Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The 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.

DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day 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.

FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.

The 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.

DAILIES TOTAL (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism.

DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic 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 1.50 diopters of astigmatism .

The 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.

Device Description

Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable. The lens material of Focus DAILIES, DAILIES AquaComfort Plus, and FreshLook One-Day products is nelfilcon A. DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. The lenses are supplied sterile in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave.

AI/ML Overview

This document is a 510(k) premarket notification for several types of soft contact lenses manufactured by Alcon Laboratories, Inc. The purpose of this submission is to demonstrate that the modified devices are substantially equivalent to their legally marketed predicate devices.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

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

The document does not explicitly present a table of acceptance criteria for specific performance metrics in the way one might expect for a new device claiming improved performance. Instead, it focuses on demonstrating that the modified devices maintain the same performance specifications as their predicate devices. The acceptance criterion implicitly seems to be "no negative impact on safety, efficacy, and performance compared to predicate devices, and consistency with established standards."

The "Performance Data" section lists the types of testing conducted to support substantial equivalence, rather than specific numerical acceptance criteria.

Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility: Non-toxic and biocompatible	"Test results from a series of in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing, confirm that the minor device modification does not negatively impact the safety of the devices and that the modified devices are non-toxic and biocompatible." (All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.)
Stability: Support labeled expiration date	"Successful stability testing supports the labeled expiration date for the modified devices."
Clinical Performance: No negative impact on clinical outcomes (implicit)	"Based on the great similarity of the modified devices to the predicate devices and successful results from nonclinical testing, clinical testing was not required to establish substantial equivalence." (Therefore, no specific clinical performance metrics are reported for the modified devices beyond the established performance of the predicate lenses.)
Technological Characteristics: Maintain key specifications of predicate devices	The "Comparison of Technological Characteristics with the Predicate Device" (Table 1, pages 10-13) explicitly states "Same" for all listed technological characteristics including: Device ClassificationIntended UseLens Material (nelfilcon A, delefilcon A)Water Content (69%, 33%)Visibility TintManufacturing MethodLens Designs (Spherical, toric, multifocal)SterilizationPrimary Packaging SystemPrimary Packaging Blister ShellPackage Storage / Saline SolutionRefractive IndexLight TransmittanceOxygen Permeability (Dk)Elastic Modulus (MPa)Shelf-life

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

Biocompatibility Testing: The document states "Test results from a series of in vivo biocompatibility evaluations" but does not specify the sample size for these tests. It indicates the tests were "conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards." Provenance information (country, retrospective/prospective) is not provided.
Stability Testing: "Successful stability testing supports the labeled expiration date." No specific sample size, provenance, or detailed methodology is provided.
Clinical Testing: No clinical testing was performed for the modified devices to establish substantial equivalence. Therefore, there is no sample set, provenance, or type of study to report for clinical trials. The assumption is that the clinical performance of the predicate devices is maintained due to the minor nature of the modification.

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 as the document describes a 510(k) submission for contact lenses, which does not involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI/CAD device would. The "ground truth" for contact lenses is established through well-defined physical, chemical, and biological testing methods against established standards.

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

This information is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are used in studies where human experts are tasked with independently assessing cases, and discrepancies need to be resolved. The testing described here (biocompatibility, stability, material characteristics) does not involve such human-expert adjudication processes.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for AI/CAD systems that assist human readers in tasks like image interpretation, which is not relevant to soft contact lenses.

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

No, a standalone algorithm performance study was not done. The device in question is a physical medical device (contact lens), not an algorithm or AI system.

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

For the specific tests mentioned:

Biocompatibility: The "ground truth" is established by the results of standardized in vivo (e.g., animal models) and in vitro (e.g., cell cultures) tests based on ISO 10993 standards and measured against predefined toxicity and irritation thresholds.
Stability: The "ground truth" is established by direct measurement of physical and chemical properties of the lenses over time under various conditions to ensure they meet specifications throughout their shelf-life.
Technological Characteristics: The "ground truth" is established by direct measurement of physical properties (e.g., refractive index, water content, oxygen permeability, elastic modulus) using validated scientific methods, compared against the known values of the predicate devices and product specifications.

8. The sample size for the training set

This information is not applicable. The submission is for a physical medical device (contact lenses), not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for a contact lens product.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a caduceus, a symbol associated with medicine and healthcare. The FDA name is written in blue, with "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

April 10, 2018

Alcon Laboratories, Inc. Andreas Friese Regulatory Project Director, GRA Alcon Vision Care Alcon / CIBA Vision GmbH Industriering 1, Grosswallstadt, DE 63868 Bavaria

Re: K180398

Trade/Device Name: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 12, 2018 Received: February 13, 2018

Dear Andreas Friese:

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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours.

J Angelo Green -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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510(k) Number (if known) K180398

Device Name Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

Indications for Use (Describe)

The 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.

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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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K180398

Device Name

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

Indications for Use (Describe)

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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510(k) Number (if known) K180398

Device Name FreshLook One-Day

Indications for Use (Describe)

The 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.

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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510(k) Number (if known) K180398

Device Name DAILIES TOTAL1, DAILIES TOTAL1 Multifocal

Indications for Use (Describe)

The 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.

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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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K180398 510(k) SUMMARY

This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.

Submitter of 510(k) I.

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Primary Contact Person:	Dr. Andreas FrieseRegulatory Project Director, GRA Alcon Vision Care
Phone:	+49 6022-240-514
Fax:	+49 6022-240-512
Email:	andreas.friese@alcon.com
Back up Contact Person:	Sherri Lakota,Head, GRA Alcon Vision Care
Phone:	817-615-5472
Fax:	817-551-4630
Email:	sherri.lakota@alcon.com
Date Prepared:	February 12, 2018

II. Devices Subject to this 510(k)

Trade Names:	DAILIES AquaComfort Plus soft contact lenses:DAILIES AquaComfort Plus, DAILIES AquaComfort PlusToric, DAILIES AquaComfort Plus Multifocal
	Focus DAILIES soft contact lenses:Focus DAILIES, Focus DAILIES Toric, Focus DAILIESProgressives
	DAILIES Total1 soft contact lenses:DAILIES Total1, DAILIES Total1 Multifocal
	FreshLook One-Day soft contact lenses:FreshLook One-Day
Common Name:Classification Name:	Soft Contact LensesSoft (Hydrophilic) Contact Lens

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Device Classification:	Class II [21 CFR 886.5925]
Product Code:	LPL, MVN

III. Predicate Device

The 510(k) devices are modifications of the same predicate devices, i.e. the currently legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K172066 (DAILIES AquaComfort Plus products), K153643 (Focus DAILIES products), K050213 (FreshLook One-Day product) and K113168 (DAILIES Total1 products).

IV. Device Description

Spherical lenses: Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 Toric lenses: Focus DAILIES Toric and DAILIES AquaComfort Plus Toric Multifocal lenses: Focus DAILIES Progressives, DAILIES AquaComfort Plus Multifocal and DAILIES Total1 Multifocal

The lens material of Focus DAILIES, DAILIES AquaComfort Plus, and FreshLook One-Day products is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with Nformylmethyl acrylamide) and 69% water. For Focus DAILIES and DAILIES AquaComfort Plus products the lens material further contains non-functionalized PVA (high- and/or ultra-high molecular weight PVA) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint®) to make the lenses easier to see when handling. Additionally, lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue (CFR 74.3045) and phthalocyanine green (CFR 73.3124). FreshLook One-Day color contact lenses are printed with an intermittent coating containing the following pigments (either alone or in combination): iron oxides, titanium dioxide, Cu-phthalocyanine blue, chromium oxide and phthalocyanine green. All pigments are approved color additives for use in contact lenses.

DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. Delefilcon A soft contact lenses are surface coated with hydrophilic components. The lenses contain a color additive (copper phthalocyanine blue) to assist handling tint). In addition, lenses

{8}------------------------------------------------

contain 1,2-Dimyristoyl-sn-glycero-3-phosphocholine which is considered a 'comfort agent' to improve lens wearing comfort by physical mode of action (water binding and lens lubricating effect).

Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 products are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).

The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top. The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (for DAILIES AquaComfort Plus and DAILIES Total1) and/or approximately 0.85 ml (for Focus DAILIES and FreshLook One-Day) of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES AquaComfort Plus family lenses additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each (Focus DAILIES, DAILIES AquaComfort Plus, DAILIES Total1) and/or 10 lenses each (FreshLook One-Day), respectively.

V. Indications for Use

The 510(k) devices are a modification of the same predicate devices. The Indications for Use remain the same, as follows:

DAILIES AquaComfort Plus:

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

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Focus DAILIES:

Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The 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.

FreshLook One-Day:

The 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.

DAILIES Total1:

DAILIES TOTAL 1 (delefilcon A) 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 with up to approximately 1.50 diopters (D) of astigmatism.

DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and 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 1.50 diopters of astigmatism .

The 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.

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VI. Comparison of Technological Characteristics with the Predicate Device

The following matrix (Table 1) summarizes the characteristics of the modified devices as compared to the predicate devices:

Element ofComparison	Predicate Devices	Modified Devices
Administrative / Regulatory Information
510(k) Number	K172066 (DAILIESAquaComfort Plus)K153643 (Focus DAILIES)K050213 (FreshLook One-Day)K113168 (DAILIESTotal1)	To be assigned
Product Name	DAILIES AquaComfortPlus, DAILIESAquaComfort Plus Toric,DAILIES AquaComfortPlus MultifocalFocus DAILIES, FocusDAILIES Toric, FocusDAILIES ProgressivesFreshLook One-DayDAILIES Total1, DAILIESTotal1 Multifocal	Same
DeviceClassificationInformation	Class II, Daily Wear Soft(Hydrophilic) Contact Lenses,21 CFR 886.5925 (b) (1)	Same
Indications For Use Information
Intended Use	One-day contact lenses for theoptical correction of vision.Single use, daily disposablewear.	Same
Element ofComparison	Predicate Devices	Modified Devices
Technology Information
Lens Material	nelfilcon A (FocusDAILIES, DAILIESAquaComfort Plus andFreshLook One-Day)delefilcon A (DAILIESTotal1)	Same
Water Content	69% (Focus DAILIES,DAILIES AquaComfortPlus and FreshLook One-Day)33% (DAILIES Total1)	Same
Visibility Tint	Focus DAILIES, DAILIESAquaComfort Plus andDAILIES Total1: Lightblue (copper phthalo-cyanine blue)FreshLook One-Day: Notint	Same
ManufacturingMethod	Lightstream Technology: Fullmold cast	Same
Lens Designs	Spherical, toric, multifocal(Focus DAILIES andDAILIES AquaComfortPlus)Spherical (FreshLook One-Day)Spherical, multifocal(DAILIES Total1)	Same
Sterilization	Steam sterilization, validatedautoclave	Same
PrimaryPackagingSystem inGeneral	Foil blister pack containersystem: Polypropylene blistershell sealed with a polyestercoated aluminum foil lidding	Same

Table 1: Substantial Equivalence Comparison

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	Table 1: Substantial Equivalence Comparison

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Element ofComparison	Predicate Devices	Modified Devices
PrimaryPackagingBlister Shell	Injection-moldedpolypropylene blister shellmade from Flint HillsResources P4C5N-046polypropylene or Formosa4142T polypropylene	Same
PrimaryPackaging FoilLidding	Multi-layer laminatestructure polyester-coatedaluminum foil liddingsupplied by Constantia-Hueck FolienCurrent 2017 grade assupplied by Constantia-Hueck Folien	Multi-layer laminatestructure polyester-coatedaluminum foil liddingsupplied by Constantia-Hueck FolienModified 2018 grades assupplied by Constantia-Hueck Folien
Package Storage/ Saline Solution	Nelfilcon A products:Phosphate-acetate bufferedsaline with up to 0.05%Poloxamer 108.Additionally contains PEGand HPMC (for DAILIESAquaComfort Plus)Delefilcon A products:Phosphate buffered salinesolution withapproximately 0.3% ofpolymeric wetting agentsconsisting of copolymers ofpolyamidoamine and poly(acrylamide-acrylic acid)	Same

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Element ofComparison	Predicate Devices	Modified Devices
Performance Specifications including any Testing
RefractiveIndex	Nelfilcon A products: 1.38Delefilcon A products: 1.42	Same
LightTransmittance	Nelfilcon A products:92%T ( 88%T forFreshLook One-Day)Delefilcon A products:93%T	Same
OxygenPermeability(Dk)	Nelfilcon A products: 26Delefilcon A products: 140	Same
Elastic Modulus	Nelfilcon A products: 0.9MPaDelefilcon A products: 0.7MPa	Same
Biocompatibility	Biocompatible as confirmed byappropriate biocompatibilitytesting	Same
Shelf-life	Up to 60 months asconfirmed by shelf-lifestability testing (FocusDAILIES and DAILIESAquaComfort Plus)Up to 48 months asconfirmed by shelf-lifestability testing (FreshLookOne-Day, DAILIES Total1)	Same

Table 1: Substantial Equivalence Comparison

In accordance with the criteria for claims of substantial equivalence in the FDA guidance Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the information provided supports the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process.

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VII. Performance Data

Performance testing was conducted in consideration of the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and applicable ISO standards for contact lenses. The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility Testing

Test results from a series of in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing, confirm that the minor device modification does not negatively impact the safety of the devices and that the modified devices are non-toxic and biocompatible.

All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.

Stability Testing

Successful stability testing supports the labeled expiration date for the modified devices.

Clinical Testing

Based on the great similarity of the modified devices to the predicate devices and successful results from nonclinical testing, clinical testing was not required to establish substantial equivalence.

VIII. Conclusions

The cumulative results of all performance testing demonstrate the safety, efficacy and performance of the modified devices and, thus, substantial equivalence to the predicate devices.

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.

J Angelo Green -S

Indications for Use (Describe)

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Indications for Use (Describe)

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Indications for Use (Describe)

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Indications for Use (Describe)

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K180398 510(k) SUMMARY

Submitter of 510(k) I.

II. Devices Subject to this 510(k)

III. Predicate Device

IV. Device Description

V. Indications for Use

DAILIES AquaComfort Plus:

Focus DAILIES:

FreshLook One-Day:

DAILIES Total1:

VI. Comparison of Technological Characteristics with the Predicate Device

Table 1: Substantial Equivalence Comparison

VII. Performance Data

Biocompatibility Testing

Stability Testing

Clinical Testing

VIII. Conclusions

§ 886.5925 Soft (hydrophilic) contact lens.

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

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

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

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