(30 days)
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.
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.
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.
§ 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.