CONTACT LENSES METRO-G 3X (HIOXIFILCON B)

K964902 · Metro Optics of Austin, Inc. · LPL · Mar 11, 1997 · Ophthalmic

Device Facts

• Record ID: K964902
• Device Name: CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
• Applicant: Metro Optics of Austin, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

METRO-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphapic and/or non-aphakic persons with non-diseased eyes. The Spherical lenses are available from +20.00 to -20.00 Diopters for persons with up to 1.50 Diopters of astigmatism where the astigmatism does not interfere with visual acuity. METRO-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZETRO-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction. The material, BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermal) or the chemical (not heat) disinfection system.

Device Story

Lathe-cut soft (hydrophilic) contact lens; hemispherical shell geometry. Material: hioxifilcon B (copolymer of 2-HEMA and GMA); 52% polymer, 48% water. Functions as refractive medium to focus light on retina. Used by patients for daily wear vision correction. Disinfection via heat or chemical systems. Non-ionic polymer composition.

Clinical Evidence

No clinical data. Evidence based on pre-clinical bench testing: toxicology, microbiology, autoclave validation, and lens stability studies. Preservative uptake tests performed by ALCON. All results within normal limits.

Technological Characteristics

Material: hioxifilcon B (copolymer of 2-hydroxyethyl methacrylate and 2,3-dihydroxypropyl methacrylate). Non-ionic polymer. Water content: 48%. Form factor: Lathe-cut hemispherical shell (spherical and toric). Disinfection: Heat or chemical. Clear or blue visibility tint.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. Spherical lenses: +20.00 to -20.00 D, up to 1.50 D astigmatism. Toric lenses: +20.00 to -20.00 D, up to 4.50 D astigmatism.

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

• METRO-G 55 (5X) (hioxifilcon A)

Submission Summary (Full Text)

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MAR 11 1997

SUPPLEMENT to K964902 METRO-G 3X (hioxifilcon B) JAN. 20, 1997

6.0 SUMMARY of SAFETY AND EFFECTIVENESS

# I. General Information:

A. Generic (USAN) Name: hioxifilcon B

B. Device Trade Name: METRO-G 3X (hioxifilcon B)
Spherical and Toric Soft
(Hydrophilic) Contact Lenses for
Daily Wear in Clear and with a Blue
Visibility Tint

C. Sponsor's Name and Address: METRO OPTICS of AUSTIN, INC.
15802 Vision Drive
Pflugerville, TX 78660
[phone]

D. 510(k) Number: K964902

# II. Indications

METRO-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphapic and/or non-aphakic persons with non-diseased eyes. The Spherical lenses are available from +20.00 to -20.00 Diopters for persons with up to 1.50 Diopters of astigmatism where the astigmatism does not interfere with visual acuity.

METRO-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZETRO-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.

The material, BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermal) or the chemical (not heat) disinfection system.

# III. Device Description

METRO-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical shell. The Toric has a Toric Base Curve. The non-ionic material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA).

The copolymer consists of 52% METRO-G 3X (hioxifilcon B) and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

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510(k) NOTIFICATION for METRO-G 3X (hioxifilcon B) Jan. 20, 1997

# 6.0 SUMMARY OF SAFETY AND EFFECTIVENESS

The lens METRO-G 3X (hioxifilcon B) is made from BENZ-G 3X (hioxifilcon B) optical buttons. When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.

BENZ-G 3X (hioxifilcon B) optical buttons with visibility tint were subjected to extraction studies and showed no identifiable evidence of tint pigment leeching.

## IV. Alternative Practices or Procedures

Alternative practices or procedures are in the use of available prescription products Soft and RGP Contact Lenses and spectacles for the same indication.

## V. Technical Summaries

### A. Pre Clinical

1. Toxicology

Toxikon ran all pre-clinical studies necessary for review for Class II daily wear soft (hydrophilic) contact lenses. Results were within normal limits.

2. Microbiology

Relevant studies have been run and are included with this 510(k) notification. This includes autoclave validation.

3. Lens compatibility studies were run by the developer of the polymer and are referenced in his 510(k) Notification.

Conclusion: Within Normal Limits

4. Lens Stability The Shelf life studies have been started by Metro Optics of Austin, Inc. and will be complete early in 1997. The procedure is based on sample supplied by FDA in Guidance Document for 510(k) for Daily Wear Contact Lenses, May 1994. Study will be completed in late January 1997 to assure sterility to the one year duration. No product will be distributed until tests are complete and the FDA has approved manufacture and distribution.

5. Preservative Uptake Tests were run by ALCON and were referenced by the developer of the polymer in his 510(k).

Results were within normal limits.

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510(k) NOTIFICATION for METRO-G 3X (hioxifilcon B) Jan. 20, 1997

## 6.0 SUMMARY OF SAFETY AND EFFECTIVENESS

This application includes application for Heat and Chemical (Not Heat) disinfection as the polymer as the polymer is Non-ionic. In house tests showing that heat has no injurious effect on the lenses made of this polymer.

This summary of safety and effectiveness enclosed covers the hioxifilcon B lathe-cut lens made by METRO OPTICS of AUSTIN, INC.

A favorable recommendation from the FDA for the METRO-G 3X (hioxifilcon B) Spherical and Toric Contact Lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or with blue visibility tint for daily wear use is anticipated. We feel that a review of notification will show that this polymer is close enough to the approved METRO-G 55 (5X) (hioxifilcon A) (48% water as opposed to 58% water). The METRO-G 55 (5X) was both safe and effective for its intended purpose of a daily wear contact lens.

Should additional information be desired, please contact Wally Stirling, South East Regulatory Associates, Inc. 770-475-1668.

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