Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

K153643 · Alcon Laboratories, Inc. · LPL · Jan 20, 2016 · Ophthalmic

Device Facts

• Record ID: K153643
• Device Name: Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
• Applicant: Alcon Laboratories, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jan 20, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

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 (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.

Device Story

Soft (hydrophilic) contact lenses made of nelfilcon A polymer; 69% water content. Designed for daily disposable wear; single use only. Manufactured via Lightstream® Technology (full mold cast with integrated print step). Available in spherical, toric, and multifocal designs. Used by patients for vision correction; prescribed by eye care professionals. Lenses supplied sterile in blister packs with buffered saline. Visibility tint (phthalocyanine blue) and print inks (phthalocyanine blue/green) added for handling. Device provides optical correction for refractive errors; improves visual acuity for patients with myopia, hyperopia, astigmatism, or presbyopia.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical process validation and comparison of physical/chemical properties to the predicate device.

Technological Characteristics

Material: 69% water, 31% nelfilcon A (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). FDA Group 2 (high water, nonionic). Refractive index 1.38. Oxygen permeability 26 barrer (Dk-Polarographic method). Sterilization: Steam (autoclave). Packaging: Blister pack with phosphate-acetate buffered saline and Poloxamer 108.

Indications for Use

Indicated for daily wear optical correction of refractive ametropia (myopia, hyperopia, astigmatism) in non-aphakic, non-diseased eyes. Progressives indicated for myopia/hyperopia and/or presbyopia with reading addition ≤ +3.00D and astigmatism ≤ 2.00D.

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

• Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives (nelfilcon A) contact lenses (K083216)

Reference Devices

• DAILIES® AquaComfort Plus® family of (nelfilcon A) soft contact lenses

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

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: K153643

> Trade/Device Name: Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives 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

{1}------------------------------------------------

(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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K153643

#### Device Name

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives

#### Indications for Use (Describe)

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 (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.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.*

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Ink Shelf Life Change

{3}------------------------------------------------

# 510(k) Summary

# 1. Submitter Information:

| Company: | Alcon Laboratories, Inc.<br>6201 South Freeway<br>Fort Worth, TX USA 76134-2099 |
|-------------------------|---------------------------------------------------------------------------------|
| Primary Contact Person: | Dr. Andreas Friese<br>Principal Regulatory Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Back up Contact Person: | Sherri Lakota<br>Head Global Regulatory Affairs, Vision Care |
| Telephone: | 817-615-5472 |
| Fax: | 817-551-4630 |
| Email: | [e-mail] |
| Date Prepared: | 12 October 2015 |

## 2. Device Name:

| Common Name: | Soft Contact Lens |
|-------------------------|-------------------------------------------------------------------------|
| Trade/Proprietary Name: | Focus® DAILIES®, Focus® DAILIES® Toric,<br>Focus® DAILIES® Progressives |
| Classification Name: | Daily Wear Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II [21 CFR 886.5925 (b) (1)] |

## 3. Predicate Device:

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives (nelfilcon A) contact lenses (cleared under K083216) have been identified as predicate device.

# 4. Description of Device:

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

{4}------------------------------------------------

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<br>(0.10 mm for -3.00 D spherical) |

Lenses have the following properties:

| Refractive index: | 1.38 |
|----------------------|----------------------------------------------------------------------|
| Light transmittance: | approximately 96 %T |
| Water content: | 69% by weight |
| Oxygen permeability | 26 barrer measured at 35°C<br>(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).

## 5. Indications for Use:

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 non-diseased 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.

{5}------------------------------------------------

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.

# 6. 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 |
|----------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|
| | Focus DAILIES® Family<br>(nelfilcon A) One-Day Soft<br>Contact Lens | Focus DAILIES® Family<br>(nelfilcon A) One-Day Soft<br>Contact Lens |
| 510(k)<br>number: | TBD | K083216 |
| Intended Use: | Daily Wear,<br>Daily Disposable | Daily Wear,<br>Daily Disposable |
| Material<br>Classification: | FDA Group 2<br>(>50% H2O, nonionic polymer) | FDA Group 2<br>(>50% H2O, nonionic polymer) |
| Lens<br>Material: | nelfilcon A | nelfilcon A |
| Water<br>Content: | 69% | 69% |
| Power Range: | +20.00 to -20.00 D | +20.00 to -20.00 D |
| Visibility Tint: | With or without copper<br>phthalocyanine | With or without copper<br>phthalocyanine |
| Manufacturin<br>g Method: | Lightstream® Technology:<br>Full mold cast, integrated print<br>step | Lightstream® Technology:<br>Full mold cast, integrated print<br>step |
| Lens Designs: | Spherical, toric, multifocal | Spherical, toric, multifocal |
| Sterilization: | Steam sterilization,<br>validated autoclave | Steam sterilization,<br>validated autoclave |
| Packaging: | Blister pack | Blister pack |
| Package<br>Storage Saline<br>Solution: | Phosphate-acetate buffered saline<br>with up to 0.5% Poloxamer 108. | Phosphate-acetate buffered saline<br>with up to 0.5% Poloxamer 108. |

Table 1: Substantial Equivalence Comparison

{6}------------------------------------------------

# 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:

Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (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 Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (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.