Luminopia One

K221659 · Luminopia, Inc. · QQU · Nov 4, 2022 · Ophthalmic

Device Facts

• Record ID: K221659
• Device Name: Luminopia One
• Applicant: Luminopia, Inc.
• Product Code: QQU · Ophthalmic
• Decision Date: Nov 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5500
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Intended Use

Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.

Device Story

Luminopia One is a software-only digital therapeutic (SaMD) for pediatric amblyopia; used at home with off-the-shelf head-mounted displays (HMDs). The system includes a mobile application, prescription manager portal, patient portal, and backend service layer. The mobile app displays patient-selected video content (TV shows/movies) modified by therapeutic algorithms to break interocular suppression and encourage amblyopic eye usage. Algorithms reduce contrast to the stronger eye and apply dichoptic masks to both eyes to promote binocular combination. The HMD acts as the computing platform and stereoscopic viewing device. Healthcare providers prescribe the therapy; patients use it at home. The device aims to improve visual acuity by encouraging binocular vision. This submission adds the Pico G2 4K HMD as a compatible hardware platform.

Clinical Evidence

Bench testing only. Hardware and optical testing confirmed the Pico G2 4K HMD meets minimum requirements for resolution, luminance, luminance uniformity, contrast, cross-talk, and IPD. Software testing (unit, integration, functional, regression, negative, and thermal) validated proper application performance and integration on the new HMD. All tests passed.

Technological Characteristics

SaMD; operates on off-the-shelf HMDs (Samsung Gear, Pico G2 4K). Requires Wi-Fi. Therapeutic mechanism: dichoptic presentation with contrast reduction and superimposed masks. Minimum HMD requirements: ≥48 cd/m² luminance, ≥90% Michelson contrast, ≥14.0 pixels/degree resolution, ≥52mm IPD support, ≥60Hz refresh rate, >90 min battery, <500g weight, Snapdragon 821 or equivalent processing.

Indications for Use

Indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or mild strabismus. Adjunct to full-time refractive correction. Not studied in patients with >12 months prior treatment (excluding refractive correction).

Regulatory Classification

Identification

A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia. Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. It is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, as an adjunct to full-time refractive correction.

Special Controls

In combination with the general controls of the FD&C Act, the digital therapy device for amblyopia is subject to the following special controls: - Clinical performance testing must demonstrate that the device performs as intended (1) under anticipated conditions of use with labeled compatible visual display devices, including evaluation of all adverse events and device performance to improve measures of visual function. - (2) Software verification, validation, and hazard analysis must be performed. Documentation must include characterizations of the technical specifications of the software. - (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. All visual displays intended for use must undergo compatibility testing to ensure adequate display resolution, luminance, contrast, field of view, image quality, appropriate optical image distance, and verify their compatibility with the software and intended user (such as appropriate interpupillary distance). - (4) Labeling must include the following: - (i) The minimum hardware and operating system requirements that support the software of the device: - (ii) The models of the visual displays validated to be compatible with this device; - The length of treatment and/or retreatment supported by clinical performance (iii) testing; and - A summary of the clinical performance testing conducted with the device. (iv) - Labeling comprehension testing with intended users must be performed. (૨)

Predicate Devices

• Luminopia One (DEN210005)

Submission Summary (Full Text)

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November 4, 2022

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Luminopia, Inc. Scott Xiao CEO 955 Massachusetts Ave #335 Cambridge, Massachusetts 02139

Re: K221659

Trade/Device Name: Luminopia One Regulation Number: 21 CFR 886.5500 Regulation Name: Digital Therapy Device For Amblyopia Regulatory Class: Class II Product Code: QQU Dated: September 27, 2022 Received: September 27, 2022

Dear Scott Xiao:

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 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

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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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Elvin Y. Na -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

Enclosure

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# Indications for Use

510(k) Number (if known) K221659

Device Name Luminopia One

### Indications for Use (Describe)

Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Luminopia. The logo features two overlapping eye-shaped figures in different shades of blue. The word "luminopia" is written in a sans-serif font below the eye figures, also in blue. The logo is simple and modern, with a focus on the company name and a visual representation of vision or sight.

# 510(K) SUMMARY

510(k) Owner: Luminopia, Inc. Address: 955 Massachusetts Ave #335, Cambridge, MA 02139 Phone: [phone] Fax: [phone] Contact Person: Scott Xiao Date Prepared: November 3, 2022

Trade Name: Luminopia One Common Name: Digital Therapy Device for Amblyopia Classification: Class II Classification Name: Digital Therapy Device for Amblyopia Regulation Number: 886.5500 Product Code: QQU

Predicate Device: Luminopia One (Submission Number: DEN210005)

Indications for Use: Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.

## Device Description:

Luminopia One is Software as a Medical Device (SaMD) that is intended to improve vision in pediatric patients with amblyopia. The Luminopia One SaMD consists of four software-only components: the Mobile Application, the Prescription Manager Portal, the Patient Portal, and the Backend Service Layer. The first 3 components are user-facing, while the Backend Service Layer is designed to only communicate with the other 3 components. The Luminopia One SaMD is intended for prescription use only, in an at-home environment.

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The Mobile Application ("Mobile App") consists of two software units: the Video Content Platform and the Therapeutic Algorithms. The Video Content Platform allows the Patient to browse from a library of popular TV shows and movies and select videos to watch. The Video Content Platform, without the Therapeutic Algorithms, is analogous to consumer video applications (e.g., YouTube, Netflix). The Therapeutic Algorithms provide the actual treatment, by applying modifications to the videos shown by the Video Content Platform.

It is hypothesized that the Therapeutic Algorithms improve vision by breaking interocular suppression and encouraging amblyopic eye usage. The Therapeutic Algorithms are applied to patient-selected video content in the same manner for every video. The algorithms reduce contrast to the stronger eye's input to break interocular suppression and encourage amblyopic eye usage. Additionally, parts of each eye's input are occluded by dichoptic masks superimposed over the video content to promote binocular combination. The masks rotate through predefined pairs over the course of treatment.

The Mobile App is designed to be used with commercially available, off-the-shelf head-mounted displays ("HMDs") and does not require any hardware modifications or customization. These HMDs can either consist of a headset combined with a display unit or consist of an all-in-one unit. The HMD serves two functions. Firstly, the HMD serves as the computing platform for the Mobile App, analogous to a smartphone for a mobile medical application. The HMD requires a Wi-Fi connection to run the Mobile App. Secondly, the HMD serves as a viewing device for dichoptic presentation of the content in the app, similar to a stereoscope device (FDA Product Code: HJR). During usage, the Mobile App displays a separate image to each of the Patient's eyes within the HMD, and the images appear as one when viewed together.

The predicate device was evaluated in a clinical study using the Samsung Gear HMD. The proposed modification is the addition of the Pico G2 4K HMD to the list of compatible HMDs in the Directions For Use for the Luminopia One SaMD. Both HMDs meet the following set of minimum requirements:

| Parameter | Samsung Gear HMD | Pico G2 4K HMD |
|------------------------------------------------------------------|----------------------------|------------------------------------------------------|
| Luminance and luminance<br>uniformity | ≥ 48 cd/m² | ≥ 48 cd/m² |
| Michelson contrast (low<br>spatial frequency) | ≥ 90% across field of view | ≥ 90% across field of view |
| Michelson contrast (high<br>spatial frequency grille<br>pattern) | Baseline requirement | Equivalent or higher than<br>Samsung Gear HMD across |

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| | | field of view¹ |
|---------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------|
| Resolution | ≥ 14.0 pixels/degree (vertical)<br>≥ 14.4 pixels/degree (horizontal) | ≥ 14.0 pixels/degree (vertical)<br>≥ 14.4 pixels/degree<br>(horizontal) |
| IPD range support | Meets requirements ≥ 52mm<br>IPD | Meets requirements ≥ 52mm<br>IPD |
| Internet capability | Yes | Yes |
| Battery capacity | > 90 min | > 90 min |
| Weight | < 500 g (± 5%) | < 500 g (± 5%) |
| RF compliance | Yes | Yes |
| Audio support | Yes | Yes |
| Power button | Yes | Yes |
| Eye glasses compatibility | Yes | Yes |
| Processing capacity | > Snapdragon 821 | > Snapdragon 821 |
| Refresh rate | ≥ 60 Hz | ≥ 60 Hz |
| Field of view | ≥ 51.9 degrees (horizontal)<br>≥ 30.6 degrees (vertical) | ≥ 51.9 degrees (horizontal)<br>≥ 30.6 degrees (vertical) |

## Substantial Equivalence:

| Feature | Subject Device | Cleared Device<br>(DEN210005) | Impact |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Class | II | II | No change |
| Classification | 886.5500 | 886.5500 | No change |
| Product code | QQU | QQU | No change |
| Labeling | | | |
| Indications for | Luminopia One is a | Luminopia One is a | No change |
| Use | software-only digital<br>therapeutic designed to be<br>used with commercially<br>available Head-Mounted<br>Displays (HMDs) which<br>are compatible with the<br>software application.<br>Luminopia One is<br>indicated for improvement<br>in visual acuity in<br>amblyopia patients, aged<br>4-7, associated with<br>anisometropia and/or with<br>mild strabismus, having<br>received treatment<br>instructions (frequency<br>and duration) as<br>prescribed by a trained<br>eye-care professional.<br>Luminopia One is<br>intended for both<br>previously treated and<br>untreated patients;<br>however, patients with<br>more than 12 months of<br>prior treatment (other than<br>refractive correction) have<br>not been studied.<br>Luminopia One is<br>intended to be used as an<br>adjunct to full-time<br>refractive correction, such<br>as glasses, which should<br>also be worn under the<br>HMD during Luminopia<br>One therapy. Luminopia<br>One is intended for<br>prescription use only, in<br>an at-home environment. | software-only digital<br>therapeutic designed to be<br>used with commercially<br>available Head-Mounted<br>Displays (HMDs) which<br>are compatible with the<br>software application.<br>Luminopia One is<br>indicated for improvement<br>in visual acuity in<br>amblyopia patients, aged<br>4-7, associated with<br>anisometropia and/or with<br>mild strabismus, having<br>received treatment<br>instructions (frequency<br>and duration) as<br>prescribed by a trained<br>eye-care professional.<br>Luminopia One is<br>intended for both<br>previously treated and<br>untreated patients;<br>however, patients with<br>more than 12 months of<br>prior treatment (other than<br>refractive correction) have<br>not been studied.<br>Luminopia One is<br>intended to be used as an<br>adjunct to full-time<br>refractive correction, such<br>as glasses, which should<br>also be worn under the<br>HMD during Luminopia<br>One therapy. Luminopia<br>One is intended for<br>prescription use only, in<br>an at-home environment. | |
| Prescription/<br>over-the-counter<br>use | Prescription-use only | Prescription-use only | No change |
| Use environment | Home use | Home use | No change |
| Compatible<br>HMDs listed in<br>labeling | - Samsung Gear HMD<br>- Pico G2 4K | - Samsung Gear HMD | Does not<br>introduce new<br>technological<br>characteristics<br>or questions of<br>safety and<br>effectiveness |
| Technological Characteristics | | | |
| Device type | Software as a Medical<br>Device (SaMD) | Software as a Medical<br>Device (SaMD) | No change |
| Device design | 4 software-only<br>components:<br>- Mobile Application<br>- Prescription Manager<br>Portal<br>- Patient Portal<br>- Backend Service Layer | 4 software-only<br>components:<br>- Mobile Application<br>- Prescription Manager<br>Portal<br>- Patient Portal<br>- Backend Service Layer | No change |
| Device materials | N/A (device is SaMD) | N/A (device is SaMD) | No change |
| Energy source | N/A (device is SaMD) | N/A (device is SaMD) | No change |
| Device feature:<br>Therapeutic<br>mechanism | Modification of visual<br>stimuli using:<br>contrast reduction +<br>dichoptic masks | Modification of visual<br>stimuli using:<br>contrast reduction +<br>dichoptic masks | No change |
| Device feature:<br>Visual stimuli | Video content | Video content | No change |
| Hardware<br>platform | Off-the-shelf Head-<br>Mounted Display (HMD) | Off-the-shelf Head-<br>Mounted Display (HMD) | No change |

¹ The Michelson contrast is lower than 90% when tested with image analysis of a high spatial frequency grille pattern for the Pico G2 4K HMD and the Samsung Gear HMD. The Pico G2 4K HMD has equivalent or higher contrast than that of the Samsung Gear HMD across the field of view, at both the nominal IPD and a 52mm IPD, and therefore meets the minimum requirement.

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The proposed modification is the addition of one additional head-mounted display (HMD) model to the list of compatible HMDs in the Directions For Use for the Luminopia One SaMD. The intended use and Indications for Use remain the same.

No design changes for the SaMD were needed to produce compatibility for this modification, and therefore, there are no changes to the technological characteristics. Any similarities or differences in the technical specifications of the off-the-shelf HMDs are relevant only insofar as

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they impact one of the HMD parameters for which there are minimum requirements relevant to safety and effectiveness. Since both the Samsung Gear HMD and the Pico G2 4K HMD met all minimum requirements, the proposed modification does not impact the safety and effectiveness of the SaMD.

## Performance Data:

Hardware bench testing and optical testing were used to establish the compatibility of the additional HMD. The hardware testing confirmed that the additional HMD met the minimum hardware requirements for resolution, luminance, luminance uniformity, contrast, cross-talk, IPD, and non-optical parameters. Software testing validated that the Mobile Application runs as intended on the additional HMD model, and that there is proper integration between the software and the HMD. The software testing methods used were unit and integration testing, functional testing, system regression testing, negative testing, and thermal testing. All of the testing passed without deviations.

## Conclusion:

The proposed modification to add one additional HMD for use with the Luminopia One SaMD does not change the intended use or the technological characteristics of the predicate device. Performance testing supported this assessment, and therefore the subject and the predicate device are Substantially Equivalent.