(56 days)
Not Found
No
The document describes a standard soft contact lens with different designs and parameters. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is indicated for the optical correction of refractive ametropia and/or presbyopia, and to enhance or alter the apparent color of the eye, which are not considered therapeutic purposes.
No
The device description clearly states its purpose is for "optical correction of refractive ametropia" and to "enhance or alter the apparent color of the eye," which are therapeutic and cosmetic functions, not diagnostic.
No
The device description clearly indicates it is a physical contact lens made of a hydrogel material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that AIR OPTIX® COLORS are soft contact lenses intended for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) and to enhance or alter the apparent color of the eye.
- No Biological Sample Testing: The device does not involve testing any biological samples from the patient. It is a physical device placed on the surface of the eye.
- Intended Use: The intended use is for vision correction and cosmetic enhancement, not for diagnosing any disease or condition.
Therefore, based on the provided text, AIR OPTIX® COLORS contact lenses do not fit the definition of an In Vitro Diagnostic device.
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) 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.
Product codes
LPL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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.
1
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
2
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) 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
3
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 Freeway | |
| Fort Worth, TX 76134-2099, USA | |
| Primary Contact Person: | Martina Heim, Ph.D., RAC |
| Director, 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.
4
IV. 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.
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 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.
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.
6
| Predicate Device | Modified Device | |
|---|---|---|
| Administrative / Regulatory Information | ||
| Trade Name | AIR OPTIX® COLORS | Same |
| Submission number | K133176 | 510(k) # to be assigned |
| Device Classification | ||
| Name | Daily Wear Soft Contact Lens | |
| 21 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 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 Print: | PCN green | |
| PCN blue | ||
| Titanium dioxide | ||
| Yellow iron oxide | ||
| Red iron oxide | ||
| Black iron oxide | PCN green | |
| PCN blue | ||
| Titanium dioxide | ||
| Yellow iron oxide | ||
| Red iron oxide | ||
| Black iron oxide | ||
| Carbazole 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 Saline | ||
| Solution | 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
7
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.
8
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.