<br>wavelength | 785 nm (Diode laser) | 750 nm (SLD) |
| Optical power | 320μW | <1.5mW |
| Frame rate | 10fps | >20Hz |
| Field of view | 40°x 30° | 36°× 30° |
| Lateral resolution | 25 μm | 25 μm |
| Focus adjustment<br>range | -15D to +10D | -20D to +20D |
| Detector type | APD | Line…