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 (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.

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.

All 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 a single use.

Device Description

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

The DAILIES® 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 contact lens material per 1994 FDA 510(k) guidance document for daily wear contact lenses. 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.

DAILIES® 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 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 package 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.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Predicate Devices)	Reported Device Performance (Modified Devices)
Technology Information
Lens Material: nelfilcon A	Same
Material Classification: FDA Group 2 (>50% H2O, nonionic)	Same
Water Content: 69%	Same
Visibility Tint: Light blue	Same
Manufacturing Method: Lightstream Technology: Full mold cast	Same
Lens Designs: Spherical, toric, multifocal	Same
Sterilization: Steam sterilization, validated autoclave	Same
Primary Packaging System: Foil blister pack	Same
Primary Packaging Blister Shell: Injection-molded polypropylene from Flint Hills Resources P4C5N-046	Injection-molded polypropylene from Flint Hills Resources P4C5N-046 or Formosa 4142T
Primary Packaging Foil Lidding: Multi-layer laminate structure polyester-coated aluminum foil lidding from Constantia-Hueck Folien or Huhtamaki	Multi-layer laminate structure polyester-coated aluminum foil lidding from Constantia-Hueck Folien or Huhtamaki
Package Storage / Saline Solution: Phosphate-acetate buffered saline with up to 0.05% Poloxamer 108. Additionally contains PEG and HPMC (for DAILIES AquaComfort Plus family)	Same
Performance Specifications
Refractive Index: 1.38	Same
Light Transmittance: ≥ 92%T	Same
Oxygen Permeability (Dk): 26	Same
Elastic Modulus: 0.9 MPa	Same
Biocompatibility: Biocompatible	Biocompatible (confirmed by testing)
Shelf-life: 60 months	60 months (confirmed by stability testing)

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

The document does not explicitly state a specific "test set" sample size for the modified devices as part of a standalone study directly assessing their primary performance against acceptance criteria in a quantitative manner. Instead, the focus is on a comparison to predicate devices and confirmation of performance through various non-clinical tests.

Biocompatibility Testing: Conducted on a "series of in vivo biocompatibility evaluations." The specific number of samples or animals used is not detailed, but it was conducted in accordance with GLP regulation (21 CFR Part 58) and relevant ISO 10993 series standards. This implies a standard, but unspecified, number of samples for such tests.
Stability Testing: Conducted to support the labeled expiration date. The sample size is not specified.
Clinical Testing: Not required due to the "great similarity of the modified devices to the predicate devices and successful results from nonclinical testing." This means no human clinical test set was used for the modified devices to establish substantial equivalence directly, in terms of primary clinical performance.

Data Provenance: The document implies that the biocompatibility and stability testing data was generated by the manufacturer (Alcon Laboratories, Inc.). There is no mention of country of origin for the data or if it was retrospective or prospective, though in vivo studies are typically prospective.

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

Not applicable. No ground truth in the sense of expert consensus on image interpretation or diagnostic performance was established for a test set, as clinical testing was not deemed necessary for the modified devices. The "ground truth" for the non-clinical tests would be the established scientific and regulatory standards for biocompatibility and stability, as interpreted by the testing labs and regulatory agencies.

4. Adjudication Method:

Not applicable. No adjudication method was mentioned for a clinical test set, as clinical testing was not performed for the modified devices to establish substantial equivalence. For non-clinical tests, reconciliation of results would follow standard laboratory practices and regulatory guidelines, rather than an adjudication method among experts for a diagnostic outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. Clinical testing was explicitly stated as "not required" due to the similarity to predicate devices and successful non-clinical testing. Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component of this device.

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

Not applicable. This device is a contact lens, not a medical imaging or diagnostic algorithm. Thus, the concept of "standalone" algorithm performance without human-in-the-loop is not relevant. The device itself is the primary product, and "performance" refers to its physical and biological properties.

7. The Type of Ground Truth Used:

The "ground truth" for the assessment of this device is based on:

Established device specifications and performance characteristics of the predicate devices (e.g., refractive index, light transmittance, oxygen permeability, elastic modulus, water content). The modified devices were compared to these established values.
Biocompatibility standards: ISO 10993 series and GLP regulations. The "truth" is whether the materials and final product meet these safety standards (e.g., non-cytotoxic, non-irritating).
Stability standards: The ability to maintain specified performance characteristics over the labeled shelf-life.

This ground truth is primarily based on measured physical and chemical properties, and established regulatory safety standards, rather than expert consensus on a diagnostic outcome or pathology.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device (contact lens), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is established, and design parameters are derived from engineering and material science, not data-driven training.

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

Not applicable, as there is no "training set" for an AI/ML algorithm.

Summary

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

November 30, 2016

Alcon Laboratories, Inc. % Dr. Andreas Friese Principal Regulatory Specialist, GRA Alcon Vision Care Alcon / CIBA Vision GmbH INDUSTRIERING 1 Grosswallstadt, DE 63868 Bayern

Re: K161391

Trade/Device Name: Dailies® AquaComfort Plus® Dailies® AquaComfort Plus® Toric,
Focus Dailies® AquaComfort Plus® Multifocal, Focus Dailies®, Focus Dailies Toric, Focus Dailies Progressives Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: October 24, 2016 Received: October 27, 2016

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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161391

Device Name

DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal; Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives

Indications for Use (Describe)

indication one (Doombo) 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® Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with nondiseased 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.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia) 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.

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

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

I. Submitter of 510(k) K161391

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Primary Contact Person:	Dr. Andreas Friese,Principal Regulatory Specialist
Phone:	+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
Phone:	817-615-5472
Fax:	817-551-4630
Email:	sherri.lakota@alcon.com
Date Prepared:	May 12, 2016

II. Devices Subject to this 510(k)

Trade Names:	DAILIES® AquaComfort Plus® family soft contact lenses:DAILIES® AquaComfort Plus®, DAILIES® AquaComfortPlus® Toric, DAILIES® AquaComfort Plus® MultifocalFocus® DAILIES® family soft contact lenses:Focus® DAILIES®, Focus® DAILIES® Toric, Focus®DAILIES® Progressives
Common Name:	Soft Contact Lenses
Classification Name:	Soft (Hydrophilic) Contact Lenses
Device Classification:	Class II [21 CFR 886.5925]
Product Code:	LPL, MVN

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III. Predicate Device

The 510(k) devices are a modification of the same predicate devices, i.e. DAILIES® AquaComfort Plus® family (nelfilcon A) and Focus® DAILIES® family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K153642 and K153643, respectively, both cleared January 20, 2016.

Device Description IV.

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 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.

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V. Indications for Use

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

Element ofComparison	Predicate DevicesFocus DAILIES® family andDAILIES® AquaComfort Plus®family soft contact lenses	Modified DevicesFocus DAILIES® family andDAILIES® AquaComfort Plus®family soft contact lenses
Administrative / Regulatory Information
510(k) number	K153642 (DAILIES AquaComfortPlus family), K153643 (FocusDAILIES family)	K161391
Product name	DAILIES AquaComfort Plus,DAILIES AquaComfort Plus Toric,DAILIES AquaComfort PlusMultifocal, Focus DAILIES, FocusDAILIES Toric, Focus DAILIESProgressives	Same
Deviceclassificationinformation	Class II, Soft (Hydrophilic) ContactLenses, 21 CFR 886.5925)	Same
Indications For Use Information
Intended use	One-day contact lenses for the opticalcorrection of refractive error. Singleuse, daily disposable wear.	Same
Technology Information
Lens Material	nelfilcon A	Same
MaterialClassification	FDA Group 2 (>50% H2O, nonionic)	Same
Water Content	69%	Same
Visibility Tint	Light blue	Same
ManufacturingMethod	Lightstream Technology:Full mold cast	Same
Lens Designs	Spherical, toric, multifocal	Same
Sterilization	Steam sterilization, validatedautoclave	Same

Table 1: Substantial Equivalence Comparison

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	Predicate Devices	Modified Devices
Element ofComparison	Focus DAILIES® family andDAILIES® AquaComfort Plus®family soft contact lenses	Focus DAILIES® family andDAILIES® AquaComfort Plus®family soft contact lenses
PrimaryPackagingSystem	Foil blister pack (polypropyleneblister shell sealed with a polyestercoated aluminum foil lidding.)	Same
PrimaryPackagingBlister Shell	Injection-molded polypropyleneblister shell made from Flint HillsResources P4C5N-046 polypropylene	Injection-molded polypropyleneblister shell made from FlintHills Resources P4C5N-046 orFormosa 4142T polypropylene
PrimaryPackaging FoilLidding	Multi-layer laminate structurepolyester-coated aluminum foillidding supplied by:• Constantia-Hueck Folien or• Huhtamaki (for Focus DAILIESfamily)• Constantia-Hueck Folien (forDAILIES AquaComfort Plusfamily)	Multi-layer laminate structurepolyester-coated aluminum foillidding supplied by:• Constantia-Hueck Folien or• Huhtamaki (for FocusDAILIES family and forDAILIES AquaComfort Plusfamily)
Package Storage/ Saline Solution	Phosphate-acetate buffered salinewith up to 0.05% Poloxamer 108.Additionally contains PEG andHPMC (for DAILIES AquaComfortPlus family)	Same
	Performance Specifications including any Testing
RefractiveIndex	1.38	Same
LightTransmittance	≥ 92%T	Same
Oxygen Per-meability (Dk)	26	Same
Elastic Modulus	0.9 MPa	Same
Biocompatibility	Biocompatible as confirmed byappropriate biocompatibility testing	Same
Shelf-life	60 months as confirmed by shelf-lifestability testing	Same

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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 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 modifications do 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.