(28 days)
Sphere/Asphere:
AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. 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 VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aplakic 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 VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric:
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.
Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses fo frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.
The Avaira Vitality (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens.
The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The Avaira Vitality (fanfilcon A) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The Avaira Vitality (fanfilcon A) lens is supplied sterile, packaged in a phosphate buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.
In its hydrated state, the Avaira Vitality (fanfilcon A) Contact Lens visibility tinted, with UV blocker, when placed on the cornea, acts as a refracting medium to focus light rays on the retina.
The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:
• Diameter: 13.5 mm to 15.0 mm
• Base Curve: 8.2 mm to 9.2 mm
• Center Thickness: 0.06 mm to 0.6 mm (varies with power)
• Powers: -20.00 D to +20.00 D
• Cylinder Powers (Toric): -0.25 D to -10.00 D
• Axis (Toric): 0° to 180°
• Add Power Range (Multifocal) +0.25 D to +4.00 D
The physical/optical properties of the lenses are:
• Specific Gravity: 1.026
• Refractive Index: 1.398 ± 0.005
• Light Transmittance: 98% +2/-5%
• Surface Character: Hydrophilic
• Water Content: 55% ± 2%
• Oxygen Permeability: 90x10-11 [(cm²/sec) x (ml O2)/ (ml x mm Hg)]
This document is a 510(k) Premarket Notification from CooperVision, Inc. to the FDA regarding their Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K213164).
Based on the provided text, the device in question is a contact lens, not an AI/ML powered device, therefore, many of the requested criteria are not applicable (N/A) or cannot be extracted from this document, as they pertain to the evaluation of AI/ML software performance.
Here's an analysis of the acceptance criteria and study information that can be extracted, and where the information is N/A:
Acceptance Criteria and Reported Device Performance
The document describes the device, its properties, and compares it to a legally marketed predicate device (K160803). The "performance data" section focuses on physical and optical properties rather than diagnostic performance metrics typically seen with AI/ML devices.
| Acceptance Criteria | Reported Device Performance (Subject Device K213164) | Predicate Device (K160803) |
|---|---|---|
| Water Content % | 55% | 55% |
| Refractive Index @ 20°C | 1.40 | 1.40 |
| Specific Gravity g/mL | 1.026 | 1.026 |
| Oxygen Permeability (Dk) | 90 | 90 |
| Base Curve, mm | 8.4 | 8.4 |
| Diameter, mm | 14.2 | 14.2 |
| Diameter Range (Lens Description) | 13.5 mm to 15.0 mm | Not explicitly listed in comparison table, but implied by "Same" for specific diameter. |
| Base Curve Range (Lens Description) | 8.2 mm to 9.2 mm | Not explicitly listed in comparison table, but implied by "Same" for specific base curve. |
| Center Thickness (Lens Description) | 0.06 mm to 0.6 mm (varies with power) | Not explicitly listed in comparison table. |
| Powers | -20.00 D to +20.00 D | Not explicitly listed in comparison table. |
| Cylinder Powers (Toric) | -0.25 D to -10.00 D | Not explicitly listed in comparison table. |
| Axis (Toric) | 0° to 180° | Not explicitly listed in comparison table. |
| Add Power Range (Multifocal) | +0.25 D to +4.00 D | Not explicitly listed in comparison table. |
| Specific Gravity | 1.026 | 1.026 |
| Refractive Index | 1.398 ± 0.005 | 1.40 |
| Light Transmittance | 98% +2/-5% | Not explicitly listed in comparison table. |
| Surface Character | Hydrophilic | Not explicitly listed in comparison table. |
| Visibility Tint | Reactive Blue #246 | Reactive Blue #246 |
| UV Blocker | Norbloc UV blocker | Present (implied by "Same" for product name) |
| Material USAN Name | fanfilcon A | fanfilcon A |
| Manufacturing Method | Molded | Molded |
| Sterilization | Moist Heat | Moist Heat |
| Primary Packaging | Blister, Foil | Blister, Foil |
| Packaging Solution | Phosphate buffered saline solution | Phosphate buffered saline solution |
| Biocompatibility Testing: Cytotoxicity | Performed (ISO 10993-5:2009) | N/A (Comparison is to predicate, not specific testing results are provided) |
| Biocompatibility Testing: Irritation & Sensitization | Performed (ISO 10993-10:2010) | N/A (Comparison is to predicate, not specific testing results are provided) |
Study Details (Focusing on AI/ML Criteria - Mostly N/A for this device)
-
Sample size used for the test set and the data provenance:
- Not applicable (N/A). This document is for a physical medical device (contact lens), not an AI/ML software device that would require a "test set" of data in the context of algorithm evaluation. The document states, "The modification does not warrant performance testing to support substantial equivalence." This implies a lack of new clinical performance studies on the finished device in general.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A). No "ground truth" establishment in the context of diagnostic agreement is described for this physical device.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable (N/A). No adjudication method is necessary for a physical contact lens.
-
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 (N/A). This is a contact lens, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable (N/A). This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable (N/A). The evaluation for this device focuses on physical properties, material composition, manufacturing, and biocompatibility, not diagnostic 'ground truth.' The basis for substantial equivalence is primarily the identical material and manufacturing process to the predicate device, along with limited biocompatibility testing.
-
The sample size for the training set:
- Not applicable (N/A). No AI/ML model for which a "training set" would be used is described.
-
How the ground truth for the training set was established:
- Not applicable (N/A). No AI/ML model or training set is described.
Summary of the Study Proving Substantial Equivalence for the Contact Lens:
The submission for K213164 (Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens) is a 510(k) application for substantial equivalence to a predicate device (K160803), which is an earlier version of the same product.
The core of the "study" proving the device meets acceptance criteria for substantial equivalence relies on:
- Demonstrating Technological Characteristics are Identical: The subject device shares the exact same material (fanfilcon A), manufacturing method (Molded), sterilization method (Moist Heat), primary packaging, packaging solution, and visibility tint with the predicate device.
- Demonstrating Performance Specifications are Identical: Key physical and optical properties like water content, refractive index, specific gravity, oxygen permeability (Dk), base curve, and diameter are listed as "Same" as the predicate device.
- Limited Biocompatibility Testing: In accordance with GLP regulation (21 CFR Part 58), biocompatibility testing was performed on the lens and packaging solution, specifically:
- ISO 10993-5:2009 (Tests for in vitro cytotoxicity)
- ISO 10993-10:2010 (Tests for irritation and skin sensitization)
The document states that "limited biocompatibility testing is adequate to support substantial equivalence" because the predicate device's lens material characteristics, primary packaging materials, and packaging solution are identical.
- Regulatory Basis: The 510(k) is submitted in accordance with the May 12, 1994 Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses. The modification (a "lens extract non-polymeric residuals specification change") was deemed by the submitter to not warrant performance testing to support substantial equivalence due to the fundamental similarities with the predicate.
In conclusion, for this specific medical device, the "acceptance criteria" revolve around demonstrating the device is fundamentally the same as a previously cleared device, supported by the specific physical and chemical properties and basic biocompatibility testing, rather than a clinical performance study with AI-specific metrics.
§ 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.