(29 days)
P830037
Not Found
No
The device description focuses on the material composition, design, and manufacturing process of contact lenses, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is indicated for the correction of visual acuity in persons with non-diseased eyes, addressing refractive errors rather than treating a disease or condition.
No
Explanation: The device is a soft contact lens indicated for the correction of visual acuity, which is a treatment rather than a diagnostic function. It explicitly states "for the correction of visual acuity in persons with nondiseased eyes."
No
The device description clearly states that the device is a family of soft contact lenses made of a specific material (phemfilcon A) and includes details about its physical properties, manufacturing process, and packaging. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of FreshLook contact lenses is for the correction of visual acuity and altering the apparent color of the eye by being placed on the eye. They do not analyze or test any biological samples.
- The device description focuses on the physical properties and materials of the contact lens. It describes the lens material, water content, colors, and packaging. This is consistent with a medical device intended for direct application to the body, not for in vitro analysis.
- The performance studies described are non-clinical and focus on stability, biocompatibility, and process validation. These are typical tests for medical devices, not IVDs, which would involve clinical studies evaluating the accuracy and reliability of diagnostic results.
In summary, FreshLook contact lenses are a medical device intended for optical correction and cosmetic enhancement, not for diagnosing or testing conditions using in vitro methods.
N/A
Intended Use / Indications for Use
FreshLook Spherical (phemfilcon A) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with nondiseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.
The FreshLook Spherical Colors, ColorBlends, and Dimensions lenses act to enhance or alter the apparent color of the eye.
The eye care professional may prescribe the lens for frequent with daily removal for cleaning and disinfection. The lens may be disinfected using a chemical disinfection system.
Product codes
LPL
Device Description
FreshLook (phemfilcon A) are a family of soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical designs and in the following lens models: FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends and FreshLook Dimensions.
FreshLook contact lenses are made of phemfilcon A lens material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-ethoxyethyl methacrylate (EOEMA). The lenses have a water content of 55% by weight.
FreshLook Colors and FreshLook ColorBlends lenses are made of clear lens material, FreshLook Handling Tint and FreshLook Dimensions are made of tinted (green handling tint) lens material polymer to facilitate lens visibility for handling.
FreshLook Colors, FreshLook ColorBlends and FreshLook Dimensions lenses are printed with an intermittent coating containing color additives listed in the color additive provisions of 21 CFR. FreshLook Colors are available in the colors Blue, Green, Hazel, Misty Gray, Sapphire Blue and Violet. FreshLook ColorBlends are available in the colors Amethyst, Blue, Brown, Gray, Green, Honey, Pure Hazel, True Sapphire, Turquoise, Gemstone Green, Brilliant Blue and Sterling Gray. FreshLook Dimensions are available in the colors Caribbean Aqua, Pacific Blue and Sea Green.
FreshLook soft contact lenses are supplied sterile. The lenses immersed in 2.5 ml isotonic borate buffered saline solution are packaged in individual foil-blister packs and are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The packaging saline contains 0.005% Poloxamer.
The foil-blister pack system consists of a thermo-formed array bottom made from polypropylene resin, sealed with an aluminum-based foil lidding. The blister packs are packaged into carton boxes available in different pack sizes.
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)
Non-clinical Testing: Successful stability and biocompatibility testing as well as process validation were completed for the modified device to verify equivalence to the predicate device. This 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)
P830037
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.
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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.
August 03, 2018
Alcon Laboratories, Inc. Andreas Friese Regulatory Project Director, GRA Alcon Vision Care Alcon/CIBA Vision GmbH Industriering 1 Grosswallstadt, Bavaria 63868 Germany
Re: K181796
Trade/Device Name: FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: June 28, 2018 Received: July 5, 2018
Dear 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
1
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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm): good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Scott E. Steffen -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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Indications for Use
510(k) Number (if known) K181796
Device Name
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
Indications for Use (Describe)
FreshLook Spherical (phemfilcon A) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with nondiseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.
The FreshLook Spherical Colors, ColorBlends, and Dimensions lenses act to enhance or alter the apparent color of the eye.
The eye care professional may prescribe the lens for frequent with daily removal for cleaning and disinfection. The lens may be disinfected using a chemical disinfection system.
| 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)
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510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
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 03, 2018 |
Devices Subject to this 510(k) II.
| Trade Names: | Soft Contact Lenses for Daily Wear (phemfilcon A material).
FreshLook Handling Tint, FreshLook Colors, FreshLook
ColorBlends, FreshLook Dimensions |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lenses |
| Classification Name: | Soft (Hydrophilic) Contact Lenses |
| Device Classification: | Class II [21 CFR 886.5925] |
| Product Code: | LPL |
III. Predicate Device
The 510(k) devices are a modification of the same predicate devices, i.e. FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends and FreshLook Dimensions (phemfilcon A) soft contact lenses, which are legally commercialized devices in the US under 510(k) P830037.
IV. Device Description
FreshLook (phemfilcon A) are a family of soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical designs and in the
4
following lens models: FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends and FreshLook Dimensions.
FreshLook contact lenses are made of phemfilcon A lens material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-ethoxyethyl methacrylate (EOEMA). The lenses have a water content of 55% by weight.
FreshLook Colors and FreshLook ColorBlends lenses are made of clear lens material, FreshLook Handling Tint and FreshLook Dimensions are made of tinted (green handling tint) lens material polymer to facilitate lens visibility for handling.
FreshLook Colors, FreshLook ColorBlends and FreshLook Dimensions lenses are printed with an intermittent coating containing color additives listed in the color additive provisions of 21 CFR. FreshLook Colors are available in the colors Blue, Green, Hazel, Misty Gray, Sapphire Blue and Violet. FreshLook ColorBlends are available in the colors Amethyst, Blue, Brown, Gray, Green, Honey, Pure Hazel, True Sapphire, Turquoise, Gemstone Green, Brilliant Blue and Sterling Gray. FreshLook Dimensions are available in the colors Caribbean Aqua, Pacific Blue and Sea Green.
FreshLook soft contact lenses are supplied sterile. The lenses immersed in 2.5 ml isotonic borate buffered saline solution are packaged in individual foil-blister packs and are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The packaging saline contains 0.005% Poloxamer.
The foil-blister pack system consists of a thermo-formed array bottom made from polypropylene resin, sealed with an aluminum-based foil lidding. The blister packs are packaged into carton boxes available in different pack sizes.
Indications for Use V.
The 510(k) devices are a modification of the same predicate devices. The Indications for Use remain the same, as follows:
FreshLook Spherical (phemfilcon A) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with nondiseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.
The FreshLook Spherical Colors, ColorBlends, and Dimensions lenses act to enhance or alter the apparent color of the eye.
The eye care professional may prescribe the lens for frequent replacement with daily removal for cleaning and disinfection. The lens may be disinfected using a chemical disinfection system.
5
VI. Comparison of Technological Characteristics with the Predicate Device
The proposed device modification involves adding an alternate foil lidding material grade from an existing approved supplier for use in the primary packaging (i.e. foilblister pack container system) of FreshLook family soft contact lenses.
The following matrix (Table 1) summarizes the characteristics of the modified device as compared to the predicate device.
| Element of
| Comparison | Predicate Device | Modified Device |
|---|---|---|
| Administrative / Regulatory Information | ||
| 510(k) Number | 510(k) (P830037) | K181796 |
| Product Name(s) | FreshLook Handling Tint, | |
| FreshLook Colors, FreshLook | ||
| ColorBlends, FreshLook | ||
| Dimensions | Same | |
| Device | ||
| Classification | ||
| Information | Class II, Soft (Hydrophilic) | |
| Contact Lenses, 21 CFR | ||
| 886.5925 | Same | |
| Indications For Use Information | ||
| Intended Use | Daily wear frequent | |
| replacement soft contact | ||
| lenses for the optical | ||
| correction of refractive error | Same | |
| Technology Information | ||
| Lens Material | phemfilcon A | Same |
| Material | ||
| Classification | FDA Group 4 (≥ 50% H2O, | |
| ionic polymer) | Same | |
| Water Content | 55% | Same |
| Visibility Tint | FreshLook Handling Tint and | |
| FreshLook Dimensions: Light | ||
| green tint; FreshLook Colors | ||
| and FreshLook ColorBlends: | ||
| No tint | Same | |
| Manufacturing | ||
| Method | Double Sided Molding | Same |
| Lens Designs | Spherical | Same |
| Sterilization | Steam sterilization, validated | |
| autoclave | Same |
| Table 1: Substantial Equivalence Comparison | ||
|---|---|---|
| -- | -- | --------------------------------------------- |
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| Element of
| Comparison | Predicate Device | Modified Device |
|---|---|---|
| Primary | ||
| Packaging System | Foil blister pack container | |
| system: Polypropylene blister | ||
| shell sealed with an | ||
| aluminum-based foil lidding | Same | |
| Primary | ||
| Packaging: Blister | ||
| Shell | Injection-molded | |
| polypropylene blister shell | Same | |
| Primary | ||
| Packaging: Foil | ||
| Lidding | Constantia-Hueck foil lidding |
- Current grade | Constantia-Hueck foil lidding
– Modified grade |
| Package Storage /
Saline Solution | Isotonic, borate buffered
saline containing 0.005%
Poloxamer | Same |
| Performance Specifications including any Testing | | |
| Refractive Index | 1.412 | Same |
| Light
Transmittance | 95% minimum at 600 nm | Same |
| Oxygen
Transmissibility | Dk/L = 20 x 10-9 (cm/s)[ml
O2/(ml・mmHg] at 35 °C | Same |
| Biocompatibility | Biocompatible as confirmed
by biocompatibility testing | Same |
| Shelf-life | 60 months as confirmed by
shelf-life stability testing | Same |
Table 1: Substantial Equivalence Comparison
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:
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Non-clinical Testing
Successful stability and biocompatibility testing as well as process validation were completed for the modified device to verify equivalence to the predicate device. This 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.
VIII. Conclusions
The cumulative results of all performance testing demonstrate the safety, efficacy and performance of the modified device and, thus, substantial equivalence to the predicate device.
Freshlook brand (phemfilcon A) soft contact lenses in modified primary packaging are substantially equivalent to the predicate lenses of material properties, biocompatibility, 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.