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

AIR OPTIX® COLORS (lotrafilcon B) toric 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 (lotrafilcon B) multifocal soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with nondiseased 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.

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: carbazole violet, iron oxides, [phthalocyaninato (2-)] copper, phthalocyanine green and titanium dioxide.

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

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 (0.08 mm for -3.00D spherical)

Lenses have the following properties:

• Refractive index: 1.42 (hydrated)
• Luminous transmittance: 95 ± 5%
• 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)

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 parameters, lens color, 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.

AI/ML Overview

I'm sorry, but this document does not contain the detailed information necessary to complete your request. This document is an FDA 510(k) clearance letter and a 510(k) summary for AIR OPTIX® COLORS contact lenses.

Here's why I cannot fulfill your request:

No Acceptance Criteria or Device Performance Table: The document states that "new color options are being added" and that "Key product characteristics remain unchanged," indicating that the performance would be substantially equivalent to the predicate device. However, it does not provide a table of specific acceptance criteria (e.g., minimum visual acuity improvement, maximum complication rate) or reported device performance against those criteria.
No Detailed Study Description: While it mentions "Performance testing was conducted in consideration of the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses" and "Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58)," it does not describe the studies in detail. It explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device." This means there aren't the types of clinical studies (with test sets, ground truth, experts, MRMC studies, standalone performance) you're asking about.
Focus on Substantial Equivalence: The document is primarily focused on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a previously cleared device. This often involves showing that fundamental characteristics and performance remain the same, rather than conducting new, large-scale clinical trials with new acceptance criteria.

Therefore, I cannot extract information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for test sets, sample size for training sets, or how ground truth for training sets was established.

The document indicates that the modification (adding new color options) did not necessitate new clinical studies to establish safety and effectiveness, as the key product characteristics and material remained the same as the predicate device. The performance data mentioned are non-clinical (physicochemical characteristics and biocompatibility) to show equivalence.

Summary

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October 25, 2017

Alcon Laboratories, Inc. Martina Heim, Ph.D., RAC Director, Global Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099

Re: K172600

Trade/Device Name: AIR OPTIX COLORS® Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: August 25, 2017 Received: August 30, 2017

Dear Martina Heim, Ph.D., RAC:

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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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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,

Denise L. Hampton -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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172600

Device Name AIR OPTIX® COLORS soft contact lenses

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.

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)	[X] Prescription Use (Part 21 CFR 801 Subpart D)	[] Over-The-Counter Use (21 CFR 801 Subpart C)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.

I. Submitter of the 510(k)

Company:	Alcon Laboratories, Inc.
	6201 South FreewayFort Worth, TX 76134-2099, USA
Primary Contact Person:	Martina Heim, Ph.D., RACDirector, Global Regulatory Affairs
Phone:	678-415-3565
Fax:	678-415-3454
Email:	martina.heim@alcon.com
Date Prepared:	21 August 2017

II. Devices Subject to this 510(k)

Trade Names:	AIR OPTIX® COLORS
Common Name:	Soft Contact Lens
Classification Name:	Soft (Hydrophilic) Contact Lenses
Device Classification:	Class II [21 CFR 886.5925 (b) (1)]
Product Code:	LPL

III. Predicate Device

The subject device, AIR OPTIX® COLORS (lotrafilcon B) soft contact lenses, is a modification of the currently commercialized AIR OPTIX® COLORS contact lens. The predicate AIR OPTIX® COLORS soft contact lenses have received FDA clearance per Premarket Notification 510(k) K133176.

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IV. Device Description

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

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 (0.08 mm for -3.00D spherical)

Lenses have the following properties:

• Refractive index:	1.42 (hydrated)
• Luminous transmittance:	95 ± 5%
• 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 - Coulometricmethod)

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Indications for Use V.

AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses with refractive power 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 up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

AIR OPTIX® COLORS (lotrafilcon B) multifocal soft contact lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) 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.

VI. Comparison to Technological Characteristics with the Predicate Device

New color options are being added to the line of AIR OPTIX® COLORS (lotrafilcon B) soft contact lenses. Key product characteristics remain unchanged, as listed in Table 1. Carbazole violet is added to the list of color additives that are used to achieve the desired shade variations in the cosmetic print pattern.

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	Predicate Device	Modified Device
Administrative / Regulatory Information
Trade Name	AIR OPTIX® COLORS	Same
Submission number	K133176	510(k) # to be assigned
Device ClassificationName	Daily Wear Soft Contact Lens21 CFR 886.5925 (b) (1)	Same
Indications For Use Information
	With refractive power:Vision Correction	Same
Intended Use	With or without refractive power:Enhance or alter the apparentcolor of the eye	Same
Wearing Schedule	Daily Wear	Same
Replacement Schedule	Up to Monthly Replacement	Same
Material and Technology Information
Lens Material	lotrafilcon B	Same
Surface Treatment	Plasma treated	Same
Manufacturing Method	Double-side molding;integrated print step	Same
Print Technology	In-mold pad print technology	Same
Color Additives for Print:	PCN greenPCN blueTitanium dioxideYellow iron oxideRed iron oxideBlack iron oxide	PCN greenPCN blueTitanium dioxideYellow iron oxideRed iron oxideBlack iron oxideCarbazole violet
Water Content	33%	Same
Refractive Index	1.42	Same
Oxygen Permeability	~110*	Same
Sterilization	Steam sterilization,validated autoclave	Same
	Predicate Device	Modified Device
Packaging	Blister pack	Same
Package Storage SalineSolution	Phosphate buffered saline with(or without) 1% Copolymer 845	Same
Lens Design and Parameters
Lens Designs	Spherical, toric, multifocal	Same
Power Range	+20.00 to -20.00D	Same
Base Curve Range	8.0 to 9.2 mm	Same
Diameter Range	13.0 to 15.0 mm	Same

Table 1. Substantial Equivalence Comparison

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Table 1. Substantial Equivalence Comparison

intrinsic Dk - Coulometric method; barrer units

VII. Performance Data

Performance testing was conducted in consideration of the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses. The following performance data are provided in support of the substantial equivalence determination:

Non-clinical Testing

A series of non-clinical testing was performed to characterize the lens material properties of AIR OPTIX® COLORS lenses and demonstrate the substantial equivalence of the modified 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® COLORS.
The modification does not impact the established safety profile for AIR OPTIX® ● COLORS soft contact lenses.

Successful stability testing supports the labeled expiration date.

Clinical Testing

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

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VIII. Conclusions

AIR OPTIX® COLORS (lotrafilcon B) soft contact lenses as modified are equivalent to the predicate device lenses and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use.

Non-clinical data demonstrates that the modified device is as safe, as effective, and performs as well as or better than the legally marketed, predicate device, AIR OPTIX® COLORS soft contact lenses.

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.