(190 days)
The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wcar for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive am etropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity.
The Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) the correction of refractive ametropia Contact Lens is indicated for daily wear for (myopia and hyperopia) and presbyopia in aphakic or or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters.
The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate, and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 55 UV (methafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 87.630 in the UVA range of 316 nm to 380 nm and 98.975 % in the UVB range of 315 % nm to 280 nm. The lens contains 55% water by weight and each lens is supplied sterile in a blister container containing 0.2 % hyaluronic acid polymer in saline solution. The lens is visibility tinted using Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.
The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Savicw-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Saview-Aqua 55 UV contact lenses:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily demonstrates substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the Saview-Aqua 55 UV lenses against numerical targets. Instead, the "acceptance criteria" are implicitly understood to be meeting or exceeding the performance characteristics of the predicate devices. The study compares key physicochemical properties.
| Characteristic | Acceptance Criteria (Implied: Comparable/Better than Predicate K051095 and K090806) | Saview-Aqua 55 UV Reported Performance | Predicate K051095 Performance | Predicate K090806 Performance |
|---|---|---|---|---|
| Material | methafilcon A (Group 4) | methafilcon A (Group 4) | methafilcon A (Group 4) | methafilcon A (Group 4) |
| Indication for use | myopia, hyperopia, presbyopia, astigmatism | myopia, hyperopia, presbyopia, astigmatism | myopia, hyperopia, presbyopia, astigmatism | myopia, hyperopia, presbyopia, astigmatism |
| Water content | 55% | 55% | 55% | 55% |
| Visible light transmittance (381 nm ~ 780 nm) | ≥ 90.3% (from predicates) | 96.78% | 90.3% | 90.30% |
| UV Transmittance | ≤ 9.1% (from predicate K051095) | 6.7% | 9.1% | 9.3% |
| UVA (316 nm ~ 380 nm) | ≤ 15.816% (from predicate K051095) | 12.370% | 15.816% | (Not specified) |
| UVB (280 nm ~ 315 nm) | ≤ 2.435% (from predicate K051095) | 1.025% | 2.435% | (Not specified) |
| Dk (35°C) | ≥ 18.9 x 10^-11 (from predicates) | 21.4 x 10^-11 | 18.9 x 10^-11 | 18.9 x 10^-11 |
| Powers | Comparable range to predicates | +12.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal) | +4.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal) | +4.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal) |
| Color | Pigment blue 15 | Pigment blue 15 | Pigment blue 15 | Pigment blue 15 |
| Refractive index (wet) | Comparable to predicates | 1.404 | 1.410 | 1.410 |
| Method of manufacture | Moulded | Moulded | Moulded | Moulded |
| Package Storage saline solution | Saline solution (some may contain hyaluronic acid polymer) | Saline solution containing hyaluronic acid polymer | Saline solution | Saline solution with hyaluropolymer |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "pre-clinical tests" and "physicochemical testing" but does not specify numerical sample sizes for these tests. It indicates the data comes from tests performed by St. Shine Optical Co., Ltd. in Taiwan, R.O.C. (the submitter). The data is generated prospectively for the purpose of this submission, but not in the context of a clinical trial on human subjects for device performance. It focuses on material properties and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable and not provided. The "ground truth" for these tests relates to the inherent physical and chemical properties of the lenses and their biological safety as tested in vitro or in animal models, not human diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable. There is no human interpretation or adjudication process described for the physicochemical and biocompatibility testing.
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 is a contact lens submission, not an AI-powered diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a contact lens submission, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this type of submission is based on:
- Physicochemical Measurements: Standardized laboratory tests to determine properties like water content, transmittance, Dk, refractive index, etc.
- Biocompatibility Standards: Results from tests showing non-toxicity, non-irritation, and absence of unsafe residues, typically assessed against established biological safety standards for medical devices (ISO 10993 series, though not explicitly cited, is standard practice).
- Sterility Testing: Ensuring the product remains sterile until the expiration date.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this device.
§ 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.