(63 days)
The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myperopia) 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-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with nondiseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal 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-Colors Aqua 42 UV lens also acts to enhance or alter the apparent color of the eye.
Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal 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 (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing compound 2-[3-(2H-Benzotriazol-2y1)-4-hydroxyphenyl] ethyl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container containing hyaluronic acid polymer in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74. The lens designs include spherical, toric and multifocal lenses.
This document pertains to a 510(k) premarket notification for Saview-Colors Aqua 42 UV (hefilcon A) Soft (hydrophilic) contact lenses. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance criteria of an AI/ML powered medical device. Therefore, many of the requested categories related to medical device performance and AI/ML studies are not applicable to this document.
However, I can extract information related to the non-clinical testing performed and the comparison to predicate devices, which serves a similar purpose of demonstrating safety and effectiveness based on established criteria for contact lenses.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Parameters):
| Acceptance Criteria Category/Test | Reported Device Performance (Saview-Colors Aqua 42 UV) | Predicate Device 1 (Saview-Colors 42 UV, K123484) | Predicate Device 2 (Saview-Aqua 55 UV, K121201) |
|---|---|---|---|
| Material (Classification) | hefilcon A (Group 1) | hefilcon A (Group 1) | methafilcon A (Group 4) |
| Indication for Use | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism |
| Water Content | 42% | 42% | 55% |
| Visible Light Transmittance | 97.06% | 97.06% | 96.78% |
| UV-A Transmittance | 9.22% | 9.22% | 12.370% |
| UV-B Transmittance | 0.49% | 0.49% | 1.025% |
| Dk (35° C) | $10.89 \times 10^{-11}$ | $10.89 \times 10^{-11}$ | $21.4 \times 10^{-11}$ |
| Powers | +12.00D to -20.00D | +12.00D to -20.00D | +12.00D to -20.00D |
| Refractive Index | 1.4347 (wet) | 1.4347 (wet) | 1.404 (wet) |
| Method of Manufacture | Moulded | Moulded | Moulded |
| Packaging | PP Blister Pack | PP Blister Pack | PP Blister Pack |
| Colorants | Iron oxides, Titanium dioxide, [Phthalocyaninato (2-)] copper, Phthalocyanine green, Carbazole violet | Iron oxides, Titanium dioxide, [Phthalocyaninato (2-)] copper, Phthalocyanine green, Carbazole violet | Copper phthalocyanine (visibility tinted) |
| Package Storage (Saline Solution) | Saline solution containing hyaluronic acid polymer | Saline solution containing hyaluronic acid polymer | Saline solution |
| Stability Testing | Performed, lenses remain sterile and properties do not change before expiration date. | Not explicitly detailed but implied for predicate. | Not explicitly detailed but implied for predicate. |
| Toxicology Testing | Cytotoxicity: showed substantial equivalence. Ocular Irritation: showed substantial equivalence. Acute Systemic Injection: showed substantial equivalence. | Not explicitly detailed but implied for predicate. | Not explicitly detailed but implied for predicate. |
| Physical/Chemical Testing | Performed (results summarized above in comparison table). | Not explicitly detailed but implied for predicate. | Not explicitly detailed but implied for predicate. |
Information not applicable or not found in the provided document, based on the nature of this 510(k) submission for contact lenses:
- Sample sized used for the test set and the data provenance: This document describes non-clinical and physical/chemical testing, not a "test set" in the context of an AI/ML model. The specific sample sizes for tests like stability, cytotoxicity, etc., are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not mentioned for these tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device requiring expert ground truth for a diagnostic outcome.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML powered device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device. For the contact lens, the "ground truth" for non-clinical tests would be established by validated test methodologies and specifications for safety and performance (e.g., ISO standards for biocompatibility, physical properties for contact lenses).
- The sample size for the training set: Not applicable, as this is not an AI/ML powered device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML powered device.
Summary of Device Meeting Acceptance Criteria:
The document explicitly states that "Information submitted in the 510(k) establishes that the Saview-Colors Aqua 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness." It further concludes that the results of stability testing, acute systemic injection, ocular irritation, and in vitro cytotoxicity tests showed the Saview-Colors Aqua 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility.
The acceptance criteria are implied to be the established safety and performance profiles, including physical characteristics and biocompatibility, demonstrated by the legally marketed predicate devices. The study proving the device meets these criteria involved a series of non-clinical tests as recommended by the "Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994." These tests focused on:
- Stability Testing: To ensure lenses remain sterile and properties do not change before the expiration date.
- Toxicology Testing: Including Cytotoxicity, Ocular Irritation, and Acute Systemic Injection to confirm biocompatibility.
- Physical/Chemical Testing: To characterize properties like water content, transmittance, Dk, powers, refractive index, etc., and compare them to predicate devices.
Clinical testing was explicitly stated as NOT required for this submission, indicating that the non-clinical data and comparison to predicate devices were sufficient to demonstrate substantial equivalence for the specified indications for use.
§ 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.