SPHERICAL AND ASPHERICAL:
A VAIRA (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

TORIC:
A VAIRA (enfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MULTIFOCAL:
AVAIRA (enfilcon A) MULTIFOCAL lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

DAILY DISPOSABLE:
The Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for single-use disposable wear.

FREQUENT REPLACEMENT:
The Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

Device Description

The Avaira (enfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, enfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The lenses are manufactured in spherical, aspherical, toric and multifocal configurations. The Avaira (enfilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510(k)s.

AI/ML Overview

This submission describes a modification to the shelf-life protocol for an already cleared device, the Avaira (enfilcon A) soft contact lens. The core device (material, design, manufacturing, and indications for use) remains unchanged from the predicate device (K071736). Therefore, the provided text does not contain typical acceptance criteria and study data for device performance as would be required for an entirely new device or a significant modification to the device's functional characteristics.

Instead, the submission focuses on demonstrating substantial equivalence based on the lack of change to critical aspects that would impact safety or effectiveness. The "acceptance criteria" here are implicitly that the modification to the shelf-life protocol does not negatively impact the previously established performance and safety of the lens. No new clinical or physiochemical studies were deemed necessary due to the nature of this particular modification.

Here's an analysis of what is available in the provided text, framed against your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Shelf-Life Protocol Modification)	Reported Device Performance (as per submission)
No change to physicochemical properties of the lenses.	Physical, optical, chemical properties remain unchanged and within established specifications.
No change to lens's ability to remain non-toxic and biocompatible with the ocular environment.	In-vivo and in-vitro toxicology study results originally conducted remain valid; lenses remain non-toxic and biocompatible.
No change in the technical characteristics, formulation, manufacturing, or sterilization processes.	These aspects are not changing and are equivalent to the predicate.
Maintenance of previously established safety and effectiveness.	Clinical data not required as the lens material, manufacturing, and indications for use are unchanged from predicate.

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

Not applicable. No new "test set" in the traditional sense of evaluating device performance was used, as the modification was to a shelf-life protocol and not the lens itself. The submission states: "Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses."

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

Not applicable. No new ground truth validation was performed as part of this modification given the nature of the change.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is irrelevant to a modification of a shelf-life protocol for contact lenses.

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

No. This type of study is irrelevant to this device (contact lens) and the nature of the modification.

7. The Type of Ground Truth Used

Not applicable to this specific submission. The original predicate device (K071736) would have established its "ground truth" through clinical trials and laboratory testing demonstrating its safety and efficacy for vision correction and ocular compatibility. For this submission, the "ground truth" is that the modified shelf-life protocol does not alter these established truths.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this submission. The submission relies on prior testing and validation of the predicate device and asserts that the proposed change (alternate package integrity test and adjusted storage temperatures) does not affect the device's fundamental characteristics.

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

Not applicable.

Summary of the Study and Acceptance Criteria for this Specific Submission (K113245):

The "study" in K113245 is not a clinical trial or performance study of the device itself. Instead, it's a demonstration that a minor modification to the shelf-life protocol (specifically, an alternate test method for package integrity and adjusted storage temperatures) does not necessitate new testing or alter the fundamental characteristics or safety of the Avaira (enfilcon A) soft contact lens.

The acceptance criteria are implicitly met by demonstrating that:

The physicochemical properties of the lens remain unchanged.
The toxicology profile (non-toxicity and biocompatibility) remains unchanged and valid.
The technical characteristics, formulation, manufacturing, and sterilization processes of the lens itself are not changing.

The "proof" relies on the logical argument presented in the submission, confirmed by the FDA, that because the core device and its fundamental processes are unchanged, and the modification relates only to how shelf-life is tested and stored (not the material's properties or interaction with the eye), then no new clinical or physiochemical studies are required. The continued validity of previous studies (from the predicate device K071736) is considered sufficient evidence.

Summary

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K113245 DEC - 2 2011

510(k) Summary

1. Applicant Name and Address
  CooperVision, Inc. 6150 Stoneridge Mall Drive Suite 370 Pleasanton CA 94588

Contact

Gwen Sharp Regulatory Affairs (925) 621-2457 gsharp@coopervision.com

Date Prepared

November 1, 2011

4. Device Identification

Trade Name:	Avaira (enfilcon A) Soft (Hydrophilic)Contact Lens
Common Name:	Soft Contact Lens
ClassificationName:	Soft (hydrophilic) Contact Lens -Daily Wear; Disposable
DeviceClassification:	Class II (21 CFR 886.5925)
FDA MaterialClass:	FDA Group I, Low Water, NonionicSoft Contact
Product Code:	MVN, LPL

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5. Device Description

6. Intended Use

SPHERICAL AND ASPHERICAL:

Avaira (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

TORIC:

Avaira (enfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MULTIFOCAL:

Avaira (enfilcon A) MULTIFOCAL lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Avaira (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The lens may also be prescribed for single-use disposable daily wear.

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7. Predicate Device(s)

Avaira (enfilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (K071736) cleared January 4. 2008.

8. Characteristics of Substantial Equivalence

The soft contact lenses have the following similarities to the predicate lens that previously received 510(k) clearance:

. have the same indicated use,
incorporate the same design, .
incorporate the same materials, .
. have the same shelf life, and
are packaged and sterilized using the same materials and processes. .

The modifications to the stability/shelf life protocol include an alternate test method for package integrity and adjusted storage temperatures for the packaged products that will be tested using alternate package integrity test method.

In summary, the enfilcon A soft contact lenses described in this submission are substantially equivalent to the predicate device.

9. Physiochemical Studies

Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses.

10. Toxicology Studies

Results from in-vivo and in-vitro studies were not required as support for this modification to shelf life protocol. Change will not affect lenses ability to remain non-toxic and biocompatible with the ocular environment.

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K113245

11. Conclusions of Non-Clinical Tests Performed:

트 Physiochemical:
The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses.
. Toxicology:
Results from in-vivo and in-vitro studies originally conducted remain valid and verify that the lenses remain non-toxic and are biocompatible with the ocular environment.

12. Clinical Studies

The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are not changing and therefore are equivalent to enfilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.

13. Conclusions

Based on no change to material, no change to manufacturing methods, no change to lens parameters and no change to indicated use, the enfilcon A soft contact lens described in this document are substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing freedom and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

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

CooperVision, Inc. c/o Ms. Gwen Sharp Global Regulatory Affairs 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588

DEC - 2 2011

Re: K113245

Trade/Device Name: Avaira (enfilcon A) Soft (Hydrophilic) Contact Lenses: Avaira (enfilcon A) Spherical and Aspherical Soft (Hydrophilic) Contact Lenses for Daily Wear Avaira (enfilcon A) Toric Soft (Hydrophilic) Contact Lenses for Daily Wear Avaira (enfilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL and MVN Dated: November 01, 2011 Received: November 02, 2011

Dear Ms. Sharp:

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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Page 2 – Ms. Gwen Sharp

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kevia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological 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): _(1) 3245

Device Name: Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses

Indications for Use:

SPHERICAL AND ASPHERICAL:

A VAIRA (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

TORIC:

A VAIRA (enfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MULTIFOCAL:

AVAIRA (enfilcon A) MULTIFOCAL lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

DAILY DISPOSABLE:

The Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for single-use disposable wear.

FREQUENT REPLACEMENT:

The Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of 1

510(k) Number K113245

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.