(637 days)
Not Found
No
The description focuses on a digital implementation of the Amsler Grid test and data reporting, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The "Intended Use" states that the device is intended to "monitor and detect central visual distortions" and "alert a healthcare provider of any changes in a patient's central visual status." It explicitly states that it is "not intended to screen or diagnose." These functions are for monitoring and detection, not for treating or curing a medical condition.
No
The device description explicitly states, "EyeCTester is not intended to screen or diagnose," and "EyeCTester is not intended to diagnose the patient." It is described as an "aid to eyecare providers to monitor and detect" changes and "to alert a healthcare provider."
Yes
The device is explicitly described as "mobile software as a medical device (SaMD) app" and the description focuses solely on the software's functionality and testing, with no mention of accompanying hardware components or hardware-specific validation.
Based on the provided information, the EyeCTester Model iOS is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The EyeCTester app does not collect or analyze any biological samples (like blood, urine, tissue, etc.). It is a software application that performs a visual test based on patient input.
- The device description focuses on a visual test. The core function is an Amsler Grid test, which is a subjective visual assessment performed by the patient.
- The intended use is for monitoring visual changes. The purpose is to track changes in central vision, not to analyze biological markers or substances.
The EyeCTester is a Software as a Medical Device (SaMD) that aids in monitoring visual function. It falls under the category of devices used for assessment and monitoring of physiological parameters, not for in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central visual distortions (maculopathies) as well as central 10-degree visual field scotomas.
EyeCTester is not intended to screen or diagnose, but it is intended to alert a healthcare provider of any changes in a patient's central visual status. The device is intended for both at-home and clinical use. The EyeCTester is indicated to be used only with compatible mobile devices.
Product codes (comma separated list FDA assigned to the subject device)
QTW
Device Description
The EyeCTester - Monitoring Application comprises a survey and a series of tests to provide remote monitoring of the patient's visual parameters from the patient's home. The EyeCTester -Monitoring application is available to patients with a prescription from the healthcare provider managing their vision. Prescribed, routine patient testing via the app allows providers to monitor vision health in the interim period between visits to the physician's clinical practice. The tool is not intended to replace the need for an in-person eye exam with a professional eve care provider. EyeCTester is not intended to diagnose the patient; diagnosis and management is the responsibility of the qualified team prescribing and interpreting the app measurements.
Prior to regular, at-home use, patients will receive training in the clinic and will then undergo training within the app and verify their understanding of how to complete testing. Pop-ups will appear throughout the app reminding the patient that the app's purpose is to monitor changes in vision, not to provide a diagnosis.
The app uses an Amsler Grid test to detect changes in visual distortions / scotomas / field cuts within the central 10 degrees of vision. The test prompts patients to outline and define distorted and/or missing areas on a series of grids while staring at a pulsating fixation point. At the end of the test, the grids are combined to display the patient's responses. The results of the assessments are summarized in a report that is provided to the prescribing healthcare provider to be interpreted and evaluated for any changes over time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central / paracentral visual system
Indicated Patient Age Range
adults ages 22 and above
Intended User / Care Setting
eyecare providers / at-home and clinical use
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)
Software Testing:
The software development and testing was executed in compliance with IEC 62304 Medical Device Software Life Cycle Processes. The results of these tests indicate that EyeCTester Amsler Grid/ Visual Field functionality is substantially equivalent to the predicate device.
Human Factors / Usability Engineering Testing:
NEDS conducted a Human Factors Validation study in which participants without visual defects were enrolled to assess the user performance and test results of the EyeCTester compared to the standard, in-office examination tools. Each participant underwent the tests twice to ensure the validity of the findings. The Human Factors Validation study indicated minimal human error risks, many of which are shared with the non-digital test analogs. Additionally, the digital, at-home, mobile (smartphone) format allow considerable improvements to the test environment and test preparation (e.g., education in a quiet and self-paced environment), compared to non-digital test analogs. Overall, all participants were observed to safely use EyeCTester's features. Based on the results from this study, the risk profile of the application is confirmed to be acceptable. The Human Factors Validation study has shown that the EyeCTester application is safe and effective for the intended users, uses, and use environments.
Clinical Testing:
Clinical testing was performed to validate the visual parameter assessments of the EyeCTester compared to the standard of care modality (paper Amsler Grid) in both healthy volunteers and patients with neuro-ophthalmic, retinal, and other diseases. Both studies were approved by wcgIRB.
These clinical studies were prospective, randomized, cross-over, 2-site studies that involved a test and re-test to evaluate repeatability and agreement between the subject device and the paper format. These studies demonstrated that a patient may use the EyeCTester application to gather psychophysiological measurements of central and paracentral vision parameters related to normative functioning of the human visual system, and these measurements are useful for remote monitoring in between clinic visits.
The data from this clinical study provide affirmation that the EyeCTester app-based test is repeatable and consistent with the results of the paper analogue. The Amsler Grid testing was consistent and repeatable across the two testing methods. An additional metric assessed during the study was rate of human error in completing the test. It was confirmed that the human error rate was below 1% in the EyeCTester app test. Overall, the clinical evaluations support the use of the EyeCTester for testing patients using the Amsler Grid test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Human error rate was below 1% in the EyeCTester app test.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Alleye (K180895)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1330 Amsler grid.
(a)
Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
September 26, 2022
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Neuro-Eye Diagnostic Systems LLC % Isabella Schmitt Director of Regulatory Affairs Proxima Clinical Research, Inc. 2450 Holcombe Blvd. Houston, Texas 77071
Re: K203594
Trade/Device Name: EyeCTester Regulation Number: 21 CFR 886.1330 Regulation Name: Amsler Grid Regulatory Class: Class I Product Code: OTW
Dear Isabella Schmitt:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 7, 2022. Specifically, FDA is updating this SE Letter as an administrative correction for a typographical error in your Trade/Device Name.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 240-402-4662, Elvin.Ng@fda.hhs.gov.
Sincerely,
Elvin Y. Ng-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
1
September 7, 2022
Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo features an abstract symbol, while the FDA part includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Neuro-Eye Diagnostic Systems LLC % Isabella Schmitt Director of Regulatory Affairs Proxima Clinical Research, Inc. 2450 Holcombe Blvd. Houston, Texas 77071
Re: K203594
Trade/Device Name: EyeQTester Regulation Number: 21 CFR 886.1330 Regulation Name: Amsler grid Regulatory Class: Class I Product Code: QTW Dated: June 4, 2021 Received: June 14, 2021
Dear Isabella Schmitt:
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
2
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 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 (OS) 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. Ng -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
3
Indications for Use
510(k) Number (if known) K203594
Device Name EyeCTester Monitoring App
Indications for Use (Describe)
The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central visual distortions (maculopathies) as well as central 10-degree visual field scotomas.
EyeCTester is not intended to screen or diagnose, but it is intended to alert a healthcare provider of any changes in a patient's central visual status. The device is intended for both at-home and clinical use. The EyeCTester is indicated to be used only with compatible mobile devices.
| 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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4
510(k) Summary
| 510(k) Owner: | Neuro-Eye Diagnostic Systems, LLC |
|---|---|
| 2020 Quenby Street | |
| Houston, TX 77005 | |
| Official Contact: | Jade Schiffman, MD |
| Telephone: +1 (281) 701-0577 | |
| E-mail: jschiffman@neuroeye.com | |
| Representative Consultant Contact: | Isabella Schmitt, RAC |
| Proxima Clinical Research, Inc. | |
| 2450 Holcombe Blvd, Suite J | |
| Houston, TX 77021 | |
| Telephone: +1 (404) 205-4653 | |
| E-mail: Isabella@ProximaCRO.com | |
| Date Summary Prepared: | 06 September 2022 |
| Trade Name: | EyeCTester - Monitoring application |
| Common Name: | Digital Amsler Grid |
| Classification: | Class I |
| Classification Number(s): | 21 CFR 886.1330 |
| Product Code(s): | QTW |
| Classification Advisory Committee: | Ophthalmology |
| Predicate Device(s): | Alleye (K180895) |
5
Device Description:
The EyeCTester - Monitoring Application comprises a survey and a series of tests to provide remote monitoring of the patient's visual parameters from the patient's home. The EyeCTester -Monitoring application is available to patients with a prescription from the healthcare provider managing their vision. Prescribed, routine patient testing via the app allows providers to monitor vision health in the interim period between visits to the physician's clinical practice. The tool is not intended to replace the need for an in-person eye exam with a professional eve care provider. EyeCTester is not intended to diagnose the patient; diagnosis and management is the responsibility of the qualified team prescribing and interpreting the app measurements.
Prior to regular, at-home use, patients will receive training in the clinic and will then undergo training within the app and verify their understanding of how to complete testing. Pop-ups will appear throughout the app reminding the patient that the app's purpose is to monitor changes in vision, not to provide a diagnosis.
The app uses an Amsler Grid test to detect changes in visual distortions / scotomas / field cuts within the central 10 degrees of vision. The test prompts patients to outline and define distorted and/or missing areas on a series of grids while staring at a pulsating fixation point. At the end of the test, the grids are combined to display the patient's responses. The results of the assessments are summarized in a report that is provided to the prescribing healthcare provider to be interpreted and evaluated for any changes over time. A comparison of the EyeCTester application with its predicate is shown in the table below.
This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, for functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.
| Specification | EyeCTester (Subject Device) | Alleye |
|---|---|---|
| 510(k) Number | K203594 | K180895 |
| Product Name | EyeCTester App | Alleye |
| Sponsor | Neuro-Eye Diagnostic Systems, LLC | Oculocare Medical AG |
| Product Code(s) | QTW | HOQ |
| Regulation Number(s) | 21 CFR 886.1330 | 21 CFR 886.1330 |
| Classification | Class I | Class I |
| Rx / OTC | Rx Only | Rx Only |
| Indications for Use | The EyeCTester Model iOS is a mobile | |
| software as a medical device (SaMD) | ||
| app for adults ages 22 and above. It is | ||
| intended to serve as an aid to eyecare | ||
| providers to monitor and detect central / | ||
| paracentral visual distortions | ||
| (maculopathies) as well as central 10- | ||
| degree visual field scotomas. | The Alleye is a mobile medical | |
| software application indicated for the | ||
| detection and characterization | ||
| of metamorphopsia, a visual distortion, | ||
| in patients with age-related macular | ||
| degeneration (AMD) and as an aid in | ||
| the monitoring of the progression of | ||
| this condition in respect of |
Table 1: Comparison of EyeCTester - Monitoring Application to Identified Predicate
6
| Specification | EyeCTester (Subject Device) | Alleye |
|---|---|---|
| EyeCTester is not intended to screen or | ||
| diagnose, but it is intended to alert a | ||
| healthcare provider of any changes in a | ||
| patient's central visual status. The | ||
| device is intended for both at-home and | ||
| clinical use. The EyeCTester is | ||
| indicated to be used only with | ||
| compatible mobile devices. | metamorphopsia. It is intended to be | |
| used by patients who have the | ||
| capability to regularly perform a simple | ||
| self-test at home. | ||
| Testing Setting | At home and in clinic | At home |
| Hardware Platform | Software application to be used at | |
| home on a patient's personal | ||
| smartphone or in clinic on an office | ||
| supplied smartphone | Software application to be used at home | |
| on a patient's personal smartphone | ||
| Amsler Grid / Visual | ||
| Field Algorithm | Measures 10-degree visual field for | |
| distortions, including crooked and | ||
| doubling, and missingness defects, via | ||
| presentation of a series of grids on | ||
| which a user fixes their vision and | ||
| manually selects and identifies areas of | ||
| visual defects. | Measures visual field for distortions, | |
| including crooked defects, through an | ||
| alignment hyperacuity task | ||
| Data Upload and | ||
| Storage | Vision test data are uploaded from the | |
| patient's smartphone to a HIPAA and | ||
| HiTech-compliant server. The data are | ||
| presented on an online physician | ||
| dashboard and within the provider's | ||
| app for review and comparison by the | ||
| prescribing healthcare professional. | Vision test data are uploaded from the | |
| patient's phone and are stored and | ||
| transmitted in encrypted form. The | ||
| Alleye platform is HIPAA-compliant, | ||
| and Alleye data is stored on physical | ||
| servers. The data are presented on an | ||
| online physician dashboard for review | ||
| and comparison by the prescribing | ||
| healthcare professional. |
Intended Use / Indications for Use:
The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central / paracentral visual distortions (maculopathies) as well as central 10-degree visual field scotomas.
EyeCTester is not intended to screen or diagnose, but it is intended to alert a healthcare provider of any changes in a patient's central visual status. The device is intended for both at-home and clinical use. The EyeCTester is indicated to be used only with compatible mobile devices.
Technological Characteristics:
The EyeCTester application provides remote visual monitoring for patients through Amsler Grid testing. Patients complete prescribed testing protocols within the application for one or both eyes
7
as assigned by their eyecare provider. Providers are then able to access and interpret the results of these tests through the app or an online server and share them with the patient after interpretation, as appropriate. Providers may also be alerted when changes in visual parameters are reported by patients through the testing, based on prespecified rules set by the provider or clinic.
Software Testing:
The software development and testing was executed in compliance with IEC 62304 Medical Device Software Life Cycle Processes. The results of these tests indicate that EyeCTester Amsler Grid/ Visual Field functionality is substantially equivalent to the predicate device.
Human Factors / Usability Engineering Testing:
NEDS conducted a Human Factors Validation study in which participants without visual defects were enrolled to assess the user performance and test results of the EyeCTester compared to the standard, in-office examination tools. Each participant underwent the tests twice to ensure the validity of the findings. The Human Factors Validation study indicated minimal human error risks, many of which are shared with the non-digital test analogs. Additionally, the digital, at-home, mobile (smartphone) format allow considerable improvements to the test environment and test preparation (e.g., education in a quiet and self-paced environment), compared to non-digital test analogs. Overall, all participants were observed to safely use EyeCTester's features. Based on the results from this study, the risk profile of the application is confirmed to be acceptable. The Human Factors Validation study has shown that the EyeCTester application is safe and effective for the intended users, uses, and use environments.
Clinical Testing:
Clinical testing was performed to validate the visual parameter assessments of the EyeCTester compared to the standard of care modality (paper Amsler Grid) in both healthy volunteers and patients with neuro-ophthalmic, retinal, and other diseases. Both studies were approved by wcgIRB.
These clinical studies were prospective, randomized, cross-over, 2-site studies that involved a test and re-test to evaluate repeatability and agreement between the subject device and the paper format. These studies demonstrated that a patient may use the EyeCTester application to gather psychophysiological measurements of central and paracentral vision parameters related to normative functioning of the human visual system, and these measurements are useful for remote monitoring in between clinic visits.
The data from this clinical study provide affirmation that the EyeCTester app-based test is repeatable and consistent with the results of the paper analogue. The Amsler Grid testing was consistent and repeatable across the two testing methods. An additional metric assessed during the study was rate of human error in completing the test. It was confirmed that the human error rate was below 1% in the EyeCTester app test. Overall, the clinical evaluations support the use of the EyeCTester for testing patients using the Amsler Grid test.
8
Conclusion:
In conclusion, the NEDS EyeCTester - Monitoring Application is demonstrated to be as safe and effective and perform as well as the identified predicate device. The Amsler Grid test has the same intended use, indication, technological characteristics, and principles of operation as the predicate. Any differences between the EyeCTester application's functionalities and the predicate device's do not alter the intended use of the device and do not raise new or different questions regarding its safety and effectiveness when use as labelled. Clinical and Human Factors testing demonstrate that the device performs as intended. Thus, the EyeCTester application is substantially equivalent to the identified predicate devices.