(209 days)
No
The document describes standard ophthalmic imaging techniques and features focused on image acquisition, alignment, and averaging. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an aid in diagnosis and management, indicating it is an imaging and diagnostic tool rather than one that provides direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in the diagnosis and management of adults having or suspected of having ocular disease."
No
The device description explicitly states it is comprised of a main body for capturing images, a computer, and an isolation transformer, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nidek Optical Coherence Tomography RS-3000 Advance is a non-contact imaging system that directly images structures within the eye (fundus, retina, optic disc, anterior chamber, cornea). It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as an aid in the diagnosis and management of ocular disease through imaging and measurement of ocular structures. This is consistent with an in vivo imaging device, not an in vitro diagnostic.
Therefore, the device falls under the category of an ophthalmic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
0BO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Scanning Laser Ophthalmoscope (SLO)
Anatomical Site
fundus, ocular structures, 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
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
accuracy of thickness measurements (± 5%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 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 Nidek Co., Ltd 510(k) Summary: RS-3000 Advance
Page 2 of 8
2
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
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
3
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
INDICATIONS FOR USE - RS-3000 ADVANCE
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.
INDICATIONS FOR USE - RS-3000 - PREDICATE DEVICE
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.
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
4
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 laser | |
| opthalmoscopy | ||
| Spectral Domain OCT | Same | |
| Scan rate | In alignment: | |
| 10fps for both SLO and OCT | ||
| In OCT image capture: | ||
| 53,000 A-Scan/s | In alignment: | |
| 30fps for OCT and 12fps for SLO | ||
| In OCT image capture: | ||
| 53,000 A-Scan/s | ||
| Light source wavelength | SLO: 785 nm | |
| OCT: 880 nm | ||
| Internal fixation target: 637 nm | ||
| External fixation lamp: | ||
| 630/565 nm | Same | |
| Same | ||
| 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) | Same | |
| Same | ||
| 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) | Same | |
| Same | ||
| 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) | Same | |
| Same | ||
| 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 Y | ||
| directions), 4 μm (in the Z | ||
| direction, eye interior) | Same | |
| Working distance | ||
| Fundus image | ||
| capture | 35.5 mm (from objective lens | |
| to eye position) | Same | |
| Anterior | ||
| segment | ||
| image capture | 14 mm (from the anterior | |
| segment adapter to the cornea) | Same | |
| Minimum pupil | ||
| diameter | ||
| required | φ2.5 mm (φ3 mm or more is | |
| recommended.) | Same | |
| LCD display | 8.4-inch TFT color LCD | Same |
| Image visibility | ||
| compensation | ||
| range | -15 D to +10 D | Same |
| Angle of view in capturing | ||
| Fundus image | ||
| capture | SLO image: 40 × 30 degree | |
| (Zoom: 20 × 15 degree) | ||
| OCT image: Scan width: 3 mm | ||
| to 9 mm, Scan depth: 2.1 mm | Same | |
| Anterior | ||
| segment | ||
| image capture | SLO image: 14 mm×12 mm | |
| OCT image: Scan width: 2 mm | ||
| to 8 mm, Scan depth: 2.1 mm | Same | |
| Vertical | ||
| movement of | ||
| main body | 32 mm or more | Same |
| Horizontal | ||
| movement of | ||
| main body | Back and forth: 40 mm or more | |
| Right and left: 85 mm or more | Same | |
| Vertical | ||
| movement of | ||
| chinrest | 62 mm or more | Same |
| Interface | ||
| function | Main body: USB (specialized | |
| for program update) | ||
| PC: USB, Ethernet, eSATA | Same | |
| Integration time | ||
| for OCT | REGULAR | REGULAR / FINE / ULTRA FINE |
| DIFFERENCES AND SIMILARITIES CHART RS-3000 VS RS-3000 ADVANCE | ||
| Model | ||
| Specifications | NIDEK RS-3000 | NIDEK RS-3000 Advance |
| Choroidal mode | Not available | Available |
| Tracing HD | Not available | Available (only for Macula line |
| mode) | ||
| Power specifications | ||
| Power supply | AC 100 V (±10%) / AC 120 V | |
| (±10%) / AC 230 V (±10%), | ||
| 50/60 Hz | Same | |
| Maximum | ||
| allowable | ||
| output | Isolation transformer, 1000 VA | Same |
| Power | ||
| consumption | Main body: 300 VA, PC: 513 VA | |
| or 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 kg | |
| Isolation transformer: 15 kg | ||
| PC (Except for monitor): 18 kg | ||
| Motorized Optical Table: 27 kg | Main body: 34 kg | |
| Isolation transformer: 18 kg | ||
| PC (Except for monitor): 18 kg | ||
| Motorized Optical Table: 28kg |
Nidek Co., Ltd
510(k) Summary: RS-3000 Advance Page 5 of 8
5
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.
.
o
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
Nidek Co., Ltd
510(k) Summary: RS-3000 Advance Page 6 of 8
6
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.
7
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
8
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.
9
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
10
INDICATIONS FOR USE STATEMENT: RS-3000 ADVANCE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: RS-3000 Advance
Indications for Use:
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.
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'