Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon 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 eves.

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 sinqle 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 lens 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 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.

The physical properties of the lens are:

Refractive Index: 1.38 (hydrated)
Center Thickness: 0.09 to 0.17 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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CIBA Vision Focus® DAILIES® contact lenses:

Overview:

This 510(k) summary for K050065 focuses on demonstrating substantial equivalence of Focus® DAILIES® contact lenses (spherical, toric, and progressives) made with an additional manufacturing additive, to previously cleared predicate devices. The study detailed is not a traditional "device performance" study in the sense of accuracy metrics for a diagnostic device, but rather a demonstration of comparability and safety for a modified medical device (contact lenses).

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the equivalence of the modified device to the predicate rather than defining specific acceptance criteria for a novel device performance. The "acceptance criteria" here are implied to be that the properties and performance of the new lenses are within the established specifications and clinical performance expectations of the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Physical/Chemical Properties Equivalence	"Results from a series of physical/chemical tests confirm that DAILIES lenses made with or without the manufacturing additive were equivalent and within established specifications for the lenses." Specific properties listed (Refractive Index, Center Thickness, Light Transmittance, Oxygen Permeability, Water Content) are identical between the modified and predicate device in the comparison table, with the exception of a minor difference in water content (69.4% vs 68.4%), which is implicitly acceptable given the overall conclusion of equivalence.
In-vitro Toxicology/Biocompatibility Equivalence	"Successful results from in-vitro toxicology tests confirm the lenses remain non-toxic and biocompatible with the ocular environment."
Clinical Performance (Vision, Health, Comfort, Fit) Equivalence	"Clinical studies 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."
Safety and Effectiveness Profile Maintenance	"Any differences which may exist between lenses made with or without the additive do not adversely affect the established performance characteristics and safety and effectiveness profile of the device."

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

Sample Size (Clinical Testing): Not explicitly stated. The document only mentions "Clinical studies."
Data Provenance: Not explicitly stated. It refers to "Clinical studies," but doesn't specify if they were retrospective or prospective, or the country of origin of the data. Given it's a 510(k) in the US, it's highly likely the studies were conducted to US regulatory standards, implying a prospective nature, but this is an inference.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for contact lenses in such a submission isn't typically established by expert consensus on discrete findings in the same way it would be for a diagnostic image analysis algorithm. Instead, it relies on clinical outcomes measured by and reported by investigators.

4. Adjudication Method for the Test Set:

Not applicable. The study described is a clinical trial comparing device performance, not an expert review of a test set where adjudication would be necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images. This submission is for contact lenses, which are a therapeutic and vision correction device, not a diagnostic one.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" for the clinical study would be:

Refractive Correction: Measured visual acuity and refractive error.
Ocular Health: Clinical examination findings by an ophthalmologist or optometrist (e.g., slit lamp examination for corneal health, conjunctival hyperemia).
Comfort and Fit: Patient-reported outcomes and clinician assessment of lens fit on the eye.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" for manufacturing would be the established manufacturing processes and quality control, not a data-driven training set.

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

Not applicable, as there is no training set in the AI/ML sense. For manufacturing and material science, the "ground truth" for establishing specifications would be derived from:

Industry standards.
Pre-existing knowledge of the material properties.
Extensive testing during product development and validation against established safety and performance benchmarks for contact lenses.
Regulatory requirements.

Summary

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K050065

Image /page/0/Picture/2 description: The image shows the logo for CIBA Vision, a Novartis company. The logo is in black and white and features the word "CIBA" stacked on top of the word "Vision". The "i" in "Vision" is replaced with an eye symbol. Below the logo, it says "A Novartis Company".

CIBA Vision Corporation 11460 Johns Creek Parkway

Duluth, Georgia 30097-1556

510(k) Summary

1. Submitter Information:

Company:	CIBA Vision Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
Contact Person:	Penny Northcutt, RAC
	Director, Global Regulatory Affairs
Telephone:	678-415-3214
FAX:	678-415-4024

Date Prepared: 10 January 2005

2. Device Name:

Common Name:
Soft Contact Lens

•	Trade/Proprietary Name: Focus® DAILIES®, Focus® DAILIES® Toric andFocus® DAILIES® Progressives(nelfilcon A) ONE-DAY CONTACT LENS
•	Classification Name: Daily WearSoft (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 Manufacturing Change-Processing Additive: K033701

Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A) One-Day Visitint lenses: K003826

4. Description of Device:

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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.

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 nondiseased eves 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.

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 cleared Premarket Notifications 510(k) K963487, K984273, K992446, K003826, K010636, K033701.
. Lens Design:

No change to established spherical, toric or multi-focal lens designs.

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Table 1:	Predicate Device	Modified Device
	Focus DAILIES (nelfilcon A)	Focus DAILIES (nelfilcon A) madewith additional PVA
Lens Material:	nelfilcon A	nelfilcon A
Material	FDA Group 2	FDA Group 2
Classification:	(> 50% H2O, nonionic polymer)	(> 50% H2O, nonionic polymer)
Water Content:	69.4%	68.4%
Power Range:	+20.00 to -20.00D	+20.00 to -20.00D
Visibility Tint:	With or without Copper Phthalocyanine	With Copper Phthalocyanine
Manufacturing	Full Mold Cast	Full Mold Cast
Method:	Lightstream Technology	Lightstream 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 Storage	Phosphate-acetate buffered saline with	Phosphate-acetate buffered saline
saline solution	up to 0.02% Poloxamer 108	with up to 0.02% Poloxamer 108

Comparison to CIBA Vision's Predicate Device

6.2 Non-clinical Testing:

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

6.3 Clinical Testing:

Clinical studies 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 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 adversely affect the established performance characteristics and safety and effectiveness profile of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2005

CIBA Vision Corporation c/o Ms. Penny M. Northcutt, RAC Director, Global Regulatory Affairs 11460 Johns Creek Parkway Duluth, GA 30097-1556

Re: K050065

Trade/Device Name: Focus® Dailies® (nelfilcon A) One-Day Contact Lens for Daily Wear (Spherical, Toric and Progressives) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: MVN Dated: May 23, 2005 Received: May 24, 2005

Dear Ms. Northcutt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is tegains actment date of the Medical Device Amendments, or to conniner of the ritar to May 20, 1978, in occordance with the provisions of the Federal Food, Drug, devices that have been received in quire approval of a premarket approval application (PMA). and Costnetter rest (110) that be device, subject to the general controls provisions of the Act. The I ou may, morelore, mainer of the Act include requirements for annual registration, listing of goleral controls pro resuring 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to such adala 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 r lease of advisou that I Driver and in that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I catalog and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Fart 677, Mooning (21 CFR Part 820); and if applicable, the electronic form in alle qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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) 827-8910. 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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, 07 January 2005, Page 1 of 1 Special 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 sinqle use.

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number	K050065
Prescription Use:	X or Over the Counter Use ☐

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.