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 (polyvinyl 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.

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges:

Power Range: -20.00D to +20.00D .
0.010 mm for -3.00D spherical (varies with power) Center Thickness: .

Lenses have the following properties:

1.38 Refractive index: .
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 CIBA VISION marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blisterpack 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). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a contact lens seeking substantial equivalence through a 510(k) submission. For such devices, acceptance criteria are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. The primary "performance" metric here is the demonstration of substantial equivalence.

Feature / Criteria	Predicate Devices (K050065, K050213)	Modified Device (Focus DAILIES Family)	Acceptance Met?
Material:	nelfilcon A	nelfilcon A	Yes
Material Class:	FDA Group 2 (>50% H2O, nonionic polymer)	FDA Group 2 (>50% H2O, nonionic polymer)	Yes
Water Content:	69%	69%	Yes
Power Range:	+20.00 to -20.00D	+20.00 to -20.00D	Yes
Visibility Tint:	With or without copper phthalocyanine	With or without copper phthalocyanine	Yes
Manuf. Method:	Lightstream Technology™: Full mold cast (K050065), Full mold cast, integrated print step (K050213)	Lightstream Technology™: Full mold cast, integrated print step	Yes (consistent with one or both predicates)
Lens Designs:	Spherical, toric, multifocal	Spherical, toric, multifocal	Yes
Sterilization:	Steam sterilization, validated autoclave	Steam sterilization, validated autoclave	Yes
Packaging:	Blister pack	Blister pack	Yes
Package Storage Saline:	Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108	Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108	Yes
Indications for Use:	Daily wear for optical correction of refractive ametropia (myopia, hyperopia, astigmatism) in non-aphakic, non-diseased eyes; Progressives for presbyopia with specific additions/astigmatism	Daily wear for optical correction of refractive ametropia (myopia, hyperopia, astigmatism) in non-aphakic, non-diseased eyes; Progressives for presbyopia with specific additions/astigmatism	Yes (explicitly stated as substantially equivalent)
Safety and Effectiveness:	Demonstrated by predicate devices	Demonstrated by substantial equivalence to predicates	Yes

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."

Therefore:

Sample Size for Test Set: Not applicable, as no new clinical testing was performed for this 510(k) submission.
Data Provenance: Not applicable.

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

Not applicable, as no new clinical (test set) data was generated or evaluated for this 510(k) submission. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical (test set) data requiring adjudication was generated.

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

No. This is a medical device (contact lens) and not an AI/software device that would typically undergo MRMC studies. The approval pathway is 510(k) where "substantial equivalence" to a predicate is the primary criterion.

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

No. This is a contact lens, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the safety and effectiveness established for the predicate devices. This would have been determined through:

Clinical Performance: Data from human clinical trials (implied to have been conducted for the original predicates).
Physical and Chemical Properties: Bench testing data comparing material characteristics.
Toxicological Testing: Data supporting biocompatibility.
Stability Testing: Data demonstrating shelf life and sterility maintenance.

For the current submission, the ground truth is essentially the established regulatory status and performance of the predicate lenses.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm was involved. If "training set" refers to the data used to initially establish the safety and effectiveness of the predicate devices, that information is not provided in this 510(k) summary.

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

Not applicable, as this is a contact lens and not an AI/software device with a "training set." The safety and effectiveness of the predicate devices were established through a combination of non-clinical (material properties, sterilization, packaging integrity, stability) and clinical testing, as is standard for contact lenses. The present submission leverages that established "ground truth" of the predicate devices to demonstrate substantial equivalence for the modified device.

Summary

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Shared Passion for Healthy Vision and Better Life		CIBA VISION Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097	04 February 2009Page 1 of 4v03
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CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses

510(k) Summary of Safety and Substantial Equivalence

510(k) Summary
K 083216

Submitter Information:

Company:	CIBA VISION® Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097	APR 14 2009
Contact Person:	Martina Heim, PhD, RACSenior Regulatory Specialist, Global Regulatory Affairsmartina.heim@cibavision.com
Telephone:	678-415-3565
FAX:	678-415-3454
Date Prepared:	27 October 2008

Device Name:

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

3. Predicate Device:

Predicate devices are:

Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lenses, as cleared under K050065, 2) FreshLook®, FreshLook® Toric, and FreshLook® Progressives (nelfilcon A) One-Day Color Contact Lens, as cleared under K050213.

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 when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.

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CIBAOVISION.	CIBA VISION Corporation
Shared Passion for Healthy Vision and Better Life	11460 Johns Creek Parkway
	Duluth, Georgia USA 30097

CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges:

Power Range: -20.00D to +20.00D .
0.010 mm for -3.00D spherical (varies with power) Center Thickness: .

Lenses have the following properties:

1.38 Refractive index: .
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:

◆

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 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. The 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: The image shows the CIBA Vision logo. The logo is black and white and features the words "CIBA VISION" in a bold, sans-serif font. The "O" in "VISION" is stylized to look like an eye. Below the logo is the tagline "Shared Passion for Healthy Vision and Better Life" in a smaller font.

CIBA VISION Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097

CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

દ. Substantial Equivalence:

The following matrix summarizes the characteristics of the modified device as compared to the predicate devices:

	Modified Device	K050065	K050213
	Focus DAILIES Family(nelfilcon A) One-Day SoftContact Lens	Focus DAILIES Family(nelfilcon A) One-DayContact Lens	FreshLook Family(nelfilcon A) One-Day ColorContact Lens
Lens Material:	nelfilcon A	nelfilcon A	nelfilcon A
MaterialClassification:	FDA Group 2(> 50% H2O, nonionicpolymer)	FDA Group 2(> 50% H2O, nonionicpolymer)	FDA Group 2(> 50% H2O, nonionicpolymer)
Water Content:	69%	69%	69%
Power Range:	+20.00 to -20.00D	+20.00 to -20.00D	+20.00 to -20.00D
Visibility Tint:	With or without copperphthalocyanine	With or without copperphthalocyanine	With or without copperphthalocyanine
ManufacturingMethod:	Lightstream Technology™:Full mold cast,integrated print step	Lightstream Technology™:Full mold cast	Lightstream Technology™:Full mold cast,integrated print step
Lens Designs:	Spherical, toric, multifocal	Spherical, toric, multifocal	Spherical, toric, multifocal
Sterilization:	Steam sterilization, validatedautoclave	Steam sterilization, validatedautoclave	Steam sterilization, validatedautoclave
Packaging:	Blister pack	Blister pack	Blister pack
Package Storagesaline solution	Phosphate-acetate bufferedsaline with up to 0.02%Poloxamer 108	Phosphate-acetate bufferedsaline with up to 0.02%Poloxamer 108	Phosphate-acetate bufferedsaline with up to 0.02%Poloxamer 108

Non-clinical Testing:

Successful stability testing supports the labeled expiration date. Additional chemical, physical, and toxicological testing results can be referenced from the predicate devices.

Clinical Testing:

The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.

Substantial Equivalence:

The Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lenses are substantially equivalent to the predicate

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110100CIBACColli
Shared Passion for Healthy Vision and Better Life

CIBA VISION Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097

CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

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), clinical performance, 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CIBA VISION Corporation c/o Martina Heim, Ph.D., RAC Senior Regulatory Specialist 11460 Johns Creek Parkway Duluth, Georgia 30097

APR 1 4-2009

Re: K083216

Trade/Device Name: Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 24, 2009 Received: March 25, 2009

Dear Dr. Heim;

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. Iisting 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 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); medical device reporting (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egeland, MD

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 STATEMENT PART II.

: : : : : : : : : : : : : : :

K083216 510(k) Number:

Device Name:

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

Indications For Use:

Section and States and 122

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over the Counter Use

ing-chun Shi

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K083216

CONFIDENTIAL

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.