Sphere/Asphere:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the spherical/aspheric design are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the toric design are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. The VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye.

Device Description

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from mififilcon A. which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lenses consist of 40.0% mififilcon A and 60.0% water by weight when immersed in saline solution. The mififilcon A name has been adopted by the United States Adopted Names Council (USAN).

The VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus Color (miffilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green, Mica.

When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >80% in the UVA range (316mm - 380mm). The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are manufactured in spherical/aspheric, toric, and multifocal design configurations.

AI/ML Overview

The provided text describes the 510(k) submission for VizionFocus contact lenses, demonstrating their substantial equivalence to predicate devices. However, this submission does not contain acceptance criteria or study details for an AI/ML powered medical device. The document pertains to contact lenses, which are physical medical devices, not software-based AI/ML devices. Therefore, a table of acceptance criteria and study proving an AI device meets acceptance criteria cannot be extracted from this text.

The information provided describes:

Device Type: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens. These are physical contact lenses, not an AI/ML powered device.
Study Purpose: To demonstrate the safety and effectiveness of the contact lenses by comparing them to legally marketed predicate devices, establishing substantial equivalence. This is a typical regulatory pathway for physical medical devices.
Studies Conducted: Non-clinical performance testing (biocompatibility/toxicology, shelf life, bench tests like refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals) and a clinical study.
Clinical Study Design: Multi-center, single-masked (examiner), bilateral, randomized concurrent-control study with 91-day treatment follow-up.
Clinical Study Sample Size: 120 subjects enrolled (60 test, 60 control), 117 completed.
Clinical Study Data Provenance: Not explicitly stated, but typically clinical trials for FDA submissions are conducted in the US or in compliance with international standards that are accepted by the FDA. The indication of a multi-center study implies diverse geographic recruitment within the study's operational regions.
Ground Truth: For the clinical study, the ground truth was established through biomicroscopy findings, symptoms, adverse reactions, and vision safety measures (keratometry changes, refractive changes, best corrected visual acuity) observed and recorded by examiners. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for an AI model.

The prompt specifically asks for details around an AI/ML powered medical device's acceptance criteria and study, which are not present in the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 17, 2024

VizionFocus Inc. Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K242413

Trade/Device Name: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 8, 2024 Received: November 19, 2024

Dear Bret 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J Angelo Green -S

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242413

Device Name

VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens

Indications for Use (Describe)

Sphere/Asphere:

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the spherical/aspheric design are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric:

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the toric design are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal:

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510 (k) SUMMARY

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: K242413

I. SUBMITTER

Date Prepared:	November 14, 2024
Name:	VIZIONFOCUS INC.
Address:	No.66, Youyi Rd., Zhunan Township,Miaoli County 350,Taiwan (R.O.C.)
Contact Person:	Angus ShihGeneral Manager
Phone number:	037-582900
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) DailyDisposable Contact Lens;VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) DailyDisposable Contact Lens;
CommonName:	lens, contact, (disposable)
ClassificationName:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
RegulatoryClass:	Class II
Product Codes:	MVN

Purpose of 510(k) Submission:

~ New Device ~

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III. PREDICATE DEVICE

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are substantially equivalent to the following predicate devices:

I "Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" By CooperVision, Inc. 510(k) number; K181920 Product Code: MVN: LPL Primary Predicate
I "AIR OPTIX plus HydraGlyde. AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric" By Alcon Laboratories, Inc. 510(k) number: K160609 Product Code: LPL Reference Predicate
"DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS" By CIBA VISION CORPORATION 510(k) number: K963487 Product Code: LPL Reference Predicate
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)" I By Vizionfocus, Inc. 510(k) number: K182247 Product Code: MVN: LPL Reference Predicate

IV. DEVICE DESCRIPTION

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Color Additive	Listing
Rutile TiO2	21 CFR § 73.3126
Iron Oxide	21 CFR § 73.3125
(Pathalocyaninto(2-))Copper	21 CFR § 74.3045
Carbazole Violet	21 CFR § 73.3107
Phthalocyanine Green	21 CFR § 73.3124
Mica	21 CFR § 73.3128

Parameter	Range	Tolerance
Chord Diameter	11.00 mm to 15.00 mm	±0.20 mm
Center Thickness	0.050 mm to 0.150 mm	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%
Base Curve	7.0 mm to 10.0 mm	±0.20 mm
Back Vertex Power (F'v)	-20.00 D to +20.00 D(in 0.25 D steps)	When 0.00 < F'v ≤ 10.00 D → ±0.25 DWhen 10.00 < F'v ≤ 20.00 D→±0.50 D
Cylinder Power (F'c)	-0.25 D to -2.25 D(in 0.25 D steps)	When 0.00 < F'c ≤ 2.00 D → ±0.25 DWhen 2.00 < F'c ≤4.00 D→±0.37 D
Cylinder Axis	10° to 180° in 10° steps(in 10° steps)	When 0.00 < F'c ≤ 1.50 D → ± 8°When F'c > 1.50 D→± 5°
Multifocal Power	+0.25 D to +4.00 D(in 0.25 D steps)	±0.25D
Oxygen Permeability(x 10-11 (cm2•mlO2)/(sec•ml•mmHg))	80	±20%
Visible Light Transmittance	>95%	±5%
Ultraviolet radiation Transmittance	< 5% TUVB<20% TUVA	TUVB (280 to 315nm) < 0.05 TvTUVA (316 to 380nm) < 0.05 Tv
Water Content	60%	±2%
Refractive Index	1.395	±0.005

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V. INDICATIONS FOR USE

Sphere/Asphere:

Toric:

Multifocal:

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are substantially equivalent to the primary predicate device identified (K181920) with regards to the following features:

트 FDA category - Group V
FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Intended use daily disposable contact lenses ■
트 Indications for use
Cast molded production method
Injection molded blister packaging

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are substantially equivalent to the reference predicate devices identified (K160609 & K963487) with regards to the following features:

FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
트 Intended use - daily wear contact lenses
Indications for use
Buffer solution (contains common ingredients with subject device buffer solution)

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The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are substantially equivalent to the reference predicate device identified (K182247) with regards to the following features:

FDA classification Soft (hydrophilic) Contact Lens (21 CFR 886.5925) 트
Intended use daily wear contact lenses ■
Indications for use (same lens design configurations) ■
Benzotriazole UV absorbing monomer (same monomer)
트 Cast molded production method (same manufacturing facility and quality controls)
트 Injection molded polypropylene blister packaging (same packaging)
Handling tint and color additives (same colorants and production process)
I Pad-printing color lens manufacturing process (same facility pad-printing process)

The following matrix illustrates the production method, lens function and material characteristics of the VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses, as well as the predicate devices.

	VizionFocus andVizionFocus ColorSilicone HydrogelBy VizionFocusInc.(Subject Device)	Clariti 1 dayBy CooperVisionInc.(K181920)	AIR OPTIX plusHydraGlydeBy AlconLaboratories, Inc.(K160609)	Dailies One-DayBy Ciba VisionCorporation(K963487)	ILICONBy Vizionfocus,Inc.(K182247)		Indications for Use
Intended Use	Daily wear,Soft (hydrophilic) contactlens	Daily wear,Soft (hydrophilic) contactlens	Daily wear,Soft (hydrophilic) contactlens	Daily wear,Soft (hydrophilic) contactlens	Daily wear,Soft (hydrophilic) contactlens	VizionFocusandVizionFocusColorSiliconeHydrogelByVizionFocusInc.(SubjectDevice)	Sphere/Asphere:The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft(hydrophilic) Contact Lenses in the spherical/aspheric design are indicated for the correction of ametropia(myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters orless that does not interfere with visual acuity.Toric:
Actions	In its hydrated state, thecontact lens, when placedon the cornea, acts as arefracting medium tofocus light rays on theretina	In its hydrated state, thecontact lens, when placedon the cornea, acts as arefracting medium to focuslight rays on the retina	In its hydrated state, thecontact lens, when placedon the cornea, acts as arefracting medium to focuslight rays on the retina	In its hydrated state, thecontact lens, when placedon the cornea, acts as arefracting medium tofocus light rays on theretina	In its hydrated state, thecontact lens, when placedon the cornea, acts as arefracting medium tofocus light rays on theretina		The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft(hydrophilic) Contact Lenses in the toric design are indicated for the correction of ametropia (myopia orhyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from-20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
FDA Classification	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic)Contact Lens (21 CFR886.5925)		Multifocal:The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft(hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractiveametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic personswith non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to+4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less thatdoes not interfere with visual acuity.
Product Code(s)	MVN	LPL; MVN	LPL	MVN	LPL; MVN		The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft(hydrophilic) Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are notintended to be cleaned or disinfected and should be discarded after a single use. The VizionFocus Color(mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted toenhance or alter the apparent color of the eye.
FDA Group	FDA Group V	FDA Group V	FDA Group V	FDA Group II	FDA Group IV		Clariti 1 dayByCooperVisionInc.(K181920)
USAN name	mififilcon A	somofilcon A	lotrafilcon B	nelfilcon A	ocufilcon D
Water Content (%)	60±2%	56±2%	33±2%	69±2%	55±2%
OxygenPermeabilityx 10-11 (cm²/sec)(mlO2)/(ml xmmHg (@ 35°C))	80	60	110	26	19.6
Refractive Index(wet)	1.395	1.4003	1.42	1.38	1.410
UV Blocker	Yes - benzotriazole	Yes - benzophenone	None Reported	None Reported	Yes - benzotriazole	AIR OPTIXplusHydraGlydeBy Alcon	Lotrafilcon B spherical soft contact lenses are indicated for the optical correction of refractive ametropia(myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to approximately1.50 diopters of astigmatism that does not interfere with visual acuity.
Manufacturing	Cast-Molded	Cast-Molded	Cast-Molded	Cast-Molded	Cast-Molded	Laboratorios	Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia(myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D)or less of astigmatism.
Color	Rutile TiO2Iron OxidePhthalocyanine BlueCarbazole VioletPhthalocyanine GreenMica	None	Phthalocyanine Blue	None Reported	Rutile TiO2Iron Oxide(Pathalocyaninto(2-))CopperCarbazole VioletPhthalocyanine Green
Blister Packaging	Yes	Yes	Yes	Yes	Yes

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The following matrix compares the indications for use of the VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses with the predicate devices.

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Inc.(K160609)	Lotrafilcon B multifocal soft contact lenses are indicated for the optical correction of presbyopia with orwithout refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyeswho may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately1.50 diopters of astigmatism.
	Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractiveametropia (myopia and hyperopia) and presbyopia in phakic or aphakic persons with non-diseased eyesand up to 6.00 diopters (D) or less of refractive and/or corneal astigmatism.Eye care professionals may prescribe the lenses for daily disposable wear (lenses are discarded uponremoval from the eye) or daily wear with removal for cleaning and disinfection (chemical, not heat) priorto reinsertion and frequent replacement, as recommended by the eye care professional.
Dailies One-DayBy Ciba	DAILIES (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the opticalcorrection of refractive ametropia (myopia, hyperopia, and astigmatism) in non-aphakic persons withnon-diseased eyes.
VisionCorporation(K963487)	DAILIES (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use DailyDisposable Wear. DAILIES lenses are not intended to be cleaned or disinfected and should be discardedafter a single use.
ILICONByVizionfocus,Inc.(K182247)	The ILICON (ocufilcon D) SPHERICAL contact lenses for daily wear are indicated for the correction ofrefractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased thatmay exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is availableclear or tinted and may be used to enhance or alter the apparent color of the eye.The ILICON (ocufilcon D) TORIC Soft Contact Lenses for daily wear are indicated for the correction ofrefractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopiaand/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tintedand may be used to enhance or alter the apparent color of the eye.The ILICON (ocufilcon D) MULTIFOCAL Soft Contact Lenses for daily wear are indicated for thecorrection of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakicpersons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interferewith visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparentcolor of the eye.The ILICON (ocufilcon D) MULTIFOCAL TORIC Soft Contact Lenses for daily wear are indicated forthe correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakicpersons with non-diseased eyes that may exhibit astigmatism up to 5.0 diopters that does not interferewith visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparentcolor of the eye.Daily wear replacement schedules may vary from patient to patient and should be decided by eye carepractitioners in consultation with their patients.Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, withcleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacementwear, the lens may be disinfected using a chemical disinfecting system.Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. Whenprescribed for daily disposable wear the lens is to be discarded after each removal.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Performance Testing

A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses. The results support the claim that the VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are substantially equivalent to the currently marketed predicate devices. Refer below to a summary of the results from the non-clinical studies.

Toxicology:

All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.

· In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses and packaging solution are not cytotoxic.
· Systemic Toxicity: The finished lenses meet the requirements of the systemic injection test in accordance with ISO 10993-11 and do not produce acute systemic toxicity.
· Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23, and the packaging solution and extracts from finished lenses produced no ocular irritation.
· Skin Sensitization Study (Maximization Test): The skin sensitization study was conducted on the finished lenses in accordance with ISO 10993-10, and the contact lens extracts did not produce skin sensitization.
· 22-Day Ocular Irritation: The 22-day ocular irritation test was conducted in accordance with ISO 9394 on the finished lenses, and the contact lenses produced no ocular irritation.

The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses use identical packaging materials as the predicate device cleared under K182247. Cytotoxicity, systemic toxicity, and acute ocular irritation studies for the final packaging materials are referenced in K182247.

Shelf Life:

Testing was performed to evaluate the stability, sterility, and package integrity of the VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.

Performance Testing - Bench:

The following bench tests were completed: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and

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quantification of polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses and the predicate device.

Clinical Testing

A multi-center, single-masked (examiner), bilateral, randomized concurrent-control study with 91-day treatment follow-up was completed. One hundred twenty (120) subjects were enrolled in the study—of which 60 subjects wore the test lenses (VizionFocus Silicone Hydrogel Daily Disposable Contact Lens) and 60 subjects wore the control lenses (Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens). Of the 120 subjects enrolled, 117 subjects completed all scheduled visits (60 subjects in the test group and 57 subjects in the control group). There were 93 females and 26 males in the study (1:0.28 ratio female: male). The average age of the subjects was 26.35 years in the test group and 26.85 years in the control group). One (1) serious adverse event was reported in the control arm (presumed microbial keratitis), and no serious adverse events were reported in the test arm. The study results establish substantially equivalent clinical performance between the test (VizionFocus Silicone Hydrogel) and control (Clariti 1 day) lenses with respect to biomicroscopy findings, symptoms, adverse reactions and vision safety measures (i.e., keratometry changes, refractive changes, and best corrected visual acuity).

VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this Premarket Notification establishes that the VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.

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.