← Product Code [QTO](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTO) · K220090
# Visibly Digital Acuity Product (K220090)
_Visibly, Inc. · QTO · Aug 12, 2022 · Ophthalmic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTO/K220090
## Device Facts
- **Applicant:** Visibly, Inc.
- **Product Code:** [QTO](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTO.md)
- **Decision Date:** Aug 12, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1150
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic
- **Attributes:** Software as a Medical Device
## Intended Use
The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye: - TRUE - visual acuity that is consistent with normal vision - FALSE - visual acuity that is not consistent with normal vision. The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective eyewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.
## Device Story
Web-based software application; enables home-based self-assessment of visual acuity. Inputs: user responses to Landolt C optotypes displayed on computer/tablet screen; user interacts via touchscreen smartphone/mobile device acting as remote. Operation: user stands 10 feet from display; software presents optotypes; user selects observed orientation on remote. Output: categorization of visual acuity per eye as 'TRUE' (consistent with normal vision) or 'FALSE' (not consistent with normal vision). Intended for use by adults 22-40; results provided to eye care provider as supportive data alongside medical history/prior prescriptions. Benefits: facilitates remote visual acuity assessment; aids clinical decision-making by providing supplemental subjective vision data.
## Clinical Evidence
Prospective, multi-center clinical study (n=329) compared VDAP to ETDRS VA Lane Test. Pooled cohort results: PPV 95.8% (95% CI: 93.6-97.6%), NPV 49.1% (95% CI: 40.0-58.1%), sensitivity 85.5% (95% CI: 81.9-88.9%), specificity 78.8% (95% CI: 69.1-87.6%). Subject-level agreement 75.9%. Reproducibility for study eyes 89.3% (p < 0.0001 vs 75% goal). Bench testing confirmed luminance (ANSI Z80.21-2010) and optotype sizing accuracy (±5% of LogMar).
## Technological Characteristics
Web-based software; standalone application. Hardware: user-supplied computer/tablet (display) and smartphone/mobile device (remote). Connectivity: internet-enabled. Optotypes: Landolt C with crowding bars. Software level of concern: moderate. Cybersecurity: encryption/access controls implemented. Sterilization: N/A (software).
## Regulatory Identification
A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.
## Predicate Devices
- Vimetrics, LLC Central Vision Analyzer (CVA-1000) ([K100095](/device/K100095.md))
## Reference Devices
- SoloHealth, Inc. SoloHealth Station ([K113402](/device/K113402.md))
- Vital Art and Science, Inc. MyVisionTrack Model 005 ([K143211](/device/K143211.md))
## Submission Summary (Full Text)
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September 30, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Visibly, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K220090
Trade/Device Name: Visibly Digital Acuity Product Regulation Number: 21 CFR 886.1150 Regulation Name: Visual Acuity Chart Regulatory Class: Class I Product Code: OTO
Dear Janice Hogan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 12, 2022. Specifically, FDA is updating this SE Letter as an administrative correction because of a typo in the Indications for Use form.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 240-402-4662, Elvin.Ng@fda.hhs.gov.
Sincerely,
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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August 12, 2022
Visibly, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K220090
Trade/Device Name: Visibly Digital Acuity Product Regulation Number: 21 CFR 886.1150 Regulation Name: Visual Acuity Chart Regulatory Class: Class I Product Code: QTO Dated: January 11, 2022 Received: January 11, 2022
Dear Janice Hogan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/5 description: The image shows the name "Tieuvi H. Nguyen -S" in a large, clear font. The text is horizontally oriented and appears to be a title or heading. The background is plain, with a faint watermark-like design that is barely visible.
for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
### K220090
Device Name
Visibly Digital Acuity Product
#### Indications for Use (Describe)
The Visibly Digital Acuity Product (VDAP) is a web-based, self-quided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye:
- . TRUE - visual acuity that is consistent with normal vision
- FALSE visual acuity that is not consistent with normal vision .
The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective evewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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### 510(k) SUMMARY Visibly, Inc.'s Visibly Digital Acuity Product K220090
### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Visibly, Inc. 207 E Ohio Street, #233 Chicago, IL 60611 Phone: 217-971-4852 Contact Person: Paul Foley CFO/COO
Date Prepared: August 11, 2022
## Name of Device
Visibly Digital Acuity Product
## Classification Name
Visual Acuity Chart (21 CFR 886.1150, Class I, Product Code QTO)
## Predicate Devices
Predicate Device:
Vimetrics, LLC Central Vision Analyzer (CVA-1000)
Reference Devices:
SoloHealth, Inc. SoloHealth Station (K113402)
Vital Art and Science, Inc. MyVisionTrack Model 005 (K143211)
#### Intended Use / Indications for Use
The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye:
- TRUE visual acuity that is consistent with normal vision ●
- FALSE - visual acuity that is not consistent with normal vision
The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective eyewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.
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## Technological Characteristics
The Visibly Digital Acuity Product is a web-based, software application intended for use by adults, at home, to aid in the evaluation of visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:
- A computer screen (the Display) which displays optotypes. O
- A touchscreen mobile device (the Remote) which operates as a remote control and o interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away.
The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's vision acuity into one of two buckets: (1) TRUE - visual acuity that is consistent with normal vision (2) FALSE - visual acuity that is not consistent with normal vision.
A table comparing the key features of the subject, predicate, and reference devices is provided below.
| | Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K220090 | K100095 | K113402 | K143211 |
| Product Code | QTO | HOX, Chart, Visual
Acuity | DXN, Automated
Blood Pressure
Monitor
HOX, Chart, Visual
Acuity | HOQ, Amsler grid |
| Indications for
Use | The Visibly Digital
Acuity Product
(VDAP) is a web-
based, self-guided
software application
intended for use by
adults, ages 22 to
40, who have the
capability to perform
a self-test at home,
to aid in the
evaluation of visual
acuity with or
without correction.
The software allows
users to view and
respond to | The CVA-1000 is
intended for use
under the direct
supervision of an
ophthalmologist or
optometrist in the
measurement of
vision at fixation in
one or both eyes, with
or without optical
correction. | The SoloHealth
Station is intended
to be used by the
general public so
that a user can
measure his/her
own blood pressure
and pulse rate and
his/her own weight.
Additionally, the
SoloHealth Station
is intended to
screen adults for
clarity of central
vision. SoloHealth
Station does not
provide a general | The
myVisionTrack®
Model 0005 is
intended for the
detection and
characterization of
central 3 degrees
metamorphopsia
(visual distortion) in
patients with
maculopathy,
including age-
related macular
degeneration and
diabetic retinopathy,
and as an aid in
monitoring |
| Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) | |
| displayed optotypes
and uses the
responses to
categorize a
patient's visual
acuity into one of
two categories, with
an individual output
for each eye:
TRUE - visual
acuity that is
consistent with
normal vision FALSE - visual
acuity that is not
consistent with
normal vision The Visibly Digital
Acuity Product
recommendations
are intended to be
supportive
recommendations
that will be used by
an eye care
provider, along with
the patient's
medical history and
profile, prior
corrective eyewear
prescriptions, and
subjective vision
data. The Visibly
Digital Acuity
Product does not
provide screening
or diagnosis of eye
health or other
disease, nor is it
intended to replace
an in-person eye
exam. | | screening of visual
function and does
not provide a
diagnosis of eye
health or other
disease. The
SoloHealth Station
only screens clarity
of central vision.
Users should
consult their
personal physicians
if they have
concerns regarding
their eyesight. | progression of
disease factors
causing
metamorphopsia. It
is intended to be
used by patients
who have the
capability to
regularly perform a
simple self-test at
home. The
myVisionTrack®
Model 0005 is not
intended to
diagnose; diagnosis
is the responsibility
of the prescribing
eye-care
professional. | |
| | Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) |
| Intended
Population | Adults, ages 22 to
40 | General Public | General Public | Patients at high risk
or already
diagnosed with
maculopathy |
| Prescription or
OTC | OTC | Prescription | OTC | Prescription home
use by patients |
| Device Type | Web-based
software application | Device with electronic
display | Device with
electronic display | Downloadable
application to cell
phone or tablet |
| Hardware
Platform | Display: Computer,
laptop or tablet
Remote:
Touchscreen
smartphone or
mobile device | Display: Computer, 2
LCD computer
monitors, keyboard,
mouse | Display: LCD
computer monitor,
Interactive Central
Vision Panel | Display: User
supplied cell phone
or tablet |
| Software
Design | Interactive software
platform with audio
and visual prompts | Interactive software
platform with audio
and visual prompts. It
has two panels:
Interactive Central
Vision Panel and
Chart Panel | Interactive software
platform with audio
and visual prompts | Interactive software
platform with visual
prompts |
| Target
Presentation | Landolt C optotypes
with crowding bars,
facing 4 different
directions (openings
at 180, 270, 0, and
90 degrees)
Optotypes are
presented singly | Multiple and Individual
optotypes (depending
on the panel selected) | Multiple optotypes
as well as
sentences and
paragraphs | Distorted and
undistorted shapes |
| How/Where
Used | At home | Clinical environments | Non-clinical
environments | At home |
| Test
Administration | Self-administration | Setup and Testing
Method is selected by
HCP | Self-administration | Self-administration |
| | Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) |
| | | Testing process is
completed via self-
administration | | |
| Test
Procedure
Summary | Based on optotypes
presented on the
Display, the user
will select what
object they see on
their Remote. The
following outputs
are generated for
Eye Care Provider
(ECP) review: (1)
user-inputted data
confirmed during
Qualification; (2)
Visual Acuity output
by eye classifying
the individual eye's
vision into one of
the following
buckets:
TRUE - visual
acuity that is
consistent with
normal vision FALSE - visual
acuity that is not
consistent with
normal vision | Chart Panel: A
monitor, viewed by
the patient, presents
traditional symbol
charts with
progressive 0.1
logMAR gradations of
symbol size, each of
which may be
presented in the
following Michelson
contrasts of black
letters presented
against a white
background in a range
of progressively
reduced contrasts.
The examiner may
view on the physician
monitor what is
presented to the
patient on the patient
monitor so he can
mark the letters that
are correctly
identified, allowing
either line-by-line or
letter-by-letter scoring.
The total letters read
correctly are recorded
as well as the
smallest line read
correctly in which the
traditional method of
scoring is utilized.
Interactive Central
Vision Panel: A
monitor is viewed by | Near distance
screening is
simulated at 17
inches through a
series of prompts
on the computer
monitor where
patients are asked
to view the clarity of
sentences and
letters at different
sizes. Far distance
screening is
simulated at 11 feet
through a view
finder on the
device. Patients
are asked to
determine the
clarity of a set of
letters. | The
myVisionTrack®
Model 0005
implements a shape
discrimination
hyperacuity (SDH)
vision test. The
distorted shape is
created by
modulating the
radius of the circle
with a sinusoid.
The user is shown
four circles and
asked to identify the
distorted circle. |
| Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) | |
| | the patient in which
automated
measurements are
conducted by an
interactive computer
program at logMAR
0.05 gradations of
symbol size. The
patient sits in a chair
in the darkened
examination room
with or without optical
correction
(spectacles, contact
lenses, or trial lenses)
and with one eye or
both eyes exposed,
he/she views in a
mirror at the end of
the room an LCD
monitor (patient
monitor) mounted on
the wall next to the
examiner's desk (total
distance entered into
the computer program
at the time of
installation). The
examiner selects the
method of operation
and contrasts to be
tested by keyboard
and mouse interaction
and with information
presented on the
physician's working
monitor. | | | |
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### Performance Data
The following testing is provided to support the safety and performance of the VDAP:
- . Luminance Testing was completed to demonstrate that the luminance of the Display hardware is above the minimum threshold for luminance (80 cd/m²) in accordance with: (1) ANSI Z80.21-2010(R2015). American National Standard for Ophthalmics -Instruments - General-Purpose Clinical Visual Acuity Charts; (2) ISO 8596:2017. Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation and (3) International Council of Ophthalmology (1984) Visual Acuity Measurement Standard.
- Optotype Sizing Testing was conducted to validate each op…
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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTO/K220090](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTO/K220090)
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