MYVISIONTRACK(TM)

• K Number: K121738
• Device Name: MYVISIONTRACK(TM)
• Manufacturer: VITAL ART AND SCIENCE INCORPORATED
• Date Cleared: 2013-02-22 ( 254 days)
• Product Code: HOQ HPT
• Regulation Number: 886.1330

Intended Use

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.

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.

Predicate Devices

K091579, K05350

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a vision test based on shape discrimination hyperacuity and mentions a clinical study, but there is no mention of AI, ML, or related concepts like neural networks, training sets, or image processing that would typically indicate the use of AI/ML.

Therapeutic

No.
The device is used for detection and monitoring of disease progression, not for treating or curing a condition.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional." It is intended for detection and monitoring, not for providing a diagnosis itself.

SaMD (Software as a Medical Device)

Yes

The device is described as a "vision function test provided on a commercially available cell phone" and implements a "shape discrimination hyperacuity (SDH) vision test". While it runs on a cell phone (hardware), the core medical device functionality is the software-based vision test itself, which processes user input to assess vision function. The description focuses on the software's capabilities and performance, not the hardware of the cell phone.

IVD (In Vitro Diagnostic)

Based on the provided information, the myVisionTrackTM device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs analyze biological samples: IVDs are designed to examine specimens derived from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
• myVisionTrackTM is a vision function test: The description clearly states that myVisionTrackTM is a "vision function test" that uses a "shape discrimination hyperacuity (SDH) vision test." It assesses a patient's ability to perceive visual distortions.
• No mention of biological sample analysis: The provided text does not mention the collection or analysis of any biological samples. The test is performed by the patient interacting with a cell phone application.

Therefore, myVisionTrackTM falls under the category of a medical device that assesses a physiological function (vision), rather than an IVD which analyzes biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

# Intended Use / Indications for Use
The myVisionTrack™ 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 myVisionTrack™ is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.

# Product codes (comma separated list FDA assigned to the subject device)
HOQ, HPT

# 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.

# Mentions image processing
Not Found

# Mentions AI, DNN, or ML
Not Found

# Input Imaging Modality
Not Found

# Anatomical Site
Central retina (3 degrees)

# Indicated Patient Age Range
Not Found

# Intended User / Care Setting
Home use for self-testing by the patient. Diagnosis is the responsibility of the prescribing eye-care professional.

# 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)
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.

# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found

# 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.
[K091579](https://510k.innolitics.com/search/K091579), K05350

# 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

Regulation Number and Section

§ 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.

Summary

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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.

1

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 [phone] or [phone] 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 [phone] or [phone] 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
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)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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: [phone]
	Fax: [phone]
	E-Mail: [e-mail]

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

5

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

6

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

5 -3

K121738

7

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
Specification | Product Code | Amsler Grid
Class I Exempt
Preamendments Device | HOQ | Notal Vision, Inc.
PreView PHP™
K050350 | HPT | Notal Vision, Inc.
ForeseeHome
K091579 | HPT | VAS
myVision Track™ Model
0003 (Proposed) | HPT |
|---------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----------------------------------------------|-----|-------------------------------------------------|-----|
| Regulation
Number | 21 CFR 886.1330 | 21 CFR 886.1605 | 21 CFR 886.1605 | 21 CFR 886.1605 | | | | | |
| Indications
for Use | Intended to rapidly
detect central and
paracentral irregularities
in the visual field. | The PreView PHP™ is
intended for use in the
detection and monitoring
the progression of Age-
related Macular
Degeneration (AMD)
including, but not limited
to, the detection of
choroidal
neovascularization (CNV). | The ForeseeHome is
intended for use in the
detection and
characterization of central
and paracentral
metamorphopsia (visual
distortion) in patients with
age-related macular
degeneration as an aid in
monitoring progression of
disease factors causing
metamorphopsia including,
but not limited to choroidal
neovascularization (CNV). It
is intended to be used at
home for patients with
stable fixation. The
ForeseeHome is not
intended to diagnose;
diagnosis is the
responsibility of the
prescribing eye-care
professional. | The myVision Track™ is
intended for the detection
and characterization of
central 3 degrees
metamorphopsia (visual
distortion) in patients with
maculopathy, including age-
related 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 myVision Track™
is not intended to diagnose;
diagnosis is the
responsibility of the
prescribing eye-care
professional. | | | | | |

:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

:

KIZI738

9

| Item | Function
Specification | Amsler Grid
Class Exempt
Preamendments Device | Notal Vision, Inc.
PreView PHP™
K050350 | Notal Vision, Inc.
ForeseeHome
K091579 | VAS
myVisionTrack™ Model
0003 (Proposed) |
|------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 4 | Target
Population | Patients at high risk or
already diagnosed with
Maculopathy | Patients already diagnosed
with age-related macular
degeneration | Patients already diagnosed
with age-related macular
degeneration | Patients already diagnosed
with Maculopathy, including
age-related macular
degeneration and diabetic
retinopathy |
| 5 | Prescription
or OTC | OTC | Prescribed by healthcare
professional. | Prescribed by healthcare
professional. | Prescribed by healthcare
professional. |
| 6 | How/Where
used | Home use for self-
testing by the patient. | Healthcare Clinic | Home use for self-testing by
the patient. | Home use for self-testing by
the patient. |
| 7 | Hardware
Platform | Paper chart. | Software Application to be
run on a customer supplied
off-the-shelf PC. | Dedicated unit with
processor, display, mouse
and software. | Software Application
delivered by the supplier on
an off-the-shelf cell phone. |
| 8 | Vision Test
algorithm
used | Patient is instructed to
identify and record blur,
distorted or missing
areas on the chart. | Preferential Hyperacuity
Test | Preferential Hyperacuity
Test | Shape Discrimination
Hyperacuity Test with an
adaptive staircase algorithm |
| 9 | Fixation
Point for the
patient
during
testing? | Yes | Yes | Yes | No. The test employs a
visual task involving global
visual integration. No
fixation is required to
perform the test. |
| 10 | Data upload
capability? | No | Not specified | Yes, through a home phone
line. | Yes, through the cell phone
connection. |

the same of the same of the same of

K121738

:

10

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.