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

K181454 · Alcon Laboratories, Inc. · LPL · Nov 21, 2018 · Ophthalmic

Device Facts

• Record ID: K181454
• Device Name: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
• Applicant: Alcon Laboratories, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended 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 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 up to approximately 6.00 diopters (D) of astigmatism. Dailies AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or 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. 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 Story

Soft contact lenses (nelfilcon A) for daily disposable wear; optical correction of refractive errors (myopia, hyperopia, presbyopia, astigmatism). Lenses manufactured via Lightstream Technology (full mold cast); supplied sterile in buffered saline with comfort additives (HMPC, PEG 400). Prescribed by eye care professionals; patient self-use for daily wear; discarded after single use. No cleaning/disinfection required. Output is visual correction for patient.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical performance testing, including physico-chemical evaluation, biocompatibility (cytotoxicity, ocular irritation, systemic toxicity per ISO 10993), sterilization validation (ISO 17665-1), and stability testing.

Technological Characteristics

Material: nelfilcon A (31% PVA, 69% water). Manufacturing: Lightstream Technology (full mold cast). Design: Spherical, Toric, Multifocal, Aspheric. Oxygen Permeability (Dk): 26 x 10^-11. Elastic Modulus: 0.9 MPa. Refractive Index: 1.38. Sterilization: Steam/autoclave. Packaging: Polypropylene blister, polyester-coated aluminum foil. Additives: HMPC, PEG 400, Poloxamer 108.

Indications for Use

Indicated for daily wear optical correction of refractive ametropia (myopia/hyperopia) in non-aphakic persons with non-diseased eyes (up to 1.50D astigmatism for standard/FreshTech; up to 6.00D for Toric). Multifocal indicated for presbyopia (with/without refractive ametropia) in phakic/aphakic persons with non-diseased eyes (up to 3.00D reading addition; up to 2.00D astigmatism).

Regulatory Classification

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.

Predicate Devices

• DAILIES AquaComfort Plus (K963487)
• DAILIES AquaComfort Plus Toric (K072777)
• DAILIES AquaComfort Plus Multifocal (K172066)
• DAILIES AquaComfort Plus (K180398)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alcon Laboratories, Inc. Katryna Warren Global Project Regulatory Director, Vision Care 6201 South Freeway Fort Worth, TX 76134-2099

Re: K181454

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: October 22, 2018 Received: October 23, 2018

Dear Katryna Warren:

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 of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely yours,

# J. Angelo Green

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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#### Alcon Response to KDA Deireiency Letter DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181454

#### Device Name

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

#### Indications for Use (Describe)

DAILIES AquaComfort Plus (nelficion 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 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 up to approximately 6.00 diopters (D) of astigmatism.

Dailies AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or 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.

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.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 the 510(k)

| Company: | Alcon Laboratories, Inc.<br>6201 South Freeway<br>Fort Worth, TX 76134-2099, USA |
|-------------------------|----------------------------------------------------------------------------------|
| Primary Contact Person: | Katryna Warren<br>Global Project Regulatory Director, Vision Care |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Back up Contact Person: | Sherri Lakota<br>Head, GRA Alcon Vision Care |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | May 30, 2018 |

# II. Devices Subject to this 510(k)

| Trade Names: | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus<br>FreshTech, DAILIES AquaComfort Plus Toric and DAILIES<br>AquaComfort Plus Multifocal |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lenses |
| Classification Name: | Soft (hydrophilic) Contact Lens |
| Device Classification: | Class II [21 CFR 886.5925] |
| Product Code: | MVN, LPL |

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# III. Predicate Device

The 510(k) devices are modifications of the same predicate devices currently legally commercialized devices cleared in the US under these 510(k) clearances: K963487, K072777, K172066, and K180398.

# IV. Device Description

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal are soft contact lenses intended for the optical correction of refractive error.

They are available in spherical, toric and multifocal designs as applicable:

- Spherical lenses: DAILIES AquaComfort Plus ●
- Aspherical lenses: DAILIES AquaComfort Plus FreshTech ●
- o Toric lenses: DAILIES AquaComfort Plus Toric
- Multifocal lenses: DAILIES AquaComfort Plus Multifocal 0

The lens material is nelfilcon A, a high water non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water. The material further contains non-functionalized PVA (high- and or Ultra molecular weight PVA) and the color additive phthalocyanine green (CFR 73.3124).

DAILIES AquaComfort Plus products are supplied sterile. The lenses are immersed in buffered saline solution and are packaged in individual foil-blister packs as primary packaging and 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. The lenses are supplied in strips of five foiled sealed blister packs each containing approximately 0.65 ml of 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 (HMPC) and polyethyleneglycol 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

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 FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in notaphakic 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 up to approximately 6.00 diopters (D) of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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 2.00 diopters (D) of astigmatism that does not interfere with visual acuity.

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.

VI. Comparison to Technological Characteristics with the Predicate Device Table 1 summarizes the characteristics of the modified device compared to the predict devices:

| Element of Comparison | Predicates Devices | Modified Device |
|----------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------|
| Administrative/ Regulatory Information | | |
| 510(k) Number | K963487, K072777, K172066,<br>K180398 | To be assigned |
| Product Name | DAILIES AquaComfort Plus,<br>DAILIES AquaComfort Plus<br>Toric, DAILIES AquaComfort<br>Plus Multifocal | DAILIES AquaComfort Plus<br>FreshTech |

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| Device Classification<br>Information | Class II, Daily Wear Soft<br>(Hydrophilic) Contact Lenses | Same |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indications for Use Information | | |
| Intended Use | One-Day contact lenses for the<br>optical correction of vision.<br>Single use, daily disposable<br>wear | Same |
| Technology Information | | |
| Lens Material | nelfilcon A | Same |
| Water Content | 69% | Same |
| Visibility Tint | Light blue (copper<br>phthalocyanine blue | Same |
| Manufacturing Method | Lightstream Technology: Full<br>mold cast | Same |
| Lens Design | Spherical, Toric, Multifocal | Aspheric |
| Sterilization | Steam sterilization, validated<br>autoclave | Same |
| Primary Packaging System in<br>General | Foil blister pack container<br>system; Polypropylene blister<br>shell sealed with a polyester<br>coated aluminum foil lidding | Same |
| Primary Packaging Blister<br>Shell | Injection-molded polypropylene<br>blister shell made from Flint<br>Hills Resources P4C5N-046<br>Polypropylene or Formosa<br>4142T polypropylene | Same |
| Primary Packaging Foil<br>Lidding | Multilayer laminate structure<br>polyester coated aluminum foil<br>lidding supplied by Constantia-<br>Hueck Folien<br>and/or Huhtamaki foil | Same |
| Package Storage/Saline<br>Solution | Phosphate-acetate buffered<br>saline with up to 0.05%<br>Poloxamer 108. Additionally<br>contains PEG and HPMC | Same |
| Performance Specifications<br>Including any Testing | | |
| Refractive Index | 1.38 (hydrated) | Same |
| Light Transmittance | ≥ 92%T @ 610 nm | Same |
| Oxygen Permeability (Dk) | $26 x 10^{-11} (cm^2/s) ml O_2/ml x mmHg)$ measured at 35°C (Fatt,<br>edge effect corrected) | Same |
| Elastic Modulus | 0.9 MPa | Same |
| Biocompatibility | Biocompatible as confirmed by<br>appropriate biocompatibility<br>testing | Same |
| Shelf-life | Up to 60 months as confirmed<br>by shelf-life stability testing | Same |

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,

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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 performed in accordance with the May 1994 FDA guideline, Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and applicable ISO standards for contact lenses. Performance data are provided in support of the substantial equivalence determination.

### Biocompatibility Testing

Test results from a series of in vitro and 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. The modified device is 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.

### Sterilization

Based on the similarity of the packaging materials and the successful completion of sterilization testing in accordance with FDA guidance and the applicable requirements of ISO 17665-1:2006

## Stability Testing

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

## Clinical Testing

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

## VIII. Conclusions

The results of device performance testing evaluation including physico-chemical, biocompatibility, sterilization and stability and the qualification of the dimensional and optical properties demonstrate that the aspheric lens design meets specifications. The results supports the substantial equivalence of the device to the predicate device.