K Number

Device Name

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

Manufacturer

CIBA VISION CORPORATION

Date Cleared

2009-04-14

(165 days)

Product Code

LPL MVN

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 (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. Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges: - Power Range: -20.00D to +20.00D . - 0.010 mm for -3.00D spherical (varies with power) Center Thickness: . Lenses have the following properties: - 1.38 Refractive index: . - 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 CIBA VISION marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blisterpack 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 establish and extend the labeled expiration date.

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

K050065, K050213

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes physical contact lenses and their material properties, with no mention of software, algorithms, or any AI/ML components.

Therapeutic

No
The device is a contact lens intended for optical correction of refractive errors, not for treating or curing a disease or condition.

Diagnostic

The device is a soft contact lens intended for optical correction of refractive ametropia and/or presbyopia, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly describes physical contact lenses made of polymer and water, not software.

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 (myopia, hyperopia, astigmatism, and presbyopia) in the eye. This is a direct interaction with the body for a therapeutic/corrective purpose.
Device Description: The description focuses on the physical properties and materials of the contact lens itself, designed to be placed on the eye.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used outside the body to analyze samples from the body. This device is used on the body for a visual correction.

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 (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.

Product codes (comma separated list FDA assigned to the subject device)

LPL, MVN

Device Description

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges:

Power Range: -20.00D to +20.00D
Center Thickness: .010 mm for -3.00D spherical (varies with power)

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 CIBA VISION marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blisterpack 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 establish and extend the labeled expiration date.

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:
Successful stability testing supports the labeled expiration date. Additional chemical, physical, and toxicological testing results can be referenced from the predicate devices.

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K050065, K050213

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

|
Shared Passion for Healthy Vision and Better Life | | CIBA VISION Corporation
11460 Johns Creek Parkway
Duluth, Georgia USA 30097 | 04 February 2009
Page 1 of 4
v03 |

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CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses

510(k) Summary of Safety and Substantial Equivalence

510(k) Summary
K 083216

Submitter Information:

| Company: | CIBA VISION® Corporation
11460 Johns Creek Parkway
Duluth, Georgia USA 30097 | APR 14 2009 |
|-----------------|------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Martina Heim, PhD, RAC
Senior Regulatory Specialist, Global Regulatory Affairs
martina.heim@cibavision.com | |
| Telephone: | 678-415-3565 | |
| FAX: | 678-415-3454 | |
| Date Prepared: | 27 October 2008 | |

Device Name:

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

3. Predicate Device:

Predicate devices are:

Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lenses, as cleared under K050065, 2) FreshLook®, FreshLook® Toric, and FreshLook® Progressives (nelfilcon A) One-Day Color Contact Lens, as cleared under K050213.

4. Description of Device:

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.

CIBAOVISION.	CIBA VISION Corporation
Shared Passion for Healthy Vision and Better Life	11460 Johns Creek Parkway
	Duluth, Georgia USA 30097

CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges:

Power Range: -20.00D to +20.00D .
0.010 mm for -3.00D spherical (varies with power) Center Thickness: .

Lenses have the following properties:

1.38 Refractive index: .
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 eves 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.

Image /page/2/Picture/0 description: The image shows the CIBA Vision logo. The logo is black and white and features the words "CIBA VISION" in a bold, sans-serif font. The "O" in "VISION" is stylized to look like an eye. 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

CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

દ. Substantial Equivalence:

The following matrix summarizes the characteristics of the modified device as compared to the predicate devices:

	Modified Device	K050065	K050213
	Focus DAILIES Family
(nelfilcon A) One-Day Soft
Contact Lens	Focus DAILIES Family
(nelfilcon A) One-Day
Contact Lens	FreshLook Family
(nelfilcon A) One-Day Color
Contact Lens
Lens Material:	nelfilcon A	nelfilcon A	nelfilcon A
Material
Classification:	FDA Group 2
(> 50% H2O, nonionic
polymer)	FDA Group 2
(> 50% H2O, nonionic
polymer)	FDA Group 2
(> 50% H2O, nonionic
polymer)
Water Content:	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 copper
phthalocyanine	With or without copper
phthalocyanine	With or without copper
phthalocyanine
Manufacturing
Method:	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
Package Storage
saline solution	Phosphate-acetate buffered
saline with up to 0.02%
Poloxamer 108	Phosphate-acetate buffered
saline with up to 0.02%
Poloxamer 108	Phosphate-acetate buffered
saline with up to 0.02%
Poloxamer 108

Non-clinical Testing:

Successful stability testing supports the labeled expiration date. Additional chemical, physical, and toxicological testing results can be referenced from the predicate devices.

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 Focus® DAILIES®, Focus® DAILIES® Toric, and Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lenses are substantially equivalent to the predicate

| 110100
CIBAC

Colli
Shared Passion for Healthy Vision and Better Life

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

CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

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), clinical performance, 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.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 image of an eagle with its wings spread, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CIBA VISION Corporation c/o Martina Heim, Ph.D., RAC Senior Regulatory Specialist 11460 Johns Creek Parkway Duluth, Georgia 30097

APR 1 4-2009

Re: K083216

Trade/Device Name: Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 24, 2009 Received: March 25, 2009

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egeland, MD

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 STATEMENT PART II.

: : : : : : : : : : : : : : :

K083216 510(k) Number:

Device Name:

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

Indications For Use:

Section and States and 122

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over the Counter Use

ing-chun Shi

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K083216

CONFIDENTIAL