(28 days)
Not Found
No
The summary describes a physical contact lens with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the "optical correction of refractive ametropia (myopia)" and "optical correction of presbyopia", which are therapeutic uses to correct vision.
No
The device is a soft contact lens intended for optical correction of refractive ametropia and to enhance or alter eye color. It is not used for diagnosing medical conditions.
No
The device is a physical contact lens made of a hydrogel material with embedded color additives. The description details the material composition, physical parameters, and packaging, all indicative of a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "optical correction of refractive ametropia" and to "enhance or alter the apparent color of the eye." This describes a device that physically interacts with the eye to improve vision and change appearance.
- Device Description: The description details the material composition, physical properties (diameter, base curve, power, thickness, refractive index, transmittance, water content, oxygen permeability), and packaging of a contact lens. These are characteristics of a medical device used for vision correction and cosmetic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (blood, urine, tissue, etc.) or provide information for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description does not align with the function of a contact lens.
N/A
Intended Use / Indications for Use
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) 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.
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.
Product codes
LPL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in consideration of the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses.
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.
Clinical Testing: The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name AIR OPTIX COLORS
Indications for Use (Describe)
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.
| 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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3
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 Freeway
Fort Worth, TX 76134-2099, USA |
|-----------------|----------------------------------------------------------------------------------|
| Contact Person: | Dr. Andreas Friese
Regulatory 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
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
4
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.
5
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.
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.
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 of
| Comparison | Predicate Device(s) | Modified Device(s) |
|---|---|---|
| Administrative / Regulatory Information | ||
| Trade Name(s) | AIR OPTIX® COLORS | Same |
| 510(k) Number | K172600 | To be assigned |
| Device Classification | ||
| Name | Daily Wear Soft Contact Lens | |
| 21 CFR 886.5925 (b) (1) | Same | |
| Element of | ||
| Comparison | Predicate Device(s) | Modified Device(s) |
| Indications For Use Information | ||
| Intended Use | With refractive power: | |
| Vision Correction | ||
| With or without refractive | ||
| power: | ||
| Enhance or alter the apparent | ||
| color 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 | ||
| PCN green | ||
| PCN blue | ||
| Titanium dioxide | ||
| Yellow iron oxide | ||
| Red iron oxide | ||
| Black iron oxide | ||
| Carbazole violet | Same | |
| Water Content | 33% | Same |
| Refractive Index | 1.42 | Same |
| Oxygen Permeability | ~110* | Same |
| Sterilization | Steam sterilization, | |
| validated autoclave | Same | |
| Primary Packaging | ||
| System | Foil blister pack: | |
| polypropylene blister shell | ||
| sealed with a polyester coated | ||
| aluminum foil lidding | Same | |
| Element of | ||
| Comparison | Predicate Device(s) | Modified Device(s) |
| Primary Packaging | ||
| Blister Shell | Injection-molded poly- | |
| propylene (PP) blister shell | Same | |
| Primary Packaging | ||
| Foil Lidding | Multi-layer laminate structure | |
| polyester-coated aluminum foil | ||
| lidding supplied by: | ||
| • Amcor | Multi-layer laminate structure | |
| polyester-coated aluminum foil | ||
| lidding supplied by: | ||
| • Amcor | ||
| • Constantia-Pirk | ||
| Package Storage | ||
| Saline 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
6
Table 1: Substantial Equivalence Comparison
7
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.
8
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.