K Number

Device Name

EYEPORT VISION TRAINING SYSTEM

Manufacturer

EXERCISE YOUR EYES, INC.

Date Cleared

2006-03-17

(267 days)

Product Code

NXR

Regulation Number

886.1290

Intended Use

The EYEPORT is indicated for the treatment of poor accommodative and vergence facility, convergence insufficiency and large accommodative lag (in non-presbyopic subjects).

Device Description

Plastic bar with alternating red and blue lights. Individual light sources turn on and off to create visual stimuli.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and lack of mention of AI/ML terms or data processing suggest a simple light-based visual stimulus device.

Therapeutic

Yes
The device is indicated for the treatment of specific medical conditions (poor accommodative and vergence facility, convergence insufficiency, and large accommodative lag), which identifies it as a therapeutic device.

Diagnostic

No
The device description and intended use indicate it is used for treatment (e.g., of poor accommodative and vergence facility), not for diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "Plastic bar with alternating red and blue lights," indicating a physical hardware component.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
EYEPORT's Function: The EYEPORT device is used to treat conditions related to eye function (accommodation and vergence). It provides visual stimuli directly to the eyes, which are part of the body. It does not analyze any specimens taken from the body.
Intended Use: The intended use clearly states treatment of eye conditions, not diagnosis based on analyzing biological samples.

Therefore, the EYEPORT falls under the category of a therapeutic or rehabilitative medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EYEPORT is indicated for the treatment of poor accommodative and vergence facility, convergence insufficiency and large accommodative lag (in non-presbyopic subjects).

Product codes

NXR

Device Description

Plastic bar with alternating red and blue lights. Individual light sources turn on and off to create visual stimuli.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eyes

Indicated Patient Age Range

The indication for use specifies "non-presbyopic subjects", implying subjects who are not of a certain age, generally considered 40 and above. The target population is also listed as "Healthy Individuals".

Intended User / Care Setting

In home or optometrist office

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 886.1290 Fixation device.

(a)
Identification. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)(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.

Summary

K051684

MAR 17 2006

510(k) Summary of Safety and Effectiveness

	EYE	Gruss Electro Wand	Vis-Flex
Indications for
Use	The EYEPORT is
indicated for the treatment
of poor accommodative
and vergence facility,
convergence insufficiency
and large accommodative
lag (in non-presbyopic
subjects).	The Gruss Electro
Wand was used for the
diagnosis and treatment
of convergence excess,
convergence
insufficiency, poor
fixations, strabismus,
and suppression.	The Vis-Flex is used
for training ocular
motor skills such as
tracking, pursuits,
saccadics, fixations,
accommodation and
convergence.
Target
Population	Healthy Individuals	Healthy Individuals	Healthy Individuals
Design	Plastic bar with alternating
red and blue lights	Metal bar with lights	Plastic bar with lights
Anatomical Sites	Eyes	Eyes	Eyes
Fundamental
Technology	Individual light sources turn
on and off to create visual
stimuli	Individual light sources
turn on and off to create
visual stimuli	Individual light sources
turn on and off to create
visual stimuli
Energy Source	AC adaptor or AA batteries	AC adaptor	AC adaptor
Where Used	In home or optometrist office	In optometrist office	In optometrist office

Side-by-side comparison of the EYEPORT, Gruss Electro Wand and Vis-Flex

The only significant differences between the EYEPORT and the two mentioned predicates are overall length of the light bar and color of the light sources. The EYEPORT is 36" long, the Gruss Electro Wand is 27" long and the Vis-Flex is 48" long. The differences in the length are primarily based on practitioner preference.

The EYEPORT makes use of alternating red and blue lights, while the Gruss Elecrtro Wand used and Vis-Flex use only red LED's. The alternating red and blue light used in the EYEPORT make use of the phenomenon of chromatic aberration to gently rock accommodation and convergence, as the lights are fixated. The red lights used in the Gruss Electro Wand and Vis-Flex function only as fixation targets,

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.

MAY 1 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Exercise Your Eyes™ (EYE), LLC c/o Jacob Liberman, O.D., Ph.D. 133 KA Drive Kula, HI 96790

Re: K051684

Trade Name: EYEPORT™ Visual Training System Regulation Number: 21 CFR 886.1290 Regulation Name: Fixation Device Regulatory Class: Class I Product Code: NXR Dated: March 6, 2006 Received: March 7, 2006

Dear Dr. Liberman:

This letter corrects our substantially equivalent letter of March 17, 2006.

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 (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.

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 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychhaus - M.D.

Malvina B. Eydelman, M.D. Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K051684

Device Name: __EYEPORT Vision Training System

Indications For Use: The EYEPORT is indicated for the treatment of poor accommodative and vergence facility, convergence insufficiency and large accommodative lag (in non-presbyopic subjects).

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Everett M. Ross

Division Sian-Off Division of Ophthalmic Ear, Nose and Throat De 510(k) Number

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