(268 days)
The Safi-gel Daily Disposable (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Safi-gel Daily Disposable Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes.
The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA), crosslinked with ethylene glycol dimethacrylate (45%). The hydrated lens contains 55% water by weight with a hyaluropolymer. The lens is tinted using a UV absorbing compound (RUVA-93) incorporated into the polymer and Pigment Blue 15 (copper phthalocyanine). The lens acts as a refracting lens to focus light rays on the retina.
The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens is available as a single vision lens, which incorporates a bi-curve reduced optic front surface. The peripheral curve is tangential at the back optic zone.
The Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens design incorporates a cylinder and base curve, and a bi-curve reduced optic front surface. The peripheral curve is tangential at the back surface. This makes both sides thicker at the upper and lower half of the front surface to keep the axis stable.
The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions:
Diameter: 14.2 mm
Center Thickness: 0.08 mm (-3.00D) dry
Base Curves: 8.70 mm and 8.30 mm
Powers: +4.00D to -6.00D (in 0.25D steps), +4.50D to +12.00D (in 0.50D steps), -6.50D to -20.00D (in 0.50D steps)
The Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions:
Diameter: 14.5 mm
Center Thickness: 0.08 mm (-3.00D) dry
Base Curves: 8.70 mm
Powers: +4.00D to -6.00D (in 0.25D steps), +4.50D to +12.00D (in 0.50D steps), -6.50D to -20.00D (in 0.50D steps)
Cylinder Power: -0.50DC to -2.50D
Axis: Full circle (in 10°steps)
The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions:
Diameter: 14.0mm to 15.0mm
Center Thickness: 0.06mm to 0.40mm
Base Curve: 8.40mm to 9.30mm
Powers: +12.00 Diopters to -20.00 Diopters
Add Powers: Continuous add power to +3.25
Zone Sizes: 1.5, 1.9 mm
The physical/optical properties of the lens are:
Refractive Index: 1.410 (wet)
Light Transmittance: 90.3%
UV Transmittance: 9.3%
Water Content: 55%
{
"1. A table of acceptance criteria and the reported device performance": null,
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": null,
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": null,
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
"8. The sample size for the training set": null,
"9. How the ground truth for the training set was established": null,
"acceptance_criteria_and_performance_table": {
"title": "Physical/Optical Properties and Performance of Safi-gel Daily Disposable Lenses",
"headers": ["Property", "Reported Performance"],
"data": [
["Refractive Index", "1.410 (wet)"],
["Light Transmittance", "90.3%"],
["UV Transmittance", "9.3%"],
["Water Content", "55%"]
]
},
"study_information": {
"study_type": "Substantial Equivalence (via physicochemical and toxicological testing)",
"test_set_sample_size": "Not specified, as clinical testing was not required. Testing was done on lens extracts.",
"data_provenance": "Not specified beyond laboratory testing of the lenses themselves.",
"number_of_experts_ground_truth": "N/A (No clinical ground truth established during this type of study)",
"adjudication_method": "N/A (No clinical ground truth established during this type of study)",
"mrmc_comparative_effectiveness_study": false,
"standalone_performance_study": true,
"ground_truth_type": "Physicochemical measurements and toxicological assays against established biological reactivity standards (e.g., ISO for cytotoxicity, systemic toxicity, ocular irritation).",
"training_set_sample_size": "N/A (No machine learning algorithm or training set for this type of device submission)",
"training_set_ground_truth_establishment": "N/A (No machine learning algorithm or training set for this type of device submission)"
},
"additional_notes": "Clinical testing was not required for these lenses because their physical/chemical properties are considered equivalent to the predicate device (cleared in [K051095](https://510k.innolitics.com/search/K051095)). Similarly, microbiological testing was not required because the manufacturing and packaging processes are the same as those for the predicate device. The submission focused on establishing substantial equivalence through physicochemical testing (water content, oxygen transmissibility, light transmission (visible and UV), and refractive index) and toxicological testing (non-cytotoxicity, no systemic toxicity, no ocular irritation). The reported performance values are intrinsic properties of the device material and design, not derived from a clinical test set with patient outcomes. The acceptance criteria for these properties would have been implicitly met by demonstrating substantial equivalence to the predicate device, which would have had its own established performance standards."
}
§ 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.