(133 days)
Not Found
No
The description focuses on standard image processing, data processing, and a reference database comparison, without mentioning AI or ML algorithms.
No.
The device is intended for measuring and imaging, not for treating any condition.
Yes
The device is intended for "measuring macular sensitivity, fixation stability and the locus of fixation" and provides "infrared retinal imaging" as well as a "reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects." These functions indicate that it is used to assess the state of the macula, which is a diagnostic purpose. The description also mentions its use in studies involving "subjects with retinal pathologies" to measure "threshold sensitivity data".
No
The device description explicitly details multiple hardware components including an optical head, chin-rest, base, infrared source, imaging system, projection system, fixation target, auto-focus system, 3-axis robot, embedded PC, and power supply. While it includes software, it is not solely software.
Based on the provided information, the MAIA™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- MAIA™'s Function: The MAIA™ device directly interacts with the patient's eye to measure macular sensitivity, fixation stability, and provide retinal imaging. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use clearly states it's for "measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging." This is a direct measurement of physiological function and imaging of an anatomical structure within the living body.
Therefore, the MAIA™ device falls under the category of an in vivo diagnostic device or a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Macular Integrity Assessment (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.
Product codes (comma separated list FDA assigned to the subject device)
HPT, HLI
Device Description
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 and a confocal imaging set-up;
- . recordings of eye movements obtained by "tracking" retinal details in the live retinal video, acquired at 25 fps, providing a measure of a patient's fixation capabilities;
- . measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in the macula, obtained as in fundus perimetry by recording a patient's subjective response (see / do not see) to a light stimulus projected at a certain location on the retina;
MAIA™ 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.
MAIA is composed of:
-
- An optical head;
-
- A chin-rest and head-rest;
-
- A base, including a touch-screen display.
The optical head comprises:
- An infrared source at 845 nm (SLD) 1.
-
- A line-scanning confocal imaging system of the retina. The line, generated by means of an anamorphic lens, is scanned on the retina while the back-reflected light is de-scanned and revealed by a linear CCD sensor;
-
- A projection system comprising visible LEDs to generate Goldmann stimuli and background at controlled luminance values;
- A fixation target in the shape of a red circle (two different dimensions available); 4.
-
- An auto-focus system.
The base of the MAIA includes:
-
- A 3-axis robot that moves the optical head;
-
- An embedded PC that hosts the control software and related interface ports;
-
- The power supply.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared illumination, Line scanning laser ophthalmoscope
Anatomical Site
Macula, central retina
Indicated Patient Age Range
The age range of the measured population for the reference database was 21-86 (mean 43, std. dev. 15).
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reference Database:
The MAIA reference database was developed by obtaining threshold sensitivity data from 494 eyes of 270 normal subjects, enrolled at 4 different clinical sites, using the predicate device, MAIA version 4.08. The age range of the measured population was 21-86 (mean 43, std. dev. 15). The default stimuli grid was used for the measurements, corresponding to the central 10° macular area.
Precision data:
A precision study was conducted which measured both individual location thresholds (n = 37 per eye) and average threshold over all locations, using the predicate device. MAIA version 4.08. The default 10° stimuli grid was used for the measurements. 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 pathology. 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.
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;
- All measurements were made using a 20° x 20° perimetric field of view. .
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 subject using 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 |
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/1 description: The image shows the date "APR 2 3 2014". The month is April, the day is the 23rd, and the year is 2014. The text is in a simple, sans-serif font and is printed in black ink on a white background. The date is likely part of a document or label.
510(k) Summary in accordance with 21 CFR 807.92(c)
| Device Proprietary Name: | CenterVue Macular Integrity Assessment (MAIA™) |
|---|---|
| Date of submission: | 9 December 2013 |
| FDA Product Code 1: | HPT |
| FDA Regulation Number 1: | 21 CFR 886.1605 |
| FDA Classification Name 1: | Perimeter, Automatic, AC-powered |
| FDA Identification 1: | 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. | |
| FDA Product Code 2: | HLI |
| FDA Regulation Number 2: | 21 CFR 886.1570 |
| FDA Classification Name 2: | Ophthalmoscope |
| FDA Identification 2: | 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. | |
| Common or Usual Name: | Automated perimeter/ophthalmoscope |
| FDA Panel: | Ophthalmology |
| FDA Classification: | Class II |
| 510(k) Owner: | CENTERVUE S.p.A. |
| via San Marco, 9H | |
| 35129 Padova | |
| Italy | |
| Telephone: +39 049 7396147 | |
| Fax: +39 049 7396148 | |
| Contact: Giuliano Barbero, Managing Director |
Special 510(k) for MAIA
CenterVue SpA
centerv at the center of vision
via San Marco, 9H 35129 Padova, Italy www.centervue.com
tel. +39 049 7396 147
fax +39 049 7396 148
e-mail: info@centervue.com
Page 1 of 7
REA: 378243 CCIAA PD
C.F.JP. IVA: 04296580287
Cap. soc.: € 205.440.00 i.v.
1
Image /page/1/Picture/0 description: The image shows the Entervue logo. The logo consists of a stylized globe-like shape above the word "entervue" in a sans-serif font. The globe is partially formed, with a grid-like pattern suggesting a network or interconnectedness. The overall design is modern and corporate.
t the center of vision
Establishment Registration Number: 3008422902
Indications for Use:
The Macular Integrity Assessment (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.
Device Description:
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 and a confocal imaging set-up;
- . recordings of eye movements obtained by "tracking" retinal details in the live retinal video, acquired at 25 fps, providing a measure of a patient's fixation capabilities;
- . measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in the macula, obtained as in fundus perimetry by recording a patient's subjective response (see / do not see) to a light stimulus projected at a certain location on the retina;
MAIA™ 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.
MAIA is composed of:
-
- An optical head;
-
- A chin-rest and head-rest;
-
- A base, including a touch-screen display.
The optical head comprises:
- An infrared source at 845 nm (SLD) 1.
-
- A line-scanning confocal imaging system of the retina. The line, generated by means of an anamorphic lens, is scanned on the retina while the back-reflected light is de-scanned and revealed by a linear CCD sensor;
-
- A projection system comprising visible LEDs to generate Goldmann stimuli and background at controlled luminance values;
- A fixation target in the shape of a red circle (two different dimensions available); 4.
-
- An auto-focus system.
Special 510(k) for MAIA
CenterVue SpA
via San Marco 9H 35129 Padova, Italy tel. +39 049 7396 147 ax +39 049 7396 148 e-mail: info@centervue.com Page 2 of 7
FA: 378243 CCIAA PD IVA: 04296580287 oc .: € 205.440,00 i.v.
2
Image /page/2/Picture/0 description: The image shows a logo for "centerview at the center of vision". The logo features a stylized eye-like graphic above the text. The eye is composed of geometric shapes and has a dark circle in the center, resembling a pupil.
The base of the MAIA includes:
-
- A 3-axis robot that moves the optical head;
-
- An embedded PC that hosts the control software and related interface ports;
-
- The power supply.
Technical/performance specifications:
Fundus imaging:
- . Line scanning laser ophthalmoscope
- . Field of view: 36° x 36°
- . Digital camera resolution: 1024 x 1024 pixel
- . Optical resolution on the retina: 25 microns
- . Optical source: superluminescent diode at 845 nm
- . Imaging speed: 25 fps
- . Working distance: 33 mm
Perimetry:
- Field of view for macular perimetry: 30° x 30°
- . Tracking speed: 25 Hz
- . Stimuli size: Goldmann III
- . Background luminance: 4 asb
- . Maximum luminance: 1000 asb
- . Stimuli dynamic range: 36 dB
Other features:
- . Minimum pupil diameter: 2.5 mm
- . Focus adjustment range: -15D and +10D (auto-focus)
- . Automatic OD/OS recognition
Clinical Performance Testing:
Reference Database:
The MAIA reference database was developed by obtaining threshold sensitivity data from 494 eyes of 270 normal subjects, enrolled at 4 different clinical sites, using the predicate device, MAIA version 4.08. The age range of the measured population was 21-86 (mean 43, std. dev. 15). The default stimuli grid was used for the measurements, corresponding to the central 10° macular area. Furthermore, the following device settings were used:
- · Number of stimuli: 61;
- Size of stimulus: Goldmann III;
Special 510(k) for MAIA
CenterVue SpA
via San Marco, 9H 35129 Padova, Italy ww.centervie.com tel. +39 049 7396 147 fax +39 049 7396 148 e-mail: info@centervue.com Page 3 of 7
REA: 378243 CCIAA PD C.F./P. IVA: 04296580287 Cap. soc.: € 205.440,00 i.v.
3
Image /page/3/Picture/0 description: The image shows a black and white drawing of the Death Star from Star Wars. The Death Star is a spherical space station with a large concave dish on one side. The surface of the Death Star is covered in a grid of lines and shapes. The drawing is simple and stylized.
- 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; .
- · 20° x 20° perimetric field of view.
Precision data:
A precision study was conducted which measured both individual location thresholds (n = 37 per eye) and average threshold over all locations, using the predicate device. MAIA version 4.08. The default 10° stimuli grid was used for the measurements. 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 pathology. 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.
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;
- All measurements were made using a 20° x 20° perimetric field of view. .
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.
Special 510(k) for MAIA
CenterVue SpA
via San Marco, 9H 35129 Padova, Italy ww.centervue.com tel. +39 049 7396 147 fax +39 049 7396 148 e-mail: info@centervue.com Page 4 of 7
REA: 378243 CCIAA PD C.F.IP. IVA: 04296580287 Cap. soc.: € 205.440.00 i.y
4
Image /page/4/Picture/0 description: The image shows the logo for Centerview. The logo consists of a stylized globe made up of small squares and rectangles, with a dark circle in the center. Below the globe, the word "centerview" is written in a lowercase, sans-serif font. Underneath "centerview", the phrase "at the center of vision" is written in a smaller font.
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 subject using 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 |
Predicate device details:
The predicate device for this Special 510(k) is the FDA 510(k)-cleared CenterVue MAIA device, cleared under 510(k) reference K092187 on 27 May 2010, the administrative details of which are:
| Device Proprietary Name: | CenterVue Macular Integrity Assessment (MAIATM) |
|---|---|
| FDA Product Code 1: | HPT |
| FDA Regulation Number 1: | 21 CFR 886.1605 |
| FDA Classification Name 1: | Perimeter, Automatic, AC-powered |
| FDA Identification 1: | 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 |
Special 510(k) for MAIA
CenterVue SpA
via San Marco, 9H 35129 Padova, Italy www.centervue.com tel. +39 049 7396 147 fax +39 049 7396 148 e-mail: info@centervue.com Page 5 of 7
REA: 378243 CCIAA PD C.F./P. IVA: 04296580287 Cap. soc.: € 205.440,00 i v.
5
Image /page/5/Picture/0 description: The image shows the logo for Centervue. The logo consists of a stylized globe with a dark circle in the center, above the word "centervue" in a sans-serif font. Below "centervue" is the tagline "at the center of vision" in a smaller font.
| FDA Product Code 2: | HLI |
|---|---|
| FDA Regulation Number 2: | 21 CFR 886.1570 |
| FDA Classification Name 2: | Ophthalmoscope |
| FDA Identification 2: | 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. | |
| Common or Usual Name: | Automated perimeter/ophthalmoscope |
| FDA Panel: | Ophthalmology |
| FDA Classification: | Class II |
| 510(k) Owner: | CENTERVUE S.p.A. |
| via San Marco, 9H | |
| 35129 Padova | |
| Italy | |
| Indications for Use: | The Macular Integrity Assessment (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. |
Comparison with predicate device:
The following aspects are identical between the subject device and the predicate device:
- . Indications for Use/Intended Use
- . Device description
- . Fundamental technology
- . Technical/performance specifications
The differences between the subject device and predicate device are in the design of certain components/sub-assemblies as well as additional functions/feature. A number of the design changes were brought about by component obsolescence and other changes were introduced to simplify manufacture.
The additional functions/features of the subject device are summarized as follows:
- Time Analysis: a new screen that allows to compare consecutive expert tests taken at different 1. times using the "follow-up" mode. It is possible to display differential threshold values as well as
Special 510(k) for MAIA
CenterVue SpA
via San Marco, 9H 35129 Padova, Italy www.centervue.com tel. +39 049 7396 147 fax +39 049 7396 148 e-mail: info@centervue.com Page 6 of 7
REA: 378243 CCIAA PD C.F /P IVA 04296580287 Cap. soc.: € 205.440.00 i.v.
6
Image /page/6/Picture/0 description: The image contains a logo for a company called "centerview". The logo consists of the word "centerview" in a lowercase sans-serif font, with the tagline "at the center of vision" underneath it in a smaller font. Above the word "centerview" is a graphic that resembles a stylized globe or sphere, with a dark circle in the center.
a time plot of all numerical indices (average threshold, fixation stability and percent reduced thresholds). This analysis does not give a diagnosis or assessment of disease progression.
-
- Option to choose among five grids rather than one: Four additional perimetric grids are now available with the Expert Test, in addition to the default one.
-
- Option to move the projection grid and to add custom stimuli: it is now possible to manually set the center of the grid selected for the Expert Test, as an alternative to the grid being automatically centered on the PRL. Stimuli at user-specified locations within the projection field can be added to those of the pre-defined grids.
-
- New threshold strategies (4-Levels-Fixed and Scotoma Finder): these two new strategies have been introduced to reduce the examination time, as in supra-threshold perimetric tests. Only four or one (respectively) intensities are tested, hence these tests do not measure the actual threshold but rather a supra-threshold response.
- ഗ് Enhanced Fixation: when a patient shows difficulties in recognizing the fixation target, this option allows to project a bright, blinking, white stimulus at the center of the field during PRL calculation.
None of these changes were found to raise new questions of safety or effectiveness.
Conclusion:
Based on the information contained within this submission, it is concluded that revised design of MAIA™ is substantially equivalent to the identified predicate device, the original design of MAIA™ cleared under K092187, which is already in interstate commerce within the USA.
Special 510(k) for MAIA
CenterVue SpA
via San Marco, 9H 35129 Padova, Italy www.centervue.com tel. +39 049 7396 147 fax +39 049 7396 148 e-mail: info@centervue.com Page 7 of 7
RFA: 378243 CCIAA PD C.F.JP, IVA: 04296580287 Cap. soc. : € 205.440.00 i.v.
7
DEPARTMENT OF HEALTH & IIUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2014
CENTERVUE, S.p.A. Mr. Roger Gray VP. Quality and Regulatory . DONAWA LIFESCIENCE CONSULTING Piazza Albania 10 Rome, Italy 00153
Re: K133758
Trade/Device Name: CenterVue Macular Integrity Assessment (MAIATM) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI, HPT Dated: March 17, 2014 Received: March 19, 2014
Dear Mr. Gray:
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.
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.
8
Page 2 - Mr. Roger Gray
:: .
You must comply with all the Act's requirements, including, but not limited to: Registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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,
Deborah L. Falls -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
9
Appendix D
Indications for Use Statement
510(k) Number (if known): K133758
Device Name: CenterVue Macular Integrity Assessment (MAIA™)
Indications for Use: The Macular Integrity Assessment (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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
1 .. . . . . . . .
X
Over-The-Counter Use (21 CFR 801 Subpart C)
0
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jan C. Callaway -S 2014.04.18 10:08:46 -04'00'
Page 1 of 1 Rev.2 Apr 4, 2008