(141 days)
Not Found
No
The summary describes automated alignment, focusing, and tracking systems based on infrared imaging and stereoscopic reconstruction, but does not mention any AI or ML algorithms for image analysis, diagnosis, or other functions. The comparison to a reference database is a standard statistical comparison, not necessarily indicative of ML.
No
The device is intended for taking digital images of the human retina and measuring characteristics like retinal sensitivity and fixation stability, which are diagnostic functions, not therapeutic.
Yes
The device is intended for "measuring retinal sensitivity, fixation stability and the locus of fixation" and contains a "reference database that is a quantitative tool for the comparison of retinal sensitivity to a database of known normal subjects." These functions are characteristic of a diagnostic device, which identifies or characterizes a disease or condition.
No
The device description explicitly details multiple hardware components including LEDs, cameras, mirrors, a dedicated tablet, joystick, push-button, and external power supply, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, the CenterVue COMPASS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CenterVue COMPASS Function: The CenterVue COMPASS directly interacts with the patient's eye by projecting light and recording their subjective response to stimuli. It also captures images of the retina. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes taking images of the retina and measuring retinal sensitivity, fixation stability, and locus of fixation. These are measurements taken directly from the living patient.
- Device Description: The description details how the device illuminates the eye and records responses and images. This is an in-vivo process, not in-vitro.
Therefore, the CenterVue COMPASS falls under the category of an ophthalmic diagnostic device used for in-vivo examination and measurement of the eye, rather than an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CenterVue COMPASS is intended for taking digital images of a human retina without the use of a mydriatic agent and for measuring retinal sensitivity, fixation stability and the locus of fixation. It contains a reference database that is a quantitative tool for the comparison of retinal sensitivity to a database of known normal subjects.
Product codes
MYC, HPT
Device Description
The CenterVue COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation. The device works with a dedicated software application, operates as a standalone unit, integrates a dedicated tablet, a joystick, a push-button and is provided with an external power supply. COMPASS operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only.
The Centervue COMPASS device operates on the following principles:
- An anterior segment alignment system is included, which uses two infrared LEDs with a centroid ● wavelength of 940 nm and two cameras, whereas the former illuminate the external eye by diffusion and the latter allow a stereoscopic reconstruction of the pupil's position, used for automated alignment purposes via pupil tracking;
- An infrared imaging system captures live monochromatic images of the central retina over a circular field of view of 60° in diameter, by an horizontal line from an infrared LED with a centroid wavelength of 850 nm and by an oscillating mirror which scans the line to uniformly illuminate the retina; such images are in turn used for auto-focusing purposes and to track eye movements, providing a measure of a patient's fixation characteristics and allowing active compensation of the position of perimetric stimuli;
- . A concurrent color imaging system allows the capture of color images of the central retina over a circular field of view of 60° in diameter, using a white LED and a blue LED combined to obtain a white light illuminating the retina by the same scan mechanism;
- · A fixation target projecting onto the retina a fixation target obtained from a green LED;
- . A stimuli projector, projecting onto the retina white light Goldmann stimuli at variable intensity and allowing measurements of threshold sensitivity at multiple locations, according to a patient's subjective response to the light stimulus projected at a certain location.
The COMPASS device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye and by recording a patient's confirmation that a certain light stimulus has been perceived or not.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared imaging, Color imaging
Anatomical Site
Retina, Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Clinical testing: Measurements have been obtained with the CenterVue COMPASS and with the Humphrey HFA-II on 200 normal subjects and on 120 subjects with pathology affecting the visual field (in particular glaucoma) to support equivalence. Subjects' age ranged from 20 to 86 years (58.5 ± 16.7).
Perimetric settings used for the measurements with both devices were:
- stimuli locations: 24-2 grid;
- threshold strategy: 4-2 (or full threshold) for COMPASS and SITA standard for HFA-II;
- stimulus size: Goldmann III;
- stimulus color: white;
- stimulus duration: 200 msec.;
- background luminance: 31.4 asb;
- maximum luminance: 10,000 asb.
Mean differences in thresholds between the Centervue COMPASS and the Humphrey HFA-II in both subjects groups were found to be equivalent to those reported for the Humphrey HFA between SITA Standard and full threshold. No adverse event was reported during the study. This demonstrates equivalence of the subject device to the predicate in terms of effectiveness.
REFERENCE DATABASE: The COMPASS reference database was developed by obtaining threshold sensitivity data from 200 eyes of 200 normal subjects. Age range of the measured population was 20 - 86 (50.6 ± 15.2).
The perimetric settings used for the measurements were:
- stimuli locations: 24-2 grid
- threshold strategy: 4-2
- stimulus size: Goldmann III
- stimulus color: white
- stimulus duration: 200 msec.
- background luminance: 31.4 asb
- maximum luminance: 10,000 asb
The reference database is only available for the 24-2 test grid.
Key Results: Mean differences in thresholds between the Centervue COMPASS and the Humphrey HFA-II in both subjects groups were found to be equivalent to those reported for the Humphrey HFA between SITA Standard and full threshold. This demonstrates equivalence of the subject device to the predicate in terms of effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape at the bottom. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2015
CenterVue S.p.A. Mr. Roberto Gabriotti QA/RA Manager via San Marco, 9h 35129 Padova, Italy
Re: K150320
Trade/Device Name: COMPASS Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC, HPT Dated: May 15, 2015 Received: Mav 20, 2015
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.
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.
1
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.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,
Kesia Y. Alexander -A
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
Food and Drug Administration
Form Approved: OMB No. 0910-0120
510(k) Number K150320
Device Name
COMPASS
Indications for Use (Describe)
The CenterVue COMPASS is intended for taking digital images of a human retina without the use of a mydriatic agent and for measuring retinal sensitivity, fixation stability and the locus of fixation. It contains a reference database that is a quantitative tool for the comparison of retinal 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)
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)
Jan C. Callaway -S
2015.06.19
12:17:42 -04'00'
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 features the logo for "centervue." Above the text, there is a stylized eye graphic. The eye is made up of small yellow and gray cubes arranged in a semi-circular shape, with a black circle representing the pupil. The text "centervue" is written in a lowercase, sans-serif font, with the "vue" portion in yellow.
510(k) Summary in accordance with 21 CFR 807.92
| Device Name: | CenterVue COMPASS |
|---|---|
| Type of submission: | Traditional |
| Date of submission: | 2 February 2015 |
| Manufacturer: | CENTERVUE SPA |
| Via San Marco 9H | |
| 35129 Padova - ITALY | |
| 510(k) Owner: | CENTERVUE SPA |
| Via San Marco 9H | |
| 35129 Padova - ITALY | |
| Phone | |
| Fax | +39 049 7396 147 |
| +39 049 7396 148 | |
| 510(k) submitter and contact | Mr. Roberto Gabriotti |
| Centervue S.p.A. | |
| Manager of Quality and Regulatory Affairs | |
| 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: | МУС; HPT |
| FDA Regulation Number: | 21 CFR 886.1570; 886.1605 |
| FDA Classification Name: | Ophthalmoscope, laser, scanning; Perimeter, Automatic, Ac-powered |
| Common Name: | Ophthalmoscope; Perimeter |
| FDA Panel: | Ophthalmology |
| 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: | The CenterVue COMPASS is intended for taking digital images of a |
| human retina without the use of a mydriatic agent and for measuring | |
| retinal sensitivity, fixation stability and the locus of fixation. It contains | |
| a reference database that is a quantitative tool for the comparison of | |
| retinal sensitivity to a database of known normal subjects. |
4
Image /page/4/Picture/0 description: The image shows the logo for Centervue. The logo features a stylized eye made up of yellow squares, with a black pupil in the center. Below the eye is the word "centervue" in a lowercase, sans-serif font.
DEVICE DESCRIPTION
The CenterVue COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation. The device works with a dedicated software application, operates as a standalone unit, integrates a dedicated tablet, a joystick, a push-button and is provided with an external power supply. COMPASS operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only.
The Centervue COMPASS device operates on the following principles:
- An anterior segment alignment system is included, which uses two infrared LEDs with a centroid ● wavelength of 940 nm and two cameras, whereas the former illuminate the external eye by diffusion and the latter allow a stereoscopic reconstruction of the pupil's position, used for automated alignment purposes via pupil tracking;
- An infrared imaging system captures live monochromatic images of the central retina over a circular field of view of 60° in diameter, by an horizontal line from an infrared LED with a centroid wavelength of 850 nm and by an oscillating mirror which scans the line to uniformly illuminate the retina; such images are in turn used for auto-focusing purposes and to track eye movements, providing a measure of a patient's fixation characteristics and allowing active compensation of the position of perimetric stimuli;
- . A concurrent color imaging system allows the capture of color images of the central retina over a circular field of view of 60° in diameter, using a white LED and a blue LED combined to obtain a white light illuminating the retina by the same scan mechanism;
- · A fixation target projecting onto the retina a fixation target obtained from a green LED;
- . A stimuli projector, projecting onto the retina white light Goldmann stimuli at variable intensity and allowing measurements of threshold sensitivity at multiple locations, according to a patient's subjective response to the light stimulus projected at a certain location.
The COMPASS device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye and by recording a patient's confirmation that a certain light stimulus has been perceived or not.
5
Image /page/5/Picture/0 description: The image shows a stylized logo. The logo is a sphere that is partially deconstructed, with yellow squares arranged around a black circle. The yellow squares are arranged in a grid-like pattern, and the black circle is located in the center of the sphere. The background is white.
centervue
TECHNICAL SPECIFICATIONS
FundusPerimetry:
- Projection field: 30° (radius)
- . Background luminance: 31.4 asb
- Maximum luminance:
- Dynamic range:
- Stimulus size:
- Stimulus duration: 200 ms
- Fixation control: 25 Hz automated retinal tracking
FundusImaging:
- Field of view:
- 60° (diameter) • Sensor resolution: 5 MPixel (2592x1944)
10000 asb
Goldmann III
0 - 50 dB
- Light source:
- Imaging modalities:
Otherfeatures:
- Non-mydriatic operation:
- Auto-focus range:
minimum pupil size 3 mm -12D to +15D
color, infrared, red-free
infrared (825-870 nm) and white LED (440-650 nm)
6
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 lowercase letters, with the "vue" portion of the word in yellow.
PREDICATE DEVICES The predicate devices selected for comparison with the CenterVue COMPASS are:
| Predicate Device 1 (primary): | MAIA |
|---|---|
| 510(k) Owner: | CenterVue |
| 510(k) Number: | K133758 |
| Clearance Date: | 2014-04-23 |
| FDA Product Code 1: | HPT |
| Classification Name 1: | Perimeter, Automatic, Ac-powered |
| Regulation Number 1: | 886.1605 |
| Product Code 2: | HLI |
| Classification Name 2: | Ophthalmoscope, Ac-powered |
| Regulation Number 2: | 886.1570 |
| Predicate Device 2: | EIDON |
| 510(k) Owner: | CenterVue |
| 510(k) Number: | K142047 |
| Clearance Date: | 2014-11-12 |
| FDA Product Code: | MYC |
| Classification Name: | Ophthalmoscope, Laser, Scanning |
| Regulation Number: | 886.1570 |
| Predicate Device 3: | Humphrey Field Analyzer (HFA-II), model 720 |
| 510(k) Owner: | Carl Zeiss, Inc. |
| 510(k) Number: | K954167 |
| Clearance Date: | 1995-11-24 |
| FDA Product Code: | HPT |
| Classification Name: | Perimeter, Automatic, Ac-powered |
| Regulation Number: | 886.1605 |
7
Image /page/7/Picture/0 description: The image shows a stylized logo. The logo is a semi-circular shape with a black circle in the center. The semi-circular shape is made up of small, yellow squares that are arranged in a grid-like pattern. The squares are set against a gray background, giving the logo a three-dimensional appearance.
centervue
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE(S)
Fundus Perimetry is the technological principle for both the subject and primary predicate device. It is based on continuous imaging of the retina using infrared illumination, to enable compensation of eye movements during perimetry. At a high level, the subject and primary predicate device are based on the same technological elements.
| Difference | Equivalence discussion |
|---|---|
| Capabilities for color and red-free | |
| imaging | No additional concern in terms of safety and effectiveness as the |
| device is equivalent to EIDON in this respect | |
| Modified optics for wider imaging | |
| field | No additional concern in terms of safety and effectiveness as the |
| device is equivalent to EIDON in this respect | |
| Use of visible light source for color | |
| and red-free imaging | No additional concern in terms of safety and effectiveness as the |
| device is equivalent to EIDON in this respect | |
| Use of additional infrared light | |
| source for alignment | No additional concern in terms of safety and effectiveness as the |
| device is equivalent to EIDON in this respect | |
| Modified optics for wider | |
| perimetry measurement field | No new concerns for safety and effectiveness vs. the primary |
| predicate device as differences represent a performance | |
| improvement | |
| Luminance parameters and | |
| measurement range | Differences are due to the adoption of Humphrey perimetric |
| standards for luminance. No new concerns for safety and | |
| effectiveness as the device is equivalent to the Humphrey HFA-II in | |
| this respect | |
| Presence of anterior eye imaging | |
| system used for patient alignment | No additional concern in terms of safety and effectiveness as the |
| device is equivalent to EIDON in this respect | |
| Use of green fixation target | |
| (instead of red) | No additional concern in terms of safety and effectiveness as the |
| device is equivalent to EIDON in this respect |
The following technological differences exist between the subject and primary predicate device:
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Electricalsafetyandelectromagneticcompatibility(EMC)
The device complies with the IEC 60601-1:2005 standard for safety and with the IEC 60601-1-2:2007 standard for EMC.
SoftwareVerificationandValidationTesting
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury. The software also complies with the IEC 62304 standard for software life cycle processes.
8
Image /page/8/Picture/0 description: The image shows a stylized logo or graphic. It features a semi-circular arrangement of small, yellow squares that appear to be arranged in a spherical pattern. At the center of this arrangement is a black circle, giving the impression of an eye or a globe with a dark center. The overall design is abstract and modern.
centervue Perimetersstandardtesting The device complies with the ISO 12866:1999 standard for perimeters.
Lighthazardtesting
The device complies with the ISO 15004-1:2006 standard for ophthalmic instruments and with the ISO 15004-2:2007 standard for light hazard protection.
Clinicaltesting
Measurements have been obtained with the CenterVue COMPASS and with the Humphrey HFA-II on 200 normal subjects and on 120 subjects with pathology affecting the visual field (in particular glaucoma) to support equivalence. Subjects' age ranged from 20 to 86 years (58.5 ± 16.7).
Perimetric settings used for the measurements with both devices were:
- . stimuli locations: 24-2 grid;
- . threshold strategy: 4-2 (or full threshold) for COMPASS and SITA standard for HFA-II;
- stimulus size: Goldmann III;
- . stimulus color: white;
- . stimulus duration: 200 msec.;
- background luminance: 31.4 asb;
- maximum luminance: 10,000 asb.
Mean differences in thresholds between the Centervue COMPASS and the Humphrey HFA-II in both subjects groups were found to be equivalent to those reported for the Humphrey HFA between SITA Standard and full threshold. No adverse event was reported during the study. This demonstrates equivalence of the subject device to the predicate in terms of effectiveness.
REFERENCE DATABASE
The COMPASS reference database was developed by obtaining threshold sensitivity data from 200 eyes of 200 normal subjects. Age range of the measured population was 20 - 86 (50.6 ± 15.2).
The perimetric settings used for the measurements were:
- stimuli locations: 24-2 grid
- threshold strategy: 4-2
- stimulus size: Goldmann III
- . stimulus color: white
- . stimulus duration: 200 msec.
- background luminance: 31.4 asb
- maximum luminance: 10,000 asb
The reference database is only available for the 24-2 test grid.
CONCLUSIONS
Based on the information contained within this submission, it is concluded that the CenterVue COMPASS is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.