SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)

K963488 · Specialty Ultravision, Inc. · LPL · Nov 20, 1996 · Ophthalmic

Device Facts

• Record ID: K963488
• Device Name: SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)
• Applicant: Specialty Ultravision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems. The Specialty Choice⁴ᵃ (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Device Story

Soft hydrophilic contact lenses; hemispherical shells made of polymerized HEMA and other monomers crosslinked with EGDMA. Designed to fit over corneal surface; provide corrective refraction for myopia, hyperopia, and astigmatism. Multifocal version addresses presbyopia. Prescribed by eyecare practitioners for daily wear; frequent replacement program. Disinfected via chemical or hydrogen peroxide systems. Benefits patient by correcting refractive errors and improving visual acuity.

Clinical Evidence

No clinical data provided; substantial equivalence based on physical, optical, and chemical property comparisons to predicate devices and use of identical manufacturing processes/materials.

Technological Characteristics

Material: methafilcon A (Group 4 ionic, high water content polymer). Composition: HEMA and other monomers crosslinked with EGDMA. Form: Hemispherical soft contact lens. Dimensions: 14.3-14.5mm diameter; 0.07-0.17mm center thickness. Sterilization: Not specified.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and presbyopia (Multifocal) or myopia/hyperopia (Single Vision) in aphakic/not-aphakic persons with non-diseased eyes and astigmatism up to 2.00D.

Regulatory Classification

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.

Predicate Devices

• LifeStyle FREQUENCY PROGRESSIVE (methaflicon A) Multifocal Soft (Hydrophilic) Contact Lens
• LifeStyle 55 (methaflicon A) Single Vision Soft (Hydrophilic) Contact Lens

Submission Summary (Full Text)

{0}

10/09/1996 16:27 9083031205 KNOPF ASSOCIATES INC PAGE 07
NOV 20 1996

510 (k) Summary K 963488

SUBMITTER:

Submitted on behalf of:

Company Name: Specialty UltraVision, Inc.
Address: 307 Orchard City Drive
Campbell, CA 95008
Phone: [phone]
Fax: [phone]

CONTACT PERSON: Dr. Garold Edwards

DATE SUMMARY PREPARED: October 8, 1996

TRADE NAME: Specialty Progressive (methaflicon A) Soft (Hydrophilic) Multifocal
Contact Lenses for Daily Wear (clear and tinted) and Specialty
Choice^AB (methaflicon A) Soft (Hydrophilic) Single Vision Contact
Lenses for Daily Wear (clear and tinted)

COMMON NAME: contact lens

SUBSTANTIALLY EQUIVALENT TO:

The Specialty Progressive (methaflicon A) Soft (Hydrophilic) Multifocal
Contact Lenses for Daily Wear (clear and tinted) and Specialty Choice^AB
(methaflicon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear
and tinted) are equivalent to The LifeStyle FREQUENCY PROGRESSIVE
(methaflicon A) Multifocal Soft (Hydrophilic) Contact Lens for Daily Wear (clear and
tinted) currently marketed in the U.S. and the LifeStyle 55 (methaflicon A) Single Vision
Soft (Hydrophilic) Contact Lens for Daily Wear (clear and tinted).

The Specialty Progressive (methaflicon A) Soft (Hydrophilic) Multifocal Contact Lenses
for Daily Wear (clear and tinted) and Specialty Choice^AB (methaflicon A) Soft
(Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted) are
substantially equivalent to the indication for use of the LifeStyle FREQUENCY
PROGRESSIVE (methaflicon A) Multifocal Soft Contact Lens for Daily Wear (clear and
tinted) marketed for use in the U.S. and the LifeStyle 55 (methaflicon A) Single Vision
Soft Contact Lens for Daily Wear (clear and tinted). Specialty UltraVision, Inc. has
received from the manufacturer of the predicate device all manufacturing information
including; but not limited to, formulation, manufacturing processes (including
polymerization conditions, tinting process, lens parameter tolerances, sterilization and
packaging, quality control/quality assurance, established shelf life data, shelf life

{1}

10/09/1996 16:27 9083031205 KNOPF ASSOCIATES INC PAGE 08

protocol), and labeling; necessary to manufacture the devices, which are the subject of K963488. In addition, Specialty UltraVision, Inc. will manufacture these devices at the same manufacturing location as the predicate devices.

This lens is in Group 4 ionic, high water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, optical, and chemical properties of the Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses for Daily Wear (clear and tinted) and the Specialty Choice^A8 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted) are equivalent to those of the LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft Contact Lens for Daily Wear (clear and tinted) and the Lifestyle 55 (methafilcon a) Single Vision Soft Contact Lens for Daily Wear (clear and tinted).

## DESCRIPTION of the DEVICE:

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

## INDICATIONS FOR USE:

Device Name: Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear (clear and tinted)

The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

{2}

10/09/1996 16:27 9083031205 KNOPF ASSOCIATES INC PAGE 09

Device Name: Specialty Choice⁴ᵃ (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted)

The Specialty Choice⁴ᵃ (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

## PARAMETERS AVAILABLE:

### Specialty Progressive (methafilcon A)

Powers: +4.00 to -5.00D
Center Thickness: .17 mm
Diameter: 14.5 mm
Base Curve: 8.4 mm (Minus lenses)
8.6 mm (Plus Lenses)

### Specialty Choice⁴ᵃ (methafilcon A)

Powers: +20.00 to -20.00D
Center Thickness: .07 mm
Diameter: 14.3 mm
Base Curve: 8.60 mm