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 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 presbyopia with or without refractive ametropia) in phakic or aphakic 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.

Device Description

The lens material of AIR OPTIX® COLORS is 33% water and 67% lotrafilcon B, a fluorosilicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group 5 (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2017. 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.

Cleared lens designs for AIR OPTIX® COLORS (lotrafilcon B) 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: -20.00 D to +20.00 D
• Center Thickness: varies with design and power (0.08 mm for -3.00 D 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 phosphate buffered saline solution (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

The provided text describes a 510(k) premarket notification for a medical device, specifically AIR OPTIX® COLORS (lotrafilcon B) Soft Contact Lenses, and a modification to its primary packaging. It details the device, its intended use, and a comparison to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets performance criteria in the way typically expected for an AI/ML medical device.

The context of the document is a regulatory submission for a contact lens and a packaging change, not a software or AI device. Therefore, the specific information requested in the prompt related to AI/ML device evaluation (e.g., test set sample size, ground truth establishment, MRMC study, effect size, training set) is not applicable or present in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a physical medical product and a packaging modification. The "Performance Data" section primarily addresses non-clinical testing to verify equivalence for the packaging change, rather than performance of the contact lens itself (which was previously established for the predicate).

Here's a breakdown of the relevant information provided, adapted to the context of the document:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formal table of acceptance criteria and performance for the device itself (the contact lens) because the 510(k) is primarily for a packaging modification. Instead, it states that "Testing resulted in all acceptance criteria being met" for the packaging modification.

Acceptance Criteria and Reported Device Performance (Related to Packaging Modification)

Acceptance Criteria	Reported Device Performance
Stability testing successful	All acceptance criteria met
Biocompatibility testing successful	All acceptance criteria met
Process validation completed	All acceptance criteria met
Maintenance of material properties	Demonstrated
Maintenance of biocompatibility	Demonstrated
Maintenance of shelf-life/expiration dating	Demonstrated
Maintenance of clinical performance	Demonstrated (no adverse effect from packaging change)
Maintenance of indications for use	Demonstrated (no adverse effect from packaging change)

Study Proving Device (Packaging Modification) Meets Acceptance Criteria

The study described is a non-clinical evaluation to demonstrate that the modified packaging (alternate foil lidding material from "Constantia-Pirk") does not negatively impact the safety and performance of the AIR OPTIX® COLORS contact lenses.

2. Sample sized used for the test set and the data provenance

Sample Size: Not explicitly stated. The document mentions "representative lotrafilcon B soft contact lenses" were used for stability, biocompatibility, and process validation testing, but does not provide specific numbers.
Data Provenance: Not explicitly stated, but it would be from internal Alcon Laboratories, Inc. testing facilities or contracted laboratories for the specific non-clinical tests conducted. The testing is reported as "successful," implying it was conducted as part of the regulatory submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the submission is for a physical medical device (contact lens) and a packaging change, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The evaluation relied on scientific and engineering testing for stability, biocompatibility, and process validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a contact lens packaging modification. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the nature of this submission. The "adjudication" here would be the scientific review and approval of the test results by qualified personnel within Alcon and subsequently by the FDA.

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

This is not applicable as the device is a contact lens, not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in the performance evaluation described.

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

This is not applicable as the device is a contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to AI/ML devices is not applicable here. For this submission, the "truth" is established by adherence to validated scientific and engineering testing methods for characteristics like material stability, sterility, and biocompatibility, as outlined in relevant standards and guidelines (e.g., FDA guidance for contact lenses, ISO standards).

8. The sample size for the training set

This is not applicable as the device is a contact lens and not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is a contact lens and not an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 15, 2022

Alcon Laboratories, Inc. Dr. Andreas Friese Regulatory Project Director 6201 South Freeway Fort Worth, TX 76134-2099

Re: K222500

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 17, 2022 Received: August 18, 2022

Dear Dr. Andreas Friese:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K222500

Device Name AIR OPTIX COLORS

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)
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.

510(k) number: K222500

Submitter Information I.

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Contact Person:	Dr. Andreas FrieseRegulatory Project Director
Phone:	+49 6022-240-514
Fax:	+49 6022-240-512
Email:	andreas.friese@alcon.com
Date Prepared:	August 16, 2022

Devices Subject to this 510(k) II.

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

III. Predicate Device

The 510(k) devices are a modification of the same predicate devices, i.e., AIR OPTIX® COLORS (lotrafilcon B) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearance: K172600.

IV. Device Description

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

Cleared lens designs for AIR OPTIX® COLORS (lotrafilcon B) 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:	-20.00 D to +20.00 D
• Center Thickness:	varies with design and power(0.08 mm for -3.00 D 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)

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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 eves 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 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 of Technological Characteristics with the Predicate Device

The proposed device modification involves adding an alternate foil lidding material for use in the primary packaging of AIR OPTIX® COLORS (lotrafilcon B) soft contact lenses. The following matrix (Table 1) summarizes the characteristics of the modified devices as compared to the predicate devices.

Element ofComparison	Predicate Device(s)	Modified Device(s)
Administrative / Regulatory Information
Trade Name(s)	AIR OPTIX® COLORS	Same
510(k) Number	K172600	To be assigned
Device ClassificationName	Daily Wear Soft Contact Lens21 CFR 886.5925 (b) (1)	Same
Element ofComparison	Predicate Device(s)	Modified Device(s)
Indications For Use Information
Intended Use	With refractive power:Vision CorrectionWith or without refractivepower: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 forPrint	PCN greenPCN blueTitanium dioxideYellow iron oxideRed iron oxideBlack iron oxideCarbazole violet	Same
Water Content	33%	Same
Refractive Index	1.42	Same
Oxygen Permeability	~110*	Same
Sterilization	Steam sterilization,validated autoclave	Same
Primary PackagingSystem	Foil blister pack:polypropylene blister shellsealed with a polyester coatedaluminum foil lidding	Same
Element ofComparison	Predicate Device(s)	Modified Device(s)
Primary PackagingBlister Shell	Injection-molded poly-propylene (PP) blister shell	Same
Primary PackagingFoil Lidding	Multi-layer laminate structurepolyester-coated aluminum foillidding supplied by:• Amcor	Multi-layer laminate structurepolyester-coated aluminum foillidding supplied by:• Amcor• Constantia-Pirk
Package StorageSaline Solution	Phosphate buffered saline(with or without) 1%Copolymer 845	Same
Lens Design and Parameter
Lens Designs	Spherical, toric, multifocal	Same
Power Range	+20.00 to -20.00 D	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

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Table 1: Substantial Equivalence Comparison

intrinsic Dk - Coulometric method; barrer units

In accordance with the criteria for claims of substantial equivalence in the FDA guidance Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the information provided supports the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process.

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

To verify equivalence of the modified device to the predicate device (AIR OPTIX® COLORS lotrafilcon B soft contact lenses), successful stability and biocompatibility testing as well as process validation were completed for representative lotrafilcon B soft contact lenses produced/packaged with the Constantia lidding foil. Testing resulted in all acceptance criteria being met.

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Clinical Testing

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

VIII. Conclusions

The cumulative results of all performance testing demonstrate the safety, efficacy and performance of the modified device(s) and, thus, substantial equivalence to the predicate device(s).

AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses in modified primary packaging including the proposed alternate 'Constantia Pirk' foil lidding material are substantially equivalent to the predicate lenses of material properties, biocompatibility, shelf-life/expiration dating, clinical performance, and indications for use.

Any differences which may exist between the modified and the predicate device do not adversely affect the established performance characteristics and safety and effectiveness profile.

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.