SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR

K963764 · Specialty Ultravision, Inc. · LPL · Jan 30, 1997 · Ophthalmic

Device Facts

• Record ID: K963764
• Device Name: SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
• Applicant: Specialty Ultravision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jan 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Specialty T (ocufilcon A) Soft (hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters. Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.

Device Story

Specialty T is a soft, hydrophilic toric contact lens made of ocufilcon A. Designed for daily wear to correct refractive ametropia (myopia, hyperopia, astigmatism). Lens features a prism-ballasted, non-truncated design with an inferior slab-off to stabilize axis orientation via eyelid interaction with the lens thickness profile. Manufactured via spin casting. Prescribed by eyecare practitioners for frequent/planned replacement. Patients perform daily cleaning and disinfection using heat, chemical, or hydrogen peroxide systems. Provides refractive correction by conforming to the corneal surface.

Clinical Evidence

Bench testing only. Comparison of physical, optical, and mechanical properties (refractive index, water content, oxygen permeability, light transmittance, modulus, tensile strength, elongation at break) between subject and predicate lenses.

Technological Characteristics

Material: ocufilcon A (Group 3 ionic, low water content polymer). Manufacturing: spin casting. Design: prism-ballasted, non-truncated toric lens with inferior slab-off. Dimensions: 14.5 mm diameter, 0.15 mm center thickness. Optical properties: 1.427 refractive index, 44.1% water content, 11.3 Dk.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism (up to 2.50D) in aphakic and non-aphakic patients with non-diseased eyes.

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

• Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens (K963764)

Submission Summary (Full Text)

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FROM : Panasonic FAX SYSTEM
PHONE NO. :
Jan. 29 1997 12:12PM P2

# 510 (k) Summary for K963764

SUBMITTER: JAN 30 1997

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: December 13, 1996

TRADE NAME: Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear

COMMON NAME: contact lens

SUBSTANTIALLY EQUIVALENT TO:

Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear is equivalent to Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear.

Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear is substantially equivalent to the indication for use of the Hydron Ultra T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear marketed for use in the US. This lens is in Group 3 ionic, low 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 T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear are equivalent to those of the Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear. The subject device utilizes the same formulation, manufacturing and sterilization processes, packaging, Quality Control/Quality Assurance Procedures and established shelf life as the predicate device, the Ocular Sciences/American Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear. A side by side comparison of the physical, optical and mechanical properties clearly establish the equivalency of these two contact lens products.

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FROM : Panasonic FAX SYSTEM
PHONE NO. :
Jan. 29 1997 12:13PM P3

# Comparison of physical/optical/mechanical properties of Ultra T lenses Vs. Specialty T Lenses

| PARAMETER | Ocular Sciences/Am. Hydron
Ultra T (ocufilcon A) Toric | | | | Specialty T (ocufilcon A)
Toric | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | units | mean | st. dev. | n | units | mean | st. dev. | n |
| refractive index | | 1.427 | 0.002 | 30 | | 1.427 | 0.001 | 30 |
| specific gravity | | 1.16* | | | | 1.16* | | |
| water content | % | 43.7 | 0.45 | 29 | % | 44.1 | 0.37 | 30 |
| oxygen permeability | | | | | | | | |
| Dk (@35 °C) | Dk** | 10.2 | 1.41 | 20 | Dk** | 11.3 | 1.43 | 20 |
| light transmittance
(@590 Nm) | % | 98.31 | 1.27 | 10 | % | 98.51 | 0.82 | 10 |
| Mechanical Properties | | | | | | | | |
| modulus | N/mm² | 0.37 | 0.048 | 21 | N/mm² | 0.36 | 0.051 | 18 |
| tensile strength | N/mm² | 0.37 | 0.048 | 21 | N/mm² | 0.34 | 0.136 | 18 |
| Elongation @
break | % | 148 | 53 | 21 | % | 165 | 69 | 18 |

## Notes:

All products are produced by a spin casting process, consequently, only hydrated lenses are available for testing.

* Measured using 10 lenses for a single measurement. The range was 1.15 to 1.17
** (cm² x ml O₂) / (sec x ml x mmHg) x 10⁻¹¹

## 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 7mm. 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. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mold to provide consistent optics. Orientation marks are molded into the front surface as part of the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort. Axis stabilization is achieved by the action of the lids on the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.

{2}

FROM : Panasonic FAX SYS EM

PHONE NO. :

Jan. 29 1997 12:13PM P4

# INDICATIONS FOR USE:

Device Name: Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear

The Specialty T (ocufilcon A) Soft (hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters.

Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.

# PARAMETERS AVAILABLE:

Specialty T (ocufilcon A)

Powers: plano to -6.00 diopters (in 0.25 diopter steps)

Cylinder Powers: -1.00, -1.50, -2.00 diopters

Axis 10° to 180° in 10° steps

Center Thickness: 0.15 mm

Diameter: 14.5 mm

Base Curve: Varies with power