Luminopia

K233720 · Luminopia, Inc. · QQU · Aug 8, 2024 · Ophthalmic

Device Facts

• Record ID: K233720
• Device Name: Luminopia
• Applicant: Luminopia, Inc.
• Product Code: QQU · Ophthalmic
• Decision Date: Aug 8, 2024
• 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 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 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 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 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 therapy. Luminopia is intended for prescription use only, in an at-home environment.

Device Story

Luminopia is a software-only digital therapeutic (SaMD) for pediatric amblyopia; used at home under prescription. Input: patient-selected video content (TV shows/movies). Operation: Mobile App runs on off-the-shelf HMDs; applies therapeutic algorithms to video stream. Algorithms reduce contrast to stronger eye to break interocular suppression; superimpose dichoptic masks to promote binocular combination. Output: modified video content presented dichoptically to patient eyes within HMD. HMD acts as computing platform and stereoscopic display. Benefit: improved visual acuity by encouraging amblyopic eye usage and binocular integration. Physician prescribes therapy; patient uses at home.

Clinical Evidence

Bench testing only. Hardware and optical testing confirmed the DPVR P1 Pro 4K HMD meets minimum requirements for resolution, luminance, luminance uniformity, contrast, cross-talk, and IPD. Software validation included unit, integration, functional, system regression, negative, and thermal testing. All tests passed.

Technological Characteristics

SaMD; four components (Mobile App, Prescription Manager Portal, Patient Portal, Backend Service Layer). Therapeutic mechanism: contrast reduction and dichoptic masking. Hardware platform: off-the-shelf HMDs (e.g., DPVR P1 Pro 4K, Pico G2 4K). Connectivity: Wi-Fi required. No physical materials or energy sources (software-only).

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 non-refractive treatment.

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 (K221659)

Submission Summary (Full Text)

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August 8, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. 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.

Luminopia, Inc. Endri Angjeli VP of Clinical Development 955 Massachusetts Ave #335 Cambridge, Massachusetts 02139

Re: K233720

Trade/Device Name: Luminopia Regulation Number: 21 CFR 886.5500 Regulation Name: Digital therapy device for amblyopia Regulatory Class: Class II Product Code: QQU Dated: July 1, 2024 Received: July 1, 2024

Dear Endri Angjeli:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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Enclosure

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# Indications for Use

Submission Number (if known)

K233720 Device Name

Luminopia

Indications for Use (Describe)

Luminopia 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 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 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 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 therapy. Luminopia is intended for prescription use only, in an at-home environment.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) SUMMARY

510(k) Owner: Luminopia, Inc. Address: 955 Massachusetts Ave #335, Cambridge, MA 02139 Phone: [phone] Fax: [phone] Contact Person: Endri Angjeli Date: August 8, 2024

Trade Name: "Luminopia One" and "Luminopia" Common Name: N/A Classification Name: Digital Therapy Device for Amblyopia (21 CFR 886.5500, Product Code: OOU)

Predicate Device: Luminopia One (Submission Number: K221659)

Indications for Use: Luminopia 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 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 eve-care professional. Luminopia 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 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 therapy. Luminopia is intended for prescription use only, in an at-home environment.

### Device Description:

Luminopia is Software as a Medical Device (SaMD) that is intended to improve vision in pediatric patients with amblyopia. The Luminopia 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 SaMD is intended for prescription use only, in an at-home environment.

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

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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 proposed modification is the addition of the DPVR P1 Pro HMD to the list of compatible HMDs in the Directions For Use for the Luminopia SaMD. All compatible HMDs meet the following set of minimum requirements:

| Parameter | Pico G2 4K HMD | Subject Device HMD<br>(DPVR P1 Pro 4K) |
|---------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Luminance and luminance<br>uniformity | ≥ 48 cd/m² | ≥ 48 cd/m² |
| Michelson contrast (low spatial<br>frequency) | ≥ 90% across field of view | ≥ 90% across field of view |
| Michelson contrast (high spatial<br>frequency grille pattern) | Baseline requirement | Equivalent or higher than<br>Samsung Gear HMD<br>across¹ |
| Resolution | ≥ 14.0 pixels/degree<br>(vertical)<br>≥ 14.4 pixels/degree<br>(horizontal) | ≥ 14.0 pixels/degree<br>(vertical)<br>≥ 14.4 pixels/degree<br>(horizontal) |
| IPD range support | Meets requirements ≥<br>52mm IPD | Meets requirements ≥<br>52mm IPD |
| Internet capability | Yes | Yes |
| Battery capacity | > 90 min | > 90 min |
| Weight | < 500 g (± 5%) | < 500 g (± 5%) |
| RF compliance | Yes | Yes |

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| 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) |

- 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 current compatible HMD cleared in K221659. The DPVR P1 Pro 4K 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.

| Feature | Subject Device | Cleared Device<br>(K221659) | Impact |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Class | II | II | No change |
| Classification | 886.5500 | 886.5500 | No change |
| Product code | QQU | QQU | No change |
| Labeling | | | |
| Indications for<br>Use | Luminopia is a software-only<br>digital therapeutic designed to<br>be used with commercially<br>available Head-Mounted<br>Displays (HMDs) which are<br>compatible with the software<br>application. Luminopia is<br>indicated for improvement in<br>visual acuity in amblyopia<br>patients, aged 4-7, associated<br>with anisometropia and/or with<br>mild strabismus, having<br>received treatment instructions<br>(frequency and duration) as<br>prescribed by a trained eye-<br>care professional. Luminopia<br>is intended for both previously<br>treated and untreated patients; | Luminopia One is a software-<br>only digital therapeutic<br>designed to be used with<br>commercially available Head-<br>Mounted Displays (HMDs)<br>which are compatible with the<br>software application.<br>Luminopia One is indicated for<br>improvement in visual acuity<br>in amblyopia patients, aged 4-<br>7, associated with<br>anisometropia and/or with mild<br>strabismus, having received<br>treatment instructions<br>(frequency and duration) as<br>prescribed by a trained eye-<br>care professional. Luminopia<br>One is intended for both | No change |
| | however, patients with more<br>than 12 months of prior<br>treatment (other than refractive<br>correction) have not been<br>studied. Luminopia is intended<br>to be used as an adjunct to full-<br>time refractive correction, such<br>as glasses, which should also<br>be worn under the HMD<br>during Luminopia therapy.<br>Luminopia is intended for<br>prescription use only, in an at-<br>home environment. | previously treated and<br>untreated patients; however,<br>patients with more than 12<br>months of prior treatment<br>(other than refractive<br>correction) have not been<br>studied. Luminopia One is<br>intended to be used as an<br>adjunct to full-time refractive<br>correction, such as glasses,<br>which should also be worn<br>under the HMD during<br>Luminopia One therapy.<br>Luminopia One is intended for<br>prescription use only, in an at-<br>home environment. | |
| Prescription/<br>over-the-<br>counter use | Prescription-use only | Prescription-use only | No change |
| Use<br>environment | Home use | Home use | No change |
| Compatible<br>HMDs listed<br>in labeling | - DPVR P1 Pro 4K<br>- Pico G2 4K | - Samsung Gear HMD<br>- Pico G2 4K | Does not<br>introduce new<br>technological<br>characteristics or<br>questions of<br>safety and<br>effectiveness |
| Technological Characteristics | | | |
| Device type | Software as a Medical Device<br>(SaMD) | Software as a Medical Device<br>(SaMD) | No change |
| Device design | 4 software-only components:<br>- Mobile Application<br>- Prescription Manager Portal<br>- Patient Portal<br>- Backend Service Layer | 4 software-only components:<br>- Mobile Application<br>- Prescription Manager Portal<br>- Patient Portal<br>- Backend Service Layer | No change |
| Device<br>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<br>feature: | Modification of visual stimuli<br>using: | Modification of visual stimuli<br>using: | No change |
| Therapeutic<br>mechanism | contrast reduction + dichoptic<br>masks | contrast reduction + dichoptic<br>masks | |
| Device<br>feature:<br>Visual stimuli | Video content | Video content | No change |
| Hardware<br>platform | Off-the-shelf Head-Mounted<br>Display (HMD) | Off-the-shelf Head-Mounted<br>Display (HMD) | No change |

## Substantial Equivalence:

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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 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 they impact one of the HMD parameters for which there are minimum requirements relevant to safety and effectiveness. Since the additional HMD meets all minimum requirements for compatibility, 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 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.