(44 days)
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The lenses are to be prescribed for single-use Daily Disposable Wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use.
DAILIES TOTAL 1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.
DAILIES TOTAL1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable:
Spherical lenses: Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1
Toric lenses: Focus DAILIES Toric and DAILIES AquaComfort Plus Toric
Multifocal lenses: Focus DAILIES Progressives, DAILIES AquaComfort Plus Multifocal and DAILIES Total1 Multifocal
The lens material of Focus DAILIES, DAILIES AquaComfort Plus and FreshLook One-Day products is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with Nformylmethyl acrylamide) and 69% water. For Focus DAILIES and DAILIES AquaComfort Plus products the lens material further contains non-functionalized PVA (high- and/or ultra-high molecular weight PVA) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint®) to make the lenses easier to see when handling. Additionally, lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue (CFR 74.3045) and phthalocyanine green (CFR 73.3124). FreshLook One-Day color contact lenses are printed with an intermittent coating containing the following pigments (either alone or in combination): iron oxides, titanium dioxide, Cu-phthalocyanine blue, chromium oxide and phthalocyanine green. All pigments are approved color additives for use in contact lenses.
DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. Delefilcon A soft contact lenses are surface coated with hydrophilic components. The lenses contain a color additive (copper phthalocyanine blue) to assist handling tint). In addition, lenses contain 1,2-Dimyristoyl-sn-glycero-3-phosphocholine which is considered a 'comfort agent' to improve lens wearing comfort by physical mode of action (water binding and lens lubricating effect).
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 products are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top. The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (for DAILIES AquaComfort Plus and DAILIES Total1) and/or approximately 0.85 ml (for Focus DAILIES and FreshLook One-Day) of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES AquaComfort Plus family lenses additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each (Focus DAILIES, DAILIES AquaComfort Plus, DAILIES Total1) and/or 10 lenses each (FreshLook One-Day), respectively.
This document is a 510(k) premarket notification for contact lenses, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include extensive de novo clinical studies with acceptance criteria for a novel AI device as would be seen for a new technology or an AI/ML diagnostic.
Therefore, the information required to answer the questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an AI device is not present in this document.
Instead, this submission focuses on demonstrating substantial equivalence based on:
- Identical Indications for Use: The modified contact lenses have the same intended use as the predicate devices.
- Similar Technological Characteristics: The materials, manufacturing methods, lens designs, sterilization, and basic performance specifications (refractive index, light transmittance, oxygen permeability, elastic modulus) are either identical or very similar to the predicate devices.
- Non-clinical Performance Testing: Biocompatibility and stability testing were performed to show that the minor modifications (primarily to the primary packaging foil lidding supplier) do not negatively impact safety or performance.
- No Clinical Testing Required: Due to the high similarity and successful non-clinical testing, clinical testing was deemed unnecessary to establish substantial equivalence.
In summary, this document is for a medical device (contact lenses) and not an AI/ML-based device. Hence, the detailed criteria for AI device validation (like acceptance criteria for AI performance, MRMC studies, ground truth establishment, etc.) are entirely irrelevant and absent from this submission.
If this question was intended for an AI/ML-based medical device, the provided document does not contain the necessary information.
§ 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.