(310 days)
Not Found
No
The document describes standard image processing for eye tracking and a reference database for comparison, but does not mention AI or ML algorithms.
No
The device is indicated for measuring and comparing macular sensitivity and fixation characteristics, and does not provide therapy or treatment.
Yes
The device is indicated for "measuring macular sensitivity, fixation stability and the locus of fixation," which involves assessing physiological parameters to provide information for diagnosis. It also includes a "reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects," further supporting its role in aiding diagnosis.
No
The device description explicitly states that the MAIA™ is a "confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection" and integrates "an automated perimeter and an ophthalmoscope." It also mentions hardware components like a computer, touch-screen display, power cord, and push-button. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MAIA™ device directly examines the patient's eye (macula and central retina) using infrared retinal imaging and visible light projection. It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly indicate direct patient interaction and measurement of physiological responses. The device measures macular sensitivity (a patient's subjective response to light stimuli), fixation stability, and the locus of fixation by projecting light onto the retina and tracking eye movements.
- The reference database is for comparison of in-vivo measurements. The database is used to compare the measured macular sensitivity of a patient to a database of known normal subjects, which is a comparison of in-vivo measurements, not in-vitro analysis of a specimen.
Therefore, the MAIA™ device falls under the category of a medical device used for in-vivo diagnostic purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Macular Integrity Assessment (MAIA™) is indicated 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.
Product codes (comma separated list FDA assigned to the subject device)
HLI, HPT
Device Description
The MAIA™ is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, using "fundus perimetry" (also "microperimetry").
MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing:
- images of the central retina over a field of view of 36° x 36°, acquired under infrared . illumination;
- recordings of eye movements obtained by "tracking" retinal details in the live retinal images and . providing a quantitative analysis of fixation characteristics;
- measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in . the macula, obtained by recording a patient's subjective response (see / don't see) to a light stimulus projected at a certain location over the retina;
- comparison of measured threshold sensitivity with a reference database obtained from normal . subjects, indicating whether measured thresholds are above or below certain percentiles.
MAIA 100 works with no pupil dilation (non-mydriatic).
MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared, Visible light projection
Anatomical Site
Central retina, macula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
The reference database was developed by obtaining threshold sensitivity data from 494 eyes of 270 normal subjects, enrolled at 4 different clinical sites. The age range of the measured population was 21-86 (mean 43, std. dev. 15). Subjects were recruited among the clinics' personnel and among the relatives of the clinics' regular patients. The following MAIA perimetric grid and other device settings were used for the measurements:
- Number of stimuli: 61; .
- Macular coverage: 10°; .
- Size of stimulus: Goldmann III; .
- Duration of stimulus: 200 ms; ●
- . Background luminance: 4 asb;
- Maximum luminance: 1000 asb; .
- Threshold algorithm: standard 4-2 staircase; ●
- . Measurement scale: 0 to 36 dB;
- . Fixation target: central circle of 1° diameter.
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)
Precision Study:
- Study Type: Precision study measuring individual location thresholds (n = 37 per eye) and average threshold over all locations.
- Sample Size: 24 subjects (12 without pathology, 12 with pathology), each tested on one eye only.
- Data Source: Two different clinical sites.
- Protocol: Three devices were used, each operated by a different operator. Each subject/eye was tested 3 times within a session (3 repeated measures for each subject).
- Key Results:
- Overall Mean and Standard Deviation:
- Normal: Overall Mean = 29.7 dB, Overall Standard deviation = 1.14 dB
- Pathology: Overall Mean = 23.5 dB, Overall Standard deviation = 4.23 dB
- Repeatability SD*:
- Normal: 0.42 dB
- Pathology: 0.75 dB
- *estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning.
- Reproducibility SD*:
- Normal: 0.96 dB
- Pathology: 0.75 dB
- *estimate of the standard deviation among measurements taken on the same subject using different operators and devices, including repeatability.
- Individual Grid Point Results:
- Normal:
- Repeatability SD: Minimum = 0.94, Median = 1.40, Maximum = 2.43
- Reproducibility SD: Minimum = 1.06, Median = 1.80, Maximum = 2.70
- Pathology:
- Repeatability SD: Minimum = 1.33, Median = 2.36, Maximum = 3.16
- Reproducibility SD: Minimum = 1.33, Median = 2.43, Maximum = 3.24
- Normal:
- Overall Mean and Standard Deviation:
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
§ 886.1605 Perimeter.
(a)
Identification. 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/1 description: The image is a black and white graphic that appears to be an abstract representation of a circular or spiral structure. The central part of the image features a solid black circle, surrounded by a white ring. The outer area of the image is filled with a pattern of irregular black and white shapes, which could be interpreted as buildings or other architectural elements. The overall impression is that of a stylized map or diagram.
mmary of safety and effectiveness
Image /page/0/Picture/3 description: The image contains the word "centervue" in a bold, sans-serif font. The letters are closely spaced together, creating a compact and unified appearance. The word is written in lowercase.
SUBMITTER INFORMATION
| A. Company name: | CenterVue SpA |
|---|---|
| B. Company address: | via Tommaseo 77, 35131, Padova, ITALY |
| C. Company phone: | +39 049 781 1828 |
| Company fax: | +39 049 781 1899 |
| D. Contact person: | Giuliano Barbaro |
| Managing Director | |
| E. Date summary prepared: | 4 April 2010 |
DEVICE IDENTIFICATION
- Ophthalmoscope, AC-powered; Automated Perimeter, AC-powered Generic Device Name: A.
- MAIA™, Macular Integrity Assessment Trade/proprietary name: в.
- C. Classification: Class II
- HLI, HPT Product Code: D.
DEVICE DESCRIPTION
The MAIA™ is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, using "fundus perimetry" (also "microperimetry").
MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing:
- images of the central retina over a field of view of 36° x 36°, acquired under infrared . illumination;
- recordings of eye movements obtained by "tracking" retinal details in the live retinal images and . providing a quantitative analysis of fixation characteristics;
- measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in . the macula, obtained by recording a patient's subjective response (see / don't see) to a light stimulus projected at a certain location over the retina;
- comparison of measured threshold sensitivity with a reference database obtained from normal . subjects, indicating whether measured thresholds are above or below certain percentiles.
MAIA 100 works with no pupil dilation (non-mydriatic).
MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.
INDICATIONS FOR USE
The Macular Integrity Assessment (MAIA™) is indicated for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference
CenterVue SpA
ia Tommaseo. 7 35131 Padova, Italy www.centervue.com
0 +30 Mg 781 1829 fax +39 049 781 1899 e-mail: info@centervue.com 378243 CCIAA PD oc .: € 480.000,00 i.v.
1
Image /page/1/Picture/0 description: The image is a black and white graphic design. It features a circular shape in the center, surrounded by a more complex, abstract pattern. The pattern consists of various geometric shapes and lines, creating a visually intricate design around the central circle.
centervue
t the center of vision
that is a quantitative tool for the comparison of macular sensitivity to a database of known
JIVALENCE
device is substantially equivalent to the combination of the following predicate devices with regard to intended use, operating principle, function:
| Predicate Device | 510(k) Holder | 510(k) No. | Date cleared |
|---|---|---|---|
| MP-1 MICROPERIMETER | Nidek Technologies Srl | K023719 | December 23rd 2002 |
| MP-1 MICROPERIMETER | Nidek Technologies Srl | K061768 | September 28th 2006 |
| CIRRUS HD-OCT(*) | Carl Zeiss Meditec Inc. | K063378 | January 26th 2007 |
(*) only with regard to its retinal imaging sub-system
CLINICAL EVALUATION
Clinical data was collected and evaluated to support the indications for use statement for MAIA™ and to demonstrate substantial equivalence to the above predicate devices.
In particular, the reference database was developed by obtaining threshold sensitivity data from 494 eyes of 270 normal subjects, enrolled at 4 different clinical sites. The age range of the measured population was 21-86 (mean 43, std. dev. 15). Subjects were recruited among the clinics' personnel and among the relatives of the clinics' regular patients. The following MAIA perimetric grid and other device settings were used for the measurements:
- Number of stimuli: 61; .
- Macular coverage: 10°; .
- Size of stimulus: Goldmann III; .
- Duration of stimulus: 200 ms; ●
- . Background luminance: 4 asb;
- Maximum luminance: 1000 asb; .
- Threshold algorithm: standard 4-2 staircase; ●
- . Measurement scale: 0 to 36 dB;
- . Fixation target: central circle of 1° diameter.
PRECISION
A precision study was conducted which measured both individual location thresholds (n = 37 per eye) and average threshold over all locations. Three devices were used, each operated by a different operator. The study included 24 subjects, each tested on one eye only: 12 without pathology and 12 with bathology. Each subject/eye was tested 3 times within a session (3 repeated measures for each subject). Subjects were nested within each configuration, that is, each subject appears in one, unique device-operator configuration only. The design was repeated twice: once for healthy eyes and once for eyes with pathologies.
CenterVue SpA
ia Tommasoo, 77 35131 Padova, Italy www.centervue.com
tel +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com
A 478243 COLA PO CF /P VA 04296580287 Cap. soc .: € 480.000.00 i.v.
2
Image /page/2/Picture/0 description: The image shows a circular design with a black circle in the center. Surrounding the central circle is a pattern of black and white shapes that resemble buildings or structures. The overall design has a somewhat abstract and urban feel, with the contrasting colors creating a visually interesting composition.
t the center of vision
ubiect selection criteria
Twelve subjects with normal eyes and 12 subjects with retinal pathologies were enrolled at two different clinical sites based on the following criteria:
- 4 normal subjects and 4 subjects with retinal pathologies enrolled at site 1 and measured with device 1 by operator 1;
- 4 normal subjects (different from above) and 4 subjects with retinal pathologies (different from above)enrolled at site 1 and measured with device 2 by operator 2;
- 4 normal subjects and 4 subjects with retinal pathologies enrolled at site 2 and measured with device 3 by operator 3;
Within each pathology category, subjects with varying parameters including age and visual acuity were enrolled. For the pathology group, subjects with early and intermediate age-related macular degeneration as well as with mild, moderate, severe and proliferative diabetic retinopathy were enrolled. Diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history. Subjects met defined inclusion criteria, but none of the exclusion criteria.
Precision results
| Normal | Pathology | |
|---|---|---|
| # subjects | 12 | 12 |
| Overall Mean | 29.7 dB | 23.5 dB |
| Overall Standard deviation | 1.14 dB | 4.23 dB |
| Repeatability SD* | 0.42 dB | 0.75 dB |
| Reproducibility SD** | 0.96 dB | 0.75 dB |
- estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning.
** estimate of the standard deviation among measurements taken on the same subject using different operators and devices, including repeatability.
Individual Grid Point Results
| Group/Parameter | Repeatability SD | Reproducibility SD | |
|---|---|---|---|
| Normal | Minimum | 0.94 | 1.06 |
| Median | 1.40 | 1.80 | |
| Maximum | 2.43 | 2.70 | |
| Pathology | Minimum | 1.33 | 1.33 |
| Median | 2.36 | 2.43 | |
| Maximum | 3.16 | 3.24 |
CONCLUSION
As described in this 510(k) Summary, all testing deemed necessary was conducted on the MAIA™ to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.
CenterVue SpA
via Tommaseo. 77 35131 Padova, Italy www.centervue.com
tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com REA: 378243 CCIAA PD CFJP, NA: 04296580287 Cap. soc.: € 480.000,00 i.v.
3
Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CenterVue SpA c/o Mr. Giuliano Barbaro Managing Director Via Tommaseo 77 Padova, Italy 35131
MAY -2 7 2010
Re: K092187
Trade/Device Name: Macular Integrity Assessment (MAIA ") Device Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter, Automatic, AC-powered Regulatory Class: Class II Product Code: HPT, HLI Dated: April 22, 2010 Received: April 26, 2010
Dear Mr. Barbaro:
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.
4
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for
Ma
Dir
Div
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image is a black and white graphic that resembles an eye. The pupil is a solid black circle in the center. The iris is a white ring around the pupil, and the rest of the eye is made up of a pattern of black and white shapes that create a spiral effect.
centervue at the center of vision
Indications for use statement
510(k) Number: K092187
Device Name: Macular Integrity Assessment (MAIATM)
Indications for use:
The Macular Integrity Assessment (MAIA™) is indicated 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.
Prescription Use M
AND/OR Over-The-Counter Use
Callaway
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092187
via Tommaseo, 77 35131 Padova, Italy www.centervue.com tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com
REA: 378243 CCIAA PD C.F./P. IVA: 04296580287 Cap. soc.; € 480,000,00 i.v.