(260 days)
The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm.
Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.
The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.
OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.
This document is a 510(k) summary for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device testing (e.g., sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies) is not applicable to this document.
However, I can extract information related to the device attributes and the comparisons made to establish equivalence, which can be seen as meeting "acceptance criteria" for chemical/physical properties rather than AI performance.
Here's a breakdown of what can be inferred and what is explicitly stated:
Acceptance Criteria and Device Performance (Analogous for Contact Lenses)
In the context of contact lenses, "acceptance criteria" are not thresholds for AI performance, but rather specifications and physical/chemical properties that demonstrate the new devices (Vexillum Zephyr and OxyPure A) are substantially equivalent to the predicate device (OxyPure Color). The table below summarizes these comparisons.
| Category | Acceptance Criteria (Predicate Device K171447: OxyPure Color) | Reported Device Performance (New Devices: Vexillum Zephyr & OxyPure A) | Result of Comparison |
|---|---|---|---|
| Applicant | Visco Vision Inc | Visco Vision Inc | Same |
| Classification | Class II | Class II | Same |
| Regulation Number | 886.5925 | 886.5925 | Same |
| Product Code | LPL, MVN | LPL, MVN | Same |
| Intended Use | Myopia, Hyperopia, astigmatism, Presbyopia | Myopia, Hyperopia, astigmatism, Presbyopia | Same |
| Replacement Schedule | Daily Wear | Daily Wear | Same |
| USAN Name | olifilcon A | olifilcon A | Same |
| FDA Category (Group) | Group 5C (Nonionic, Water |
§ 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.