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510(k) Data Aggregation
(282 days)
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. - Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement (Replacement Recommended Every 2 Weeks):
Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. - NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric: NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: NaturalVue (Etafilcon A)Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
The Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and Natural/ue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are clear or visibility-tinted, containing a UV blocker and are available in a spherical, aspherical multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from Etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% Etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
This document is a 510(k) premarket notification for three types of soft contact lenses: Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices based on material properties, biocompatibility, microbiology, bacteriostatic validation, and leachability. There are no explicit quantitative acceptance criteria stated beyond "complying with the requirement of FDA Group 4" for sterilization. Differences in oxygen permeability and percent transmittance are evaluated against the predicate devices.
| Criteria/Property | Acceptance Criteria (Implied by Predicate) | Proposed Device (Aquamax/NaturalVue Etafilcon A) Reported Performance |
|---|---|---|
| Material Properties | ||
| Production Method | Cast-Molded (for K120028 & K962804 predicates) | Cast-Molded |
| USAN Name | Etafilcon A (for K120028 & K962804 predicates) | Etafilcon A |
| Material Classification | Group 4 high water ionic (for K120028 & K962804 predicates) | Group 4 high water ionic |
| Water Content (%) | 58% (for K120028 & K962804 predicates) | 58% |
| Refractive Index | 1.4023 (for K120028 predicate) | 1.4023 |
| Oxygen Permeability (Dk) @ 35°C | Approx. $19.73 \times 10^{-11}$ (K120028) to $21.4 \times 10^{-11}$ (K962804) | $19.73 \times 10^{-11}$ (cm²/sec)(ml O₂/ml-mmHg) |
| Percent Transmittance % T at 593nm | > 95% (for K120028 & K013445 predicates), > 85% (for K962804 predicate) | > 95% |
| % T at 380-315nm (UVA) | < 30% (for K120028 & K962804 predicates) | < 30% |
| % T at 315-280nm (UVB) | < 5% (for K120028 & K962804 predicates) | < 5% |
| Biocompatibility | Negative responses for cytotoxicity, maximization, and ocular irritation | Negative responses recorded for all tests |
| Microbiology (Sterilization) | Minimum SAL of 10-6 (FDA Group 4 requirement) | Validated to deliver a minimum SAL of 10-6 |
| Bacteriostatic Validation | Effective killing of microorganisms, sterility maintained (5 years) | Steam sterilizer effective, no microbial growth for 5 years |
| Leachability | No leachable monomers and additive residues at detection levels | No leachable monomers and additive residues at detection levels |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical study with a specific sample size. The evaluation relies heavily on non-clinical tests comparing the device's properties to legally marketed predicate devices.
- Data Provenance: The document explicitly states that "Aquamax (Etaflicon A) Soft (Hydrophilic) Contact Lenses from the previous FDA cleared K120028 did not require clinical studies as the USAN name and manufacturing processes are the same as the above-mentioned ACUVUE predicate (and reference) devices." This indicates a reliance on the historical performance and existing regulatory clearances of similar devices.
- Non-Clinical Tests: These tests would involve laboratory samples of the contact lenses. The specific number of contact lenses or batches tested for each non-clinical criterion (e.g., water content, Dk, transmittance, biocompatibility) is not provided. The provenance of these laboratory samples (e.g., country of manufacture) is implicitly Taiwan, where Pegavision Corporation is located. These would be retrospective in the sense that they are conducted on manufactured devices for regulatory submission, rather than a prospective clinical trial on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no "test set" in the context of clinical data requiring expert review for ground truth. The evaluation is based on non-clinical laboratory testing and equivalence to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
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
This information is not applicable. This submission is for a medical device (contact lenses), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a contact lens and not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Laboratory measurements/standards: For material properties (water content, Dk, transmittance, refractive index), biocompatibility (standard cytotoxicity, maximization, ocular irritation tests), microbiology (sterilization SAL), bacteriostatic validation, and leachability. These are objective, quantifiable measurements against established scientific and regulatory standards.
- Demonstrated equivalence to predicate devices: The "ground truth" for the overall safety and effectiveness is largely based on the fact that the proposed devices are substantially equivalent to previously cleared devices (K120028, K013445, K962804) which have established safety and effectiveness profiles through prior regulatory review and historical clinical use.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set.
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