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 (nelfileon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and asigmatism) in not-aphakic persons with non-diseased eyes with 6.0 diopters (D) or less of astigmatism.

DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) Ore-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 nondiseased 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.

DAILIES® (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 single use.

Device Description

The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.

Nelfilcon A lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
Power Range: -20.00 D to +20.00 D
Center Thickness varies with design and power (0.10 mm for -3.00 D spherical)

Lenses have the following properties:
Refractive index: 1.38
Light transmittance: 92% (@ 610 nm)
Water content: 69% by weight
Oxygen permeability 26 barrer measured at 35°C (single point Dk-Polarographic method)

Lenses are supplied sterile in sealed blister packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other Alcon marketed lens products and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).

AI/ML Overview

The provided text is a 510(k) premarket notification for Alcon's DAILIES® AquaComfort Plus® contact lenses. It addresses the substantial equivalence of a modified device to a previously cleared predicate device.

Crucially, this document is for a medical device (contact lenses) and not an AI/ML powered medical device. Therefore, the standard questions regarding AI/ML device performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, do not apply and are not addressed in this document.

The primary focus of this 510(k) is to demonstrate that a manufacturing modification (specifically, using a new print technology for the lenses) does not adversely affect the safety and effectiveness of the device, making it substantially equivalent to the predicate device.

Here's an analysis based on the information provided, explaining why certain requested points are not applicable:

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

Acceptance Criteria: For this device modification, the core acceptance criterion was demonstrating that the manufacturing process change (new print technology) did not alter the fundamental characteristics or safety/effectiveness of the contact lens. The document states: "A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met."
Reported Device Performance: The "performance" here refers to maintaining the inherent properties and safety profile of the contact lenses. The comparison table (Table 1: Substantial Equivalence Comparison) on pages 5-6 effectively serves as the "reported device performance" against the predicate. It shows that key attributes like intended use, material, water content, power range, visibility tint, manufacturing method, sterilization, packaging, and storage saline solution are either identical or considered equivalent after the modification.
- Modified Device: DAILIES® AquaComfort Plus® Family (nelfilcon A)
- Predicate Device: DAILIES® AquaComfort Plus® Family (nelfilcon A) (K123994)

Characteristic	Modified Device	Predicate Device	Outcome / Meeting Criteria
510(k) number:	TBD	K123994	(For the new submission)
Intended Use:	Daily Wear, Daily Disposable	Daily Wear, Daily Disposable	Meets (Identical)
Material Classification:	FDA Group 2 (>50% H2O, nonionic polymer)	FDA Group 2 (>50% H2O, nonionic polymer)	Meets (Identical)
Lens Material:	nelfilcon A	nelfilcon A	Meets (Identical)
Water Content:	69%	69%	Meets (Identical)
Power Range:	+20.00 to -20.00 D	+20.00 to -20.00 D	Meets (Identical)
Visibility Tint:	With or without copper phthalocyanine	With or without copper phthalocyanine	Meets (Identical)
Manufacturing Method:	Lightstream® Technology: Full mold cast, integrated print step	Lightstream® Technology: Full mold cast, integrated print step	Meets (Identical in general "Lightstream® Technology: Full mold cast, integrated print step" description, with explicit statement regarding the specific print technology being part of this established process for predicate and other Alcon lenses.)
Lens Designs:	Spherical, toric, multifocal	Spherical, toric, multifocal	Meets (Identical)
Sterilization:	Steam sterilization, validated autoclave	Steam sterilization, validated autoclave	Meets (Identical)
Packaging:	Blister pack	Blister pack	Meets (Identical)
Package Storage Saline Solution:	Phosphate-acetate buffered saline with up to 0.5% Poloxamer 108. Contains PEG and HPMC.	Phosphate-acetate buffered saline with up to 0.5% Poloxamer 108. Contains PEG and HPMC.	Meets (Identical)

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

This document refers to "process validation" and "non-clinical testing" rather than clinical test sets in the context of an AI/ML device. The "test set" here would refer to the samples used in the non-clinical process validation, which are not specified in terms of number or provenance. There are no descriptions of patient data, as this is a physical medical device.

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):

Not applicable. There is no "ground truth" to establish in the context of an AI/ML output. Performance is demonstrated through manufacturing controls and the comparison to the existing predicate.

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

Not applicable. There is no human interpretation or adjudication of AI output.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's characteristics are compared through non-clinical validation.

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-clinical Testing: A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met."

This indicates that the manufacturer conducted internal testing and validation of their manufacturing process for the modified contact lenses. The acceptance criteria were met because these non-clinical tests confirmed that the modified lenses, despite the change in print technology, maintained all the critical physical and chemical properties as well as safety aspects of the predicate device. The detailed comparison table serves as the evidence for this equivalence. The FDA letter confirms that "FDA's issuance of a substantial equivalence determination" means they have reviewed the submission and find the device substantially equivalent based on the provided information, thus accepting the manufacturer's evidence.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.

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

January 20, 2016

Alcon Laboratories, Inc. Dr. Andreas Friese Principal Regulatory Specialist 6201 South Freeway Fort Worth, TX 76134-2099

Re: K153642

Trade/Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal Soft (hydrophilic) Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens. Regulatory Class: Class II Product Code: LPL/MVN Dated: December 18, 2015 Received: December 21, 2015

Dear Dr. 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Kesia Y. Alexander -A

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153642

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) Summary

1. Submitter Information:

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX USA 76134-2099
Primary Contact Person:	Dr. Andreas Friese	Principal Regulatory Specialist
Telephone:	+49 6022 240 514
Fax:	+49 6022 240 512
Email:	andreas.friese@alcon.com
Back up Contact Person:	Sherri Lakota	Head Global Regulatory Affairs, Vision Care
Telephone:	817-615-5472
Fax:	817-551-4630
Email:	sherri.lakota@alcon.com
Date Prepared:	12 October 2015

2. Device Name

Common Name:	Soft Contact Lens
Trade/Proprietary Name:	DAILIES® AquaComfort Plus®DAILIES® AquaComfort Plus® ToricDAILIES® AquaComfort Plus® Multifocal
Classification Name:	Daily Wear Soft (Hydrophilic) Contact Lens
Device Classification:	Class II [21 CFR 886.5925 (b) (1)]

3. Predicate Device:

DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) contact lenses (cleared under K123994) have been identified as predicate device.

4. Description of Device:

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the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.

Nelfilcon A lens designs include spherical, toric and multifocal lenses in the following parameter ranges:

Power Range:	-20.00 D to +20.00 D
Center Thickness	varies with design and power(0.10 mm for -3.00 D spherical)

Lenses have the following properties:

Refractive index:	1.38
Light transmittance:	92% (@ 610 nm)
Water content:	69% by weight
Oxygen permeability	26 barrer measured at 35°C(single point Dk-Polarographic method)

5. Indications for Use:

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DAILIES® AquaComfort Plus® Toric (nelfilcon A) One-Day 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 with 6.0 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 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.

6. Description of Safety and Substantial Equivalence:

The modification involves using the same print technology already established for the Focus® DAILIES® family of (nelfilcon A) soft contact lenses as well as for the DAILIES® AquaComfort Plus® family of (nelfilcon A) soft contact lenses. The following matrix summarizes the characteristics of the modified device as compared to the predicate device.

	Modified Device	Predicate Device
	DAILIES® AquaComfortPlus® Family (nelfilcon A)	DAILIES® AquaComfort Plus®Family (nelfilcon A)
510(k) number:	TBD	K123994
Intended Use:	Daily Wear,Daily Disposable	Daily Wear,Daily Disposable
Material	FDA Group 2	FDA Group 2
Classification:	(>50% H2O, nonionic polymer)	(>50% H2O, nonionic polymer)
Lens Material:	nelfilcon A	nelfilcon A
Water Content:	69%	69%
Power Range:	+20.00 to -20.00 D	+20.00 to -20.00 D

Table 1: Substantial Equivalence Comparison

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Visibility Tint:	With or without copperphthalocyanine	With or without copperphthalocyanine
ManufacturingMethod:	Lightstream® Technology:Full mold cast,integrated print step	Lightstream® Technology:Full mold cast,integrated print step
Lens Designs:	Spherical, toric, multifocal	Spherical, toric, multifocal
Sterilization:	Steam sterilization,validated autoclave	Steam sterilization,validated autoclave
Packaging:	Blister pack	Blister pack
PackageStorage SalineSolution:	Phosphate-acetate bufferedsaline with up to 0.5%Poloxamer 108. Contains PEGand HPMC.	Phosphate-acetate buffered salinewith up to 0.5% Poloxamer 108.Contains PEG and HPMC.

Non-clinical Testing:

A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the 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.

Substantial Equivalence:

DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, and DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses are substantially equivalent to the predicate lenses and similar to other daily wear soft contact lenses in terms of water content (69% water) and ionic characteristics (FDA Group II: high water, nonionic), and indications for use.

Any differences which may exist between the DAILIES® AquaComfort Plus , DAILIES® AquaComfort Plus® Toric, and DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses and other Group II soft hydrophilic contact lenses do not adversely affect the safety and effectiveness of the device.

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.