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.

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 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: approximately 96 %T
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

This submission (K153643) concerns a modification to Alcon's Focus® DAILIES® family of contact lenses. The modification specifically relates to an "Ink Shelf Life Change" and the use of the same print technology already established for these lenses. The FDA has determined that the modified device is substantially equivalent to the predicate device (K0833216).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that 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." However, the specific quantitative acceptance criteria for this process validation are not explicitly detailed in the provided text. The reported device performance is that the modified device meets these implicit acceptance criteria, demonstrating equivalence to the predicate.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly detailed in document)	Reported Device Performance
Material Equivalence	(Implicit: Demonstrates no adverse change in material properties with ink shelf life change)	Modified device uses same print technology, material (nelfilcon A), water content (69%), power range, visibility tint type (copper phthalocyanine), manufacturing method, sterilization, packaging, and package storage solution as predicate. Implies no change in fundamental material properties.
Process Validation	(Implicit: Demonstrates that the manufacturing process, with the ink shelf life change, consistently produces devices that meet specifications and are equivalent to the predicate.)	"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."
Safety & Effectiveness	(Implicit: No adverse effect on safety and effectiveness due to the modification.)	The modification "did not require clinical testing to establish safety and effectiveness of the modified device." The device remains "substantially equivalent" and any differences "do not adversely affect the safety and effectiveness."

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

The document explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device." This indicates that no new clinical test set with human subjects was used for this specific modification. The validation was primarily based on non-clinical testing (process validation) and comparison to the predicate device's established safety and effectiveness.

Sample Size (Test Set): Not applicable for human-in-the-loop or standalone clinical testing. For process validation, the sample size would be determined by the validation protocol, but this detail is not provided.
Data Provenance: Not applicable for a clinical test set in this specific submission. The data provenance would be related to the prior predicate device's studies and in-house process validation data, which are not described in detail here.

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

Not applicable, as no new clinical testing was performed on a test set to establish ground truth in the context of device performance in patients.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical testing was performed involving adjudication of patient outcomes or assessments.

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 device is a contact lens, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

Not applicable. This device is a physical contact lens, not a software algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this submission relies on the established safety and effectiveness of the predicate device (K083216) and the successful process validation of the modified manufacturing process. The "ground truth" here is that the modified device, due to the ink shelf life change, maintains the same physical and chemical properties and performs equivalently to the previously cleared predicate, thus not adversely altering its safety or effectiveness. This is affirmed by successful process validation and material equivalence.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/machine learning device, there is no "training set" in the conventional sense.

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

Not applicable, for the same reasons as above.

Summary

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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

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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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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® 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Ink Shelf Life Change

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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 FriesePrincipal Regulatory Specialist
Telephone:	+49 6022 240 514
Fax:	+49 6022 240 512
Email:	andreas.friese@alcon.com
Back up Contact Person:	Sherri LakotaHead 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:	Focus® DAILIES®, Focus® DAILIES® Toric,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:

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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:	approximately 96 %T
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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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(nelfilcon A) One-Day SoftContact Lens	Focus DAILIES® Family(nelfilcon A) One-Day SoftContact Lens
510(k)number:	TBD	K083216
Intended Use:	Daily Wear,Daily Disposable	Daily Wear,Daily Disposable
MaterialClassification:	FDA Group 2(>50% H2O, nonionic polymer)	FDA Group 2(>50% H2O, nonionic polymer)
LensMaterial:	nelfilcon A	nelfilcon A
WaterContent:	69%	69%
Power Range:	+20.00 to -20.00 D	+20.00 to -20.00 D
Visibility Tint:	With or without copperphthalocyanine	With or without copperphthalocyanine
Manufacturing Method:	Lightstream® Technology:Full mold cast, integrated printstep	Lightstream® Technology:Full mold cast, integrated printstep
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 buffered salinewith up to 0.5% Poloxamer 108.	Phosphate-acetate buffered salinewith up to 0.5% Poloxamer 108.

Table 1: Substantial Equivalence Comparison

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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.

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.