EYEPORT VISION TRAINING SYSTEM

• K Number: K051684
• 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
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

AI/ML Overview

The provided 510(k) summary for the EYEPORT Vision Training System (K051684) does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on design and intended use, rather than presenting performance data from clinical or technical studies.

Therefore, for your request, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. This device is a training system, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document is a 510(k) summary for a Class I device (Fixation Device), which typically requires less robust clinical evidence for clearance compared to higher-risk devices. The submission focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices (Gruss Electro Wand and Vis-Flex) based on indications for use, target population, design, anatomical sites, fundamental technology, energy source, and where used. The key differences highlighted are minor (length of the light bar and color of the light sources, with the EYEPORT's red and blue lights utilizing chromatic aberration) and are presented as design choices rather than requiring extensive performance validation.

Summary

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K051684

MAR 17 2006

510(k) Summary of Safety and Effectiveness

Submitter:	Company Name:Address:	Exercise Your Eyes, Inc.30052 Aventura, Suite CRancho Santa Margarita, CA 92688
	Mailing Address:	Exercise Your Eyes, Inc.P.O. Box 80904Rancho Santa Margarita, CA 92688
	Phone:	[phone]
	Registration:	Pending
	Manufacturing Site:	Providence Enterprise LimitedUnit 13-15, 6/F.Grand City PlazaNo. 1, Sai Lau Kok RoadTsuen Wan, N.T.Hong Kong.Ph: 11 852-2415 2293Fax: [phone]
	Contact:	Albert LeeProvidence Enterprise LimitedEmail: [e-mail] Ph: 011- (852) 9192 9731HK Office: (852) 2415 2293China Plant: 011 (86) 755-8465 4646
Official Correspondent:		Jacob Liberman, OD, PhD.
	Address:	133 KA DriveKula, Hawaii
	Phone:	[phone]
Device Identification:
	Proprietary Name:	EYEPORT Vision Training System
	Common Name:	Vision Training Device
	Classification Name:	Fixation Device

.

:

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	EYE	Gruss Electro Wand	Vis-Flex
Indications forUse	The EYEPORT isindicated for the treatmentof poor accommodativeand vergence facility,convergence insufficiencyand large accommodativelag (in non-presbyopicsubjects).	The Gruss ElectroWand was used for thediagnosis and treatmentof convergence excess,convergenceinsufficiency, poorfixations, strabismus,and suppression.	The Vis-Flex is usedfor training ocularmotor skills such astracking, pursuits,saccadics, fixations,accommodation andconvergence.
TargetPopulation	Healthy Individuals	Healthy Individuals	Healthy Individuals
Design	Plastic bar with alternatingred and blue lights	Metal bar with lights	Plastic bar with lights
Anatomical Sites	Eyes	Eyes	Eyes
FundamentalTechnology	Individual light sources turnon and off to create visualstimuli	Individual light sourcesturn on and off to createvisual stimuli	Individual light sourcesturn on and off to createvisual 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,

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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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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.