DAILIES® AquaComfort Plus® (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES® AquaComfort Plus® Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

DAILIES® (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The lens material is 69% water and 31% nelficon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.

Nelfilcon A lens designs include spherical, toric, and multifocal lenses in the following parameter ranges: Power Range: -20.00D to +20.00D, Center Thickness: varies with design and power (0.10 mm for -3.00D spherical).

Lenses have the following properties: Refractive index: 1.38, Light transmittance: ≥ 92% (@ 610 nm), Water content: 69% by weight, Oxygen permeability 26 barrer measured at 35°C (single point Dk-Polarographic method).

Lenses are supplied sterile in sealed blister-packs containing buffered saline.

AI/ML Overview

The provided document, a 510(k) Summary for Nelfilcon A Soft Contact Lenses (K123994), primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds for safety or effectiveness for the modified device. Instead, it relies on demonstrating that the modified device's characteristics are substantially equivalent to established predicate devices. The "performance" reported is therefore a comparative one against these predicates.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (vs. Predicate)
Intended Use	Same as predicate (Daily Wear, Daily Disposable)	Matches predicate
Material Classification	Same as predicate (FDA Group 2)	Matches predicate
Lens Material	Same as predicate (nelfilcon A)	Matches predicate
Water Content	Same as predicate (69%)	Matches predicate (69%)
Power Range	Same as predicate (+20.00 to -20.00D)	Matches predicate (+20.00 to -20.00D)
Visibility Tint	Same as predicate (With or without copper phthalocyanine)	Matches predicate
Manufacturing Method	Similar to predicate (Lightstream® Technology; modification: integrated print step)	"Lightstream® Technology: Full mold cast, integrated print step" (Predicate K072777 is full mold cast; Predicate K083216 is full mold cast, integrated print step) - Justifies equivalence based on print technology from one predicate.
Lens Designs	Same as predicate (Spherical, toric, multifocal)	Matches predicate
Sterilization	Same as predicate (Steam sterilization, validated autoclave)	Matches predicate
Packaging	Same as predicate (Blister pack)	Matches predicate
Package Storage Saline Solution	Similar to predicate (Phosphate-acetate buffered saline with up to 0.05% Poloxamer 108. Contains PEG and HPMC)	Matches predicate K072777; K083216 has "up to 0.02% Poloxamer 108." - Difference noted but deemed not to adversely affect safety/effectiveness.
Physicochemical Characteristics	Substantially equivalent to predicate lens	Demonstrated to be substantially equivalent
Biocompatibility	Non-toxic and non-irritating, substantially equivalent to predicate device	Demonstrated to be non-toxic and non-irritating, substantially equivalent to predicate device
Stability	Supports labeled expiration date	Successful stability testing reported to support labeled expiration date

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device."

Therefore:

Sample size for test set: Not applicable (no clinical test set used for the modified device).
Data provenance: Not applicable (no clinical data for the modified device). The documentation relies on the established safety and effectiveness of the predicate devices and non-clinical bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical testing was performed for the modified device. The "ground truth" for demonstrating substantial equivalence was derived from the established safety and performance of the predicate devices and the results of non-clinical, bench-top testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing was performed for the modified device.

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-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this medical device.

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

Not applicable. This device is a contact lens.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission stemmed from:

Substantial Equivalence to Predicate Devices: The primary "ground truth" is the established safety and effectiveness of the legally marketed predicate devices (DAILIES® AquaComfort Plus® - K072777, and FOCUS® DAILIES® - K083216). The modified device is considered safe and effective because it is fundamentally the same as these already cleared devices, with a minor modification (integrated print step from one predicate applied to the other family) that is not deemed to adversely affect safety or effectiveness.
Non-clinical Bench Testing: Physicochemical characteristics, biocompatibility (non-toxicity, non-irritation), and stability testing were performed to confirm that the modified device's properties were substantially equivalent to the predicate and supported the labeled expiration date.

8. The Sample Size for the Training Set

Not applicable, as this is a contact lens and not an algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is a contact lens and not an algorithm requiring a training set.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented is a demonstration of substantial equivalence through comparative analysis and non-clinical testing, rather than a clinical trial with acceptance criteria for a novel device.

Rationale: The modification (applying an existing print technology from one predicate contact lens family to another closely related contact lens family) was considered minor enough that new clinical data was not required.
Evidence:
- Comparative Table (Table 1): Detail-by-detail comparison of the modified device's characteristics against two predicate devices, showing that most parameters are identical or have differences (like the specific manufacturing step for integrated print or minor saline solution variations) that are justified as not impacting safety or effectiveness.
- Non-clinical Testing: Biocompatibility testing (in accordance with GLP regulation 21 CFR Part 58) confirmed the material was non-toxic and non-irritating. Physicochemical characteristics were verified as substantially equivalent. Stability testing supported the labeled expiration date.

The conclusion is that the DAILIES® AquaComfort Plus® family of lenses (with the integrated print step) is substantially equivalent to its predicate lenses and other similar daily wear soft contact lenses, and any existing differences "do not adversely affect the safety and effectiveness of the device."

Summary

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CIBA VISION Logo
Shared Passion for Healthy Vision and Better Life

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097

11-Feb-2013, v01 Page 1 of 4

Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

510(k) Summary: K123994

1. Submitter Information:

Company:	CIBA Vision Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
Contact Person:	Martina Heim, PhD, RACSenior Regulatory Specialist, Global Regulatory Affairsmartina.heim@cibavision.com
Telephone:	678-415-3565
FAX:	678-415-3454
Date Prepared:	11 Feb 2013

2. Device Name:

Common Name:	Soft Contact Lens
Trade/Proprietary Name:	DAILIES® AquaComfort Plus®
	DAILIES® AquaComfort Plus® Toric
	DAILIES® AquaComfort Plus® Multifocal
Classification Name:	Daily Wear Soft (Hydrophilic) Contact Lens
Device Classification:	Class II [21 CFR 886.5925 (b) (1)]

3. Predicate Device:

DAILIES® AquaComfort Plus® (nelfilcon A) contact lenses (cleared under K07277) and FOCUS® DAILIES® (nelfilcon A) lenses with print marks (cleared under K083216) have been identified as predicate devices for this Premarket Notification.

4. Description of Device:

The lens material is 69% water and 31% nelficon A polymer (polyvinyl alcohol partially
acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.

Nelfilcon A lens designs include spherical, toric, and multifocal lenses in the following parameter ranges:

Power Range:	-20.00D to +20.00D
Center Thickness:	varies with design and power(0.10 mm for -3.00D spherical)

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Image /page/1/Picture/0 description: The image shows the CIBA VISION logo. The logo is black and white and features the company name in bold letters. Below the company name is the tagline "Shared Passion for Healthy Vision and Better Life."

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097

11-Feb-2013. v01 Page 2 of 4

Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

Lenses have the following properties:

Refractive index: 1.38 .
Light transmittance: . ≥ 92% (@ 610 nm)
Water content: . 69% by weight
- Oxygen permeability 26 barrer

measured at 35°C (single point Dk-Polarographic method)

Lenses are supplied sterile in sealed blister-packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other CIBA Vision 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 confirm the labeled expiration date.

5. Indications for Use:

DAILIES® AquaComfort Plus® (neifilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES® AquaComfort Plus® Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

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Image /page/2/Picture/0 description: The image shows the CIBA VISION logo. The logo is in black and white and features the words "CIBA VISION" in a bold, sans-serif font. The "O" in "VISION" is replaced by an eye symbol. Below the logo is the tagline "Shared Passion for Healthy Vision and Better Life" in a smaller font.

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097

Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

6. Description of Safety and Substantial Equivalence:

The modification involves using the same print technology already established for the FOCUS DAILIES family of (nelfilcon A) soft contact lenses for the DAILIES AquaComfort Plus family of (nelfilcon A) soft contact lenses. The following matrix summarizes the characteristics of the modified device as compared to the predicate devices:

Table 1. Substantial Equivalence Comparison

	Modified Device	Predicate Device	Predicate Device
	DAILIES®AquaComfort Plus®Family	DAILIES®AquaComfort Plus®Family	FOCUS® DAILIES®Family
510(k) number	K123994	K072777	K083216
Intended Use	Daily Wear,Daily Disposable	Daily Wear.Daily Disposable	Daily Wear.Daily Disposable
MaterialClassification:	FDA Group 2(> 50% H2O, nonionicpolymer)	FDA Group 2(> 50% H2O, nonionicpolymer)	FDA Group 2(> 50% H2O, nonionicpolymer)
Lens Material:	nelfilcon A	nelfilcon A	nelfilcon A
WaterContent:	69%	69%	69%
Power Range:	+20.00 to -20.00D	+20.00 to -20.00D	+20.00 to -20.00D
Visibility Tint:	With or without copperphthalocyanine	With or without copperphthalocyanine	With or without copperphthalocyanine
ManufacturingMethod:	Lightstream®Technology:Full mold cast,integrated print step	Lightstream®Technology:Full mold cast	Lightstream®Technology:Full mold cast,integrated print step
Lens Designs:	Spherical, toric,multifocal	Spherical, toric,multifocal	Spherical, toric,multifocal
Sterilization:	Steam sterilization,validated autoclave	Steam sterilization,validated autoclave	Steam sterilization,validated autoclave
Packaging:	Blister pack	Blister pack	Blister pack
PackageStorage salinesolution	Phosphate-acetatebuffered saline with upto 0.05% Poloxamer108.Contains PEG andHPMC.	Phosphate-acetatebuffered saline with upto 0.05% Poloxamer108.Contains PEG andHPMC.	Phosphate-acetatebuffered saline with upto 0.02% Poloxamer108.

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Image /page/3/Picture/0 description: The image shows the CIBA VISION logo. The logo consists of the word "CIBA" in large, bold letters, followed by a stylized eye symbol and the word "VISION." The tagline "Shared Passion for Healthy Vision and Better Life" is printed in smaller font below the main logo.

Nelfilcon A Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

Non-clinical Testing:

A series of non-clinical testing was performed to verify equivalence of the device to the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).

The results of all non-clinical testing demonstrate:

· Physicochemical characteristics of the device are substantially equivalent to the predicate lens.
. The lens material and extracts of the device are substantially equivalent to the predicate device and are non toxic and non-irritating.

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.

Substantial Equivalence:

The DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, and DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses are substantially equivalent to the predicate lenses and similar to other daily wear soft contact lenses in terms of water content (69% water) and ionic characteristics (FDA Group II: high water. nonionic), and indications for use.

Any differences which may exist between the DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, and DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses and other Group II soft hydrophilic contact lenses do not adversely affect the safety and effectiveness of the device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird or eagle, which is a common symbol associated with health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

February 21, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ciba Vision Corporation % Martina Heim, Ph.D., RAC Senior Regulatory Specialist 11460 Johns Creek Parkway Duluth, GA 30097

Re: K123994

Trade/Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal Regulation Number: 21 CFR 886.5925 (nelfilcon A)

Regulation Name: Soft (hydrophilic) contact lens

Regulatory Class: Class II Product Code: LPL. MVN Dated: December 21, 2012 Received: December 26, 2012

Dear Dr. 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. 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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Please be advised that FDA's issuance of a substantial equivalencé 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kesia YAlexander -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): K123994

Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® Toric,

Indications For Use:

DAILIES® AquaComfort Plus® (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Y. 2013.02.20

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K123994

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.