(27 days)
AVAIRA (enfilcon A) SPHERE Soft (Hydrophilic) 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.
AVAIRA (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual 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.
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 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 Avaira (enfilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. This 510(k) submission covers a process modification to add a step to the preparation of the monomer mixture. The physical properties and dimensions of the finished lenses are unchanged from predicate 510(k)s.
The provided text describes the acceptance criteria and the study conducted for the CooperVision AVAIRA (enfilcon A) Sphere and Toric Contact Lenses.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| Tested Characteristic | Acceptance Criteria (Implied: "Same as predicate" or within acceptable range) | Reported Device Performance (Results) |
|---|---|---|
| Refractive Index | 1.40 (Predicate) | Pass |
| Total Extractables | Not explicitly stated, implied to be within acceptable range | Pass |
| Monomer Residuals | Not explicitly stated, implied to be within acceptable range | Pass |
| Ionoflux | Not explicitly stated, implied to be within acceptable range | Pass |
| Contact Angle | Not explicitly stated, implied to be within acceptable range | Pass |
| UV Transmission | Not explicitly stated, implied to be within acceptable range | Pass |
| Modulus | Not explicitly stated, implied to be within acceptable range | Pass |
| Elongation | Not explicitly stated, implied to be within acceptable range | Pass |
| Tensile Strength | Not explicitly stated, implied to be within acceptable range | Pass |
| Power Conformance | Not explicitly stated, implied to be within acceptable range | Pass |
| For Substantial Equivalence Comparison (showing alignment with predicate devices): | ||
| Indications for Use (Sphere) | Correction of ametropia in aphakic and non-aphakic persons with non-diseased eyes and astigmatism ≤2.00 diopters | Same |
| Indications for Use (Toric) | 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 correction from -0.25 to -10.00 diopters | Same |
| Single Use | Single-use, disposable | Same |
| Replacement | Daily Wear, disinfect using chemical or hydrogen peroxide disinfectant when prescribed for planned replacement | Same |
| Material USAN Name | enfilcon A | Same |
| Principle of Operation | Designed to fit over corneal surface of eye to provide corrective refraction for functional conditions of the eye | Same |
| Refractive Index | 1.40 | Same |
| Oxygen Permeability x 10 -11 | 100 (cm²/sec)(ml O₂)/ml*mmHg) | Same |
| Base Curve | 8.2 to 9.2 mm | Same |
| Diameter | 13.5 to 15.0 mm | Same |
| Power Range | -20.00 to +20.00 D | Same |
| Cylinder Power | -0.25 to -10.00 D | Same |
| Water Content (avg, %wt) | 46% | 46% |
| Monomer sonication step | No | Yes |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" sample size for clinical studies because it explicitly states that "In-vivo clinical studies were not required for this change." The evaluation was based on physiochemical studies.
- Data Provenance: The physiochemical studies were "conducted by CooperVision following scientific protocols." No specific country of origin or whether it was retrospective or prospective is mentioned, but it implies internal, prospective laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Since in-vivo clinical studies were not required and the assessment was based on physiochemical properties, there was no "ground truth" established by experts in a clinical context for a test set. The ground truth was based on physical and chemical measurements against established specifications for contact lenses and comparison to predicate devices.
4. Adjudication method for the test set:
- Not applicable. No clinical test set involving human judgment was used. The physiochemical studies would involve laboratory measurements conforming to predefined technical specifications.
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 submission is for contact lenses, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is for contact lenses, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the physiochemical studies was based on physical and chemical measurements of the lens properties (e.g., refractive index, oxygen permeability, water content, modulus, etc.) against established scientific standards and comparison to the characteristics of the predicate device (AVAIRA Sphere and Toric Soft Contact Lenses, K071736/K113759).
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device (contact lenses), not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set was used.
§ 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.