MYVISIONTRACK(TM)
Device Facts
| Record ID | K121738 |
|---|---|
| Device Name | MYVISIONTRACK(TM) |
| Applicant | Vital Art and Science Incorporated |
| Product Code | HOQ · Ophthalmic |
| Decision Date | Feb 22, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1330 |
| Device Class | Class 1 |
| Attributes | Software as a Medical Device, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K121738 · Feb 22, 2013 | MYVISIONTRACK(TM) | Vital Art and Science Incorporated | Longitudinal patient self-test data (home-use) | A 6-month longitudinal study was conducted to evaluate the device's performance in a home-use setting, assessing patient compliance and the ability to detect disease progression in patients with diabetic retinopathy. | Home-use monitoring; Longitudinal study; Diabetic retinopathy; Patient compliance |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| 6-month Clinical Study; Longitudinal study; Follow-up/Duration: 6 months | Patients with diabetic retinopathy (DR); Sample Size: 36 individuals | Not applicable for this study | Detection of disease progression (using 0.2 logMAR notification rule), patient compliance, and ability to self-monitor vision function. |
Indications for Use
The myVisionTrackTM is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
Device Story
myVisionTrack is a software-based vision function monitor running on a commercial smartphone. It implements a shape discrimination hyperacuity (SDH) test to detect central 3-degree metamorphopsia. The device displays three circles on the screen; the user identifies the distorted circle. An adaptive staircase algorithm modulates the distortion amplitude to determine the lowest detectable level. Unlike predicate devices, it does not require stable fixation. Patients perform self-tests at home; results are automatically uploaded via cellular connection to a physician portal. Physicians review longitudinal data to monitor disease progression and determine if clinical intervention is required. The device enables timely detection of vision changes, potentially improving patient outcomes in maculopathy management.
Clinical Evidence
A 6-month longitudinal clinical study of 36 individuals with diabetic retinopathy (DR) was conducted. Participants performed weekly tests (2,338 total measurements). The study demonstrated the device's ability to distinguish between mild-to-moderate non-proliferative DR and severe/proliferative DR, where traditional acuity tests failed. Compliance was 84% with an average of 1.7 tests per week. The study validated that patients can effectively self-monitor at home and established a 0.2 logMAR notification rule for physician alerts.
Technological Characteristics
Software application running on off-the-shelf smartphone. Uses shape discrimination hyperacuity (SDH) test with adaptive staircase algorithm. Does not require fixation. Connectivity via cellular network for data upload. Conforms to ISO 13485, IEC 62304 (software life cycle), IEC 60601-1 (safety), and IEC 60601-1-11 (home healthcare environment).
Indications for Use
Indicated for patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, to detect and monitor central 3-degree metamorphopsia. Intended for home self-testing by patients capable of regular use. Not for diagnosis.
Regulatory Classification
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.
Predicate Devices
- ForeseeHome (K091579)
- PreView PHP (K05350)
- Amsler Grid (Class I Exempt)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2017
Vital Art and Science Incorporated Mike Bartlett President 2725 N. Spring Drive Richardson, TX 75082
Re: K121738
Trade/Device Name: myVisionTrack™ Model 0003 Regulation Number: 21 CFR 886.1330 Regulation Name: Amsler grid Regulatory Class: Class I Product Code: HOQ Dated: January 15, 2013 Received: January 17, 2013
Dear Mike Bartlett:
This letter corrects our substantially equivalent letter of February 22, 2013
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. 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.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation
(21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
# Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Change Control Table, Change History
## Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---------|-----------------------------------------------|---------------------|---------------|
| 1.00 | Alexander Beylin, Biomedical<br>Engineer, ODE | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
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## Indications for Use
510(k) Number (if known) K121738
Device Name myVisionTrackTM Model 0003
### Indications for Use (Describe)
The my Vision TrackTM is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# FEB 2 2 2013
### 510(k) Summary (Revised from Original) 5.
Date prepared: May 24, 2012
K Number K121738
Submitter:
Vital Art and Science Incorporated 2725 N. Spring Drive Richardson, TX 75082-4233
| Contact Person: | Mike Bartlett |
|-----------------|-----------------------------------------------|
| | President, Vital Art and Science Incorporated |
| | Phone: 214-929-2931 |
| | Fax: 972-238-0420 |
| | E-Mail: mike.bartlett@myvisiontrack.com |
### Name of the Device and Classification
Type of 510(k) Submission: Traditional Trade Name: myVisionTrack™ Model 0003 Common Name: Home vision function monitor Reason for Premarket Notification: New Device Regulation Number: 21 CFR 886 1605 Regulation Name: Perimeter, Automatic, AC-Powered Regulatory Class: Class I Product Code: HPT
### Predicate Devices:
The Vital Art and Science Incorporated my VisionTrack™ Model 0003 (mVT™) is substantially equivalent to the following combination of predicate medical devices:
- ForeseeHome supplied by Notal Vision; Perimeter, Automatic, AC-Powered, 21 . CFR 886.1605; K091579; Product Code: HPT
- PreView PHPTM supplied by Notal Vision; Perimeter, Automatic, AC-Powered, . 21 CFR Part 886.1605; K05350; Product Code: HPT
- Amsler Grid, a Class I Exempt Preamendments Medical Device (21 CFR . 886.1330); Product Code: HOQ
### 510(k) Summary
5 -1
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### Brief Device Description:
The myVisionTrack™ is a vision function test provided on a commercially available cell phone. The myVisionTrack™ implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. This enables regular monitoring of disease progression, and for timely detection of significant changes in vision function. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
### Indications for Use:
The my VisionTrack™ is intended for the detection and characterization of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The my Vision Track™ is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
### Indications for Use as compared to the Predicate Device:
myVisionTrackTM and the three predicate devices provide a method for a user to self-test their own vision function. All are used to detect significant changes in vision, which indicate disease progression.
The Amsler Grid, in various paper chart forms, is the most commonly prescribed method for home vision monitoring today. Studies have shown that most patients cannot use it effectively for a number of reasons, including the requirement for the user to remember previous results and to determine for themselves if a significant change has occurred.
myVisionTrack™ and the two devices from Notal Vision are automated devices which present visual test stimuli, collect user responses and compare current results to previous test results to determine if a significant change in vision function has occurred.
All three devices use a "hyperacuity" algorithm that tests the user's ability to detect differences in multiple stimuli. my Vision Track™ uses a test algorithm that does not require the user to fixate on a single point during the test. Therefore, it is not limited to users who have a stable fixation, which is a requirement of the Notal Vision devices.
### 510(k) Summarv
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The ForeseeHome and PreView PHP™ test the central and paracentral area of the retina whereas my VisionTrack™ tests only the central 3 degrees of the retina which is a smaller area. The predicate devices are intended for users diagnosed with age-related macular degeneration (AMD) whereas my VisionTrack™ is intended for users diagnosed with maculopathy, of which AMD and diabetic retinopathy (DR) are the primary diseases.
### Principles of Operation:
The test images used by my VisionTrack™ are shown in Figure 5.1 where (a) is an undistorted image and (b) is a distorted image. The distorted version is created by modulating the radius of the circle with a sinusoid.
Image /page/6/Picture/3 description: The image shows two different shapes. The shape on the left is a circle. The shape on the right is a wavy circle with 8 points. The text "cyc/360" is at the bottom of the image.
(a) unmodulated (b) modulated Fig. 5.1. Patterns in the shape discrimination
In the test the user is shown three circles and asked to identify the distorted circle, as shown in Figure 5.2. The test begins with a large amplitude of distortion and moves quickly through a series of test images where the distortion amplitude is reduced in order to determine the lowest detectable level of distortion.
Image /page/6/Picture/6 description: The image shows a smartphone with a gray screen displaying three shapes. There is a circle on the left, a star in the middle, and another circle on the right. The shapes are outlined in a lighter gray color, contrasting with the darker gray background of the screen.
Figure 5.2
510(k) Summary
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K121738
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### Clinical Testing Summary
Numerous published studies have shown that patients with AMD and other forms of maculopathy have significantly poorer results as compared to normal subjects on the shape discrimination test. VAS has performed our own 6-month Clinical Study on the specific shape discrimination hyperacuity test used in myVisionTrack™. This study of diabetic retinopathy (DR) patients did show a significant difference between those patients with mild-to-moderate non-proliferative DR (NPDR) and those with very severe NPDR or proliferative DR (PDR), whereas traditional clinic-based visual acuity and contrast sensitivity tests were not able to detect a significant difference. In this study, where patients were asked to test at least once per week for 6 months, there was an average weekly compliance rate of 84%, and the average number of times the patients performed the test was 1.7. This study verified that patients could and would effectively self-monitor their own vision function at home using myVisionTrackTM.
In this 6-month longitudinal study, we collected data on 36 individuals taking weekly measurements for a total of 2338 measurements. Individuals in this study had no significant change of disease condition over the 6-month period based on clinical judgment. Using the 6-month longitudinal study, we found 36 examples where a physician would have been notified according to the 0.2 logMAR notification rule.
### Substantial Equivalence Comparison
The substantial equivalence of the my VisionTrack™ to the predicate devices is summarized in Table 5.1 below. Each of these devices provide a vision self-test for the patient.
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| Function<br>Specification | Product Code | Amsler Grid<br>Class I Exempt<br>Preamendments Device | HOQ | Notal Vision, Inc.<br>PreView PHP™<br>k050350 | HPT | Notal Vision, Inc.<br>ForeseeHome<br>k091579 | HPT | VAS<br>myVision Track™ Model<br>0003 (Proposed) | HPT |
|---------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----------------------------------------------|-----|-------------------------------------------------|-----|
| Regulation<br>Number | 21 CFR 886.1330 | 21 CFR 886.1605 | 21 CFR 886.1605 | 21 CFR 886.1605 | | | | | |
| Indications<br>for Use | Intended to rapidly<br>detect central and<br>paracentral irregularities<br>in the visual field. | The PreView PHP™ is<br>intended for use in the<br>detection and monitoring<br>the progression of Age-<br>related Macular<br>Degeneration (AMD)<br>including, but not limited<br>to, the detection of<br>choroidal<br>neovascularization (CNV). | The ForeseeHome is<br>intended for use in the<br>detection and<br>characterization of central<br>and paracentral<br>metamorphopsia (visual<br>distortion) in patients with<br>age-related macular<br>degeneration as an aid in<br>monitoring progression of<br>disease factors causing<br>metamorphopsia including,<br>but not limited to choroidal<br>neovascularization (CNV). It<br>is intended to be used at<br>home for patients with<br>stable fixation. The<br>ForeseeHome is not<br>intended to diagnose;<br>diagnosis is the<br>responsibility of the<br>prescribing eye-care<br>professional. | The myVision Track™ is<br>intended for the detection<br>and characterization of<br>central 3 degrees<br>metamorphopsia (visual<br>distortion) in patients with<br>maculopathy, including age-<br>related macular<br>degeneration and diabetic<br>retinopathy, and as an aid in<br>monitoring progression of<br>disease factors causing<br>metamorphopsia. It is<br>intended to be used by<br>patients who have the<br>capability to regularly<br>perform a simple self-test at<br>home. The myVision Track™<br>is not intended to diagnose;<br>diagnosis is the<br>responsibility of the<br>prescribing eye-care<br>professional. | | | | | |
:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
KIZI738
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| Item | Function<br>Specification | Amsler Grid<br>Class Exempt<br>Preamendments Device | Notal Vision, Inc.<br>PreView PHP™<br>k050350 | Notal Vision, Inc.<br>ForeseeHome<br>k091579 | VAS<br>myVisionTrack™ Model<br>0003 (Proposed) |
|------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 4 | Target<br>Population | Patients at high risk or<br>already diagnosed with<br>Maculopathy | Patients already diagnosed<br>with age-related macular<br>degeneration | Patients already diagnosed<br>with age-related macular<br>degeneration | Patients already diagnosed<br>with Maculopathy, including<br>age-related macular<br>degeneration and diabetic<br>retinopathy |
| 5 | Prescription<br>or OTC | OTC | Prescribed by healthcare<br>professional. | Prescribed by healthcare<br>professional. | Prescribed by healthcare<br>professional. |
| 6 | How/Where<br>used | Home use for self-<br>testing by the patient. | Healthcare Clinic | Home use for self-testing by<br>the patient. | Home use for self-testing by<br>the patient. |
| 7 | Hardware<br>Platform | Paper chart. | Software Application to be<br>run on a customer supplied<br>off-the-shelf PC. | Dedicated unit with<br>processor, display, mouse<br>and software. | Software Application<br>delivered by the supplier on<br>an off-the-shelf cell phone. |
| 8 | Vision Test<br>algorithm<br>used | Patient is instructed to<br>identify and record blur,<br>distorted or missing<br>areas on the chart. | Preferential Hyperacuity<br>Test | Preferential Hyperacuity<br>Test | Shape Discrimination<br>Hyperacuity Test with an<br>adaptive staircase algorithm |
| 9 | Fixation<br>Point for the<br>patient<br>during<br>testing? | Yes | Yes | Yes | No. The test employs a<br>visual task involving global<br>visual integration. No<br>fixation is required to<br>perform the test. |
| 10 | Data upload<br>capability? | No | Not specified | Yes, through a home phone<br>line. | Yes, through the cell phone<br>connection. |
the same of the same of the same of
K121738
:
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K121738
### Standards to which Vital Art and Science Incorporated claims conformance for the myVisionTrack™ Model 0003
1) ISO 13485:2003 / EN ISO 13485:2003 / AC:2009 "Medical devices - Quality management systems - Requirements for regulatory purposes"
2) AAMI / ANSI / ISO 14971:2007/(R)2010, "Medical devices - Application of risk management to medical devices"
3) IEC 60234:2006 Ed. 1.0, "Medical device software - Software life cycle processes"
4) IEC 60601-1:2005 + A1:2012, 'Medical electrical equipment Part 1: General requirements for basic safety and essential performance"
5) IEC 60601-1-2:2007, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard Electromagnetic compatibility - Requirements and tests"
6) IEC 60601-1-11:2010, "Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment"
### Conclusion
In conclusion, the proposed my VisionTrack™ as compared to the already cleared predicate devices has:
- . Similar indications for use:
- Similar physical composition, in that all use visual testing software delivered on a ● validated hardware platform and operating system;
- � Similar, but with a vision test algorithm that does not require a patient to focus on a single point constantly during testing;
- A similar method of operation for the patient to perform self-testing at home; and .
- Similar central monitoring of patient self-test results, but with a mobile device . upload method that does not require the patient to have a home phone or to perform any setup.
Based on our non-clinical and clinical testing of the my VisionTrack™ Model 0003 we have concluded that the my VisionTrack™ Model 0003 is as safe, as effective and performs at least as safely and effectively as the predicate devices.
