(162 days)
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00 diopters to -10.00 diopters.
The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. The lenses are intended for daily wear and are to be replaced every three months (quarterly). When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in 0.9% saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is available clear or tinted for visibility using phthalocyanine blue, tinted in unique pattern to enhance or alter the apparent color of the eye. Each unique patterns may be distributed under unique or "private label" trade names. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: C.I Reactive Black 5, Titanium Dioxide (TiO2), Carbazole Violet (i.e.,C.I Pigment Violet 23), Phthalocyanine green (i.e.,C.I PIgment Green 7), D&C Yellow No. 10, D&C Red No. 17, [Phthalocyaninato (2-)] Copper (i.e.,C.I PIgment Blue 15).
When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material—in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The provided FDA 510(k) clearance letter and associated documentation for the P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) primarily focus on demonstrating substantial equivalence to a predicate device based on bench testing. This type of submission relies on comparing physical, chemical, and design characteristics, along with performance against established standards, rather than extensive clinical studies or AI algorithm performance.
Therefore, many of the typical acceptance criteria and study details relevant to AI/ML medical devices (such as MRMC studies, expert consensus for ground truth on a large test set, etc.) are not explicitly present or applicable in this regulatory context.
However, based on the provided text, I can infer and extract the acceptance criteria and the type of study conducted to prove the device meets these criteria in the context of a 510(k) for contact lenses.
Here's the breakdown:
Acceptance Criteria and Device Performance (P-CON Contact Lenses)
The acceptance criteria for this device are established by demonstrating that its physicochemical, mechanical, and biocompatibility properties are substantially equivalent to a legally marketed predicate device (K221517) and that it complies with relevant ISO standards and FDA guidance for soft contact lenses.
Table 1: Acceptance Criteria and Reported Device Performance
| Feature/Property | Acceptance Criteria (Implied/Predicate-based/Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia (and astigmatism ≤ 1.50 Diopters). Can be clear or tinted, for daily wear, quarterly replacement, chemical disinfection. | Matches predicate's intended use (corrects myopia, handles astigmatism ≤ 1.50 D, available clear/tinted, daily wear, quarterly replacement, chemical disinfection). |
| Actions | Acts as a refractive medium to focus light on the retina. | Equivalent to predicate. |
| FDA Group | Group 1 ( |
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”