(218 days)
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.
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.
Here's an analysis of the provided text regarding the MAIA device, focusing on acceptance criteria and study details:
The document is a 510(k) premarket notification for the CenterVue MAIA device, which is an ophthalmoscope and perimeter. The submission is for a revised version of a previously cleared device (K133758), with the only change being the introduction of a new "Fixation Training" (FT) software function.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results for the new Fixation Training (FT) software function. Instead, it relies on demonstrating that the new software does not alter the safety or effectiveness of the previously cleared device and meets relevant software and risk management standards.
However, the comparison table (Table 1) provides performance specifications for various features of the MAIA device and its predicates. While not "acceptance criteria" in the sense of a numerical pass/fail for the specific new feature, these are the performance characteristics being maintained or compared.
Here's a table based on the provided predicate comparison, focusing on relevant aspects mentioned:
| Feature/Criterion | Primary Predicate Device (PD1) (K133758) | Secondary Predicate Device (PD2) (K061768) | Subject Device (MAIA with FT) | Comparison / Implied Acceptance of Performance (for FT) |
|---|---|---|---|---|
| For Fixed Hardware/Existing Functionality | ||||
| Retinal imaging system | Line Scanning Ophthalmoscope | Fundus camera | Line Scanning Ophthalmoscope | Same as PD1. Assumed performance is maintained. |
| Background luminance perimetry | 4 asb | 4 asb | 4 asb | Same as PD1 & PD2. Assumed performance is maintained. |
| Stimuli size | Goldmann III | Goldmann I-V | Goldmann III | Same as PD1. Assumed performance is maintained. |
| Minimum pupil size | 2.5 mm | 4.0 mm | 2.5 mm | Same as PD1. Assumed performance is maintained. |
| Maximum luminance | 1000 asb | 400 asb | 1000 asb | Same as PD1. Assumed performance is maintained. |
| Stimuli dynamic range | 36 dB | 20 dB | 36 dB | Same as PD1. Assumed performance is maintained. |
| Imaging field | 36° x 36° | 45° circular (diameter) | 36° x 36° | Same as PD1. Performance maintained. |
| Imaging and tracking speed | 25 Hz | 25 Hz | 25 Hz | Same as PD1 & PD2. Performance maintained. |
| Imaging resolution | 1024 x 1024 | 768 x 576 | 1024 x 1024 | Same as PD1. Performance maintained. |
| Perimetry field | 30° x 30° | 40° circular (diameter) | 30° x 30° | Same as PD1. Performance maintained. |
| 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. Performance maintained. |
| Imaging wavelength for eye tracking | 850 nm | > 800 nm | 850 nm | Same as PD1, equivalent to PD2. Performance maintained. |
| For New Fixation Training (FT) Software | ||||
| Means for identification of FTT | Not available | Manually by eye practitioner using IR retinal image | Manually by eye practitioner using IR retinal image | Same as PD2. Implied acceptance of this method. |
| Fixation stability indices | P1, P2 and BCEA | P1, P2 and BCEA | P1, P2 and BCEA | Same as PD1 & PD2. Assumed these are still accurately calculated by the device after FT use. |
| Feedback to patient during FT | Not available | Repetition frequency of audible pulses | Repetition frequency of audible pulses | Same as PD2. Implied acceptance of this feedback mechanism. |
| Software Standards Compliance | IEC 60601-1:2005, IEC 60601-1-2:2007, ISO 12866:1999, ISO 15004-1:2006, ISO 15004-2:2007, ISO 14971:2007, ISO 62304:2006 | Not explicitly stated for specific FT | ISO 62304: 2006, ISO 14971: 2007 | Compliance with these software and risk management standards for the FT function. |
The crucial "study" for the new FT function is its compliance with software development and risk management standards, rather than a clinical performance study with numerical criteria. The document states: "the Fixation Training software meets the requirements of: ISO 62304: 2006, ISO 14971: 2007." This is the primary demonstration of its acceptability.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical test set with a sample size for the new Fixation Training (FT) software. The submission focuses on the software's compliance with standards and its technological similarity to a feature in a secondary predicate device (Nidek MP1).
The core of the submission is that the FT function is independent, does not interfere with existing functions, and no other design changes were made. Therefore, the detailed studies for the underlying hardware and existing functions (macular sensitivity, fixation stability measurement, retinal imaging) from the K133758 clearance are implicitly reused.
There is no mention of country of origin for new data or whether any hidden data was retrospective or prospective, as no new clinical data is presented for the FT feature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. Since no new clinical test set is described for the FT function, there is no mention of experts establishing a ground truth for such a set. The acceptance of the FT function hinges on its compliance with international software and risk management standards and its functionality being similar to an existing predicate device.
4. Adjudication Method for the Test Set
Not Applicable. No new clinical test set requiring adjudication is described for the FT function.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe an MRMC comparative effectiveness study for the new Fixation Training (FT) software. The submission is centered on substantial equivalence to predicate devices and software standard compliance, not on demonstrating improved human reader performance with or without AI assistance. The FT function itself is for patient rehabilitation, not for aiding human readers in diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The Fixation Training (FT) is a software feature that provides real-time feedback to the patient based on fixation point tracking. While the tracking itself is an algorithm, the FT functionality is described with the patient in the loop, acting on the audible feedback. The document states: "the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient." This is an algorithm-driven feature intended for use with a human (patient) in the loop (for visual rehabilitation). It is not a standalone diagnostic algorithm for interpretation by an expert.
7. The Type of Ground Truth Used
For the new Fixation Training (FT) software:
- Software Design/Functionality: The "ground truth" for accepting the FT feature is its compliance with ISO 62304: 2006 (Medical device software – Software life cycle processes) and ISO 14971: 2007 (Medical devices – Application of risk management to medical devices). This represents a ground truth that the software is developed safely and effectively according to recognized standards.
- Functional Equivalence: The comparison to the Nidek MP1 (PD2) for the visual rehabilitation/fixation training aspects also acts as a form of "ground truth" for functional equivalence, showing that similar technology is already marketed and cleared.
For the core device functions (macular sensitivity, fixation stability measurement, retinal imaging), the ground truth for their original clearance (K133758) would have been established through clinical data, expert consensus, and comparison to other cleared devices, but these details are not provided in this document as it's a submission for an updated feature, not the initial clearance.
8. The Sample Size for the Training Set
Not Applicable / Not Provided. The document does not describe any machine learning or AI algorithm that would require a "training set" in the conventional sense for the new Fixation Training (FT) feature. The FT function appears to be based on deterministic algorithms for tracking and feedback, rather than a learned model.
9. How the Ground Truth for the Training Set Was Established
Not Applicable / Not Provided. As no training set is described, there's no mention of how its ground truth was established.
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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.
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120Expiration 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 adatabase 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) |
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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 SpAVia San Marco 9h35129 Padova - ITALY |
| 510(k) Owner: | CenterVue SpAVia San Marco 9h35129 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 GabriottiQA/RA ManagerVia 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 devicecontaining illumination and viewing optics intended to examine themedia (cornea, aqueous, lens, and vitreous) and the retina of theeye. A perimeter is an AC-powered or manual device intended todetermine the extent of the peripheral visual field of a patient. Thedevice projects light on various points of a curved surface, and thepatient 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 predicatedevice (PD2) | Subject device | Comparison |
| Device name | MAIA | MP1 | MAIA | N/A |
| DeviceManufacturer | 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 RegulationNumber | 886.1605, 886.1570 | 886.1605, 886.1120 | 886.1605, 886.1570 | Same as PD1 |
| Item | Primary predicate device(PD1) | Secondary predicatedevice (PD2) | Subject device | Comparison |
| FDA ClassificationName | 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 RegulationNumber | 886.1605, 886.1570 | 886.1605, 886.1120 | 886.1605, 886.1570 | Same as PD1 |
| Device description | Perimeter for macularintegrity assessment | Micro-perimeter for thediagnosis of retinaldisease | Perimeter for macularintegrity assessment | Same as PD1 |
| Indications for use | MAIA is intended formeasuring macularsensitivity, fixationstability and the locus offixation, as well asproviding infrared retinalimaging. It contains areference database that isa quantitative tool for thecomparison of macularsensitivity to a database ofknown normal subjects. | The MP-1 is indicated foruse as:- Color retinography- Fixation examiner- Fundus-relatedmicroperimetry- Visual rehabilitation | The Centervue MAIA isintended for:• measuring macularsensitivity,• measuring fixationstability and the locusof fixation,• providing infraredretinal imaging, and• aiding visualrehabilitation.It contains a referencedatabase that is aquantitative tool for thecomparison of macularsensitivity to a databaseof known normal subjects. | Similar toPD1, partiallythe same asPD2 |
| Retinal imagingsystem | Line ScanningOphthalmoscope | Fundus camera | Line ScanningOphthalmoscope | Same as PD1 |
| Backgroundluminance forperimetry | 4 asb | 4 asb | 4 asb | Same as PD1& PD2 |
| Stimuli size | Goldmann III | Goldmann I-V | Goldmann III | Same as PD1 |
| Minimum pupilsize | 2.5 mm | 4.0 mm | 2.5 mm. | Same as PD1 |
| Maximumluminance | 1000 asb | 400 asb | 1000 asb | Same as PD1 |
| Stimuli dynamicrange | 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,differentfrom PD2 |
| Imaging andtracking speed | 25 Hz | 25 Hz | 25 Hz | Same as PD1& PD2 |
| Table 1 - Predicate device comparison table | ||||
| Item | Primary predicate device(PD1) | Secondary predicatedevice (PD2) | Subject device | Comparison |
| Imaging resolution | 1024 x 1024 | 768 x 576 | 1024 x 1024 | Same as PD1,differentfrom PD2 |
| Perimetry field | 30° x 30° | 40° circular (diameter) | 30° x 30° | Same as PD1,differentfrom PD2 |
| Perimetric grids | 10° macular, 6° macular,10-2, customizable withinfield | Customizable within field | 10° macular, 6° macular,10-2, customizable withinfield | Same as PD1,equivalent toPD2 |
| Imagingwavelength foreye tracking | 850 nm | > 800 nm | 850 nm | Same as PD1,equivalent toPD2 |
| Means foridentification ofthe FTT | Not available | Manually by eyepractitioner using IRretinal image | Manually by eyepractitioner using IRretinal image | Same as PD2 |
| Fixation stabilityindices | P1, P2 and BCEA | P1, P2 and BCEA | P1, P2 and BCEA | Same as PD1& PD2 |
| Feedback topatient duringFixation Training | Not available | Repetition frequency ofaudible pulses | Repetition frequency ofaudible 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.
§ 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.