The EyeYon (hioxifilcon D) Spherical soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The EyeYon (hioxifilcon D) Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 4.00 diopters (D) or less of astigmatism.

The EyeYon (hioxifilcon D) Multifocal soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, and/or presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 0.75 diopters of astigmatism.

The EyeYon (hioxifilcon D) Multifocal Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 4.00 diopters (D) or less of refractive and/or corneal astigmatism.

The Hyper-CL™ (hioxifilcon D) Therapeutic soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia in phakic persons with non-diseased eyes. The lenses may be prescribed for therapeutic use to promote corneal healing and relieve corneal pain by protecting the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The EveYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses for Daily Wear are fabricated from hioxifilcon D, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The EveYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses are manufactured from CONTAFLEX 54 optical blanks, supplied by Contamac Ltd (cleared under K150590).

The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lens design includes two (2) different base curves, and a peripheral groove including 4-16 fenestrations. When worn on the eve the Hyper-CL™ lens design creates a tear film reservoir between the corneal surface and the back surface of the contact lens. The fenestrations improve tear mixing efficiency.

AI/ML Overview

The provided document is a 510(k) summary for EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses and Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses. This document describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on non-clinical performance data and material properties. However, it does not contain a detailed study proving that the device meets specific acceptance criteria related to clinical performance metrics like accuracy, sensitivity, or specificity for a diagnostic or AI device.

Therefore, many of the requested information points, particularly those related to clinical studies, expert adjudication, and AI performance, cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the document, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or performance metrics in terms of accuracy, sensitivity, or specificity. Instead, it focuses on the material properties and manufacturing consistency.

Acceptance Criteria	Reported Device Performance
Material Properties (compared to predicate CONTAFLEX 54):
USAN name	hioxifilcon D (Matches predicate)
Water Content (%)	54±2% (Matches predicate)
Oxygen Permeability	20.96 x 10⁻¹¹ (cm²/sec)(ml O₂)/(ml x mmHg @ 35°C) (Matches predicate)
FDA Group	FDA Group 2 (>50% H₂O, non-ionic polymer) (Matches predicate)
Specific Gravity	1.12 (hydrated) (Matches predicate)
Manufacturing Verification (Bench Testing):	All lenses manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Shelf Life Studies:	Studies conducted to establish expiration dating (sterility, stability, package integrity).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in a way that relates to a "test set" for clinical performance. The manufacturing verification involved "all lenses" from manufacturing runs to check specifications, but this isn't a clinical test set. The shelf-life studies involved samples for sterility, stability, and package integrity, but specific numbers are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The substantial equivalence is based on material properties and non-clinical bench testing, not on interpretation by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

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

There is no mention of an MRMC study or AI assistance. This document describes contact lenses, not an AI diagnostic or assistance device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a contact lens and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the material properties and manufacturing verification, the "ground truth" would be the established chemical and physical standards for contact lens materials (e.g., ISO, ANSI standards) and the specifications of the predicate device (CONTAFLEX 54). For shelf-life studies, the ground truth would be accepted methods for assessing sterility, stability, and package integrity. There is no expert consensus or pathology data mentioned in this context.

8. The sample size for the training set

This information is not applicable as this is not an AI device with a "training set."

9. How the ground truth for the training set was established

This information is not applicable.

Summary

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Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2016

EyeYon Medical % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068

Re: K153305

Trade/Device Name: EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses for Daily Wear, Hyper-CL (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: II Product Code: LPL Dated: February 25, 2016 Received: March 1, 2016

Dear Mr. Andre:

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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" (21 CFR 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 yours,

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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Indications for Use

510(k) Number (if known) K153305

Device Name

EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses for Daily Wear (Sphere, Toric, Multifocal Toric) Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses for Daily Wear

Indications for Use (Describe)

The EyeYon (hioxifileon D) Multifocal soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, and/or presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 0.75 diopters of astigmatism.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K153305 Applicant information: November 10th, 2015 Date Prepared: EyeYon Medical Name: Golda Meir 5 Nes Ziona Address Israel Contact Person: Malca Chen-Zion Phone number: +972.73.7803607 EyeReg Consulting, Inc. US Agent: Bret Andre Phone number (503) 333-2246 Fax number (503) 419-4475

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Trade Name:	EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses for Daily Wear (Sphere, Toric, Multifocal, Multifocal Toric)Hyper-CLTM (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses for Daily Wear

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Equivalent Devices:

The EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses are substantially equivalent to the following predicate device(s):

Predicate device:	"CONTAFLEX 54 (hioxifilcon D)"Manufactured/distributed by Contamac Ltd.510(k) number; K150590
	"CIBA VISION (lotrafilcon A)"Manufactured/distributed by CIBA VISION Corporation510(k) number; K073459

EveYon Medical & Hyper-CLTM (hioxifilcon D) Device Description:

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The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the EyeYon & Hyper-CLTM (hioxifilcon D) Soft (hydrophilic) Contact Lenses are:

Refractive Index	1.5193 (hydrated)
Light Transmission	greater than 96%
Water Content	54% ± 2%
Specific Gravity (wet)	1.120
Oxygen Permeability	20.96 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C),(revised Fatt method).

The EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses are available in the following parameter ranges:

• Diameter:	10.0 mm to 17.0 mm
• Base Curve:	6.0 mm to 10.0 mm
• Center Thickness:	varies (0.12 mm at +3.00 D)
• Powers:	-20.00 D to +20.00 D (0.25 D steps)
o Toric:	up to -4.00 D (0.50 D steps)
o Multifocal:	up to +3.00 D

Intended Use:

The Eye Yon (hioxifilcon D) Spherical soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The EyeYon (hioxifilcon D) Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 4.00 diopters (D) or less of astigmatism.

The Eye Yon (hioxifilcon D) Multifocal soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, hyperopia, and/or presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 0.75 diopters of astigmatism.

The Hyper-CL™ (hioxifilcon D) Therapeutic soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia in phakic persons with non-diseased eyes. The lenses may be prescribed for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as

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well as post-surgical conditions resulting from cataract extraction and corneal surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Summary of Non-Clinical Performance Data:

The EyeYon & Hyper-CLTM (hioxifilcon D) Soft (hydrophilic) Contact Lenses are manufactured from CONTAFLEX 54 (hioxifilcon D) optical blanks, supplied by Contamac Ltd. The properties and safety profile for the CONTAFLEX 54 (hioxifilcon D) soft contact lens material may be referenced in K150590.

Additional non-clinical studies performed by Eye Yon Medical include:

Shelf Life Studies-EyeYon Medical conducted studies (sterility, stability, package integrity) to establish expiration dating for the EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses.

Manufacturing Verification (Bench Testing)-manufacturing verification testing was conducted to demonstrate the ability of Eve Yon Medical to manufacture lenses, on a repeatable basis, from (hioxifilcon D) optical blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Non-clinical data presented in this submission support substantial equivalence of this EyeYon & Hyper-CL™ (hioxifilcon D) Soft (hydrophilic) Contact Lens to the already marketed CONTAFLEX 54 hioxifilcon D (K150590).

Substantial Equivalence:

The EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses are substantially equivalent to the predicate device as depicted in the following table, and do not raise different questions of safety and effectiveness than the predicate device identified previously.

The following table depicts the pre-clinical characteristics of the Hyper-CLIM (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lens materials, as well as the predicate devices:

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Substantial Equivalence Matrix

	EyeYon MedicalEyeYon & Hyper-CLTM(Subject Device)	Contamac Ltd.CONTAFLEX 54(Predicate Device)	CIBA VISIONCorporationCIBA VISIONlotrafilcon A(Predicate Device)
Intended Use	Same as predicate devices	Indicated for daily wear forthe correction of visualacuity in aphakic and notaphakic persons with non-diseased eyes with myopiaor hyperopia.	Indicated for therapeuticuse to promote cornealhealing and relievecorneal pain by protectingthe cornea during thetreatment of acute orchronic pathologies. Alsomay provide opticalcorrection.
Functionality	Same as predicate devices	After machining from theoptical blank, the contactlenses act as a refractivemedium that focus lightrays from near and distantobjects on the retina.	the contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina. May also be usedas a bandage to protectand promote healing forthe cornea.
Classification Name	Same as predicate devices	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)
Production Method	Lathe cut	Lathe cut	Fully molded
USAN name	hioxifilcon D	hioxifilcon D	Lotrafilcon A
Water Content (%)	54±2%	54±2%	76±2%
Oxygen Permeability	$20.96 x 10^{-11}$(cm2/sec)(mlO2)/(ml x mmHg@ 35°C)) (revised Fatt method)	$20.96 x 10^{-11}$(cm2/sec)(mlO2)/(ml xmmHg @ 35°C)) (revisedFatt method)	$140 x 10^{-11}$(cm2/sec)(mlO2)/(ml xmmHg @ 35°C)) (revisedFatt method)
FDA Group	FDA Group 2(>50% H2O, non-ionicpolymer)	FDA Group 2(>50% H2O, non-ionicpolymer)	FDA Group 1(<50% H2O, non-ionicpolymer)
Specific Gravity	1.12 (hydrated)	1.12 (hydrated)	-

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.