(118 days)
The CenterVue RETIA 2 is a confocal scanning ophthalmoscope indicated for infrared and auto-fluorescence imaging of a human retina with or without the use of a mydriatic agent.
The CenterVue RETIA 2 is a modification of the CenterVue EIDON (K142047). RETIA 2 is a scanning ophthalmoscope which uses infrared light to obtain infrared-reflectance images of the retina and blue light to obtain auto-fluorescence images of the retina. RETIA 2 operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes: 1. Optical head, including a removable lens cap; 2. Patient head-rest, including removable front-rest; 3. Patient chin rest; 4. Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick and an external power supply. RETIA 2 operates based on the following principles: a) An illumination system consisting of infrared LEDs (850nm, 940nm), a blue LED (450nm) and 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's retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror 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's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking. - . The blue LED (450 nm) is used to illuminate the retina and capture fluorescence retinal images. The retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror 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 including a barrier filter (high-pass with a cutoff at 500 nm) stops back-reflected light from the retina and only allows fluorescent light to be detected for imaging. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 5 megapixels. c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's front lens. RETIA 2 interacts with the patient by directing infrared- and blue-wavelength illumination for imaging purposes and green illumination for fixation purposes into the patient's eye. The chin-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.
The document describes the CenterVue RETIA 2, a confocal scanning ophthalmoscope, and its comparison to predicate devices, specifically the CenterVue EIDON (K142047) and Heidelberg SPECTRALIS (K172649). The study primarily focuses on demonstrating that the RETIA 2 provides infrared and autofluorescence images that are similar to those of the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or other quantitative metrics for image quality or diagnostic performance. Instead, it relies on a qualitative comparison.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produce infrared images similar to the predicate device (CenterVue EIDON). | "The comparison showed that RETIA 2 provides infrared... images that are similar to those of the mentioned devices." |
| Produce autofluorescence images similar to the reference device (Heidelberg SPECTRALIS). | "The comparison showed that RETIA 2 provides... autofluorescence images that are similar to those of the mentioned devices." |
| Continued conformance with relevant safety and performance standards. | ISO 15004-2 (Light Hazard Protection): RETIA 2 fulfills requirements for a group 1 determination (no potential light hazard). ISO 15004-1: Complies with the standard for ophthalmic instruments. IEC 60601-1:2005 and IEC 60601-1-2:2007: Complies for electrical safety and electromagnetic compatibility. IEC 62304: Software complies with the standard. ISO 10940: Complies with applicable requirements for Fundus Cameras. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample size for the test set (number of images or patients). It states: "Images of eyes with and without diagnosed pathology were included in the comparison."
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide this information. It only states that images "with and without diagnosed pathology were included," implying that some form of diagnosis or ground truth was available, but it doesn't describe how it was established or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify the adjudication method used for the comparison.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance or its impact on human reader improvement. The study described is a device-to-device comparison based on image similarity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone imaging system. The "performance data - Clinical" section describes a comparison of images generated by the RETIA 2 against images from predicate devices. This represents the standalone performance of the device in generating images, as there's no mention of a human in the loop for interpreting the images for the purpose of this comparison study. However, it's not an "algorithm only" study as the device is a piece of hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "images of eyes with and without diagnosed pathology." This suggests that the ground truth for image classification (e.g., presence or absence of pathology) was based on pre-existing diagnoses, likely from clinicians or medical records. However, the exact nature of this "diagnosis" (e.g., expert consensus, pathology reports, clinical outcomes) is not further detailed.
8. The sample size for the training set
The document does not mention a training set, as the study described is a device comparison for image similarity, not an AI model requiring training data.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI model is described.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym "FDA" appearing above the words "U.S. FOOD & DRUG ADMINISTRATION".
May 30, 2018
CenterVue S.p.A Roberto Gabriotti Quality and Regulatory Affairs Manager via San Marco 9h 35219 Padova. ITALY
Re: K180293
Trade/Device Name: Retia 2 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: March 27, 2018 Received: April 2, 2018
Dear Roberto Gabriotti:
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. Iisting 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.
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
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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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Denise L. Hampton -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/202 See PRA Statement below.
510(k) Number (if known)
Device Name
RETIA 2
Indications for Use (Describe)
The CenterVue RETIA 2 is a confocal scanning ophthalmoscope indicated for infrared and auto-fluorescence imaging of a human retina with or without the use of a mydriatic agent.
Type of Use (Select one or both, as applicable)
7 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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Image /page/3/Picture/0 description: The image contains the logo for Centervue. The logo features a stylized globe made of yellow squares, with a black circle in the center resembling an eye. Below the globe is the word "centervue" in a lowercase, sans-serif font, with the "vue" portion in yellow.
510(k) Summary
| Proprietary Name: | RETIA 2 |
|---|---|
| Type of submission: | Traditional |
| Date of submission: | January 29th, 2018 |
| Last revised on: | May 25th, 2018 |
| Manufacturer: | CENTERVUE S.p.A.Via San Marco 9H35129 Padova - ITALY |
| Applicant and contact | Mr. Roberto GabriottiCentervue S.p.A.Manager of Quality and Regulatory AffairsVia San Marco 9H, 35129 Padova - ITALYPhone: +39 049 501 8399Fax: +39 049 501 8398Email: roberto.gabriotti@centervue.com |
| Product Code: | MYC |
| Regulation Number: | 886.1570 |
| Common Name: | Ophthalmoscope |
| Panel: | Ophthalmic |
| Class: | Class II |
| Indications for Use: | The CenterVue RETIA 2 is a confocal scanning ophthalmoscopeindicated for infrared and auto-fluorescence imaging of a human retinawith or without the use of a mydriatic agent. |
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Image /page/4/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made of yellow and gray squares, with a black circle in the center representing the pupil. Below the eye is the word "centervue" in lowercase letters.
Device description
The CenterVue RETIA 2 is a modification of the CenterVue EIDON (K142047).
RETIA 2 is a scanning ophthalmoscope which uses infrared light to obtain infrared-reflectance images of the retina and blue light to obtain auto-fluorescence images of the retina.
RETIA 2 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 and an external power supply.
RETIA 2 operates based on the following principles:
- An illumination system consisting of infrared LEDs (850nm, 940nm), a blue LED (450nm) and a green a) 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's retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror 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's optical axis. The LEDS are switched on during all exams in order to enable pupil tracking.
- . The blue LED (450 nm) is used to illuminate the retina and capture fluorescence retinal images. The retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror 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 including a barrier filter (high-pass with a cutoff at 500 nm) stops back-reflected light from the retina and only allows fluorescent light to be detected for imaging. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 5 megapixels.
- c) An anterior segment alignment system is included, using two cameras and the two IR LEDs. The LEDs illuminate the anterior segment by diffusion, whereas the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's front lens.
RETIA 2 interacts with the patient by directing infrared- and blue-wavelength illumination for imaging purposes and green illumination for fixation purposes into the patient's eye. The chin-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.
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Image /page/5/Picture/0 description: The image contains the logo for Centervue. The logo features a stylized globe made of yellow and gray blocks, with a black circle in the center resembling an eye. Below the globe, the word "centervue" is written in lowercase letters.
TECHNICAL SPECIFICATIONS
Class and type of applied part
- . Class I, Type B (according to IEC 60601-1)
IP classification:
- . IPX0 (according to the degree of protection provided by the enclosure with respect to harmful penetration of particulate matter or water).
Image acquisition:
- Non-mydriatic (minimum pupil size 2.5 mm)
- . Field of view: 60° (H) x 55° (V) captured in a single exposure
- Sensor size: 5 Mpixel (2592 x 1944)
- Light source: near infrared (825-870 nm) and blue LED (440-475 nm)
- Working distance: 28 mm
- Resolution: 30 pixels/deg
- Resolution on retina: 17 microns
- Pixel pitch: 9.3 µm
Other features:
- Imaging modalities: IR, auto-fluorescence
- Automatic operation: auto-alignment, auto-focus, auto-exposure, auto-capture
- . Auto-focusing adjustment range: -12D to +15D
- Dynamic, programmable internal fixation target, in every position of the field
- . Tablet operated, with multi-touch, color display
- Ethernet connection through device
- . Embedded hard disc (SSD)
Dimensions:
- . Weight: 25 Kg
- Size: 620 X 590 X 360 mm
Power supply:
- Voltage: 12 V DC
- Power consumption: 60 W
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Image /page/6/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made up of yellow squares arranged in a spherical shape, with a black pupil in the center. Below the eye is the word "centervue" in a lowercase, sans-serif font.
Comparison with predicate device
The predicate device selected for comparison with the CenterVue RETIA 2 is identified as follows:
| Proprietary Name: | EIDON |
|---|---|
| Manufacturer: | CenterVue S.p.A. |
| 510(k) Number: | K142047 |
| Clearance Date: | 12 November 2014 |
| FDA Product Code: | MYC |
| Classification Name: | Ophthalmoscope, Laser, Scanning |
| Regulation Number: | 886.1570 |
The following device was used as reference:
| Proprietary Name: | SPECTRALIS |
|---|---|
| Manufacturer: | Heidelberg Engineering Gmbh |
| 510(k) Number: | K172649 |
| FDA Product Code: | MYC |
| Classification Name: | Ophthalmoscope, Laser, Scanning |
| Regulation Number: | 886.1570 |
The Subject Device and the Predicate Device share many identical or similar properties and features. In particular, the fundamental scientific technology of the subject device is unchanged from the predicate and remains confocal, line scanning, LED-based, ophthalmoscopy. Also, the principle of operation, mechanism of action and interaction with the patient are unchanged.
With respect to EIDON, the RETIA 2 includes some modifications which enable it to capture fundus autofluorescence images, using the same base technology and maintaining the same Intended Use and Indications for Use.
Specifically, functional differences between RETIA 2 and EIDON are as follows:
- . RETIA 2 does not allow the capture of color images, using white light;
- RETIA 2 allows the capture of auto-fluorescence images, using blue LED light.
Technological differences between RETIA 2 and EIDON include:
| Characteristic | CenterVue EIDON | CenterVue RETIA 2 |
|---|---|---|
| Imaging system | Scanning LED imaged to CMOS sensor | Scanning LED imaged to CMOS sensor with barrier filter for auto-fluorescence imaging |
| Imaging sensor | Color CMOS, 4608x3288 pixels (14 MP) | Monochrome CMOS, 2592x1944 pixels (5 MP) |
| Visible light source for imaging | Blue LED and white LEDs | Blue LED (more powerful) |
| Imaging modalities | Infrared, color, red-free | Infrared, auto-fluorescence |
4 Neither the CenterVue EIDON nor the RETIA 2 contain lasers but rather use LEDs for confocal imaging
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Image /page/7/Picture/0 description: The image is a logo for a company called "centerview". The logo features a stylized eye made up of yellow squares and a black circle. The eye is positioned above the company name, which is written in a lowercase sans-serif font. The overall design is modern and minimalist.
| Characteristic | CenterVue EIDON | CenterVue RETIA 2 |
|---|---|---|
| Flash controlelectronic board | The board contains some modifications needed to drivethe modified blue LED | |
| Software | The device software is modified to implement fundusauto-fluorescence imaging and remove color retinalimaging |
None of these differences have any significant effect on safety or effectiveness of the Subject Device. Notably, with respect to the impact of these design modifications on a key part of the product's risk analysis (i.e. optical radiation safety), Centervue has confirmed conformance with the applicable recognized standard, ISO 15004-2, making these modifications eligible for a Special 510(k) notification.
Performance data - Bench
Continued conformance with the following standards has been confirmed in support of the substantial equivalence determination:
ISO 15004-2 (light Hazard Protection)
RETIA 2 fulfills the requirements for a group 1 determination according to ISO 15004-2:2007, i.e. ophthalmic instruments for which no potential light hazard exists.
ISO 15004-1
The subject device complies with the ISO 15004-1:2006 standard for ophthalmic instruments.
Electrical safety and electromagnetic compatibility The device complies with IEC 60601-1:2005 and IEC 60601-1-2:2007.
IEC 62304
The device software complies with IEC 62304.
ISO 10940
RETIA 2 complies with the applicable requirements of ISO 10940 - Ophthalmic instruments — Fundus Cameras.
Performance data - Clinical
The imaging properties of the RETIA 2 were assessed by comparing infrared images taken with the RETIA 2 with infrared images taken using the predicate device (CenterVue EIDON, K142047) and by comparing autofluorescence images taken with the RETIA 2 with auto-fluorescence images taken with the reference device (Heidelberg SPECTRALIS, K172649). Images of eyes with and without diagnosed pathology were included in the comparison.
The comparison showed that RETIA 2 provides infrared and autofluorescence images that are similar to those of the mentioned devices.
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Image /page/8/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized globe made of yellow and gray blocks, with a black circle in the center resembling an eye. Below the globe, the word "centervue" is written in lowercase letters, with the "vue" portion in yellow.
Conclusion
Based on the information contained within this submission, it is concluded that the CenterVue RETIA 2 is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.
§ 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.