Focus® DAILIES® and Focus® DAILIES® Toric (neifilcon 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.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of 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. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A) ONE-DAY CONTACT LENS are daily wear soft contact lenses intended for single use daily disposable wear. The Dailies lens is a spherical soft contact, Dailies toric lenses have a double thin zone design, and the Dailies Progressives iens is a progressive aspheric simultaneous vision soft contact lens. A constant near power profile is incorporated into each Progressive lens across the full range of distance powers. The near and intermediate powers are concentrated primarily in the central portion of the optical zone while the surrounding portion is weighted toward distance. The continuous changes in power across the surface of the lens allow patients requiring a reading addition of up to +3.00 diopters to see clearly at far, intermediate and near distances.

The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are clear or tinted from edge to edge for visibility purposes with the color additive copper phthalocyanine (CuP).

Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphateacetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the Focus® DAILIES® family of contact lenses (nelfilcon A) to demonstrate substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Focus® DAILIES® lenses were based on demonstrating equivalence to the predicate device (Focus® DAILIES® (nelfilcon A) made without an additive) across key physical/chemical properties and clinical performance. The study aimed to show that lenses made with a manufacturing additive were within established specifications and maintained comparable performance.

Acceptance Criteria Category	Specific Metric	Predicate Device Performance / Acceptance Limit (if explicitly stated)	Reported Device Performance (with additive)	Outcome
Material Properties	FDA Material Classification	FDA Group 2 (> 50% H2O, nonionic polymer)	FDA Group 2 (> 50% H2O, nonionic polymer)	Met
	Water Content	69.4%	68.4%	Met (within equivalent range)
	Light Transmittance (clear lenses)	100%	100%	Met
	Oxygen Permeability (Dk, Coulometric) [35° C, Fatt corrected]	~25 barrer	25.86 barrer	Met (within equivalent range)
Design Characteristics	Power Range	+20.00 to -20.00D	+20.00 to -20.00D	Met
	Visibility Tint	With or without Copper Phthalocyanine	With or without Copper Phthalocyanine	Met
	Manufacturing Method	Full Mold Cast, Lightstream Technology	Full Mold Cast, Lightstream Technology	Met
	Lens Design	Spherical and/or Multi-focal (No change to established designs)	Spherical and/or Multi-focal	Met
Packaging & Sterilization	Sterilization	Steam sterilization, Validated autoclave	Steam sterilization, Validated autoclave	Met
	Packaging	Blister Pack	Blister Pack	Met
	Package Storage Saline Solution	Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108	Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108	Met
Clinical Performance	Overall Performance (vision, health, comfort, fit)	Similar to concurrent predicate control	Demonstrated similar overall performance to concurrent predicate control	Met
Biocompatibility	Toxicity & Biocompatibility	Non-toxic and biocompatible with ocular environment	Remain non-toxic and biocompatible with the ocular environment	Met

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

The document does not explicitly state the numerical sample size for the clinical test set. It mentions "A one-month clinical study". The provenance of the data (country of origin) is not specified. The study appears to be prospective as it's a "one-month clinical study" evaluating the device's performance.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study's evaluation of "vision, health, comfort, and fit." Clinical studies often involve ophthalmologists or optometrists for these assessments, but this is not specified here.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices, rather than contact lenses. The study focused on demonstrating equivalence to an existing device rather than human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a contact lens, not a software algorithm. The "performance" refers to the physical and clinical characteristics of the lens itself.

7. Type of Ground Truth Used

The ground truth for the physical and chemical properties was derived from established specifications and validated measurements against those specifications, comparing the new formulation to the predicate device. For the clinical performance, the ground truth was based on clinical evaluation of vision, health, comfort, and fit which would implicitly involve expert (clinician) assessments, but the exact mechanism for establishing "ground truth" (e.g., expert consensus on what constitutes "similar performance") is not detailed.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set in that context. The "training set" for manufacturing would be the established manufacturing processes and quality controls that lead to the "established specifications" mentioned.

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

Not applicable, as it's not an AI/ML device. For contact lens manufacturing, ground truth (or acceptable quality standards) is established through rigorous engineering specifications, material science, and regulatory requirements, which are then validated through extensive testing (physical, chemical, and clinical).

Summary

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DEC 1 5 2003

CIBA Vision® Corporation				Page 1 of 4
11460 Johns Creek Parkway
Duluth, GA USA 30097
Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES®
Progressives
(nelfilcon A) ONE-DAY Soft Contact Lenses
510(k) Summary of Safety and Effectiveness

510(k) Summary , K

O33701

1. Submitter Information:
Company:	CIBA Vision Corporation
	11460 Johns Creek Parkway
	Duluth, Georgia USA 30097
Contact Person:	Alicia M. Plesnarski, RAC
	Director, Global Regulatory Affairs
Telephone:	678-415-3924
FAX:	678-415-3454
Date Prepared:	24 November 2003
2. Device Name:
Common Name:	Soft Contact Lens
Trade/Proprietary Name:	Focus® DAILIES®, Focus® DAILIES® Toric and
	Focus® DAILIES® Progressives
	(nelfilcon A) ONE-DAY CONTACT LENS
Classification Name:	Daily Wear
	Soft (hydrophilic) Contact Lens
Device Classification:	Class II [21 CFR 886.5925 (b) (1)]
3. Predicate Device(s):
	Lens Material: CIBA Vision's Focus® DAILIES® (nelfilcon A) One-Day Contact Lens
	Clear lenses (spherical & toric):	K943487
	VISITINT® lenses:	K984273
	Manufacturing Change-Surfactant Additive:	K010636
	Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A) One-Day
	Visitint lenses:	K003826

4. Description of Device:

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CIBA Vision.A Novartis Company	CIBA Vision® Corporation11460 Johns Creek ParkwayDuluth, GA USA 30097	Page 2 of 4
------------------------------------	-------------------------------------------------------------------------------	-------------

Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES®
Progressives
(nelfilcon A) ONE-DAY Soft Contact Lenses

510(k) Summary of Safety and Effectiveness

requiring a reading addition of up to +3.00 diopters to see clearly at far, intermediate and near distances.

Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphateacetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108.

The physical properties of the lens are:

Refractive Index:	1.38 (hydrated)
Center Thickness:	0.09 to0.17 mm(0.10 at -3.00D; 0.15 at +3.00D)
Light Transmittance:	96% (approx)
Oxygen Permeability (Dk):[35° C, Fatt corrected]	26 x 10-11 (cm²/sec) (ml O2/ml x mm Hg)
Water Content:	69% by weight in normal saline

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.

The lenses are to be prescribed for single use daily disposable wear. DAILIES® lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

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Image /page/2/Picture/0 description: This image shows a product information label for CIBA Vision Corporation, located at 11460 Johns Creek Parkway in Duluth, GA 30097. The label indicates that it is page 3 of 4. The product is Focus DAILIES, Focus DAILIES Toric, and Focus DAILIES Progressives, which are (nelfilcon A) ONE-DAY Soft Contact Lenses, and the label is a 510(k) Summary of Safety and Effectiveness.

6. Description of Safety and Substantial Equivalence

6.1 Comparison to Predicate Device (s):

Lens Material [Predicate Lens current Focus DAILIES (nelfilcon A)]: . Lens material, chemical composition, formulation (except for addition of the manufacturing additive), manufacturing process, packaging and the sterilization method and cycle remain unchanged from the descriptions previously provided in motion and order remarket Notifications 510(k) K963487, K992446, K003826, K010636.
Lens Design: . No change to established spherical, toric or multi-focal lens designs.

	Comparison to CIBA Vision's Predicate Device
Table 1:	Predicate DeviceFocus DAILIES (nelfilcon A) made without additive nelfilcon A	Focus DAILIES (nelfilcon A) made with additive nelfilcon A
Lens Material:
MaterialClassification:	FDA Group 2(> 50% H2O, nonionic polymer)	FDA Group 2(> 50% H2O, nonionic polymer)
Water Content:	69.4%	68.4%
Light Transmittance(clear lenses):	100%	100%
Oxygen Permeability(Dk, Coulometric):	~ 25 barrer	25.86 barrer
Power Range:	+20.00 to -20.00D	+20.00 to -20.00D
Visibility Tint:	With or without Copper Phthalocyanine	With or without CopperPhthalocyanine
ManufacturingMethod:	Full Mold CastLightstream Technology	Full Mold CastLightstream Technology
Lens Design:	Spherical and/or Multi-focal	Spherical and/or Multi-focal
Sterilization:	Steam sterilization, Validatedautoclave	Steam sterilization, Validatedautoclave
Packaging:	Blister Pack	Blister Pack
Package Storagesaline solution	Phosphate-acetate buffered saline withup to 0.02% Poloxamer 108	Phosphate-acetate buffered salinewith up to 0.02% Poloxamer 108

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Image /page/3/Picture/0 description: This image shows a document from CIBA Vision Corporation located in Duluth, GA. The document is labeled as "Page 4 of 4". The document discusses Focus DAILIES Toric and Focus DAILIES Progressives (nelfilcon A) ONE-DAY Soft Contact Lenses and is a 510(k) Summary of Safety and Effectiveness.

6.2 Non-clinical Testing

Results from a series of physical/chemical tests confirm that DAILIES lenses made r with or without the manufacturing additive were equivalent and within established specifications for the lenses. Successful results from in-vivo and in-vitro toxicology tests confirm the lenses remain non-toxic and biocompatible with the ocular environment.

6.3 Clinical Testing:

A one-month clinical study demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear.

7. Substantial Equivalence

DAILIES lenses made with or without the manufacturing additive are equivalent and within established specifications for the lens. The lenses maintain clinical performance expectations, established physical/chemical characteristics, and are stable and biocompatible with the ocular environment.

Any differences which may exist between lenses made with or without the additive do not adverselv affect the established performance characteristics and safety and effectiveness profile of the device.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alicia M. Plesnarski Director, Global Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097-1556

Re: K033701

Trade Name: Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL; MVN Dated: November 24, 2003 Received: November 28, 2003

Dear Ms. Plesnarski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Alicia M. Plesnarski

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Palgi Rosenthal

A. Ralph Rosenthal, 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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Part III. Indications for Use Statement v01, 24-Nov-03, Page 1 of 1 Premarket Notification 510(k): (nelfilcon A) Soft Contact Lens

INDICATIONS FOR USE STATEMENT PART III.

510(k) Number:

Device Name(s):

Focus® DAILIES®, Focus® Toric, Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lens

Indications For Use:

The lenses are to be prescribed for single-use daily disposable wear. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ((21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,

Nose and Throat Devices

510(k) Number K 033701

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.