(261 days)
Not Found
No
The description of the "Therapeutic Algorithms" indicates they apply fixed modifications (reducing contrast, applying predefined masks) to video content, which does not suggest the use of AI or ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as a "digital therapeutic" and is "indicated for improvement in visual acuity in amblyopia patients." It provides "actual treatment" by applying "therapeutic algorithms" to video content to improve vision.
No
The device is a therapeutic software designed for the improvement of visual acuity in amblyopia patients, not for diagnosing conditions.
Yes
The device description explicitly states that Luminopia is "Software as a Medical Device (SaMD)" and consists of "four software-only components." While it is designed to be used with commercially available HMDs, the device itself is the software application and its associated components, not the hardware. The testing described focuses on software compatibility and performance on the HMD, not on the HMD hardware itself as the medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of Luminopia clearly states it is a software-only digital therapeutic used with a Head-Mounted Display (HMD) to treat amblyopia by modifying visual content. It does not involve the analysis of any biological samples (blood, urine, tissue, etc.).
- The intended use is for treatment, not diagnosis. The indication for use is "improvement in visual acuity in amblyopia patients," which is a therapeutic goal, not a diagnostic one.
- The device description focuses on software algorithms and visual presentation. The components described (Mobile Application, Prescription Manager Portal, Patient Portal, Backend Service Layer) and the mechanism of action (reducing contrast, applying dichoptic masks) are all related to delivering a visual therapy, not performing laboratory tests on specimens.
Therefore, Luminopia 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 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.
Product codes
QQU
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 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 (DPVR P1 Pro 4K) |
|---|---|---|
| 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 |
| 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) |
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
aged 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
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Enclosure
3
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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4
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: 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
5
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
(DPVR P1 Pro 4K) |
|---------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 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
across¹ |
| 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) |
-
- 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
(K221659) | Impact |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Class | II | II | No change |
| Classification | 886.5500 | 886.5500 | No change |
| Product code | QQU | QQU | No change |
| Labeling | | | |
| 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 eye-
care professional. Luminopia
is intended for both previously
treated and untreated patients; | 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 | No change |
| | 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. | 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 | - DPVR P1 Pro 4K
- Pico G2 4K | - Samsung Gear HMD
- Pico G2 4K | 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: | Modification of visual stimuli
using: | Modification of visual stimuli
using: | No change |
| Therapeutic
mechanism | contrast reduction + dichoptic
masks | contrast reduction + dichoptic
masks | |
| 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 |
Substantial Equivalence:
7
8
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.