DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (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 (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.

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.

Device Description

DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.

The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high and 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.

DAILIES AquaComfort Plus soft contact lenses 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 foil-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 phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline 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.

AI/ML Overview

This document describes the 510(k) submission for Alcon Laboratories, Inc.'s DAILIES AquaComfort Plus contact lenses, focusing on an extension of their expiration dating. As such, the study described is primarily related to shelf-life stability and not clinical performance or artificial intelligence (AI) device performance. Therefore, many of the requested categories are not applicable (N/A) or cannot be extracted from this document, as it does not describe a clinical performance study with human readers or an AI algorithm.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Predicate Device)	Reported Device Performance (Modified Device)
Shelf-life	60 months	84 months (confirmed by shelf-life stability testing)
Biocompatibility	Biocompatible (as confirmed by biocompatibility testing)	Biocompatible (cytotoxicity testing by Cell Growth Inhibition (CGI) and Modified ISO/USP Elution (MEL) methods completed, all acceptance criteria met to verify equivalence to predicate device)
Refractive Index	1.38	Same
Light Transmittance	$\ge$ 92%T	Same
Oxygen Permeability (Dk)	26	Same
Elastic Modulus	0.9 MPa	Same
(Other material properties, manufacturing method, packaging, etc.)	Same as predicate	Same

2. Sample Size Used for the Test Set and the Data Provenance

This document does not specify a distinct "test set" in the context of an AI algorithm or traditional clinical trial. The testing performed was primarily non-clinical stability testing.

Sample Size: Not explicitly stated for stability testing within this document. Stability studies involve testing multiple samples over time.
Data Provenance: The document implies in-house testing by Alcon Laboratories, Inc., as part of the manufacturing and regulatory compliance process. The country of origin of the data is not specified beyond Alcon's location (Fort Worth, TX for the company, and the contact person in Germany). The data is retrospective in the sense that it's gathered over time as part of a stability study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

N/A. This submission focuses on shelf-life and biocompatibility, not clinical expert-based ground truth for device performance in diagnosis or image interpretation.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically employed in clinical studies or for ground truth establishment for AI where multiple experts might disagree. This is not relevant to the non-clinical stability testing described.

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

N/A. This device is a contact lens, and the submission is for an extended shelf-life. There is no AI component or human reader comparative effectiveness study involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This is not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

Shelf-life: The "ground truth" is derived from established laboratory testing protocols and standards for contact lens stability (e.g., measuring physical and chemical properties over time).
Biocompatibility: The "ground truth" is based on recognized in vitro cytotoxicity testing methods (Cell Growth Inhibition and Modified ISO/USP Elution methods) and their pre-defined acceptance criteria for biocompatibility, often benchmarked against predicate devices or regulatory standards.

8. The Sample Size for the Training Set

N/A. There is no AI model or training set described.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable as there is no AI model or training set.

Summary

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September 22, 2020

Alcon Laboratories, Inc. Dr. Andreas Friese Regulatory Project Director Industriering 1 Grosswallstadt, Bavaria 63868 Germany

Re: K202448

Trade/Device Name: DAILIES AquaComfort Plus / DAILIES AquaComfort Plus FreshTech / DAILIES AquaComfort Plus Toric / DAILIES AquaComfort Plus Multifocal Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 24, 2020 Received: August 26, 2020

Dear Dr. 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. 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 located 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.

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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

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/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, 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202448

Device Name

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

Indications for Use (Describe)

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia) and/or presbyopia in not-aphakic persons with non-diseased eves 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.

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

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K202448

510(k) Summary 8

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

I. Submitter Information

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Contact Person:	Dr. Andreas Friese, Regulatory Project Director
Phone:	+49 6022-240-514
Fax:	+49 6022-240-512
Email:	andreas.friese@alcon.com
Date Prepared:	August 20, 2020

Devices Subject to this 510(k) II.

Trade Names:	DAILIES AquaComfort Plus,DAILIES AquaComfort Plus FreshTech,DAILIES AquaComfort Plus Toric,DAILIES AquaComfort Plus Multifocal
Common Name:	Soft Contact Lenses
Classification Name:	Soft (Hydrophilic) Contact Lenses
Device Classification:	Class II [21 CFR 886.5925]
Product Code:	LPL, MVN

III. Predicate Device

The 510(k) devices are a modification of the same predicate devices, i.e. DAILIES AquaComfort Plus family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearance: K181454.

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IV. Device Description

DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.

Indications for Use V.

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

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VI. Comparison of Technological Characteristics with the Predicate Device

The proposed device modification involves a labeling change in terms of an extension of the expiration dating for DAILIES AquaComfort Plus soft contact lenses.

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

Element ofComparison	Predicate Device(s)	Modified Device(s)
Administrative / Regulatory Information
510(k) Number	K181454	To be assigned
Product Name(s)	DAILIES AquaComfort Plus,DAILIES AquaComfort Plus FreshTech, DAILIESAquaComfort Plus Toric, DAILIES AquaComfort PlusMultifocal	Same
DeviceClassificationInformation	Class II, Soft (Hydrophilic)Contact Lenses, 21 CFR886.5925	Same
Indications For Use Information
Intended Use	One-day contact lenses for theoptical correction of refractiveerror. Single use, dailydisposable wear.	Same
Technology Information
Lens Material	nelfilcon A	Same
MaterialClassification	FDA Group II (>50% H2O,nonionic)	Same
Element ofComparison	Predicate Device(s)	Modified Device(s)
Water Content	69%	Same
Visibility Tint	Light blue	Same
ManufacturingMethod	Lightstream Technology:Full mold cast	Same
Lens Designs	Spherical, aspherical, toric,multifocal	Same
Sterilization	Steam sterilization, validatedautoclave	Same
PrimaryPackaging System	Foil blister pack:polypropylene blister shellsealed with a polyester coatedaluminum foil lidding	Same
PrimaryPackaging BlisterShell	Injection-molded poly-propylene (PP) blister shell	Same
PrimaryPackaging FoilLidding	Multi-layer laminate structurepolyester-coated aluminumfoil lidding supplied by:Constantia-Pirk Folien Huhtamaki	Same
Package Storage /Saline Solution	Phosphate-acetate bufferedsaline (with PEG and HPMCadditives for DAILIES Aqua-Comfort Plus products) and upto 0.05% Poloxamer 108	Same
Performance Specifications including any Testing
Refractive Index	1.38	Same
LightTransmittance	$\ge$ 92%T	Same
OxygenPermeability (Dk)	26	Same
Elastic Modulus	0.9 MPa	Same
Biocompatibility	Biocompatible as confirmedby biocompatibility testing	Same
Shelf-life	60 months as confirmed byshelf-life stability testing	84 months as confirmed byshelf-life stability testing

Table 1: Substantial Equivalence Comparison

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Table 1: Substantial Equivalence Comparison

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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.

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

Non-clinical Testing

Successful stability testing including biocompatibility testing, i.e. cytotoxicity testing by Cell Growth Inhibition (CGI) and Modified ISO/USP Elution (MEL) methods, was completed for the modified device to verify equivalence to the predicate device. This resulted in all acceptance criteria being met.

Clinical Testing

The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.

VIII. Conclusions

The cumulative results of performance testing demonstrate the safety, efficacy and performance of the modified device(s) and, thus, substantial equivalence to the predicate device(s).

DAILIES AquaComfort Plus (nelfilcon A) soft contact lenses with extended shelf-life are substantially equivalent to the predicate lenses of material properties, biocompatibility, clinical performance, and indications for use.

Any differences which may exist between the modified and the predicate device do not adversely affect the established performance characteristics and safety and effectiveness profile.

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.