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Found 329 results
510(k) Data Aggregation
(79 days)
multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
Regulation Number: 21 CFR 886.5925
Name:** Soft (Hydrophilic) Contact Lens (daily wear)
Device Classification: Class II (21 CFR 886.5925
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity.
Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.
Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multi-focal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.
Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, and Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is for frequent replacement wear. Eye care practitioners may prescribe the lens for frequent replacement wear. For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).
Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens:
- The lens designs include spherical, toric and multifocal lenses.
- UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
- Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
- The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution with PEG.
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(225 days)
Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Regulation Number: 21 CFR 886.5925
Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Regulation Number: 21 CFR 886.5925
hydrophilic) Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925
Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN |
| FDA Classification: | Class II |
| Predicate
Sphere/ Asphere
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D.
Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.
Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition of +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.
Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear or visibility tinted, incorporate a UV blocker, and are available in spherical, aspherical, toric, and multifocal designs. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propylbis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and Triallyl isocyanurate (TAIC) via photopolymerization. The copolymer consists of 50% Toufilcon B and 50% water by weight when immersed in a borate-buffered saline solution. There are two types of buffer solutions: one contains Tween 80, Polyethylene Glycol, and Sodium Hyaluronate; the other contains the same components with the addition of Cyanocobalamin. The visibility tinted lens is tinted with Reactive Blue 19, 21 CFR 73.3121. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN).
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(58 days)
K254052**
Trade/Device Name: DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal
Regulation Number: 21 CFR 886.5925
) contact lens
Classification Name: Lenses, Soft Contact, Daily Wear
Regulation Number: 886.5925
DAILIES TOTAL1® (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 that does not interfere with visual acuity.
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.
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.
DAILIES TOTAL1® (sphere) and DAILIES TOTAL1® Multifocal are soft contact lenses made from delefilcon A lens material. Delefilcon A is a silicone hydrogel material with a water content of approximately 33% and a water gradient surface treatment. The lenses have a light blue tint that makes them easier to see when handling. When hydrated and placed on the cornea, DAILIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.
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(207 days)
hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF)
Regulation Number: 21 CFR 886.5925
Contact Lens
Common Name: Soft Contact Lenses, Daily Wear
Device Classification: 21CFR 886.5925
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in presbyopic phakic and aphakic persons with non-diseased eyes who exhibit 1.00D or less of astigmatism that does not interfere with visual acuity. The lens mitigates the effects of presbyopia by providing an Extended Depth of Focus (EDOF).
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is to be prescribed for single-use disposable wear and are to be discarded after each removal.
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocyanine) to make the lens more visible for handling.
The anterior surface of the contact lens is designed with a spherical geometry across the optical zone. The lens includes a centrally located zone with a diameter of 1.0 mm and a dome-shaped profile. This central zone allows the transmission of light but is not intended to focus light to produce distinct retinal images. The curvature of the central zone is steeper than that of the surrounding optical power zone and is designed to provide a power difference relative to the base spherical power of at least +6.00 diopters. The central, functional optically inactive zone is intended to increase the depth of focus for the wearer.
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(239 days)
multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
Regulation Number: 21 CFR 886.5925
Name:** Soft (Hydrophilic) Contact Lens (daily wear)
Device Classification: Class II (21 CFR 886.5925
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity.
Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.
Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non- diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multi-focal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.
Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, and Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear. Eye care practitioners may prescribe the lens for daily disposable wear. The lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
The lens designs include spherical, toric and multifocal lenses.
UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution with PEG.
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(273 days)
A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)
Regulation Number: 21 CFR 886.5925
Classification Name:** Lenses, Soft Contact, Daily Wear
Device Classification: II
Regulation Number: 886.5925
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or reusable daily wear in a Frequent Replacement Program.
DISPOSABLE WEAR:
When prescribed for Disposable Wear, the Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens is to be discarded after each removal.
FREQUENT/PLANNED REPLACEMENT WEAR:
When prescribed for Frequent/Planned Replacement Wear, the Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a copolymer of silicone-containing monomers and hydrophilic monomers, and has 44% water by weight.
These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 315 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive. The lens is marked with wording "321" to help user better distinguish the correct side before inserting in eyes.
The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with A) PMB Packaging Solution, or B) Cyanocobalamin Packaging Solution depends on customer's requirement.
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(160 days)
:** Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
Regulation Number: 21 CFR 886.5925
Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925
Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN |
| FDA Classification: | Class II |
-
Sphere and Asphere
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere and Asphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. -
Toric
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters. -
Multifocal
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
The lenses are intended for single-use disposable wear.
The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing materials. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19", "Reactive Red 180", and "Reactive Yellow 15", which are approved color additives by the U.S. FDA and listed in 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).
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(111 days)
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
Regulation Number: 21 CFR 886.5925
lenses, soft contact, daily wear
Classification Name: Soft (hydrophilic) Contact Lens (21 CFR 886.5925
- FDA category - Group V
- FDA classification – Class II, Soft (hydrophilic) Contact Lens (21 CFR 886.5925
- FDA category - Group V
- FDA classification – Class II, Soft (hydrophilic) Contact Lens (21 CFR 886.5925
) | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | Soft (hydrophilic) Contact Lens (21 CFR 886.5925
Sphere and Asphere:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the spherical and aspheric design are indicated for monthly disposable wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the toric design is indicated for monthly disposable wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
Multifocal:
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens in the multifocal design is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is a hemispherical shell with a molded base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lens is fabricated from somofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 44.0% somofilcon A and 56.0% water by weight when immersed in saline solution. The somofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (316nm - 380nm).
The VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens is manufactured in spherical/aspheric, toric, multifocal design configurations. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.050 mm to 0.200 mm | When ≤ 0.10 mm ±0.010 mm + 10% When > 0.10 mm ±0.015 mm + 5% |
| Base Curve | 7.0 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | -20.00 D to +20.00 D (in 0.25 D steps) | When 0.00 < |
| Cylinder Power (F'c) | -0.25 D to -2.25 D (in 0.25 D steps) | When 0.00 < F'c ≤ 2.00 D ±0.25 D When 2.00 < F'c ≤4.00 D±0.37 D |
| Cylinder Axis | 10° to 180° in 10° steps (in 10° steps) | When 0.00 < F'c ≤ 1.50 D ± 8° When F'c > 1.50 D± 5° |
| Multifocal Power | +0.25 D to +4.00 D (in 0.25 D steps) | ±0.25D |
| Oxygen Permeability (x 10-11 (cm2•ml O2)/(sec•ml•mmHg)) | 60 | ±20% |
| Visible Light Transmittance | >95% | ±5% |
| Ultraviolet radiation Transmittance | < 5% TUVB <20% TUVA | TUVB (280 to 315nm) < 0.05 TV TUVA (316 to 380nm) < 0.05 TV |
| Water Content | 56% | ±2% |
| Refractive Index | 1.398 | ±0.005 |
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(162 days)
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Regulation Number: 21 CFR 886.5925
Common Name: Contact Lens, Daily Wear
- Classification Name: Soft (hydrophilic) Contact Lens (21 CFR 886.5925
) - Product Code: LPL
- Panel: Ophthalmic
- Regulation Number: 886.5925
- Device Class: Class II
**05
code | LPL | LPL | - |
| Regulatory class | Class II | Class II | - |
| Regulation Number | 21 CFR 886.5925
| 21 CFR 886.5925 | - |
| Intended use | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted
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 (<50% H₂O, non-ionic polymer) | Group 1 (38±2% H₂O, polymacon) |
| Production Method | Fully molded | Fully molded |
| USAN Name | polymacon | polymacon |
| Water Content (%) | 38±2% | 38±2% |
| Oxygen Permeability (x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method) | Within criteria specified in FDA guidance 'Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway' (March 28, 2023). | 9.40 ± 20% (Stated as within FDA guidance criteria) |
| Specific Gravity | Not explicitly stated as a comparative criterion, but measured internally. | 1.124 ± 0.0371 |
| Refractive Index (hydrated) | Comparable to predicate (1.438 ± 0.005) or within acceptable range. | 1.437 ± 0.005 |
| UV Blocker | No UV Blocker (equivalent to predicate) | No |
| Pad-Printed Tinting | Yes (equivalent to predicate) | Yes |
| Primary Packaging | Blister pack with Aluminum foil seal | Blister pack with Aluminum foil seal (Small and Big) |
| Sterilization Method | Steam sterilization | Steam sterilization |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating (ocular), non-systemically toxic, non-pyrogenic (material-mediated), non-toxic in rabbit eyes. Packaging also non-cytotoxic, non-irritating, non-toxic. | All specified tests (Cytotoxicity, Sensitization, Acute Ocular Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Determination of Biocompatibility of Contact Lenses in Rabbit Eyes) showed positive results (non-toxic, non-irritating, etc.). Primary packaging also passed. |
| Shelf Life | Stability, sterility, and package integrity maintained for labeled expiration date. | Data shows 5 years validity. |
| Physicochemical & Mechanical Properties | Meet design specifications (Shape and Appearance, Diameter, Basecurve, Center Thickness, Power, Visible light transmittance, Contact angle, Water contents, Oxygen permeability, Refractive Index, Specific Gravity, pH, Osmolality). | All specified tests were completed and verify compliance. |
Study Proving Device Meets Acceptance Criteria
The study performed to demonstrate that the P-CON contact lenses meet the acceptance criteria is primarily a non-clinical bench testing program aimed at demonstrating substantial equivalence to a predicate device and compliance with recognized standards. This is typical for Class II medical devices like contact lenses where a predicate exists and safety/effectiveness can be established through engineering and material characterization rather than clinical trials requiring human subject data for efficacy.
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Sample Size and Data Provenance for Test Set:
- Test Set (Bench Testing): The document does not specify exact sample sizes for each bench test (e.g., number of lenses or material samples tested for biocompatibility, oxygen permeability, etc.). This information is typically detailed in the full test reports referenced in the 510(k) submission, not typically summarized in the clearance letter.
- Data Provenance: The testing was conducted by E.O.S Co., Ltd. (company based in Korea, South). Biocompatibility testing was conducted in accordance with ISO 10993 series and GLP (Good Laboratory Practice) regulations, implying established, documented procedures. Given it's bench testing for a new device, it is prospective in nature (i.e., new tests were performed on the subject device).
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Number of Experts and Qualifications for Ground Truth for Test Set:
- Not Applicable in the context of this 510(k). This is not an AI/ML device requiring expert interpretation of images for ground truth. The "ground truth" for contact lens performance is derived from physical measurements (e.g., water content, oxygen permeability), chemical analyses (e.g., material composition), and standardized biological tests (e.g., cytotoxicity assays). These "truths" are established by validated laboratory equipment and protocols, not subjective expert consensus.
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Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, "adjudication" is usually for resolving discrepancies in expert human reads, which is not relevant for bench testing of device characteristics. The results are quantitative measurements against defined specifications.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not done. This type of study is specifically designed for evaluating diagnostic performance of AI or imaging devices with human readers, and it is not relevant for a contact lens 510(k) submission.
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Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Not Applicable. This device is a physical medical device (contact lens), not a standalone algorithm.
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Type of Ground Truth Used:
- The "ground truth" for this device's performance is established through:
- Physical and Chemical Measurements: Directly measured properties like water content, oxygen permeability, refractive index, diameter, base curve, etc. against pre-defined specifications or predicate values.
- Standardized Biocompatibility Assays: Results from tests performed according to ISO 10993 series (e.g., cytotoxicity, sensitization, irritation) against established pass/fail criteria.
- Predicate Device Comparison: Demonstrating that key characteristics are "substantially equivalent" to a previously cleared predicate device.
- The "ground truth" for this device's performance is established through:
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Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of this 510(k) as it's not an AI/ML device. The device's design and manufacturing process are based on established engineering principles for contact lenses, not a learned model from data.
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How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set was used.
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(313 days)
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Regulation Number: 21 CFR 886.5925
Common Name: Contact Lens, Daily Wear
- Classification Name: Soft (hydrophilic) Contact Lens (21 CFR 886.5925
) - Product Code: LPL
- Panel: Ophthalmic
- Regulation Number: 886.5925
- Device Class: Class II
**05
code | LPL | LPL | - |
| Regulatory class | Class II | Class II | - |
| Regulation Number | 21 CFR 886.5925
| 21 CFR 886.5925 | - |
| Intended use | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted
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 text is a 510(k) clearance letter for contact lenses. While it details the device, its intended use, and substantial equivalence to a predicate device, crucial information regarding acceptance criteria for AI/algorithm performance and the study that proves the device meets the acceptance criteria (specifically in the context of AI/algorithm evaluation) is not present.
The document focuses on the physical and biological properties of contact lenses and manufacturing processes, not on an AI or algorithmic component that would require a study with an AI-specific acceptance criterion, ground truth establishment, or MRMC studies. The "Non-Clinical Test Conclusion" section primarily refers to biocompatibility, shelf life, and physicochemical/mechanical properties testing, all of which are standard for contact lenses and do not involve AI performance evaluation.
Therefore, I cannot fulfill the request as the input document does not contain the necessary information about AI/algorithm performance.
If this were a document for an AI-powered medical device, the information would typically be found in dedicated sections detailing "Clinical Performance Study," "Software Verification and Validation," or similar.
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