AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

AIR OPTIX® COLORS Toric (Iotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with 6.00 diopters (D) or less of astigmatism.

AIR OPTIX® COLORS Multifocal (Iotraficon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and/or presbyonia in phakic or aphakic persons with non-diseased eves 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.

AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.

The lenses may be prescribed for frequent wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Device Description

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group V (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2006/Amd.1:2009. A cosmetic pattern is embedded into the back surface of the lens, containing a combination of the following color additives: iron oxides, titanium dioxide, [phthalocyaninato (2-)] copper, and phthalocyanine green.

Lens designs for AIR OPTIX® COLORS (lotrafilcon B) lenses include spherical, toric, and multifocal lenses in the following parameter range:

Power Range: -20.00D to +20.00D
Center Thickness: varies with design and power (0.08 mm for -3.00D spherical)
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm

Lenses have the following properties:

Refractive index: 1.422 (hydrated)
Light transmittance: > 95% (380 - 780 nm)
Water content: 33% by weight in normal saline
Oxygen permeability: 110 x 10 -11 (cm2/sec)(ml O2/ml x mm Hg), measured at 35°C (intrinsic Dk-Coulometric method)

AI/ML Overview

The provided document describes the K133176 510(k) submission for AIR OPTIX® COLORS (lotrafilcon B) Contact Lenses. It details non-clinical and clinical testing performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission, the acceptance criteria are not explicitly stated as numerical thresholds for specific performance metrics in the provided text. Instead, the study aims to demonstrate "substantial equivalence" to the predicate device, AIR OPTIX® AQUA.

The reported device performance for AIR OPTIX® COLORS is compared implicitly through the conclusion of substantial equivalence.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (AIR OPTIX® COLORS)
Visual Acuity	Comparable to AIR OPTIX® AQUA	Similar to AIR OPTIX® AQUA
Subjective Comfort	Comparable to AIR OPTIX® AQUA	Similar to AIR OPTIX® AQUA
Subjective Handling	Comparable to AIR OPTIX® AQUA	Similar to AIR OPTIX® AQUA
Lens Fit	Comparable to AIR OPTIX® AQUA	Similar to AIR OPTIX® AQUA
Lens Surface Characteristics	Comparable to AIR OPTIX® AQUA	Similar to AIR OPTIX® AQUA
Biomicroscopic Findings	Comparable to AIR OPTIX® AQUA	Similar to AIR OPTIX® AQUA
Discontinuations	No significant difference from AIR OPTIX® AQUA (excluding cosmetic reasons)	Not explicitly detailed, but implied to be comparable to AIR OPTIX® AQUA
Ocular Adverse Events	No significant difference from AIR OPTIX® AQUA	Not explicitly detailed, but implied to be comparable to AIR OPTIX® AQUA
Physicochemical Properties	Substantially equivalent to AIR OPTIX® AQUA	Substantially equivalent to AIR OPTIX® AQUA
Biocompatibility	Non-toxic and non-irritating, substantially equivalent to predicate	Non-toxic and non-irritating, substantially equivalent to predicate
Shelf-life & Sterility	Maintained as established through stability studies	Successfully supported labeled expiration date

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

Sample Size: A total of 147 subjects were enrolled and randomized in the clinical study.
Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It was a prospective study, indicated by the description "3-month prospective, randomized, controlled, open-label, parallel-group, multi-center study."

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

The document does not describe the establishment of a "ground truth" in the sense of expert consensus on specific visual outcomes or physiological findings for each subject. Instead, the study relies on the performance of the lenses as observed and measured by the "eye care professional" and reported by the subjects. There is no mention of a ground truth panel of experts evaluating the test set.

4. Adjudication Method (for the test set)

No adjudication method is described for the test set. The clinical study seems to have collected data directly from subjects and clinicians without an independent adjudication process for critical endpoints.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a contact lens, and the study evaluated its clinical performance directly, not an AI system assisting human readers.

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

A standalone performance study was not done. This device is a contact lens and does not involve an algorithm to be tested in a "standalone" fashion.

7. The Type of Ground Truth Used

The "ground truth" for this study is the clinical and physiological response of human subjects wearing the contact lenses, as measured by visual acuity, biomicroscopy, subjective assessments (comfort, vision, handling), and reported adverse events. For non-clinical aspects, the ground truth relates to established physical properties (refractive index, Dk, water content) and safety standards (biocompatibility, non-toxicity).

8. The Sample Size for the Training Set

There is no mention of a training set as this is a medical device (contact lens) and not an AI/algorithm-based product requiring a training set in the conventional sense. The "training" for the device would have been its manufacturing development and quality control processes.

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

Not applicable, as there is no training set in the context of an AI/algorithm. For the manufacturing of the lenses, the "ground truth" for quality and performance would be established through internal specifications, quality control, and adherence to recognized standards for contact lens materials and manufacturing. This information is not detailed in the provided summary.

Summary

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K133176

510(K) SUMMARY AIR OPTIX® COLORS (lotrafilcon B) Contact Lenses 1/27/2013

l. Submitter Information:

Company*:	Ciba Vision Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
Contact Person:	Martina Heim, Ph.D., RACSenior Principal Regulatory Specialist
Telephone:Facsimile:Email:Date Prepared:	678-415-3565678-415-3454martina.heim@alcon.com20 December 2013

With the merger between Alcon, Inc. and Novartis AG in April 2011, Ciba Vision Corporation and Alcon Laboratories, Inc. both became part of the newly formed Alcon eye care division within the Novartis group.

2. Device Name:

• Common Name:	Soft Contact Lens
• Trade/Proprietary Name:	AIR OPTIX® COLORS (lotrafilcon B)
• Classification Name:	Daily Wear Soft Contact Lens
• Device Classification:	Class II [21 CFR 886.5925 (b) (1)]

3. Predicate Device:

The predicate devices are Ciba Vision AIR OPTIX® AQUA (lotrafilcon B) soft contact lenses cleared under Premarket Notification 510(k) K073459 and Ciba Vision FreshLook ColorBlends® (phemfilcon A) soft contact lenses, approved for daily and extended wear under PMA P830037/S047.

4. Description of Device:

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K133176

Lens designs for AIR OPTIX® COLORS (lotrafilcon B) lenses include spherical, toric, and multifocal lenses in the following parameter range:

Power Range:	-20.00D to +20.00D
Center Thickness:	varies with design and power(0.08 mm for -3.00D spherical)
Diameter Range:	13.0 to 15.0 mm
Base Curve Range:	8.0 to 9.2 mm

Lenses have the following properties:

. Refractive index: 1.422 (hydrated) Light transmittance: . > 95% (380 - 780 nm)
- Water content: 33% by weight in normal saline
. 110 x 10 -11 (cm2/sec)(ml O2/ml x mm Hg), . Oxygen permeability
- measured at 35°C (intrinsic Dk-Coulometric method)

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845 (labeled as buffered saline containing 0.2 % VP/DMAEMA Copolymer). The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens color and 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 further extend the labeled expiration date.

5. Indications for Use:

AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

AIR OPTIX® COLORS Toric (lotrafilcon B) soft contact lenses are indicated for daily wear 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.

AIR OPTIX® COLORS Multifocal (lotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or

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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.

AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.

The lenses may be prescribed for frequent/planned replacement wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

6. Description of Safety and Substantial Equivalence:

AIR OPTIX® COLORS differ from AIR OPTIX® AQUA by featuring a cosmetic pattern which is embedded into the lens surface and partially masks the natural eye color to provide an enhanced appearance. The cosmetic pattern is applied through an in-mold pad printing process. The following tables summarize the characteristics of the modified device as compared to the predicate devices:

	Modified Device	Predicate Device	Predicate Device
	AIR OPTIX®COLORS	AIR OPTIX®AQUA	FreshLookColorBlends
Submission #	To be assigned	K073459 / P010019	P830037/S047
Intended Use	Vision CorrectionWith or withoutrefractive power:Enhance or alter theapparent color ofthe eye	Vision CorrectionN/A	Vision CorrectionWith or withoutrefractive power:Enhance or alter theapparent color of theeye
Wearing Schedule	Daily Wear	Daily and ExtendedWear	Daily Wearrecommended
Material	Group V (silicone	Group V (silicone	FDA Group 4
Classification:	hydrogel) hydrogelcontact lensmaterial accordingto ISO 18369-1:2006/.1:2009	hydrogel) hydrogelcontact lens materialaccording to ISO18369-1:2006/.1:2009	(> 50% H2O, ionicpolymer)
Lens Material:	lotrafilcon B	lotrafilcon B	phemfilcon A
Surface treatment	plasma treated	plasma treated	N/A

Product comparison:

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K133176

Technological characteristics:

	Modified DeviceAIR OPTIX®COLORS	Predicate DeviceAIR OPTIX®AQUA	Predicate DeviceFreshLookColorBlends
Submission #	To be assigned	K073459 / P010019	P830037/S047
ManufacturingMethod:	Double-sidemoldingintegrated print step	Double-side molding	Double-side moldingintegrated print step
Print technology	In-mold pad printtechnology	N/A	Pad print technologyon lens surface
Color additives forprint:	PCN GreenPCN BlueTitanium dioxideYellow iron oxideRed iron oxideBlack iron oxide	N/A	PCN GreenPCN BlueTitanium dioxideYellow iron oxideRed iron oxideBlack iron oxideBrown iron oxideChromium oxideCarbazole violetMica coated with IOMica coated withTiO2
Visibility Tint:	N/A	PCN Blue	PCN Green (optional)
Lens Designs:	Spherical, toric,multifocal	Spherical, toric,multifocal	Spherical, toric
Sterilization:	Steam sterilization,validated autoclave	Steam sterilization,validated autoclave	Steam sterilization,validated autoclave
Packaging:	Blister pack	Blister pack	Blister pack
Package Storagesaline solution	Phosphate bufferedsaline with (orwithout)1% Copolymer 845	Phosphate bufferedsaline with (orwithout)1% Copolymer 845	Borate bufferedsaline with 0.005%poloxamer

Parameter comparison:

	Modified Device	Predicate Device	Predicate Device
	AIR OPTIX®COLORS	AIR OPTIX®AQUA	FreshLookColorBlends
Submission #	To be assigned	K073459 / P010019	P830037/S047
Water Content:	33%	33%	55%
Power Range:	+20.00 to -20.00D	+20.00 to -20.00D	+20.00 to -20.00Dfor daily wear
Base Curve Range	8.0 to 9.2 mm	8.0 to 9.2 mm	7.80 to 9.00 mm
Diameter Range	13.0 to 15.0 mm	13.0 to 15.0 mm	12.0 to 15.0 mm
Refractive Index	1.422	1.422	1.409
OxygenPermeability*	110*	110*	16.1**

x 10 -11 (cm²/sec)(ml x mm Hg); measured at 35°C (intrinsic Dk-Coulometric method)

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** x 10 -11 (cm/s)[m] O2/(ml · mmHg] at 35 °C (Dr. Irving Fatt Method)

Non-clinical Testing:

A series of non-clinical testing was performed to characterize the lens material properties of AIR OPTIX® COLORS and demonstrate the substantial equivalence of the new device 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:

Physicochemical characteristics of the modified device are substantially equivalent . to the predicate lens, AIR OPTIX® AQUA.
. The lens material and extracts of the modified device are substantially equivalent to the predicate device and are non-toxic and non-irritating.

Successful stability testing supports the labeled expiration date.

Clinical Testing:

The subjective and objective performance and the physiological response of AIR OPTIX® COLORS soft contact lenses was evaluated in a 3-month prospective, randomized, controlled, open-label, parallel-group, multi-center study. A total of one hundred forty seven (147) subjects were enrolled and randomized to wear either test AIR OPTIX® COLORS (lotrafilcon B) or control AIR OPTIX® AQUA (lotrafilcon B) soft contact lenses, following a 2:1 subject allocation ratio as recommended by EN ISO 11980:2009 and the US FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994. This study consisted of 7 scheduled visits conducted over a 3 month period.

The primary efficacy variable of this trial was visual acuity. The secondary efficacy variables were subjective ratings of vision, comfort, and handling, lens fit, and lens surface characteristics. The safety variables of this trial were biomicroscopy findings, discontinuations (excluding cosmetic reasons), and all ocular adverse events.

Summary

The AIR OPTIX® COLORS and AIR OPTIX® AQUA lenses performed comparably during this study. In general, biomicroscopic findings, visual acuity, fit characteristics, lens surface

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performance, and subjective assessments were similar in the AIR OPTIX® COLORS and AIR OPTIX® AQUA groups. The study demonstrated substantial equivalence of AIR OPTIX® COLORS lenses to AIR OPTIX® AQUA lenses, the predicate device.

Substantial Equivalence:

AIR OPTIX® COLORS (lotrafilcon B) soft contact lenses packaged are equivalent to the predicate device lenses and similar to other daily wear soft contact lenses in terms of material properties, biocompatibility, clinical performance, and indications for use.

Any differences which may exist between AIR OPTIX® COLORS lenses and the predicate devices do not adversely affect the established performance characteristics and safety and effectiveness profile.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 12, 2014

CIBA Vision Corporation % Martina Heim, Ph.D., RAC Senior Principal Regulatory Specialist 11460 Johns Creek Parkway Duluth, GA 30097

Re: K133176

Trade/Device Name: AIR OPTIX® COLORS (lotrafilcon B) Regulation Number: 21 CFR 886.5925 Regulation Name: Daily Wear Soft (Hydrophilic) Contact Lenses Regulatory Class: Class II Product Code: LPL Dated: December 20, 2013 Received: December 23, 2013

Dear Dr. Heim:

This letter corrects our substantially equivalent letter of January 29, 2014.

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.

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Page 2 - Dr. Martina Heim

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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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.

Sincerely vours.

Kesia Y. Alexander -S

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133176

Device Name

AIR OPTIX® COLORS (lotrafilcon B) Soft Contact Lens

Indications for Use (Describe)

AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.

The lenses may be prescribed for frequent wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Jeffrey M. Brocious -S 2014.02.05 13:09:13 -05'00'

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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.