DAILIES TOTAL 1® (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.

DAILIES TOTAL 1® (delefilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.

DAILIES TOTAL 1® (delefilcon A) multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of astigmatism and who may require a reading addition of +3.00 diopters (D) or less.

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 33% water and 67% delefilcon A, a silicone containing hydrogel with added phosphatidylcholine. The core lens material containing 33% water transitions through a water gradient to a hydrogel surface layer that exceeds 80% water. Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.

Delefilcon A lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges:
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm
Power Range: -20.00D to +20.00D
Center Thickness: varies with design and power (0.09 mm for -3.00D spherical)

Lenses have the following properties:
Refractive index: 1.42 (hydrated)
Light transmittance: ≥ 93% (@610 nm, -1.00D)
Water content: 33% by weight in normal saline
Surface water content: ≥ 80%
Oxygen permeability: 140 x 10-11 [(cm2 /sec)(ml O2 /ml.mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)

AI/ML Overview

Here's an analysis of the provided text regarding the Delefilcon A Soft Contact Lenses (DAILIES TOTAL1®) K113168 submission, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for contact lenses primarily focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific numerical performance acceptance criteria in the same way a diagnostic algorithm might. The core "acceptance criteria" here are defined by the predicate device's properties and established safety/efficacy.

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Delefilcon A)	Comparison/Outcome
Non-clinical Properties	(Implicit: Similar to or better than predicate, non-toxic, biocompatible, optically/dimensionally/physico-chemically comparable)
Intended Use	Daily Disposable Wear	Daily Disposable Wear	Equivalent
Mode of Action	Refracting medium to focus light rays on the retina	Refracting medium to focus light rays on the retina	Equivalent
Lens Material Group	ISO Group V (silicone hydrogel)	ISO Group V (silicone hydrogel)	Equivalent
Manufacturing Method	Molded	LightStream	Different method, but efficacy & safety demonstrated.
Sterilization Method	Moist Heat	Moist Heat	Equivalent
Packaging	Blister Pack	Blister Pack	Equivalent
Handling Tint	Lt. Blue	Lt. Blue	Equivalent
Refractive Index	1.41	1.42	Similar (minor difference)
Water Content (%)	48%	33% (core), ≥ 80% (surface)	Different, but considered acceptable due to water gradient design.
Oxygen Permeability	55 (hydrated Dk)	140 (intrinsic Dk-Coulometric method)	Significantly higher (better).
BC/Diameter (mm)	8.5/14.2	8.5/14.1	Similar (minor difference)
Power (D)	various	various	Equivalent
Biocompatibility	Non-toxic, non-irritating (implied)	Non-toxic, non-irritating	Meets (explicitly stated)
Optical/Dimensional/Physico-chemical Properties	Consistent with marketed lenses (implied)	Consistent with or better than predicate lenses tested	Meets (explicitly stated)
Compatibility with Rewetting Drops/Saline	(Implicit: Compatible)	Compatible with commonly available contact lens rewetting drops and saline solutions	Meets (explicitly stated)
Clinical Performance	(Implicit: Similar safety and efficacy to predicate lens)
Primary Safety Variable	Biomicroscopy findings (similar to predicate)	Similar performance between test and control lenses	Meets (explicitly stated)
Primary Efficacy Variable	Visual acuity (similar to predicate)	Similar performance between test and control lenses	Meets (explicitly stated)
Other Variables	Refraction, keratometry, subjective ratings (vision, comfort, handling) (similar to predicate)	Similar performance between test and control lenses	Meets (explicitly stated)

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

Test Set Sample Size:
- Clinical Study: 60 subjects for the Delefilcon A (test) lenses and 30 subjects for the Narafilcon B (control) lenses. (Total: 90 subjects)
- Non-clinical Testing: The text does not specify sample sizes for non-clinical tests (e.g., in vitro material testing, biocompatibility).
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was conducted retrospectively or prospectively. However, the description "a three-month clinical study was conducted" and "prospective, randomized, parallel group design" strongly indicates a prospective study. The submitter, CIBA VISION Corporation, is based in Duluth, Georgia, USA, suggesting the study likely took place in the US or under US regulatory oversight.

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

This type of information is generally not applicable to a contact lens submission, as "ground truth" in the context of diagnostic AI/ML is typically established by expert consensus on image interpretation or pathology.

For contact lenses, the "ground truth" for efficacy and safety variables like visual acuity, biomicroscopy findings, and subjective ratings (comfort, vision, handling) is established through standardized clinical examination procedures performed by qualified investigators and ophthalmologists/optometrists who conduct the clinical trial. Their qualifications are assumed to be appropriate for conducting clinical trials involving contact lenses. The number of such experts involved is not specified but would include the clinical investigators and potentially a data safety monitoring board.

4. Adjudication Method (for the test set)

The document mentions "biomicroscopy findings" as a primary safety variable and "visual acuity" as a primary efficacy variable. For these objective measurements, adjudication in the sense of expert consensus on ambiguous cases (as in image interpretation) is generally not performed. Measurements are typically taken by trained clinical personnel. Subjective ratings (vision, comfort, handling) are self-reported by the subjects. There is no indication of an adjudication method described for the clinical trial data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a soft contact lens, not an AI/ML-driven diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not performed. The clinical study performed was a direct comparison of the new lens to a predicate lens.

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

This is not applicable. The device is a physical medical device (contact lens), not an algorithm. So a standalone algorithm performance study was not done.

7. The Type of Ground Truth Used

For the clinical study:

Safety: Established through biomicroscopy findings (objective clinical assessment of eye health by investigators) and observation of adverse events.
Efficacy: Established through visual acuity measurements (objective assessment) and refraction/keratometry (objective measurements).
Patient Experience: Established through subjective ratings of vision, comfort, and handling (patient-reported outcomes).

For the non-clinical testing:

Material Properties: Established through standardized laboratory testing (e.g., refractive index measurements, water content testing, oxygen permeability Dk measurement).
Biocompatibility: Established through GLP-compliant (21 CFR Part 58) non-clinical biocompatibility testing as per established industry standards.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device (contact lens), not an AI/ML algorithm that requires a "training set."

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

This is not applicable, as there is no training set for a contact lens device.

Summary

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MAR	3
0	2012

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '113168'. The numbers are written in a simple, slightly irregular style, typical of handwriting.

CIDA VISION.
Shared Passion for Healthy Vision and Better Life

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

27-Mar-2012, v03 Page 1 of 4

Delefilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

510(k) Summary - K113168

1. Submitter Information:

Company:	CIBA VISION Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
Contact Person:	Alicia M. Plesnarski, RACDirector, Regulatory Affairs
Telephone:Facsimile:Email:	678-415-3924678-415-3454alicia.plesnarski@cibavision.com

2. Device Name:

Date Prepared:

Soft Contact Lens ● Common Name:
DAILIES TOTAL 1® (delefilcon A) Trade/Proprietary Name: .

27-Mar-2012

Daily Wear Soft Contact Lens � Classification Name:
Class II [21 CFR 886.5925 (b) (1)] Device Classification: .

3. Predicate Device:

· The predicate device is Johnson & Johnson VISTAKON® 1-DAY ACUVUE® TruEye (narafilcon B) soft contact lenses packaged in buffered saline. Narafilcon B lenses belona to ISO Group V (silicone hydrogel). Johnson & Johnson VISTAKON 1-DAY ACUVUE TruEye lenses have FDA 510(k) clearance per K100349, 21-May-2010.

4. Description of Device:

Delefilcon A lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges:

13.0 to 15.0 mm . Diameter Range:
Base Curve Range: 8.0 to 9.2 mm .
-20.00D to +20.00D � Power Range:
Center Thickness: varies with design and power � (0.09 mm for -3.00D spherical)

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CIBAVISION.

Shared Passion for Healthy Vision and Better Life

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

27-Mar-2012. v03 Page 2 of 4

Delefilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

Lenses have the following properties:

1.42 (hydrated) Refractive index: .
- ≥ 93% (@610 nm, -1.00D) Light transmittance:
33% by weight in normal saline Water content: .
Surface water content: ≥ 80% .
140 x 10-11 Oxygen permeability . [{cm2 /sec)(ml O2 /ml.mmHg}] measured at 35°C (intrinsic Dk-Coulometric method)

Each lens is packaged in a foil-sealed plastic containing phosphate buffered saline solution with approximately 0.3% of polymeric wetting agents consisting of copolymers of polyamidoamine and poly(acrylamide-acrylic acid) and are steam sterilized. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed contact 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 and physical stability of the lens and integrity of the package (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

5. Indications for Use:

DAILIES TOTAL1® (delefilcon A) spherical soft contact ienses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism.

DAILIES TOTAL 10 for Astigmatism (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES TOTAL 1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.

DAILIES TOTAL 1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of astigmatism and who may require a reading addition of +3.00 diopters (D) or less.

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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CIBA VISION TM
Shared Passion for Healthy Vision and Better Life

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

27-Mar-2012, v03 Page 3 of 4

Delefilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

6. Description of Safety and Substantial Equivalence:

A series of non-clinical tests were performed to characterize lens material properties and establish substantial equivalence to the predicate device. All testing was conducted in accordance with the May 1994 FDA guidance document titled Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses and in conformance to applicable device regulations. Results verify that delefilcon A contact lenses are nontoxic and biocompatible, have material characteristics in common with currently marketed soft contact lenses intended for vision correction and demonstrate substantial equivalence to the previously FDA cleared predicate (control) lenses listed in Table 1.

	Predicate Device	New Device
Product Name	Johnson & Johnson®VISTAKON® 1-DAYACUVUE® TruEye™(narafilcon B)	CIBA VISION®DAILIES TOTAL1®(delefilcon A)
Intended Use	Daily Disposable Wear	Daily Disposable Wear
Mode of Action	When hydrated and placed onthe cornea, lenses act as arefracting medium to focuslight rays on the retina.	When hydrated and placed onthe cornea, lenses act as arefracting medium to focuslight rays on the retina.
510(k) Number	K100349	To be assigned
Lens Material Group **	ISO Group V	ISO Group V
Manufacturing Method	Molded	LightStream
Sterilization Method	Moist Heat	Moist Heat
Packaging	Blister Pack	Blister Pack
Handling Tint	Lt. Blue	Lt. Blue
Refractive Index	1.41	1.42
Water Content (%)	48	33
Oxygen permeability	55	140
BC/Diameter (mm)	8.5/14.2	8.5/14.1
Power (D)	various	various

Table 1. Substantial Equivalence Comparison

**Per EN ISO 18369-1/Amd.1:2009

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K113168

CIBAVISION.

Shared Passion for Healthy Vision and Better Life

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

27-Mar-2012, v03 Page 4 of 4

Delefilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

Conclusions drawn from Studies

Nonclinical Testing:

A series of nonclinical testing was performed to verify substantial equivalence of delefiloon A contact lenses to the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58). The results of all non-clinical testing demonstrate:

The lens material and extracts of the device are non toxic and non-irritating. .
The device has optical, dimensional and physico-chemical properties in common . with currently marketed soft contact lenses intended for vision correction and consistent with or better than, the predicate lenses tested.
The lenses are compatible with commonly available contact iens rewetting drops and . saline solutions.

Clinical Testing:

A three-month clinical study was conducted to assess the safety and efficacy of DAILIES TOTAL1® (delefilcon A) soft contact lenses for single use, daily disposable wear. The clinical study also provided data to establish substantial equivalence with the predicate, control lens.

The study evaluated 60 delefilcon A (test) subjects in a 2:1 ratio with the 30 narafilcon B (control) subjects in a prospective, randomized, parallel group design. The primary safety and efficacy variables were biomicroscopy findings and visual acuity respectively. Additional variables tested include refraction, keratometry, and subjective ratings of vision, comfort and handling.

The study results showed similar performance between the test delefilcon A and control narafilcon B lenses in the clinically relevant areas of fit, vision, comfort, health and handling when worn on a daily disposable wear basis.

Risks and Benefits:

The risks of the subject device are the same as those normally attributed to the wearing of silicone hydrogel contact lenses on a single use, daily wear basis. The benefits to the patient are the same as those for other silicone hydrogel contact lenses.

Substantial Equivalence:

Delefilcon A soft contact lenses are substantially equivalent to the predicate contact lens and similar to other daily wear soft contact lenses in terms of material water content (33% water), ionic characteristics, ISO Group V: silicone hydrogel and indications for use.

Any differences which may exist between the delefilcon A soft contact lens and other ISO Group V silicone hydrogel soft contact lenses do not adversely affect the safety and effectiveness of the device when worn under single use, daily wear conditions.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol with three lines extending upwards, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Ciba Vision Corporation c/o Ms. Alicia M. Plesnarski, RAC Director, Regulatory Affairs 11460 Johns Creek Parkway Duluth, GA 30097

MAR 3 0 2012

Re: K113168

Trade/Device Name: DAILIES TOTAL1® (delefilcon A) Soft Contact Lenses

for Daily Disposable Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Codes: LPL, MVN Dated: March 21, 2012 Received: March 22, 2012

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. 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-maypublish further announcements concerning your device in the Federal Register.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K113168

Device Name:

DAILIES TOTAL 1® (delefilcon A) Soft Contact Lenses

Indications For Use:

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.

X Prescription Use: AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Marc Robboy

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K113168

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.