Visibly Digital Acuity Product

{0}------------------------------------------------ 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {4}------------------------------------------------ ### 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. {5}------------------------------------------------ ## 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<br>Acuity Product<br>(subject) | Vimetrics Central<br>Vision Analyzer 1000<br>(CVA-1000)<br>(predicate) | SoloHealth Station<br>(reference) | MyVisionTrack<br>Model 0005<br>(reference) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K220090 | K100095 | K113402 | K143211 | | Product Code | QTO | HOX, Chart, Visual<br>Acuity | DXN, Automated<br>Blood Pressure<br>Monitor<br>HOX, Chart, Visual<br>Acuity | HOQ, Amsler grid | | Indications for<br>Use | The Visibly Digital<br>Acuity Product<br>(VDAP) is a web-<br>based, self-guided<br>software application<br>intended for use by<br>adults, ages 22 to<br>40, who have the<br>capability to perform<br>a self-test at home,<br>to aid in the<br>evaluation of visual<br>acuity with or<br>without correction.<br>The software allows<br>users to view and<br>respond to | The CVA-1000 is<br>intended for use<br>under the direct<br>supervision of an<br>ophthalmologist or<br>optometrist in the<br>measurement of<br>vision at fixation in<br>one or both eyes, with<br>or without optical<br>correction. | The SoloHealth<br>Station is intended<br>to be used by the<br>general public so<br>that a user can<br>measure his/her<br>own blood pressure<br>and pulse rate and<br>his/her own weight.<br>Additionally, the<br>SoloHealth Station<br>is intended to<br>screen adults for<br>clarity of central<br>vision. SoloHealth<br>Station does not<br>provide a general | The<br>myVisionTrack®<br>Model 0005 is<br>intended for the<br>detection and<br>characterization of<br>central 3 degrees<br>metamorphopsia<br>(visual distortion) in<br>patients with<br>maculopathy,<br>including age-<br>related macular<br>degeneration and<br>diabetic retinopathy,<br>and as an aid in<br>monitoring | | Visibly Digital<br>Acuity Product<br>(subject) | Vimetrics Central<br>Vision Analyzer 1000<br>(CVA-1000)<br>(predicate) | SoloHealth Station<br>(reference) | MyVisionTrack<br>Model 0005<br>(reference) | | | displayed optotypes<br>and uses the<br>responses to<br>categorize a<br>patient's visual<br>acuity into one of<br>two categories, with<br>an individual output<br>for each eye:<br>TRUE - visual<br>acuity that is<br>consistent with<br>normal vision FALSE - visual<br>acuity that is not<br>consistent with<br>normal vision The Visibly Digital<br>Acuity Product<br>recommendations<br>are intended to be<br>supportive<br>recommendations<br>that will be used by<br>an eye care<br>provider, along with<br>the patient's<br>medical history and<br>profile, prior<br>corrective eyewear<br>prescriptions, and<br>subjective vision<br>data. The Visibly<br>Digital Acuity<br>Product does not<br>provide screening<br>or diagnosis of eye<br>health or other<br>disease, nor is it<br>intended to replace<br>an in-person eye<br>exam. | | screening of visual<br>function and does<br>not provide a<br>diagnosis of eye<br>health or other<br>disease. The<br>SoloHealth Station<br>only screens clarity<br>of central vision.<br>Users should<br>consult their<br>personal physicians<br>if they have<br>concerns regarding<br>their eyesight. | progression of<br>disease factors<br>causing<br>metamorphopsia. It<br>is intended to be<br>used by patients<br>who have the<br>capability to<br>regularly perform a<br>simple self-test at<br>home. The<br>myVisionTrack®<br>Model 0005 is not<br>intended to<br>diagnose; diagnosis<br>is the responsibility<br>of the prescribing<br>eye-care<br>professional. | | | | Visibly Digital<br>Acuity Product<br>(subject) | Vimetrics Central<br>Vision Analyzer 1000<br>(CVA-1000)<br>(predicate) | SoloHealth Station<br>(reference) | MyVisionTrack<br>Model 0005<br>(reference) | | Intended<br>Population | Adults, ages 22 to<br>40 | General Public | General Public | Patients at high risk<br>or already<br>diagnosed with<br>maculopathy | | Prescription or<br>OTC | OTC | Prescription | OTC | Prescription home<br>use by patients | | Device Type | Web-based<br>software application | Device with electronic<br>display | Device with<br>electronic display | Downloadable<br>application to cell<br>phone or tablet | | Hardware<br>Platform | Display: Computer,<br>laptop or tablet<br>Remote:<br>Touchscreen<br>smartphone or<br>mobile device | Display: Computer, 2<br>LCD computer<br>monitors, keyboard,<br>mouse | Display: LCD<br>computer monitor,<br>Interactive Central<br>Vision Panel | Display: User<br>supplied cell phone<br>or tablet | | Software<br>Design | Interactive software<br>platform with audio<br>and visual prompts | Interactive software<br>platform with audio<br>and visual prompts. It<br>has two panels:<br>Interactive Central<br>Vision Panel and<br>Chart Panel | Interactive software<br>platform with audio<br>and visual prompts | Interactive software<br>platform with visual<br>prompts | | Target<br>Presentation | Landolt C optotypes<br>with crowding bars,<br>facing 4 different<br>directions (openings<br>at 180, 270, 0, and<br>90 degrees)<br>Optotypes are<br>presented singly | Multiple and Individual<br>optotypes (depending<br>on the panel selected) | Multiple optotypes<br>as well as<br>sentences and<br>paragraphs | Distorted and<br>undistorted shapes | | How/Where<br>Used | At home | Clinical environments | Non-clinical<br>environments | At home | | Test<br>Administration | Self-administration | Setup and Testing<br>Method is selected by<br>HCP | Self-administration | Self-administration | | | Visibly Digital<br>Acuity Product<br>(subject) | Vimetrics Central<br>Vision Analyzer 1000<br>(CVA-1000)<br>(predicate) | SoloHealth Station<br>(reference) | MyVisionTrack<br>Model 0005<br>(reference) | | | | Testing process is<br>completed via self-<br>administration | | | | Test<br>Procedure<br>Summary | Based on optotypes<br>presented on the<br>Display, the user<br>will select what<br>object they see on<br>their Remote. The<br>following outputs<br>are generated for<br>Eye Care Provider<br>(ECP) review: (1)<br>user-inputted data<br>confirmed during<br>Qualification; (2)<br>Visual Acuity output<br>by eye classifying<br>the individual eye's<br>vision into one of<br>the following<br>buckets:<br>TRUE - visual<br>acuity that is<br>consistent with<br>normal vision FALSE - visual<br>acuity that is not<br>consistent with<br>normal vision | Chart Panel: A<br>monitor, viewed by<br>the patient, presents<br>traditional symbol<br>charts with<br>progressive 0.1<br>logMAR gradations of<br>symbol size, each of<br>which may be<br>presented in the<br>following Michelson<br>contrasts of black<br>letters presented<br>against a white<br>background in a range<br>of progressively<br>reduced contrasts.<br>The examiner may<br>view on the physician<br>monitor what is<br>presented to the<br>patient on the patient<br>monitor so he can<br>mark the letters that<br>are correctly<br>identified, allowing<br>either line-by-line or<br>letter-by-letter scoring.<br>The total letters read<br>correctly are recorded<br>as well as the<br>smallest line read<br>correctly in which the<br>traditional method of<br>scoring is utilized.<br>Interactive Central<br>Vision Panel: A<br>monitor is viewed by | Near distance<br>screening is<br>simulated at 17<br>inches through a<br>series of prompts<br>on the computer<br>monitor where<br>patients are asked<br>to view the clarity of<br>sentences and<br>letters at different<br>sizes. Far distance<br>screening is<br>simulated at 11 feet<br>through a view<br>finder on the<br>device. Patients<br>are asked to<br>determine the<br>clarity of a set of<br>letters. | The<br>myVisionTrack®<br>Model 0005<br>implements a shape<br>discrimination<br>hyperacuity (SDH)<br>vision test. The<br>distorted shape is<br>created by<br>modulating the<br>radius of the circle<br>with a sinusoid.<br>The user is shown<br>four circles and<br>asked to identify the<br>distorted circle. | | Visibly Digital<br>Acuity Product<br>(subject) | Vimetrics Central<br>Vision Analyzer 1000<br>(CVA-1000)<br>(predicate) | SoloHealth Station<br>(reference) | MyVisionTrack<br>Model 0005<br>(reference) | | | | the patient in which<br>automated<br>measurements are<br>conducted by an<br>interactive computer<br>program at logMAR<br>0.05 gradations of<br>symbol size. The<br>patient sits in a chair<br>in the darkened<br>examination room<br>with or without optical<br>correction<br>(spectacles, contact<br>lenses, or trial lenses)<br>and with one eye or<br>both eyes exposed,<br>he/she views in a<br>mirror at the end of<br>the room an LCD<br>monitor (patient<br>monitor) mounted on<br>the wall next to the<br>examiner's desk (total<br>distance entered into<br>the computer program<br>at the time of<br>installation). The<br>examiner selects the<br>method of operation<br>and contrasts to be<br>tested by keyboard<br>and mouse interaction<br>and with information<br>presented on the<br>physician's working<br>monitor. | | | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ### 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…