(107 days)
Not Found
No
The description focuses on the optical and mechanical components and principles of operation, with no mention of AI or ML algorithms for image analysis or other functions. The performance studies listed are related to technical specifications and safety standards, not AI/ML performance metrics.
No.
The device is strictly for diagnostic imaging of the retina, not for treatment or therapy.
Yes
The device is intended for "taking digital images of a human retina." While it collects images that can be used for diagnosis, its explicit purpose is image acquisition, not the interpretation or analysis of those images to identify specific diseases or conditions.
No
The device description clearly outlines multiple hardware components including an optical head, patient head-rest, chin rest, base with a touch-screen tablet, USB joystick, external power supply, illumination system with various LEDs, imaging system with a CMOS camera, and an anterior segment alignment system. While it runs a dedicated software application, it is fundamentally a hardware device with integrated software.
Based on the provided information, the CenterVue EIDON is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease.
- CenterVue EIDON's Function: The CenterVue EIDON directly images the human retina in vivo (within the living body). It does not analyze specimens taken from the patient.
- Intended Use: The intended use is "for taking digital images of a human retina." This is an imaging function, not an in vitro diagnostic test.
Therefore, the CenterVue EIDON falls under the category of an ophthalmic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The CenterVue EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent.
Product codes (comma separated list FDA assigned to the subject device)
MYC
Device Description
The CenterVue EIDON scanning ophthalmoscope operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes:
-
- Optical head, including a removable lens cap;
-
- Patient head-rest, including removable front-rest;
-
- Patient chin rest;
- Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick 4. and an external power supply.
EIDON uses infrared and visible light to obtain colored confocal digital images of a human retina without a mydriatic agent.
The CenterVue EIDON device operates on the following principles:
- An illumination system consisting of infrared (IR) LEDs (850nm, 940nm), a white LED, a blue LED and a) a green LED illuminates the patient eye with the following functionality:
- The IR LED with a centroid wavelength of 850 nm allows the capture of IR photos. The patient retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°.
- • Two IR Leds with a centroid wavelength of 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine optical axis. The LEDs are switched on during all exams in order to enable pupil tracking.
- The white and blue LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°.
- The green LED is used as fixation target.
- b) An imaging system collects back-reflected light from the retina and creates a high resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 14 megapixels.
- An anterior segment alignment system is included, using two cameras and the two IR LEDs: the c) LEDs illuminate the anterior segment by diffusion, whereas allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument front lens.
The EIDON device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared and visible light (confocal digital images)
Anatomical Site
Human retina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests:
The CenterVue EIDON device has been tested and found to be in conformance with IEC 60601-1:2005 and IEC 60601-1-2:2007. In addition, the device meets the requirements of ISO 10940:2009, ISO 15004-1:2006, and ISO 15004-2:2007.
Performance data:
Sensor resolution: 4608 x 3288
Resolution on retina: 59.7 pixel / deg
Optical resolution: 15.1 microns at the center
Field of view: 60.0° x 55.1°
Pixel pitch: 4.79 microns
Range of focus: -12 D to +15D
Minimum pupil size: 3 mm
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing to the right. The profiles are connected and appear to be layered on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
CenterVue S.p.A. Mr. Roger Gray V.P. Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 00153 Rome, Italy
Re: K142047
Trade/Device Name: CenterVue EIDON Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: September 30, 2014 Received: October 2, 2014
Dear Mr. Gray:
This letter corrects our substantially equivalent letter of November 12, 2014.
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/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
2
Indications for Use
510(k) Number (if known) K142047
Device Name CenterVue EIDON
Indications for Use (Describe)
The CenterVue EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the logo for centervue. The logo consists of the word "centervue" in lowercase letters, with a stylized globe above it. The globe is made up of gray squares and has a black circle in the center.
510(k) Summary in accordance with 21 CFR 807.92(c)
| Device Name: | CenterVue EIDON Ophthalmoscope |
|---|---|
| Type of 510(k) submission: | Traditional |
| Date of Submission: | 24 July 2014 (summary revised on 18 September 2014) |
| Manufacturer: | CenterVue S.p.A. |
| via San Marco 9h | |
| 35129 Padova | |
| Italy | |
| 510(k) Owner: | CenterVue S.p.A. |
| via San Marco 9h | |
| 35129 Padova | |
| Italy | |
| Phone: | |
| Fax: | +39 049 7396 147 |
| +39 049 7396 148 | |
| 510(k) Submitter and Contact: | Mr Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome | |
| Italy | |
| Phone: +39 06 578 2665 | |
| Fax: +30 06 574 3786 | |
| Email: rgray@donawa.com | |
| FDA Product Code: | MYC |
| FDA Regulation Number: | 886.1570 |
| FDA Classification Name: | Ophthalmoscope |
| Classification Panel: | Ophthalmic |
| Common Name: | Ophthalmoscope |
| FDA Classification: | Class II |
| FDA 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. | |
| Indications for Use/Intended Use: | The CenterVue EIDON is intended for taking digital images of a |
| human retina without the use of a mydriatic agent. |
4
Image /page/4/Picture/0 description: The image shows the logo for Centervue. The logo consists of a stylized globe-like shape above the word "centervue" in lowercase letters. The globe is made up of several gray blocks arranged in a circular pattern, with a black circle in the center. The word "centervue" is written in a simple, sans-serif font.
Device Description:
The CenterVue EIDON scanning ophthalmoscope operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes:
-
- Optical head, including a removable lens cap;
-
- Patient head-rest, including removable front-rest;
-
- Patient chin rest;
- Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick 4. and an external power supply.
EIDON uses infrared and visible light to obtain colored confocal digital images of a human retina without a mydriatic agent.
The CenterVue EIDON device operates on the following principles:
- An illumination system consisting of infrared (IR) LEDs (850nm, 940nm), a white LED, a blue LED and a) a green LED illuminates the patient eye with the following functionality:
- The IR LED with a centroid wavelength of 850 nm allows the capture of IR photos. The patient retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°.
- • Two IR Leds with a centroid wavelength of 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine optical axis. The LEDS are switched on during all exams in order to enable pupil tracking.
- The white and blue LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°.
- The green LED is used as fixation target.
- b) An imaging system collects back-reflected light from the retina and creates a high resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 14 megapixels.
- An anterior segment alignment system is included, using two cameras and the two IR LEDs: the c) LEDs illuminate the anterior segment by diffusion, whereas allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument front lens.
The EIDON device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment.
Bench tests
The CenterVue EIDON device has been tested and found to be in conformance with IEC 60601-1:2005 and IEC 60601-1-2:2007. In addition, the device meets the requirements of ISO 10940:2009, ISO 15004-1:2006, and ISO 15004-2:2007.
5
Image /page/5/Picture/0 description: The image shows a stylized logo. The logo features a sphere with a dark center, surrounded by a series of gray cubes that appear to be orbiting or partially encasing the sphere. The cubes are arranged in a circular pattern, giving the impression of a three-dimensional structure. The overall design is modern and abstract.
Performance data:
| Performance item | Requirements | Test results |
|---|---|---|
| Sensor resolution | 14 megapixels (4608 x 3288) | 4608 x 3288 |
| Resolution on retina | 60 pixel / deg | 59.7 pixel / deg |
| Optical resolution | 15 microns at the center | 15.1 microns at the center |
| Field of view | 60° (H) × 55° (V) | 60.0° x 55.1° |
| Pixel pitch | 4.9 microns max | 4.79 microns |
| Range of focus | -12 D to +15D | -12 D to +15D |
| Minimum pupil size | 3 mm | 3 mm |
Comparison with predicate devices:
The predicate devices selected for comparison with the CenterVue EIDON Ophthalmoscope are:
| Predicate Device 1: | EasyScan |
|---|---|
| 510(k) Sponsor: | i-Optics B.V. |
| 510(k) Number: | K111988 |
| Clearance Date: | 28 October 2011 |
| FDA Product Code: | MYC |
| Classification Name: | Scanning Laser Ophthalmoscope |
| Regulation No: | 886.1570 |
| Predicate Device 2: | Digital Retinography system (DRS) |
| 510(k) Sponsor: | CenterVue S.p.A. |
| 510(k) Number: | K101935 |
| Clearance Date: | 27 October 2010 |
| FDA Product Code: | HKI |
| Classification Name: | Ophthalmic Camera |
| Regulation No: | 886.1120 |
The Subject Device and the Predicate Devices share many identical or similar properties and features. Differences include:
- . Field of view
- . Imaging principle
- . Fixation target
- . Working distance
- Sensor size
- . Minimum pupil size
None of these differences have any significant effect on safety or effectiveness of the Subject Device.
Conclusion:
Based on the information contained within this submission, it is concluded that the CenterVue EIDON Ophthalmoscope is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.