(149 days)
No
The description of the "Therapeutic Algorithms" indicates they apply modifications to videos in a predefined and consistent manner ("in the same manner for every video"), rather than adapting or learning from data, which is characteristic of AI/ML. The modifications are based on reducing contrast and applying rotating masks, which are fixed rules.
Yes
The "Intended Use / Indications for Use" states that Luminopia One is "a software-only digital therapeutic designed for improvement in visual acuity in amblyopia patients". The "Device Description" further elaborates that it "is intended to improve vision in pediatric patients with amblyopia" and "provides the actual treatment".
No
The 'Intended Use / Indications for Use' section states that "Luminopia One is indicated for improvement in visual acuity in amblyopia patients," which describes a therapeutic effect, not a diagnostic one.
Yes
The device description explicitly states that Luminopia One is "Software as a Medical Device (SaMD)" and consists of "four software-only components." It also clarifies that it is designed to be used with "commercially available, off-the-shelf head-mounted displays" and "does not require any hardware modifications or customization." While hardware testing of the HMD is mentioned for compatibility, the device itself is defined as software.
Based on the provided text, Luminopia One is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Luminopia One is a therapeutic device: Luminopia One is a software-only digital therapeutic that directly treats a condition (amblyopia) by modifying visual input presented to the patient. It does not analyze any biological samples.
- The intended use is therapeutic: The intended use clearly states "improvement in visual acuity in amblyopia patients". This is a therapeutic outcome, not a diagnostic one.
- The device description focuses on treatment mechanisms: The description explains how the software modifies video content to break interocular suppression and encourage amblyopic eye usage, which are therapeutic mechanisms.
Therefore, Luminopia One falls under the category of a therapeutic device, specifically a Software as a Medical Device (SaMD), rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
QQU
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.
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 ambinocular 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
4-7
Intended User / Care Setting
Prescription use only, in an at-home environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
November 4, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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: 857-365-6636 Fax: 857-336-6605 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.
4
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 | ||
| uniformity | ≥ 48 cd/m² | ≥ 48 cd/m² |
| Michelson contrast (low | ||
| spatial frequency) | ≥ 90% across field of view | ≥ 90% across field of view |
| Michelson contrast (high | ||
| spatial frequency grille | ||
| pattern) | Baseline requirement | Equivalent or higher than |
| Samsung Gear HMD across |
5
| field of view¹ | ||
|---|---|---|
| Resolution | ≥ 14.0 pixels/degree (vertical) | |
| ≥ 14.4 pixels/degree (horizontal) | ≥ 14.0 pixels/degree (vertical) | |
| ≥ 14.4 pixels/degree | ||
| (horizontal) | ||
| IPD range support | Meets requirements ≥ 52mm | |
| IPD | Meets requirements ≥ 52mm | |
| IPD | ||
| Internet capability | Yes | Yes |
| Battery capacity | > 90 min | > 90 min |
| Weight | Snapdragon 821 | > Snapdragon 821 |
| Refresh rate | ≥ 60 Hz | ≥ 60 Hz |
| Field of view | ≥ 51.9 degrees (horizontal) | |
| ≥ 30.6 degrees (vertical) | ≥ 51.9 degrees (horizontal) | |
| ≥ 30.6 degrees (vertical) |
Substantial Equivalence:
| Feature | Subject Device | Cleared Device
(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
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. | 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. | |
| Prescription/
over-the-counter
use | Prescription-use only | Prescription-use only | No change |
| Use environment | Home use | Home use | No change |
| Compatible
HMDs listed in
labeling | - Samsung Gear HMD
- Pico G2 4K | - Samsung Gear HMD | Does not
introduce new
technological
characteristics
or questions of
safety and
effectiveness |
| Technological Characteristics | | | |
| Device type | Software as a Medical
Device (SaMD) | Software as a Medical
Device (SaMD) | No change |
| Device design | 4 software-only
components: - Mobile Application
- Prescription Manager
Portal - Patient Portal
- Backend Service Layer | 4 software-only
components: - Mobile Application
- Prescription Manager
Portal - Patient Portal
- 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:
Therapeutic
mechanism | Modification of visual
stimuli using:
contrast reduction +
dichoptic masks | Modification of visual
stimuli using:
contrast reduction +
dichoptic masks | No change |
| Device feature:
Visual stimuli | Video content | Video content | No change |
| Hardware
platform | Off-the-shelf Head-
Mounted Display (HMD) | Off-the-shelf Head-
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.
6
7
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
8
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.