(109 days)
DAILIES TOTAL1 (delefilcon A) and DAILIES TOTAL1 Asphere (delefilcon A) 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 that does not interfere with visual acuity.
DAILIES TOTAL1 for ASTIGMATISM (delefilcon A) 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 6.00 diopters (D) of astigmatism.
DAILIES TOTAL1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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 (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia, hyperopia) 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 6.00 diopters (D) of astigmatism.
The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The DAILIES TOTAL 1® family of daily disposable soft contact lenses are made from delefilcon A, a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. The delefilcon A silicone hydrogel material is considered a Group 5C material according to ISO 18369-1:2017 (defined as: "enhanced oxygen permeable material", water content less than 50%, no ionic monomer or oligomer at pH 6 to pH 8).
Modified DAILIES TOTAL1® lenses contain a combination of light absorbing chromophores. Specifically, benzotriazole UV absorbing monomers are used to block UV radiation and, additionally, reduce transmittance in the range from 380 nm. The color additive [phthalocyaninato (2-)] copper (synonym: copper phthalocyanine) provides a light blue-green handling tint.
Lens designs for the modified DAILIES TOTALI® (delefilcon A) lenses include spherical, asphere, toric, multifocal, and multifocal toric lenses in the following parameter range:
- Diameter Range: 13.0 to 15.0 mm
- Base Curve Range: 8.0 to 9.2 mm
- Power Range: -20.00D to +20.00D
- Center Thickness: varies with design and power (0.09 mm for -3.00D spherical)
Lenses have the following properties:
- Refractive index: 1.42 (hydrated)
- Water content: 33% by weight in normal saline
- Oxygen permeability 140 barrer units measured at 35 °C (intrinsic Dk - Coulometric method)
- % Light transmittance, visible: 90 ± 5% (average over 380 to 780 nm)
- % UV transmittance UVA (315-380 nm):
The provided text describes modifications to already cleared contact lenses (DAILIES TOTAL1®). The submission (K182782) focuses on showing that the modified device remains substantially equivalent to the predicate device. Therefore, the information required for a study proving device meets acceptance criteria, particularly for a new device with specific performance metrics, is not directly applicable or comprehensively provided as it would be for a novel AI/software medical device.
Based on the document, here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one would expect for an AI/software device with quantitative metrics like sensitivity, specificity, etc.
Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" is assessed by showing that the modified device's characteristics are the "same as" the predicate device in key areas, and that non-clinical testing confirms its safety and effectiveness.
Here's a table derived from the "Comparison to Technological Characteristics with the Predicate Device" and "Performance Data" sections:
| Characteristic/Criterion | Predicate Device Specification | Subject Device Performance (Modified DAILIES TOTAL1® lenses) | Acceptance (vs. Predicate) |
|---|---|---|---|
| Intended Use | Vision correction | Same | Met |
| Wearing Schedule | Daily wear | Same | Met |
| Replacement Schedule | Daily disposable | Same | Met |
| Material Classification | Group 5C, low water silicone hydrogel according to ISO 18369-1:2017 | Same | Met |
| Lens Material | Delefilcon A | Same | Met |
| Surface Treatment | Water gradient surface treatment | Same | Met |
| Manufacturing Method | LightStream (molded) | Same | Met |
| Visibility Tint | [phthalocyaninato (2-)] copper | Same | Met |
| Lens Marks | None | Molded lens marks (e.g. fiducial mark for toric lenses) | Different (but considered acceptable, likely not impacting substantial equivalence negatively) |
| Lens Designs | Spherical, toric, multifocal, multifocal toric | Spherical, asphere, toric, multifocal, multifocal toric | Different (broader range, but deemed substantially equivalent) |
| Power Range | +20.00 to -20.00D | Same | Met |
| Base Curve Range | 8.0 to 9.2 mm | Same | Met |
| Diameter Range | 13.0 to 15.0 mm | Same | Met |
| Water Content | 33% | Same | Met |
| Refractive Index | 1.42 | Same | Met |
| Oxygen Permeability | 140 barrer units* | Same | Met |
| Sterilization | Steam sterilization, validated autoclave | Same | Met |
| Packaging | Polypropylene blister shell sealed with polyester coated aluminum foil lidding | Same | Met |
| Package Storage Saline Solution | Phosphate buffered saline (PBS) with polymeric wetting agents | Same | Met |
| Physicochemical characteristics | (Implicitly, those of the predicate) | Substantially equivalent to predicate | Met |
| Biocompatibility | (Implicitly, non-toxic, non-irritating, non-sensitizing, non-genotoxic) | Non-toxic, non-irritating, non-sensitizing, and non-genotoxic | Met |
| Stability Testing | (Implicitly, supports labeled expiration date) | Successful stability testing supports the labeled expiration date | Met |
| Light transmittance, visible (380-780 nm) | (Not explicitly stated for predicate in comparison table, but implied by "Light transmittance properties (incl. UV and UV-Vis) are supported by testing...") | 90 ± 5% (average over 380 to 780 nm) | Met (against ISO standard / internal specification) |
| UVA (315-380 nm) transmittance | (Not explicitly stated for predicate in comparison table) |
§ 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.