DAILIES TOTAL 1® (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL1® Toric (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes 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 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 TOTAL 1® Multifocal Toric (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 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

DAILIES TOTAL 1® (delefilcon A) soft contact lenses may be made available in sphere, toric, multifocal, and multifocal toric lens designs.
The lens material, delefilcon A, is a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment.
When hydrated and placed on the cornea, DALIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.
It is considered a Group 5C material according to ISO 18369-1:2017. The lenses have a light blue tint that makes to see when handling.
The modified lenses are tinted using Reactive Blue 247.
The lenses are cast-molded and have a water gradient surface treatment. Lenses may be made available in the following parameter range:

Diameter: 13.0 to 15.0 mm
Base Curve: 8.0 to 9.2 mm
Power Range: +20.0 D to -20.0 D
Center Thickness: 0.070 mm to 0.340 mm (varies with power)
Cylinder Power: Up to 5.00 D
Cylinder Axis: 1° to 180°
ADD power: Up to 5.00 D
Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution with polymeric wetting agents that form the water gradient surface.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding Alcon Laboratories' DAILIES TOTAL1® contact lenses. It addresses the substantial equivalence of modifications to the existing device.

Here's an analysis to extract the requested information regarding acceptance criteria and the study proving the device meets them:

Important Note: This FDA document approves modifications to an existing contact lens. Therefore, the "acceptance criteria" and "study" described here are primarily focused on demonstrating that the modified device remains substantially equivalent to the predicate device, rather than proving a new device's initial safety and effectiveness from scratch. This distinction is crucial for interpreting the provided information.

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

Based on the document, the acceptance criteria are not presented in a formal table with specific numerical targets. Instead, the document states that the performance testing aimed to demonstrate "substantial equivalence" to the predicate device. The reported device performance is described qualitatively as "demonstrated to be substantially equivalent" and "all with passing results."

Here's a breakdown of the areas tested and the general "performance":

Acceptance Area	Implicit Acceptance Criteria	Reported Device Performance
Lens Material Properties	Substantially equivalent to predicate device (e.g., Refractive Index, Light Transmittance, Oxygen Permeability, Water Content).	"The predicate and subject DAILIES TOTAL 1® (delefilcon A) soft contact lenses have the same lens material properties: - Refractive Index (hydrated): 1.42 - Light Transmittance: ≥ 93% (@ 610 nm, -1.00 D) - Oxygen Permeability: 140 barrer - Water Content: 33% by weight in normal saline"
Dimensional & Optical Properties	Substantially equivalent to predicate device (maintaining appropriate ranges for diameter, base curve, power, center thickness, cylinder, ADD).	"Lens material properties, dimensional and optical properties, and extractables and residuals were demonstrated to be substantially equivalent to the predicate device." The document also lists the available parameter ranges: - Diameter: 13.0 to 15.0 mm - Base Curve: 8.0 to 9.2 mm - Power Range: +20.0 D to -20.0 D - Center Thickness: 0.070 mm to 0.340 mm (varies with power) - Cylinder Power: Up to 5.00 D - Cylinder Axis: 1° to 180° - ADD power: Up to 5.00 D
Extractables & Residuals	Levels should be safe and substantially equivalent to the predicate.	"Lens material properties, dimensional and optical properties, and extractables and residuals were demonstrated to be substantially equivalent to the predicate device."
Shelf-Life Stability	Packaged lenses must remain sterile and stable for the labeled expiration date.	"Results of an ongoing shelf-life stability study demonstrate that packaged lenses remain sterile and stable for the labeled expiration date."
Biocompatibility	Must pass all relevant ISO 10993 series tests and GLP requirements, showing no unacceptable biological risk.	"Nonclinical biocompatibility testing was conducted... and relevant parts of the ISO 10993 series. Specifically, the following testing was completed, all with passing results: - Cytotoxicity Studies (lens, lens extracts, and package saline) per ISO 10993-5 - Ocular Irritation / Toxicity (Ocular) in Rabbits - Ocular biocompatibility of soft contact lenses, 22-day Evaluation per ISO 9394 - Ocular biocompatibility of package saline, 22-Day Evaluation per ISO 9394 - Primary ocular irritation studies per ISO 19993-10 (lens extracts and package saline) - Sensitization Studies (lens extracts and package saline) per ISO 10993-10 - Acute Systemic Toxicity Study in Mice (lens extracts) per ISO 10993-11 - Genotoxicity Studies (lens extracts and package saline) per ISO 10993-12" Additional testing for packaging foil: "Cytotoxicity Studies (foil lidding, foil lidding extracts) per ISO 10993-5", "Ocular Irritation / Toxicity (Ocular) in Rabbits", "Primary ocular irritation studies per ISO 19993-10 (foil lidding extracts)." All "passing results".
Sterilization (Moist Heat)	Must effectively sterilize the lenses and maintain sterility in packaging.	"Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs..." (Implied successful sterilization method).

2. Sample sizes 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 numerical sample sizes for any of the non-clinical tests (e.g., number of lenses tested for material properties, number of animals in biocompatibility studies). It only mentions that testing was conducted "using GxP conditions," referring to good x practice (e.g., Good Manufacturing Practices, Good Laboratory Practices).

The data provenance (country of origin, retrospective/prospective) is also not specified. Given the regulatory nature and the mention of GLP for biocompatibility, these studies would have been prospective and conducted according to relevant international standards.

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 or not provided in this document.

No expert ground truth for classification/diagnosis: The testing described is primarily physical, chemical, and biological (biocompatibility) in nature for a medical device (contact lens). There is no "ground truth" in the sense of expert human interpretation of medical images or patient conditions, as would be the case for an AI diagnostic device.
Standards-based evaluation: The "ground truth" for these tests comes from established industry standards (e.g., ISO for contact lenses, ISO 10993 for biocompatibility) and regulatory guidelines (e.g., FDA 510(k) Guidance for Class II Contact Lenses). The "experts" involved would be the testing laboratories' personnel with expertise in these specific tests and their interpretation according to the standards. Their specific qualifications and numbers are not detailed here.

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

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or human-in-the-loop performance evaluations for diagnostic devices where human experts disagree on interpretations. Here, the testing is non-clinical/laboratory-based against pre-defined physical, chemical, and biological criteria and established standards.

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

This information is not applicable. This document is for a contact lens, not an AI diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. This document is for a contact lens; there is no algorithm or AI involved. The "device performance" refers to the physical, chemical, and biological properties of the contact lens itself.

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

The "ground truth" for the non-clinical testing of this contact lens is based on:

Established industry standards: Primarily ISO 18369-2, -3, -4 for contact lenses and ISO 10993 series for biocompatibility.
FDA guidance documents: Specifically the May 1994 FDA guideline titled "Premarket Notification 510(k) Guidance Document for Class II Contact Lens testing."
Prior device specifications: The modified device is compared to the predicate device to demonstrate substantial equivalence across various properties.
GLP (Good Laboratory Practices) requirements: For biocompatibility testing (21 CFR Part 58).

So, the ground truth is standards-based and regulatory-guidance driven, ensuring the device meets pre-defined safety and performance thresholds for physical, chemical, and biological attributes, and remains equivalent to a previously cleared device.

8. The sample size for the training set

This information is not applicable. This is a physical medical device (contact lens), not a machine learning/AI model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

Summary

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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.

November 16, 2023

Alcon Laboratories, Inc. Martina Heim Director. Global Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099

Re: K232921

Trade/Device Name: DAILIES TOTAL1®; DAILIES TOTAL1® Toric; 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: September 19, 2023 Received: September 19, 2023

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical-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.

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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 -S

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

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Indications for Use

Submission Number (if known)

K232921

Device Name

DAILIES TOTAL 18: DAILIES TOTAL 1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL 1® Multifocal Toric

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Dver-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Sumn

Prepared on: 2023-11-08

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Alcon Laboratories, Inc.
Applicant Address	6201 South Freeway Fort Worth TX 76134-2099 United States
Applicant Contact Telephone	(678) 415-3565
Applicant Contact	Dr. Martina Heim
Applicant Contact Email	martina.heim@alcon.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	DAILIES TOTAL1®;DAILIES TOTAL1® Toric;DAILIES TOTAL1® Multifocal;DAILIES TOTAL 1® Multifocal Toric
Common Name	Soft (hydrophilic) contact lens
Classification Name	Lenses, Soft Contact, Daily Wear
Regulation Number	886.5925
Product Code	LPL

Legally Marketed Predicate Devices

	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K113168	DAILIES TOTAL1; DALIES TOTAL1 FOR ASTIGMATISM; DAILIJ	LPL

Device Description Summary

	21 CFR 807.92(a)(4)
DAILIES TOTAL 1® (delefilcon A) soft contact lenses may be made available in sphere, toric, multifocal, and multifocal toric lens designs.The lens material, delefilcon A, is a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment.

handling. When hydrated and placed on the cornea, DALIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.

It is considered a Group 5C material according to ISO 18369-1:2017. The lenses have a light blue tint that makes to see when

Intended Use/Indications for Use

DAILIES TOTAL 1® (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with up to aproximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL 1® Toric (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.

DALIES 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

21 CFR 807.92(a)(5)

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acuity.

DALIES TOTAL 1º Multifocal Toric (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 eves 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.

Indications for Use Comparison

The indications for use of the subject device remain the same as for the predicate device.

Technological Comparison

The predicate and subject DAILIES TOTAL 1® (delefilcon A) soft contact lenses have the same lens material properties:

Refractive Index (hydrated): 1.42
· Light Transmittance: ≥ 93% (@ 610 nm, -1.00 D)
Oxygen Permeability: 140 barrer

• Water Content: 33% by weight in normal saline

The modified lenses are tinted using Reactive Blue 247.

The lenses are cast-molded and have a water gradient surface treatment. Lenses may be made available in the following parameter range:

Diameter: 13.0 to 15.0 mm
Base Curve: 8.0 to 9.2 mm
Power Range: +20.0 D to -20.0 D
· Center Thickness: 0.070 mm to 0.340 mm (varies with power)
Cylinder Power: Up to 5.00 D
· Cylinder Axis: 1° to 180°
· ADD power: Up to 5.00 D

Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution with polymeric wetting agents that form the water gradient surface.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Performance testing for the modified DAILIES TOTAL 1 % (delefilcon A) soft contact lenses followed the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lench testing was conducted using GxP conditions, and, where applicable ISO 18369-2, -3, -4 standards. Lens material properties, dimensional and optical properties, and extractables and residuals were demonstrated to be substantially equivalent to the predicate device. Results of an ongoing shelf-life stability study demonstrate that packaged lenses remain sterile and stable for the labeled expiration date.

Nonclinical biocompatibility testing was conducted in accordance with the GLP requlation (21 CFR Part 58) and relevant parts of the ISO 10993 series. Specifically, the following testing was completed, all with passing results:

· Cytotoxicity Studies (lens, lens extracts, and package saline) per ISO 10993-5
Ocular Irritation / Toxicity (Ocular) in Rabbits
Ocular biocompatibility of soft contact lenses, 22-day Evaluation per ISO 9394
Ocular biocompatibility of package saline, 22-Day Evaluation per ISO 9394
Primary ocular irritation studies per ISO 19993-10 (lens extracts and package saline)
Sensitization Studies (lens extracts and package saline) per ISO 10993-10
Acute Systemic Toxicity Study in Mice (lens extracts) per ISO 10993-11
· Genotoxicity Studies (lens extracts and package saline) per ISO 10993-12

Additional biocompatibility testing was conducted to support minor changes of the primary packaging foil lidding material. Biocompatibility testing for the blister shells was previously submitted for the predicate device.

· Cytotoxicity Studies (foil lidding, foil lidding extracts) per ISO 10993-5
Ocular Irritation / Toxicity (Ocular) in Rabbits
Primary ocular irritation studies per ISO 19993-10 (foil lidding extracts)

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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The scope of the device modification did not require clinical testing to establish safety and effectiveness of the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process is supported by nonclinical testing.

Non-clinical data demonstrates that the subject device is as effective, and performs as well as or better than the legally marketed, predicate device. Modified DALIES TOTAL1® (delefilcon A) soft contact lenses are substantially equivalent to the predicate device lenses, and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use.

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.