DAILIES TOTAL1 (delefilcon A) and DAILIES TOTAL1 Asphere (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL1 for ASTIGMATISM (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.

DAILIES TOTAL1 Multifocal (delefilcon A) soft contact lenses are indicated 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 (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia, 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 6.00 diopters (D) of astigmatism.

The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The DAILIES TOTAL 1® family of daily disposable soft contact lenses are made from delefilcon A, a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. The delefilcon A silicone hydrogel material is considered a Group 5C material according to ISO 18369-1:2017 (defined as: "enhanced oxygen permeable material", water content less than 50%, no ionic monomer or oligomer at pH 6 to pH 8).

Modified DAILIES TOTAL1® lenses contain a combination of light absorbing chromophores. Specifically, benzotriazole UV absorbing monomers are used to block UV radiation and, additionally, reduce transmittance in the range from 380 nm. The color additive [phthalocyaninato (2-)] copper (synonym: copper phthalocyanine) provides a light blue-green handling tint.

Lens designs for the modified DAILIES TOTALI® (delefilcon A) lenses include spherical, asphere, toric, multifocal, and multifocal toric 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 (0.09 mm for -3.00D spherical)

Lenses have the following properties:

Refractive index: 1.42 (hydrated)
Water content: 33% by weight in normal saline
Oxygen permeability 140 barrer units measured at 35 °C (intrinsic Dk - Coulometric method)
% Light transmittance, visible: 90 ± 5% (average over 380 to 780 nm)
% UV transmittance UVA (315-380 nm): < 10.0%
UVB (280-315 nm): < 1.0%

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents that form the water gradient surface. 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, 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 modifications to already cleared contact lenses (DAILIES TOTAL1®). The submission (K182782) focuses on showing that the modified device remains substantially equivalent to the predicate device. Therefore, the information required for a study proving device meets acceptance criteria, particularly for a new device with specific performance metrics, is not directly applicable or comprehensively provided as it would be for a novel AI/software medical device.

Based on the document, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one would expect for an AI/software device with quantitative metrics like sensitivity, specificity, etc.
Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" is assessed by showing that the modified device's characteristics are the "same as" the predicate device in key areas, and that non-clinical testing confirms its safety and effectiveness.

Here's a table derived from the "Comparison to Technological Characteristics with the Predicate Device" and "Performance Data" sections:

Characteristic/Criterion	Predicate Device Specification	Subject Device Performance (Modified DAILIES TOTAL1® lenses)	Acceptance (vs. Predicate)
Intended Use	Vision correction	Same	Met
Wearing Schedule	Daily wear	Same	Met
Replacement Schedule	Daily disposable	Same	Met
Material Classification	Group 5C, low water silicone hydrogel according to ISO 18369-1:2017	Same	Met
Lens Material	Delefilcon A	Same	Met
Surface Treatment	Water gradient surface treatment	Same	Met
Manufacturing Method	LightStream (molded)	Same	Met
Visibility Tint	[phthalocyaninato (2-)] copper	Same	Met
Lens Marks	None	Molded lens marks (e.g. fiducial mark for toric lenses)	Different (but considered acceptable, likely not impacting substantial equivalence negatively)
Lens Designs	Spherical, toric, multifocal, multifocal toric	Spherical, asphere, toric, multifocal, multifocal toric	Different (broader range, but deemed substantially equivalent)
Power Range	+20.00 to -20.00D	Same	Met
Base Curve Range	8.0 to 9.2 mm	Same	Met
Diameter Range	13.0 to 15.0 mm	Same	Met
Water Content	33%	Same	Met
Refractive Index	1.42	Same	Met
Oxygen Permeability	140 barrer units*	Same	Met
Sterilization	Steam sterilization, validated autoclave	Same	Met
Packaging	Polypropylene blister shell sealed with polyester coated aluminum foil lidding	Same	Met
Package Storage Saline Solution	Phosphate buffered saline (PBS) with polymeric wetting agents	Same	Met
Physicochemical characteristics	(Implicitly, those of the predicate)	Substantially equivalent to predicate	Met
Biocompatibility	(Implicitly, non-toxic, non-irritating, non-sensitizing, non-genotoxic)	Non-toxic, non-irritating, non-sensitizing, and non-genotoxic	Met
Stability Testing	(Implicitly, supports labeled expiration date)	Successful stability testing supports the labeled expiration date	Met
Light transmittance, visible (380-780 nm)	(Not explicitly stated for predicate in comparison table, but implied by "Light transmittance properties (incl. UV and UV-Vis) are supported by testing...")	90 ± 5% (average over 380 to 780 nm)	Met (against ISO standard / internal specification)
UVA (315-380 nm) transmittance	(Not explicitly stated for predicate in comparison table)	< 10.0%	Met (against internal specification)
UVB (280-315 nm) transmittance	(Not explicitly stated for predicate in comparison table)	< 1.0%	Met (against internal specification)

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

Non-clinical Testing: The document states, "A series of non-clinical testing was performed to characterize the lens material properties..." and "Light transmittance properties (incl. UV and UV-Vis) are supported by testing in accordance with ISO 18369-3:2017." However, specific sample sizes (e.g., number of lenses tested for physicochemical properties, UV transmittance) are not provided.
Clinical Testing: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device." Therefore, there was no test set for clinical performance, and thus no data provenance or sample size for such. The substantial equivalence was based on non-clinical data and the similarity to the predicate device.

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

Not applicable, as there was no clinical test set requiring expert ground truth for performance evaluation in this 510(k) submission. The evaluation was based on material characterization and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring adjudication in this submission.

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

Not applicable. This device is a contact lens, not an AI/software medical device that assists human readers (e.g., radiologists).

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

Not applicable. This device is a contact lens, not a standalone algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" was established by established scientific methods and international standards (e.g., ISO 18369-3:2017 for light transmittance, ISO 10993 series for biocompatibility, and GLP regulation for biocompatibility studies' conduct). The comparison was primarily against the known characteristics of the predicate device and relevant standards.

8. The sample size for the training set

Not applicable. This is a contact lens product, not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

{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.

January 18, 2019

Alcon Laboratories, Inc. Martina Heim Global Project Regulatory Director, Global Regulatory Affairs, Vision Care 6201 South Freeway Fort Worth, TX 76134

Re: K182782

Trade/Device Name: DAILIES TOTAL1 Soft Contact Lenses: DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: December 17, 2018 Received: December 21, 2018

Dear Martina Heim:

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.

{1}------------------------------------------------

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.html; 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 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 yours,

J Angelo Green -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)

K182782

Device Name DAILIES TOTAL 1 soft contact lenses: DAILIES TOTAL 1, DAILIES TOTAL 1 Asphere, DAILIES TOTAL 1 for ASTIGMATISM, DAILES TOTAL 1 Multifocal, DAILIES TOTAL 1 Multifocal Toric

Indications for Use (Describe)

DAILIES TOTAL1 (delefilcon A) and DAILIES TOTAL1 Asphere (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL 1 for ASTIGMATISM (delefilcon A) soft contact leases are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to 6.00 diopters (D) of astigmatism.

DAILIES TOTAL 1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic 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 (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL 1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia, 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 6.00 diopters (D) of astigmatism.

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)

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 of the 510(k) I.

Company:		Alcon Laboratories, Inc.
		6201 South Freeway
		Fort Worth, TX 76134-2099, USA
Primary Contact Person:		Martina Heim, Ph.D., RAC
Phone:		(678) 415-3565
Fax:		n/a
Email:		Martina.Heim@alcon.com
Back up Contact Person:		Sherri Lakota
Phone:		(817) 615-5472
Fax:		817-302-4574
Email:		Sherri.Lakota@alcon.com
Date Prepared:		17 December 2018

II. Devices Subject to this 510(k)

Trade Names:	DAILIES TOTAL1® soft contact lenses:DAILIES TOTAL1®, DAILIES TOTAL1® Asphere,DAILIES TOTAL1® for ASTIGMATISM, DAILIESTOTAL1® Multifocal, DAILIES TOTAL1® MultifocalToricAlternate family trade name: DAILIES TOTAL1® PRO
Common Name:	Soft contact lens
Classification Name:	Soft (hydrophilic) contact lens [for daily wear]
Device Classification:	21 CFR 886.5925 (b) (1)
Product Code:	LPL, MVN

{4}------------------------------------------------

III. Predicate Device

The subject device is a modification of the currently commercialized DAILIES TOTAL 10 (delefilcon A) soft contact lens. The predicate DAILIES TOTAL1 soft contact lenses have received FDA clearance per Premarket Notification 510(k) K113168, with recent updates cleared under K180398 and K180669.

IV. Device Description

Lens designs for the modified DAILIES TOTALI® (delefilcon A) lenses include spherical, asphere, toric, multifocal, and multifocal toric lenses in the following parameter range:

13.0 to 15.0 mm . Diameter Range:

• Base Curve Range:	8.0 to 9.2 mm
• Power Range:	-20.00D to +20.00D
• Center Thickness:	varies with design and power

(0.09 mm for -3.00D spherical)
Lenses have the following properties:

• Refractive index:	1.42 (hydrated)
• Water content:	33% by weight in normal saline
• Oxygen permeability	140 barrer units
	measured at 35 °C (intrinsic Dk - Coulometric method)

{5}------------------------------------------------

% Light transmittance, visible: 90 ± 5% (average over 380 to 780 nm) . UVA (315-380 nm): < 10.0% % UV transmittance . UVB (280-315 nm): < 1.0%
Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents that form the water gradient surface. 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, 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.

V. Indications for Use

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

VI. Comparison to Technological Characteristics with the Predicate Device

Table 5-1 summarizes the characteristics of the modified device compared to the predict devices:

	Predicate Device	Subject Device
Trade Name (brand)	DAILIES TOTAL1®	DAILIES TOTAL1®
Submission Number	K113168	510(k) # to be assigned
Device Classification Name	Daily Wear Soft Contact Lens21 CFR 886.5925 (b)(1)	Daily Wear Soft Contact Lens21 CFR 886.5925 (b)(1)
Intended Use	Vision correction	Same
Wearing Schedule	Daily wear	Same
Replacement Schedule	Daily disposable	Same
Material Classification	Group 5C, low water siliconehydrogel according toISO 18369-1:2017	Same
Lens Material	Delefilcon A	Same
Surface Treatment	Water gradient surface treatment	Same
Manufacturing Method	LightStream (molded)	Same
Visibility Tint	[phthalocyaninato (2-)] copper	Same
Lens marks	none	Molded lens marks (e.g. fiducialmark for toric lenses)
Lens Designs	Spherical, toric, multifocal,multifocal toric	Spherical, asphere, toric, multifocal,multifocal toric

Table 5-1 Substantial Equivalence Comparison

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

	Predicate Device	Subject Device
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
Water Content	33%	Same
Refractive Index	1.42	Same
OxygenPermeability	140 barrer units*	Same
Sterilization	Steam sterilization, validatedautoclave	Same
Packaging	Polypropylene blister shell sealedwith polyester coated aluminumfoil lidding	Same
Package StorageSaline Solution	Phosphate buffered saline (PBS)with polymeric wetting agents	Same

1 barrer = x 10 -11 (cm2/sec)(ml O2 /ml x mm Hg)

Performance Data VII.

Performance testing was performed in accordance with the May 1994 FDA guideline, Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, and applicable ISO standards for contact lenses. 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 the modified DAILIES TOTAL1® lenses and demonstrate the substantial equivalence of the modified device to the predicate device. Light transmittance properties (incl. UV and UV-Vis) are supported by testing in accordance with ISO 18369-3:2017. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58). All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.

The results of all non-clinical testing demonstrate:

{8}------------------------------------------------

. Physicochemical characteristics of the modified device are substantially equivalent to the predicate lens, currently commercialized DAILIES TOTAL 1® lenses.
The lens material, lens extracts and package saline of the device are non-toxic, non-irritating, non-sensitizing, and non-genotoxic.
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. The claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process is supported by the pre-clinical testing summarized above.

VIII. Conclusions

DAILIES TOTAL1® (delefilcon A) soft contact lenses as modified are substantially equivalent to the predicate device lenses, DAILIES TOTAL1, 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, unmodified DAILIES TOTAL1 soft contact lenses.

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.