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.

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.

AI/ML Overview

This document describes the 510(k) submission for FreshLook contact lenses, which are a modification of already cleared devices. The modification involves adding an alternate foil lidding material grade for the primary packaging. As such, the study focuses on demonstrating that this packaging change does not negatively impact the device's performance, safety, or effectiveness.

Here's a breakdown of the requested information based on the provided text:

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

The document states that "all acceptance criteria [were] met" for the non-clinical testing. However, it does not explicitly list what those acceptance criteria were for each specific test, nor does it provide detailed quantitative performance results for the modified device beyond stating they are "Same" as the predicate for most performance specifications. The table below summarizes the listed performance specifications from the comparison table (Table 1), indicating that the modified device is expected to meet these same specifications.

Element of Comparison	Acceptance Criteria (Predicate Device Specification)	Reported Device Performance (Modified Device)
Refractive Index	1.412	Same (1.412)
Light Transmittance	95% minimum at 600 nm	Same (95% minimum at 600 nm)
Oxygen Transmissibility (Dk/L)	20 x 10^-9 (cm/s)[ml O2/(ml・mmHg] at 35 °C	Same (20 x 10^-9 (cm/s)[ml O2/(ml・mmHg] at 35 °C)
Biocompatibility	Biocompatible as confirmed by biocompatibility testing	Same (Biocompatible as confirmed by biocompatibility testing)
Shelf-life	60 months as confirmed by shelf-life stability testing	Same (60 months as confirmed by shelf-life stability testing)
Stability Testing	(Implied to be successful, criteria not specified)	Successful; all acceptance criteria met by modified device
Biocompatibility Testing	(Implied to be successful, criteria not specified)	Successful; all acceptance criteria met by modified device
Process Validation	(Implied to be successful, criteria not specified)	Successful; all acceptance criteria met by modified device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the non-clinical tests (stability, biocompatibility, process validation). It primarily focuses on comparing the modified device's characteristics to the predicate. The data provenance is not specified, but the submission is from Alcon Laboratories, Inc. in the USA, with the contact person in Germany, which implies the testing may have been conducted internationally. The testing appears to be prospective, as it was conducted for the modified device to verify equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this submission. The device is a soft contact lens, and the study is a non-clinical evaluation of a packaging change. It does not involve diagnostic image analysis or clinical expert review in the manner described by this question. The "ground truth" here is the physical and chemical properties and performance of the lens with the new packaging, compared to the established performance of the predicate device.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical trials or studies where human expert review disagreement needs to be resolved for ground truth establishment, often in diagnostic AI studies. This submission involves non-clinical laboratory testing.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools. The current submission is for a medical device (contact lens) where the modification is a packaging material change, and the evaluation is non-clinical.

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

This question is not applicable to the device described. The device is a contact lens, not an algorithm or AI system.

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

The "ground truth" in this context refers to the established performance characteristics and safety profile of the predicate device. The modified device's performance was compared against these established specifications through non-clinical laboratory testing (stability, biocompatibility, process validation). Therefore, the "ground truth" is essentially the physical, chemical, and biological performance characteristics and safety data of the legally marketed predicate device, as determined by prior validated testing.

8. The sample size for the training set

This information is not applicable. The submission is for a physical medical device (contact lens) and involves non-clinical testing of a packaging change, not the development or training of an algorithm or AI model.

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

This information is not applicable for the reasons stated in point 8.

Summary

{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.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181796

Device Name

FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions

Indications for Use (Describe)

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)

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.

Submitter Information I.

Company:	Alcon Laboratories, Inc.6201 South FreewayFort 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, FreshLookColorBlends, 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.

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 ofComparison	Predicate Device	Modified Device
Administrative / Regulatory Information
510(k) Number	510(k) (P830037)	K181796
Product Name(s)	FreshLook Handling Tint,FreshLook Colors, FreshLookColorBlends, FreshLookDimensions	Same
DeviceClassificationInformation	Class II, Soft (Hydrophilic)Contact Lenses, 21 CFR886.5925	Same
Indications For Use Information
Intended Use	Daily wear frequentreplacement soft contactlenses for the opticalcorrection of refractive error	Same
Technology Information
Lens Material	phemfilcon A	Same
MaterialClassification	FDA Group 4 (≥ 50% H2O,ionic polymer)	Same
Water Content	55%	Same
Visibility Tint	FreshLook Handling Tint andFreshLook Dimensions: Lightgreen tint; FreshLook Colorsand FreshLook ColorBlends:No tint	Same
ManufacturingMethod	Double Sided Molding	Same
Lens Designs	Spherical	Same
Sterilization	Steam sterilization, validatedautoclave	Same

		Table 1: Substantial Equivalence Comparison
--	--	---------------------------------------------

{6}------------------------------------------------

Element ofComparison	Predicate Device	Modified Device
PrimaryPackaging System	Foil blister pack containersystem: Polypropylene blistershell sealed with analuminum-based foil lidding	Same
PrimaryPackaging: BlisterShell	Injection-moldedpolypropylene blister shell	Same
PrimaryPackaging: FoilLidding	Constantia-Hueck foil lidding- Current grade	Constantia-Hueck foil lidding– Modified grade
Package Storage /Saline Solution	Isotonic, borate bufferedsaline containing 0.005%Poloxamer	Same
Performance Specifications including any Testing
Refractive Index	1.412	Same
LightTransmittance	95% minimum at 600 nm	Same
OxygenTransmissibility	Dk/L = 20 x 10-9 (cm/s)[mlO2/(ml・mmHg] at 35 °C	Same
Biocompatibility	Biocompatible as confirmedby biocompatibility testing	Same
Shelf-life	60 months as confirmed byshelf-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:

{7}------------------------------------------------

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.

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.

Scott E. Steffen -S

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(k) Summary

Submitter Information I.

Devices Subject to this 510(k) II.

III. Predicate Device

IV. Device Description

Indications for Use V.

VI. Comparison of Technological Characteristics with the Predicate Device

VII. Performance Data

Non-clinical Testing

Clinical Testing

VIII. Conclusions

§ 886.5925 Soft (hydrophilic) contact lens.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW