(218 days)
No
The description focuses on a new software function for fixation training based on real-time distance feedback, not AI/ML algorithms.
Yes.
The device aids visual rehabilitation and is intended to help Vision Rehabilitation Specialists train patients to improve fixation stability, which are therapeutic applications.
Test: Is this device a diagnostic device?
No
Explanation: The Intended Use section states that the device is "aiding visual rehabilitation" and "measuring macular sensitivity, measuring fixation stability and the locus of fixation, providing infrared retinal imaging". While measuring and imaging can be part of diagnosis, the primary purpose is rehabilitation, and it also explicitly states it's intended to "aid visual rehabilitation". The "Fixation Training" function further supports the rehabilitation purpose. Although it measures and provides a reference database, these are described as "aiding visual rehabilitation" and a "quantitative tool for the comparison", not explicitly for diagnosis.
No
The device description explicitly states that the MAIA device interacts with the patient by directing illumination into the patient's eye and includes a chin-rest and head-rest that contact the patient. It also mentions a motorized chin-rest and a patient proximity sensor. These are hardware components, indicating it is not a software-only device. The submission is for a software change to an existing hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Function: The Centervue MAIA directly interacts with the patient's eye using light and measures physiological responses (macular sensitivity, fixation stability). It does not analyze samples taken from the body.
- Intended Use: The intended uses listed (measuring macular sensitivity, fixation stability, retinal imaging, aiding visual rehabilitation) are all related to direct assessment and intervention on the patient's eye, not analysis of in vitro samples.
- Device Description: The description details how the device interacts with the patient's eye and provides feedback based on eye movements, further supporting its in vivo nature.
Therefore, the Centervue MAIA is an in vivo diagnostic and rehabilitation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Centervue MAIA is intended for:
• measuring macular sensitivity,
• measuring fixation stability and the locus of fixation,
• providing infrared retinal imaging, and
• aiding visual rehabilitation.
It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.
Product codes
MYC, HPT
Device Description
A previous version of the CenterVue MAIA, a device for macular integrity assessment, has been cleared by FDA under K133758 on 23 April 2014. The present submission relates to a revised version of the MAIA device in which the only difference between the subject device and the MAIA device cleared under K133758 is in the software, where a new function called "Fixation Training" (FT) has been introduced to aid visual rehabilitation of patients with unstable fixation. The FT is independent from the functions available in the device cleared under K133758 and it does not interfere or modify the original functions in any way. No other design changes are being introduced by this revision to the MAIA device.
The FT is intended for visual rehabilitation, to help Vision Rehabilitation Specialists train patients with unstable fixation to improve their fixation stability.
A FT session consists of asking the patient to move his/her gaze according to the trainer's instructions and to an audible signal, so to attempt fixation of the internal visual target using a specific retinal area, which is identified by the trainer ahead of the training session. The center of such area is called Fixation Training Target (FTT).
During the FT session, the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient in the form of pulses of a certain repetition frequency. The number of pulses / sec (i.e. the repetition frequency) is inversely proportional to the distance between the patient's fixation point at that time and the FTT; when such distance falls below one degree, the sound becomes continuous. Optionally, before starting the FT session, operators are able to replace the continuous sound with an MP3 audio file.
The MAIA device interacts with the patient by directing 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. The biocompatibility of the patient-contacting materials, which are the same as used in the previous version of the subject device (K133758) has been established.
The MAIA device operates as a 'stand-alone' device and does not need to interface with other medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
infrared retinal imaging
Anatomical Site
macular, retinal, eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Vision Rehabilitation Specialists
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8. 2016
CenterVue S.p.A Mr. Roberto Gabriotti QA & RA Manager Via San Marco, 9H 35129 Padova, Italy
Re: K153181
Trade/Device Name: MAIA Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC, HPT Dated: March 15, 2016 Received: April 29, 2016
Dear Mr. 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, 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 devicerelated 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" (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.
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.
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 | |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------|
| Food and Drug Administration | | | |
| 510(k) Number (if known) | K153181 | | |
| Device Name | MAIA | | |
| Indications for Use (Describe) | The Centervue MAIA is intended for:
• measuring macular sensitivity,
• measuring fixation stability and the locus of fixation,
• providing infrared retinal imaging, and
• aiding visual rehabilitation.
It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a
database of known normal subjects. | | |
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ 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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made of gray and yellow squares, with a black circle in the center representing the pupil. Below the eye is the word "centervue" in a lowercase, sans-serif font, with the "vue" portion in a slightly bolder typeface.
510(k) Summary in accordance with 21 CFR 807.92
| Device Name: | CenterVue MAIA |
|---|---|
| Type of 510(k) submission: | Traditional |
| Date of submission: | 15th October 2015 |
| Manufacturer: | CenterVue SpA |
| Via San Marco 9h | |
| 35129 Padova - ITALY | |
| 510(k) Owner: | CenterVue SpA |
| Via San Marco 9h | |
| 35129 Padova - ITALY | |
| Phone: | +39 049 7396 147 |
| Fax: | +39 049 7396 148 |
| FDA Registration Number: | 3008422902 |
| Owner/Operator Number: | 10032778 |
| 510(k) Submitter and Contact: | Mr. Roberto Gabriotti |
| QA/RA Manager | |
| Via San Marco 9H, 35129 Padova - ITALY | |
| Phone: | +39 049 7396 147 |
| Fax: | +39 049 7396 148 |
| Email: | roberto.gabriotti@centervue.com |
| FDA Product Code: | MYC, HPT |
| FDA Regulation Number: | 886.1570 |
| FDA Classification Name: | Ophthalmoscope; Perimeter, Automatic, Ac-powered |
| Classification Panel: | Ophthalmic |
| Common Name: | Ophthalmoscope; Perimeter |
| 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. A perimeter is an AC-powered or manual device intended to | |
| determine the extent of the peripheral visual field of a patient. The | |
| device projects light on various points of a curved surface, and the | |
| patient indicates whether he or she sees the light. | |
| Indications for Use / Intended Use: | The Centervue MAIA is intended for: |
| measuring macular sensitivity,measuring fixation stability and the locus of fixation,providing infrared retinal imaging, andaiding visual rehabilitation. |
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Image /page/4/Picture/0 description: The image shows the logo for Centerview. The logo features the word "centerview" in lowercase letters, with the "vue" portion in yellow. Above the text is a stylized eye graphic, composed of gray and yellow squares arranged in a spherical shape, with a black circle representing the pupil.
It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.
Device description
A previous version of the CenterVue MAIA, a device for macular integrity assessment, has been cleared by FDA under K133758 on 23 April 2014. The present submission relates to a revised version of the MAIA device in which the only difference between the subject device and the MAIA device cleared under K133758 is in the software, where a new function called "Fixation Training" (FT) has been introduced to aid visual rehabilitation of patients with unstable fixation. The FT is independent from the functions available in the device cleared under K133758 and it does not interfere or modify the original functions in any way. No other design changes are being introduced by this revision to the MAIA device.
The FT is intended for visual rehabilitation, to help Vision Rehabilitation Specialists train patients with unstable fixation to improve their fixation stability.
A FT session consists of asking the patient to move his/her gaze according to the trainer's instructions and to an audible signal, so to attempt fixation of the internal visual target using a specific retinal area, which is identified by the trainer ahead of the training session. The center of such area is called Fixation Training Target (FTT).
During the FT session, the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient in the form of pulses of a certain repetition frequency. The number of pulses / sec (i.e. the repetition frequency) is inversely proportional to the distance between the patient's fixation point at that time and the FTT; when such distance falls below one degree, the sound becomes continuous. Optionally, before starting the FT session, operators are able to replace the continuous sound with an MP3 audio file.
The MAIA device interacts with the patient by directing 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. The biocompatibility of the patient-contacting materials, which are the same as used in the previous version of the subject device (K133758) has been established.
The MAIA device operates as a 'stand-alone' device and does not need to interface with other medical devices.
Bench tests
Because no hardware or firmware change or modification was applied, on respect of the device cleared under K133758, the predicate device maintains compliance with the same electrical safety and performance standards that were applied for the device cleared under K133758, these being:
- IEC 60601-1:2005
- . IEC 60601-1-2:2007
- ISO 12866:1999
- ISO 15004- 1:2006
- ISO 15004-2:2007
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Image /page/5/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made up of gray and yellow squares, with a black circle in the center representing the pupil. Below the eye is the word "centervue" in a lowercase sans-serif font, with the "vue" portion of the word in yellow.
- ISO 14971: 2007
- ISO 62304: 2006
The same test reports submitted for the MAIA device cleared under K133758 are still valid. In addition, the Fixation Training software meets the requirements of:
- ISO 62304: 2006
- . ISO 14971: 2007
Identification of predicate devices
The predicate devices selected for comparison with the subject device are identified as follows:
| Primary Predicate Device (PD1): | CenterVue MAIA (primary) |
|---|---|
| 510(k) Owner: | CenterVue |
| 510(k) Number: | K133758 |
| Clearance Date: | 23 April 2014 |
| FDA Product Code: | HPT, HLI |
| FDA Regulation Number: | 886.1605, 886.1570 |
| FDA Classification Name: | Perimeter, Automatic, AC-powered; Ophthalmoscope, AC-powered |
| FDA Classification: | Class II |
| Secondary Predicate Device (PD2): | Nidek MP1 (secondary) |
| 510(k) Owner: | Nidek |
| 510(k) Number: | K061768 |
| Clearance Date: | 28 September 2006 |
| FDA Product Code: | HKI, HPT |
| FDA Regulation Number: | 886.1120, 886.1605 |
| FDA Classification Name: | Perimeter, Automatic, AC-powered; Ophthalmic Camera, AC-powered |
Predicate Device comparison
There are no differences in hardware between the subject and primary predicate device.
With regard to software, there are no differences between the subject device and the primary predicate device other than the Fixation Training software, which is not available in the predicate device. With regard to the Fixation Training software and its underlying technological characteristics, there are no substantial differences between the subject device and the secondary predicate device.
Table 1 provides a comparison between the subject device and the predicate devices.
| Table 1 - Predicate device comparison table | ||||
|---|---|---|---|---|
| Item | Primary predicate device | |||
| (PD1) | Secondary predicate | |||
| device (PD2) | Subject device | Comparison | ||
| Device name | MAIA | MP1 | MAIA | N/A |
| Device | ||||
| Manufacturer | CenterVue | Nidek | Centervue | N/A |
| 510(k) Reference | K133758 | K061768 | N/A | N/A |
| FDA Product Code | HPT, HLI | HPT, HKI | HPT, HLI | Same as PD1 |
| FDA Regulation | ||||
| Number | 886.1605, 886.1570 | 886.1605, 886.1120 | 886.1605, 886.1570 | Same as PD1 |
| Item | Primary predicate device | |||
| (PD1) | Secondary predicate | |||
| device (PD2) | Subject device | Comparison | ||
| FDA Classification | ||||
| Name | Perimeter, Automatic, | |||
| AC-powered; | ||||
| Ophthalmoscope, | ||||
| AC-powered | Perimeter, Automatic, | |||
| AC-powered; | ||||
| Ophthalmic Camera, | ||||
| AC-powered | Perimeter, Automatic, | |||
| AC-powered; | ||||
| Ophthalmoscope, | ||||
| AC-powered | Same as PD1 | |||
| FDA Regulation | ||||
| Number | 886.1605, 886.1570 | 886.1605, 886.1120 | 886.1605, 886.1570 | Same as PD1 |
| Device description | Perimeter for macular | |||
| integrity assessment | Micro-perimeter for the | |||
| diagnosis of retinal | ||||
| disease | Perimeter for macular | |||
| integrity assessment | Same as PD1 | |||
| Indications for use | MAIA is intended for | |||
| measuring macular | ||||
| sensitivity, fixation | ||||
| stability and the locus of | ||||
| fixation, as well as | ||||
| providing infrared retinal | ||||
| imaging. It contains a | ||||
| reference database that is | ||||
| a quantitative tool for the | ||||
| comparison of macular | ||||
| sensitivity to a database of | ||||
| known normal subjects. | The MP-1 is indicated for | |||
| use as: |
- Color retinography
- Fixation examiner
- Fundus-related
microperimetry - Visual rehabilitation | The Centervue MAIA is
intended for:
• measuring macular
sensitivity,
• measuring fixation
stability and the locus
of fixation,
• providing infrared
retinal imaging, and
• aiding visual
rehabilitation.
It contains a reference
database that is a
quantitative tool for the
comparison of macular
sensitivity to a database
of known normal subjects. | Similar to
PD1, partially
the same as
PD2 |
| Retinal imaging
system | Line Scanning
Ophthalmoscope | Fundus camera | Line Scanning
Ophthalmoscope | Same as PD1 |
| Background
luminance for
perimetry | 4 asb | 4 asb | 4 asb | Same as PD1
& PD2 |
| Stimuli size | Goldmann III | Goldmann I-V | Goldmann III | Same as PD1 |
| Minimum pupil
size | 2.5 mm | 4.0 mm | 2.5 mm. | Same as PD1 |
| Maximum
luminance | 1000 asb | 400 asb | 1000 asb | Same as PD1 |
| Stimuli dynamic
range | 36 dB | 20 dB | 36 dB | Same as PD1 |
| Features relevant to the Fixation Training | | | | |
| Imaging field | 36° x 36° | 45° circular (diameter) | 36° x 36° | Same as PD1,
different
from PD2 |
| Imaging and
tracking speed | 25 Hz | 25 Hz | 25 Hz | Same as PD1
& PD2 |
| Table 1 - Predicate device comparison table | | | | |
| Item | Primary predicate device
(PD1) | Secondary predicate
device (PD2) | Subject device | Comparison |
| Imaging resolution | 1024 x 1024 | 768 x 576 | 1024 x 1024 | Same as PD1,
different
from PD2 |
| Perimetry field | 30° x 30° | 40° circular (diameter) | 30° x 30° | Same as PD1,
different
from PD2 |
| Perimetric grids | 10° macular, 6° macular,
10-2, customizable within
field | Customizable within field | 10° macular, 6° macular,
10-2, customizable within
field | Same as PD1,
equivalent to
PD2 |
| Imaging
wavelength for
eye tracking | 850 nm | > 800 nm | 850 nm | Same as PD1,
equivalent to
PD2 |
| Means for
identification of
the FTT | Not available | Manually by eye
practitioner using IR
retinal image | Manually by eye
practitioner using IR
retinal image | Same as PD2 |
| Fixation stability
indices | P1, P2 and BCEA | P1, P2 and BCEA | P1, P2 and BCEA | Same as PD1
& PD2 |
| Feedback to
patient during
Fixation Training | Not available | Repetition frequency of
audible pulses | Repetition frequency of
audible pulses | Same as PD2 |
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Image /page/6/Picture/0 description: The image contains the logo for Centervue. The logo features a stylized eye made up of yellow squares and a black pupil. Below the eye is the word "centervue" in a lowercase sans-serif font, with the "vue" portion of the word in yellow.
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Image /page/7/Picture/0 description: The image contains the logo for "centerview". The logo consists of a stylized globe with a large eye in the center. The globe is made up of gray and yellow squares, and the eye is black with a white highlight. Below the globe is the word "centerview" in a sans-serif font, with "vue" in yellow.
The only differences identified between the predicate devices and the subject device are:
- Indications for use statement
- . Imaging and perimetry field
- . Imaging resolution
None of these differences introduce new issues of safety and effectiveness. The remaining technical aspects of the devices are identical or very similar.
Conclusion
Based on the information contained in this submission, it is concluded that the CenterVue MAIA is substantially equivalent to the identified predicate devices already in interstate commerce within the USA and that any differences that do exist have no effect on the safety and effectiveness of the device.