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The I-55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The I-55 (methafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The I-55 (methafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The I-55 (methafilcon A) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

The I-55 soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

The nonionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).

I-55 lenses are available clear, visibility tinted (for handling), and tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives:

[Phthalocyaninato(2-)] copper
D&C Green No.6
D&C Red No.17
D&C Violet No.2
D&C Yellow No.10
Titanium dioxide

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive(s) on the front surface of the contact lens in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens in the location that corresponds to the iris, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.5 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (methafilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are:

Refractive Index: 1.415
Light Transmission (clear): greater than 90%
Light Transmission (tinted): greater than 90%
Surface Character: hydrophilic
Water Content: 55±2%
Specific Gravity: 1.039 (hydrated)
Oxygen Permeability: 19.01 x 10-11 (cm²/sec)(mlO₂)/(ml x hPa @ 35°C)) (revised Fatt method)

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the sphere, toric, multifocal, and toric multifocal design configurations with the following features and properties:

Chord Diameter: 13.00 mm to 15.00 mm
Center Thickness: 0.080 mm to 0.580 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range

• Sphere Power: -12.00D to +12.00D in 0.25D steps
• Cylinder Power (toric): -0.25D to -2.25D in 0.25D steps
• Cylinder Axis (toric): 10° to 180° in 10° steps
• Multifocal Power: +1.25 to +2.50 in 0.25D steps

The provided text describes the 510(k) premarket notification for "I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear." This document focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study to prove acceptance criteria for a new AI-powered diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this submission. The document explicitly states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." (Page 0)

And throughout the "Pre-Clinical Performance Data" and "Substantial Equivalence" sections (Pages 7-9), it continuously refers to establishing equivalence with predicate devices and using their established safety profiles and manufacturing processes. It does not describe a new study to prove adherence to a fresh set of acceptance criteria for a novel device, especially not an AI-enabled one.

Instead, the document details the equivalence of the I-55 contact lenses to predicate devices based on:

• Intended Use: The I-55 lenses have the same intended use (correction of visual acuity in aphakic/not aphakic persons with non-diseased eyes with myopia or hyperopia, and/or astigmatism, and/or presbyopia) as the primary predicate device (PolyVue Distribution, Inc. "I-55 (methafilcon A)" K080794). The tinted versions are also equivalent to the PolyVue Technologies, Inc. "HD/HDT, PV/PVT (polymacon)" K013220 for color enhancement.
• Functionality: Both the subject device and predicate devices act as refractive media to focus light on the retina.
• Indications: Daily wear, soft (hydrophilic) contact lens.
• Production Method: Fully-molded, identical to predicate devices.
• Material (USAN name): The subject device uses "methafilcon A," which is the same as the primary predicate device (K080794). The secondary predicate device (K013220) uses "polymacon."
• Physical Properties:
  • Water Content: 55±2% for the subject device and the primary predicate (K080794). The secondary predicate (K013220) has 38±2%.
  • Oxygen Permeability: 19.01 x 10-11 (cm²/sec)(mlO₂)/(ml x hPa @ 35°C) (revised Fatt method) for the subject device and primary predicate (K080794). The secondary predicate (K013220) has 8.40 x 10-11.
  • Specific Gravity: 1.039 (hydrated) for the subject device and primary predicate (K080794).
• Pre-Clinical Performance Data: The submission relies on pre-clinical data from the predicate device (K080794) for "consistency of the physical and material properties," "sterility," and "biocompatibility." Additional testing was performed on the I-55 soft contact lenses regarding the stability of parameters, toxicity/irritation (including color additives), and ensuring finished lenses remained within original specifications (Page 7).
• Manufacturing and Sterilization: The subject device will use identical processes and a cGMP quality assurance program as the predicate device (K080794) for manufacturing and sterilization. The process for incorporating color additives is identical to the HD/HDT, PV/PVT (polymacon) predicate (K013220).

In summary, this document is a 510(k) submission demonstrating substantial equivalence to existing devices, not a study evaluating acceptance criteria for a novel device, especially an AI one. Therefore, the specific questions posed are not addressed in this type of regulatory filing.

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