(140 days)
Luminopia One DEN210005
Not Found
No
The summary mentions "real-time eye tracking" and "image processing" based on gaze position, but there is no mention of AI, ML, or related terms like deep learning or neural networks in the provided text. The description focuses on the dichoptic presentation and eye-tracking technology for tailoring visual stimuli.
Yes
The device is indicated for "improvement in visual acuity in amblyopia patients" and its description states it is "aimed for improving visual acuity and stereo acuity," which are therapeutic goals.
No
Explanation: The device is described as a system indicated for "improvement in visual acuity in amblyopia patients" and "aimed for improving visual acuity and stereo acuity under dichoptic conditions." This indicates a therapeutic or treatment function, not a diagnostic one.
No
The device description explicitly states that the CureSight™ system comprises the "CureSight-CS100 device (console and anaglyph glasses)" in addition to the "CureSight Web-App/Portal". The anaglyph glasses are also mentioned as being worn during treatment. These are physical hardware components, not solely software.
Based on the provided information, the CureSight™ system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- The CureSight™ system directly interacts with the patient's eyes. It uses eye-tracking and presents visual stimuli to the patient's eyes for therapeutic purposes (improving visual acuity). It does not analyze any biological specimens.
- The intended use is therapeutic, not diagnostic. The system is indicated for "improvement in visual acuity in amblyopia patients," which is a treatment goal, not a diagnostic one.
Therefore, the CureSight™ system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CureSight™ system is indicated for improvement in visual acuity in amblyopia patients, aged 4 -
N/A
0
September 29, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services 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.
NovaSight Ltd. % Lee Kramm President, Chief Strategist and Medical Officer Regulatory Pathways Group, Inc. 340 S. Lemon Ave. #2471 Walnut. California 91789
Re: K221375
Trade/Device Name: CureSight-CS100 Regulation Number: 21 CFR 886.5500 Regulation Name: Digital Therapy Device For Amblyopia Regulatory Class: Class II Product Code: QQU Dated: August 25, 2022 Received: August 29, 2022
Dear Lee Kramm:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K221375
Device Name CureSight CS100 System
Indications for Use (Describe)
The CureSight™ system is indicated for improvement in visual acuity in amblyopia patients, aged 4 - years, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. CureSight™ is intended for both previously treated and untreated patients and is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the anaglyph glasses during CureSight™ 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) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K221375
| APPLICANT: | NovaSight Ltd.
1 Hayarden St.
Airport City 7019801
Israel |
|-----------------------------|---------------------------------------------------------------------------------------------|
| OFFICIAL CORRESPONDENT: | Ran Yam
CEO
+972-3 6422868 (Office)
+972 50 7591609 (Mobile)
ran@nova-sight.com |
| DATE SUMMARY PREPARED: | September 28, 2022 |
| TRADE/MODEL NAME: | CureSight™-CS100 system |
| COMMON NAME: | Digital Therapy Device For Amblyopia |
| DEVICE CLASSIFICATION /CODE | 886.5500, Class II
QQU |
| PREDICATE DEVICE: | Luminopia One
DEN210005 (October 20, 2021) |
DEVICE DESCRIPTION
The CureSight™ system is an eye-tracking-based system aimed for improving visual acuity and stereo acuity under dichoptic conditions. The technology is based on real-time eye tracking and separation of the visual stimuli presented on a monitor into two separate digital channels, one for each eye. Using this dichoptic method, any streamed video content can be tailored individually per eye and then presented simultaneously to each eye.
During the treatment, dichoptic anaglyph (red-blue) glasses that are part of the CureSight system are to be worn over the habitual spectacle correction.
The CureSight™ system comprises the following components/modules:
- CureSight-CS100 device (console and anaglyph glasses) ●
- CureSight Web-App/Portal
CureSight™ system is aimed for improving visual acuity and stereo acuity under dichoptic conditions, using digital content in pediatric patients (age 4 to 7 years on a study-approved device displaying single surrounded optotypes, as follows:
- a. Visual acuity in the amblyopic eye 20/32 to 20/100 inclusive
- b. Best-corrected dominant-eye VA meeting the following criteria:
- . If age 4, 20/40 or better by Lea symbol per ATS
- If age 5 and older, 20/32 or better by ATS-HOTV using LEA symbols for age 7 years
- c. Interocular difference ≥ 2 logMAR lines (Lea symbol per ATS)
Participants assigned to the binocular treatment group were prescribed the CureSight treatment to watch for 90 minutes per day, five days per week for 16 weeks. Participants assigned to control group were prescribed to wear an adhesive patch over the dominant eye for 2 hours per day, seven days per week for 16 weeks.
All participants were asked to wear their habitual optical correction regularly during the entire study period. Participants in the treatment group were instructed to always wear optical correction glasses under the anaglyph red-blue glasses.
The primary effectiveness endpoint for this study was:
Change (improvement) from baseline in Distance VA of the amblyopic eve (AEDVA) to week 16 in both study groups. The improvement is calculated as the difference between the baseline AEDVA and the AEDVA at each visit. Success Criterion: If the improvement in amblyopic eye distance VA (AEDVA) of the Binocular treatment (CureSight) group from baseline to 16 weeks is not inferior to that of the amblyopic eye of the control (patching) group within a margin of -0.10 logMAR, then the primary effectiveness endpoint will have been successfully met.
The secondary effectiveness endpoints for this study were:
- . Change from baseline in stereo acuity score (Randot preschool test) score to week 16 as measured in arcseconds in the treatment group.
- . Change from baseline in binocular distance VA to week 16 as measured in LogMAR in the treatment group.
- Change from baseline in binocular distance VA to week 16 as measured in LogMAR compared between the treatment and control groups.
10
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. Change from baseline in stereo acuity (Randot preschool test) score to week 16 as measured in arcseconds compared between the treatment and control groups.
Safety outcomes consisted of: -
. Incidence of Adverse Events
- The frequency, severity, and causality of adverse events (AEs), related and un-related o to binocular treatment and occurring during the study in the treatment and control groups.
-
Distance VA of the Fellow Eye .
- Change from baseline in Distance VA of the fellow eye (FEDVA) to week 16 in both o study groups.
- The proportion of subjects with loss of 0.2 or more logMAR lines (10 or more letters) o of FEDVA from baseline to the 16-week exam in the treatment and control groups.
-
Ocular Alignment
- The proportion of subjects with development of new strabismus (no heterotropia at o baseline and the presence of near and/or distance heterotropia at 16 weeks) or an increase from baseline ≥10Δ in a pre-existing strabismus at 16 weeks in the two arms.
-
Diplopia (ATS Diplopia Questionnaire) The proportion of subjects with each level of diplopia in both study arms. O
-
. Adverse Symptoms and Events using a 5-item symptom survey regarding the presence of various ocular symptoms in both study arms.
The subjects enrolled in the study were between 4 and 1-2 lines | 0.0% | 0.0% | 0.0% | 0.0% | 2.27% | 0.0% | 0.0% | 0.0% |
| decrease | (0/45) | (0/46) | (0/44) | (0/47) | (1/44) | (0/46) | (0/43) | (0/49) |
| > 2 lines decrease | 2.22% | 0.0% | 0.0% | 2.13% | 0.0% | 0.0% | 0.0% | 0.0% |
| | (1/45) | (0/46) | (0/44) | (1/47) | (0/44) | (0/46) | (0/43) | (0/49) |
Based on participants with available data at each visit. Categorical variables presented as n/N (%) where N is the number of participants with available data.
2 Original visual acuity measurements captured using logMAR. A 1-line improvement from baseline corresponds to a change of 0.10 logMAR.
At week 16, the median change from baseline in stereo acuity (Randot preschool test) demonstrated a significant improvement by 0.40 log arcseconds in the study treatment group (Range: -0.65 to 1.77, P1 Includes all adverse events in all enrolled subjects (ITT population), even if classified as Not Related to study treatment. Data presented as: n (%) [m], where n is number of participants with event and m is the number of events. Participants may experience more than one AE.
2 New ocular deviation in a participant without a tropia at baseline
3 Increase in ocular deviation ≥ 10∆ in a participant with a tropia at baseline
4 Decrease ≥ 2 logMAR lines from baseline
5 Includes seasonal allergies and viral infections, including COVID-19
6 Other AEs in control group include rage attack and syncope
CONCLUSION
As described in this 510(k) Summary, the subject and predicate devices have the same intended use and similar indications for use. The minor differences in technological characteristics between the subject and predicate devices raise no new issues of safety or effectiveness. Performance testing and results from the clinical study further establish the safety and effectiveness of the subject device when used in accordance with its labeling. Therefore, the CureSight-CS100 System is substantially equivalent to the predicate Luminopia One device cleared under DEN210005.