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510(k) Data Aggregation
(250 days)
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/ or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
The lenses are intended for single-use disposable wear.
The Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).
The provided document (K222885) is a 510(k) Premarket Notification for contact lenses, specifically Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).
It is crucial to understand that this document describes a submission for a medical device (contact lenses), NOT an AI/ML-powered diagnostic device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML systems (such as those involving test sets, ground truth establishment by experts, MRMC studies, etc.) do not apply to this submission.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance tests conducted to demonstrate the safety and effectiveness of the contact lenses. The acceptance criteria are based on established standards for contact lens properties and safety.
Here's an interpretation based on the provided document, framed within the context of a traditional medical device submission, rather than an AI/ML algorithm:
Acceptance Criteria and Study for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
The device, Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), is a Class II medical device. Its acceptance criteria and proof of meeting them are primarily based on demonstrating substantial equivalence to legally marketed predicate devices through a combination of non-clinical (laboratory) testing and established material safety.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this contact lens device are derived from the performance characteristics of predicate devices and general industry standards for soft contact lenses. The reported device performance is compared against these benchmarks to demonstrate substantial equivalence.
| Characteristic / Acceptance Criteria | Predicate Device K201268 (Ethos Aquell) | Predicate Device K213119 (Innova Vision Hydrogel) | Proposed Device (Pegavision) |
|---|---|---|---|
| Production Method | Cast-Molded | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A | Hioxifilcon A |
| Material Classification | Group II (high water non-ionic) | Group II (high water non-ionic) | Group II (high water non-ionic) |
| Water Content (%) | 59% | 59% | 59% |
| Refractive Index | 1.400 | 1.400 | 1.400 |
| Oxygen Permeability (edge corrected) @ 35°C ($\text{cm}^2/\text{sec} \cdot \text{mlO}_2/\text{ml} \cdot \text{mmHg}$) | $20.6 \times 10^{-11}$ | $25 \times 10^{-11}$ | $23.2 \times 10^{-11}$ |
| Transmittance Visible light @ 380-780nm | > 95% | > 95% | > 95% |
| Transmittance UVA @ 380-315nm |
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