The Nidek Optical Coherence Tomography RS-3000 Advance, 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 .
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 Description

The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the fundus and its ocular structures. The device captures an image of the fundus using both a Scanning Laser Ophthalmoscope and Optical Coherence Tomography.
The Nidek RS-3000 Advance is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as an aid in the diagnosis and management of the retinal disease. In addition, the anterior segment adapter (special lens unit) attached over the objective lens of the main body 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.
Fundus images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the fundus (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape, structure, and evidence of pathology of the fundus and retina can be observed.
The RS-3000 Advance is comprised of a main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, and an isolation transformer. The RS-3000 Advance offers the following features:

. High-speed OCT imaging for image capture that is resistant to the effect of subtle eye movements during eye fixation
. High-quality OCT imaging by creating an averaged image from multiple images captured using high-speed OCT imaging
. Simultaneous capture of SLO and OCT images for accurate and easy alignment to the fundus
. Fundus auto focusing, OCT image position detection function, and auto polarization function
. Automatic alignment to and capture of previously captured parts of the fundus
. Easy operation and image capture using the control panel of the main body or the PC mouse
. The tracing HD feature provides the averaged OCT image which uses the greater number of the images than the normal HD scan. This function is available in Macula Line scan only.
. OCT sensitivity setting (Regular/Fine/Ultra-fine) enables users to use different exposure time of the line CCD camera for OCT imaging.

AI/ML Overview

The Nidek RS-3000 Advance is an ophthalmic camera for observing the fundus and its ocular structures. The device captures images of the fundus using both a Scanning Laser Ophthalmoscope and Optical Coherence Tomography. The device passed non-clinical performance evaluations.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Retinal thickness measurement accuracy	Within the repeatability limits of the predicate device (RS-3000) for full retinal thickness, inner retinal thickness, outer retinal thickness, and RNFL thickness.	The clinical performance summary states: "Results show that the measurements of full retinal thickness, inner retinal thickness, outer retinal thickness, and RNFL thickness with the different OCT sensitivity settings in RS-3000 Advance are similar to the thickness measurements of RS-3000. All mean differences are within the repeatability limits of RS-3000 (K121622). This indicates that the 3 sensitivities of RS-3000Advance are equivalent to RS-3000."
Measurement errors accuracy	±5% accuracy of thickness measurements.	The non-clinical performance summary states: "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 Advance was found to maintain sufficient accuracy and to meet requirement specifications."
Compliance with standards	Meet requirements of applicable FDA recognized consensus standards.	The non-clinical performance summary states: "The Nidek Optical Coherence Tomography RS-3000 Advance...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 was found to meet the requirements of the applicable parts."

2. Sample Size and Data Provenance (Test Set)

The provided document does not explicitly state the sample size used for the clinical test set or the country of origin of the data. It merely describes the results of the clinical performance summary against the predicate device. The clinical study was a comparative study between the RS-3000 Advance and its predicate device, the RS-3000, to demonstrate equivalence, focusing on thickness measurements. The data is implicitly prospective if it refers to newly acquired measurements from the RS-3000 Advance, compared to established measurements from the RS-3000.

3. Number of Experts and Qualifications (Test Set Ground Truth)

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given it's a comparison study to a predicate device, the "ground truth" for the new device's measurements is its similarity to the predicate device's measurements, which themselves would have been validated.

4. Adjudication Method (Test Set)

The document does not specify any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was mentioned or described. The study focused on the performance of the device itself (specifically, its measurement capabilities) compared to a predicate device.

6. Standalone (Algorithm Only) Performance Study

The clinical study described is a standalone performance study in the sense that it evaluates the device's ability to measure various retinal thicknesses with its different sensitivity settings. It compares these measurements directly to those from an existing, legally marketed predicate device (RS-3000) to establish equivalence for the algorithm's output. The performance is evaluated based on the consistency of the measurements.

7. Type of Ground Truth Used (Clinical Test Set)

The ground truth used for the clinical evaluation was implicitly the measurements obtained by the legally marketed predicate device, Nidek RS-3000. The study aimed to show that the RS-3000 Advance's measurements for retinal thickness (full, inner, outer, and RNFL) were "similar" and "within the repeatability limits" of the RS-3000. For the non-clinical performance, the ground truth was "the device requirement specification of ± 5% accuracy of thickness measurements".

8. Sample Size for the Training Set

The document does not provide information regarding a training set size. This device is an Optical Coherence Tomography (OCT) system that captures images and performs direct measurements, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The term "training set" is not applicable here as it's a hardware device with inherent measurement capabilities.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, the concept of a "training set" and its associated ground truth establishment is not relevant for this device. The device's measurement accuracy is likely established through calibration and comparison to known physical standards or previously validated instruments during its development and testing phases, rather than through a machine learning training process.

Summary

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K132223

Image /page/0/Picture/1 description: The image shows the logo for NIDEK CO., LTD. The logo includes an eye symbol on the left, followed by the company name in bold, uppercase letters. Below the company name is the address: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan. The text below the address indicates that NIDEK are manufacturers, exporters, and importers of ophthalmic instruments and opto-electronics instruments.

TEL +81-533-67-6611
FAX +81-533-67-6610
URL http://www.nidek.co.jp
http://www.nidek.com

9. 510(K) SUMMARY

Date Prepared

October 31, 2013

SPONSOR/TRADITIONAL 510(K) OWNER/ MANUFACTURER

Nidek Co., Ltd. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Telephone: Facsimile: Email: Establishment Registration Number:

+81-533-67-8901 +81-533-67-6628 yoneji_mizuno@nidek.co.jp 8030392

OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 2856 Whispering Shores Dr. Vermilion, OH 44089 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 Advance

Nidek Co., Ltd

510(k) Summary: RS-3000 Advance Page 1 of 8

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Image /page/1/Picture/0 description: The image shows the logo for NIDEK CO., LTD. The logo consists of a stylized eye graphic with the word "NIDEK" underneath. Next to the logo is the company name, "NIDEK CO., LTD.", followed by the address "34-14, Maehama, Iliraishi-rche, Gamagori, Aichi 443-0038, Japan". Below the address, it states that NIDEK are manufacturers, exporters, and importers of ophthalmic instruments and opto-electronics instruments.

TEL +81-533-67-6611
FAX +81-533-67-6610
URL http://www.nidek.co.jp/
http://www.nidek.com

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

0BO:

Class II § 21 CFR 886.1570

LEGALLY MARKETED PREDICATE DEVICE

Trade/Device Name:	RS-3000
Applicant:	Nidek
510(k) Premarket Notification number:	K121622
Classification:	Class II
FDA Product Code:	OBO
Establishment Registration number:	8030392

GENERAL DEVICE DESCRIPTION

The Nidek RS-3000 Advance is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as an aid in the diagnosis and management of the retinal disease. In addition, the anterior segment adapter (special lens unit) attached over the objective lens of the main body 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.

Fundus images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the fundus (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a Nidek Co., Ltd 510(k) Summary: RS-3000 Advance

Page 2 of 8

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Image /page/2/Picture/0 description: The image shows the logo for NIDEK CO., LTD. The logo consists of a stylized eye graphic above the word "NIDEK" in bold, block letters. To the right of the logo is the company name, "NIDEK CO., LTD.", also in bold letters. Below the company name is the address: "34-14, Maohama, Hiraishi-cho, Gamagori, Aichi 443-0038, Japan" and a description of the company: "Manufacturers, Exporters & importers of Ophthalmic Instruments, and".

TEL +81-533-67-6611

FAX +81-533-67-6610

URL http://www.nidek.co.jp

http://www.nidek.com

wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape, structure, and evidence of pathology of the fundus and retina can be observed.

The RS-3000 Advance is comprised of a main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, and an isolation transformer. The RS-3000 Advance offers the following features:

. High-speed OCT imaging for image capture that is resistant to the effect of subtle eye movements during eye fixation
. High-quality OCT imaging by creating an averaged image from multiple images captured using high-speed OCT imaging
. Simultaneous capture of SLO and OCT images for accurate and easy alignment to the fundus
. Fundus auto focusing, OCT image position detection function, and auto polarization function
. Automatic alignment to and capture of previously captured parts of the fundus
. Easy operation and image capture using the control panel of the main body or the PC mouse
. The tracing HD feature provides the averaged OCT image which uses the greater number of the images than the normal HD scan. This function is available in Macula Line scan only.
. OCT sensitivity setting (Regular/Fine/Ultra-fine) enables users to use different exposure time of the line CCD camera for OCT imaging.

Nidek Co., Ltd

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Image /page/3/Picture/0 description: The image shows the logo for NIDEK CO., LTD. The logo consists of the word "NIDEK" in bold, black letters, followed by "CO., LTD." in a smaller font. Below the company name is the address "34-14, Moohama, Hiraishi-cho, Gamagori, Aichi 443-0038, Japan". The text below the address states that NIDEK is a manufacturer, exporter, and importer of ophthalmic instruments and opto-electronics instruments.

TEL +81-533-67-6611

FAX +81-533-67-6610

URL http://www.nidek.co.jp

http://www.nidek.com

INDICATIONS FOR USE - RS-3000 ADVANCE

. 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.

INDICATIONS FOR USE - RS-3000 - PREDICATE DEVICE

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.

SUBSTANTIAL EQUIVALENCE

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

Nidek Co., Ltd

510(k) Summary: RS-3000 Advance Page 4 of 8

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34-14, Machama, I liraishirese, Gamagerl, Aich! 443-0038, Jaoan Namelachinas, Exportars & importers of Ochilladere Instruments, and OptoElockovics instruments

TEL = +81-533-67-6611
FAX = +81-533-67-6610
FAX = 481-533-67-6610
URL = http://www.niddsk.comp
http://www.niddck.com

COMPARISON TABLE OF TECHNOLOGICAL CHARACTERISTICS

DIFFERENCES AND SIMILARITIES CHART RS-3000 VS RS-3000 ADVANCE
Specifications	Model NIDEK RS-3000	NIDEK RS-3000 Advance
Measurement principle	Confocal scanning laseropthalmoscopySpectral Domain OCT	Same
Scan rate	In alignment:10fps for both SLO and OCTIn OCT image capture:53,000 A-Scan/s	In alignment:30fps for OCT and 12fps for SLOIn OCT image capture:53,000 A-Scan/s
Light source wavelength	SLO: 785 nmOCT: 880 nmInternal fixation target: 637 nmExternal fixation lamp:630/565 nm	SameSame
Optical resolution
Fundus image capture	SLO:25 µm (in the X and Y directions)OCT:20 µm (in the X and Y directions), 7 µm (in the Z direction, Eye interior)	SameSame
Anterior segment image capture	SLO:50 µm (in the X and Y directions)OCT:20 µm (in the X and Y directions), 7 µm (in the Z direction, Eye interior)	SameSame
Display resolution
Fundus image capture	SLO:7.5 µm or less (in the X and Y directions)OCT:3 µm or less (in the X and Y directions), 4 µm (in the Z direction, eye interior)	SameSame
Anterior segment image capture	SLO:20 µm or less (in the X and Y directions)	Same
DIFFERENCES AND SIMILARITIES CHART RS-3000 VS RS-3000 ADVANCE
Model	NIDEK RS-3000	NIDEK RS-3000 Advance
Specifications	OCT:2 μm or less (in the X and Ydirections), 4 μm (in the Zdirection, eye interior)	Same
Working distance
Fundus imagecapture	35.5 mm (from objective lensto eye position)	Same
Anteriorsegmentimage capture	14 mm (from the anteriorsegment adapter to the cornea)	Same
Minimum pupildiameterrequired	φ2.5 mm (φ3 mm or more isrecommended.)	Same
LCD display	8.4-inch TFT color LCD	Same
Image visibilitycompensationrange	-15 D to +10 D	Same
Angle of view in capturing
Fundus imagecapture	SLO image: 40 × 30 degree(Zoom: 20 × 15 degree)OCT image: Scan width: 3 mmto 9 mm, Scan depth: 2.1 mm	Same
Anteriorsegmentimage capture	SLO image: 14 mm×12 mmOCT image: Scan width: 2 mmto 8 mm, Scan depth: 2.1 mm	Same
Verticalmovement ofmain body	32 mm or more	Same
Horizontalmovement ofmain body	Back and forth: 40 mm or moreRight and left: 85 mm or more	Same
Verticalmovement ofchinrest	62 mm or more	Same
Interfacefunction	Main body: USB (specializedfor program update)PC: USB, Ethernet, eSATA	Same
Integration timefor OCT	REGULAR	REGULAR / FINE / ULTRA FINE
DIFFERENCES AND SIMILARITIES CHART RS-3000 VS RS-3000 ADVANCE
ModelSpecifications	NIDEK RS-3000	NIDEK RS-3000 Advance
Choroidal mode	Not available	Available
Tracing HD	Not available	Available (only for Macula linemode)
Power specifications
Power supply	AC 100 V (±10%) / AC 120 V(±10%) / AC 230 V (±10%),50/60 Hz	Same
Maximumallowableoutput	Isolation transformer, 1000 VA	Same
Powerconsumption	Main body: 300 VA, PC: 513 VAor less, PC monitor: 60 VA	Same
Dimensions	Main body:380 mm (W) × 524 mm (D) ×499 to 531 mm (H)Isolation transformer:142 mm (W) × 564 mm (D) ×239 mm (H)Motorized Optical Table:592 mm (W) × 472 mm (D) ×596 to 794 mm (H)	Main body:380 mm (W) × 524 mm (D) ×499 to 531 mm (H)Isolation transformer:142 mm (W) × 564 mm (D) ×239 mm (H)Motorized Optical Table:639 mm (W) × 472 mm (D) ×600 to 850 mm (H)
Mass	Main body: 34 kgIsolation transformer: 15 kgPC (Except for monitor): 18 kgMotorized Optical Table: 27 kg	Main body: 34 kgIsolation transformer: 18 kgPC (Except for monitor): 18 kgMotorized Optical Table: 28kg

Nidek Co., Ltd

510(k) Summary: RS-3000 Advance Page 5 of 8

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Image /page/5/Picture/0 description: The image contains the logo for NIDEK. The logo consists of an eye-like symbol above the word "NIDEK" in a bold, sans-serif font. The eye symbol is stylized, featuring a large circle representing the pupil and a curved shape above it representing the upper eyelid.

34.14. Maghama. Hiroishirche, Gamogor, Aichi 443-0038, Jacan Manulachirers, Exporters & Importers of Opintrolinie Instruments, and Opto Electronics Instruments TEL = +81-533-67-6611
FAX = +81-533-67-6811
URL = 811-533-67-6810
URL = lutp://www.niddsk.com.jp
http://www.niddsk.com

KI http://www.nidek.co.jp
http://www.nidek.com

Nidek Co., Ltd

510(k) Summary: RS-3000 Advance Page 6 of 8

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Image /page/6/Picture/0 description: The image shows the logo for Nidek. The logo consists of a stylized eye above the word "NIDEK" in bold, sans-serif capital letters. The eye is composed of a thick outline and a white circle in the center, suggesting a pupil.

34-14, Mashima, Hiroishicho, Gamagori, Aichi 443-0038, Japan
Manufacturers, Exporters & importers of Ophthalmic Instruments, and Opto Electronics Instruments

TEL +81-533-67-6611
FAX +81-533-67-6610
URI http://www.qist.co.jp

IRL https://www.nidck.co.kr
https://www.nidck.com

CLINICAL PERFORMANCE SUMMARY

Results show that the measurements of full retinal thickness, inner retinal thickness, outer retinal thickness, and RNFL thickness with the different OCT sensitivity settings in RS-3000 Advance are similar to the thickness measurements of RS-3000.

All mean differences are within the repeatability limits of RS-3000 (K121622). This indicates that the 3 sensitivities of RS-3000Advance are equivalent to RS-3000.

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Image /page/7/Picture/0 description: The image shows the logo of NIDEK CO., LTD. The logo consists of a stylized eye graphic on the left, followed by the company name in bold, black letters. Below the company name is the address: 34-14, Moohama, Hiraishicho, Gamagori, Aichi 443-0038, Japan. The text below the address indicates that NIDEK are manufacturers, exporters, and importers of ophthalmic instruments and opto-electronics instruments.

NON-CLINICAL PERFORMANCE SUMMARY

The Nidek Optical Coherence Tomography RS-3000 Advance, 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 was found to meet the requirements of the applicable parts.

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 Advance was found to maintain sufficient accuracy and to meet requirement specifications.

CONCLUSION

In summary, Nidek Co., Ltd., is of the opinion that the Nidek Optical Coherence Tomography RS-3000 Advance, with Image Filing Software NAVIS-EX, does not introduce any new potential safety risks, is as effective, and performs as well as devices currently on the market, and concludes that the Nidek Optical Coherence Tomography RS-3000 Advance, with Image Filing Software NAVIS-EX, is substantially equivalent to the predicate device.

This summary of the 510(k) premarket notification for the NIDEK Optical Coherence Tomography RS-3000 Advance is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

Nidek Co., Ltd

510(k) Summary: RS-3000 Advance Page 8 of 8

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The emblem is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Public Health Service

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

February 19, 2014

Nidek Co., Ltd % Ms. Lena Sattler Orasi Consulting. LLC 2856 Whispering Shores Dr. Vermilion, OH 44089

Re: K132323

Trade/Device Name: Nidek RS-3000 Advance Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: January 14, 2014 Received: January 13, 2014

Dear Ms. Sattler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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.

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Page 2 -- Ms. Lena Sattler

You must comply with all the Act's requirements, including, but not limited to: Registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/McdicalDevices/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -S

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

Enclosure

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INDICATIONS FOR USE STATEMENT: RS-3000 ADVANCE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: RS-3000 Advance

Indications for Use:

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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 -S 2014.02.18 09:58:38 -05'00'

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.