K Number

Device Name

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

Manufacturer

ALCON LABORATORIES, INC.

Date Cleared

2016-01-20

(30 days)

Product Code

LPL

Regulation Number

886.5925

Intended Use

Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft 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. Focus® DAILIES® Progressives (nelfilcon A) One-Day soft 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. The 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% nelfilcon A polymer (polyviny) 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: -20.00 D to +20.00 D Center Thickness varies with design and power (0.10 mm for -3.00 D spherical) Lenses have the following properties: Refractive index: 1.38 Light transmittance: approximately 96 %T 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 Alcon 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).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K083216

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical contact lens and its material properties. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.

Therapeutic

No.
The device is indicated for the optical correction of refractive ametropia, which is a structural correction rather than a therapeutic treatment for disease.

Diagnostic

The device is a contact lens intended for optical correction of refractive ametropia and/or presbyopia, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

The device described is a physical contact lens made of polymer and water, not a software program.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "optical correction of refractive ametropia" and "presbyopia." This describes a device used to correct vision, not to diagnose a condition by examining samples from the human body.
Device Description: The description focuses on the physical properties of the contact lens material and design, not on reagents, instruments, or systems used to examine specimens.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is clearly described as a contact lens for vision correction, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) 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.

The 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.

Product codes

LPL, MVN

Device Description

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

Lenses have the following properties:
Refractive index: 1.38
Light transmittance: approximately 96 %T
Water content: 69% by weight
Oxygen permeability 26 barrer measured at 35C (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 Alcon 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eyes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing: A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met.
Clinical Testing: The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K083216

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

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

January 20, 2016

Alcon Laboratories, Inc. Dr. Andreas Friese Principal Regulatory Specialist 6201 South Freeway Fort Worth, TX 76134-2099

Re: K153643

Trade/Device Name: Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens. Regulatory Class: Class II Product Code: LPL/MVN Dated: December 18, 2015 Received: December 21, 2015

Dear Dr. 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. 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.

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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 yours,

Kesia Y. Alexander -A

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

Indications for Use

510(k) Number (if known)

K153643

Device Name

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives

Indications for Use (Describe)

The 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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Ink Shelf Life Change

510(k) Summary

1. Submitter Information:

| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX USA 76134-2099 |
|-------------------------|---------------------------------------------------------------------------------|
| Primary Contact Person: | Dr. Andreas Friese
Principal Regulatory Specialist |
| Telephone: | +49 6022 240 514 |
| Fax: | +49 6022 240 512 |
| Email: | andreas.friese@alcon.com |
| Back up Contact Person: | Sherri Lakota
Head Global Regulatory Affairs, Vision Care |
| Telephone: | 817-615-5472 |
| Fax: | 817-551-4630 |
| Email: | sherri.lakota@alcon.com |
| Date Prepared: | 12 October 2015 |

2. Device Name:

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

3. Predicate Device:

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives (nelfilcon A) contact lenses (cleared under K083216) have been identified as predicate device.

4. Description of Device:

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

Lenses have the following properties:

Refractive index:	1.38
Light transmittance:	approximately 96 %T
Water content:	69% by weight
Oxygen permeability	26 barrer measured at 35°C
(single point Dk-Polarographic method)

5. Indications for Use:

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft 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.

The 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.

6. Substantial Equivalence:

The modification involves using the same print technology already established for the Focus® DAILIES® family of (nelfilcon A) soft contact lenses as well as 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 device.

	Modified Device	Predicate Device
	Focus DAILIES® Family
(nelfilcon A) One-Day Soft
Contact Lens	Focus DAILIES® Family
(nelfilcon A) One-Day Soft
Contact Lens
510(k)
number:	TBD	K083216
Intended Use:	Daily Wear,
Daily Disposable	Daily Wear,
Daily Disposable
Material
Classification:	FDA Group 2
(>50% H2O, nonionic polymer)	FDA Group 2
(>50% H2O, nonionic polymer)
Lens
Material:	nelfilcon A	nelfilcon A
Water
Content:	69%	69%
Power Range:	+20.00 to -20.00 D	+20.00 to -20.00 D
Visibility Tint:	With or without copper
phthalocyanine	With or without copper
phthalocyanine
Manufacturin
g Method:	Lightstream® Technology:
Full mold cast, integrated print
step	Lightstream® Technology:
Full mold cast, integrated print
step
Lens Designs:	Spherical, toric, multifocal	Spherical, toric, multifocal
Sterilization:	Steam sterilization,
validated autoclave	Steam sterilization,
validated autoclave
Packaging:	Blister pack	Blister pack
Package
Storage Saline
Solution:	Phosphate-acetate buffered saline
with up to 0.5% Poloxamer 108.	Phosphate-acetate buffered saline
with up to 0.5% Poloxamer 108.

Table 1: Substantial Equivalence Comparison

Non-clinical Testing:

A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the 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.

Substantial Equivalence:

Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (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 Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (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.