BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS

K983894 · Bausch & Lomb, Inc. · LPL · Nov 18, 1998 · Ophthalmic

Device Facts

• Record ID: K983894
• Device Name: BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
• Applicant: Bausch & Lomb, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D. The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

Device Story

Hemispherical flexible contact lens; copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone; 70% water content. Corrects refractive ametropia (myopia, hyperopia, astigmatism). Prescribed by eye care practitioners for daily wear; requires patient cleaning, rinsing, and chemical disinfection. Lens provides vision correction via physical refraction of light through the lens material. Benefits include vision correction and ease of handling via visibility tint.

Clinical Evidence

No new clinical data presented. Substantial equivalence is based on the established safety profile of the predicate device (K974780), which included compatibility testing of lens care regimens and clinical performance testing.

Technological Characteristics

Hydrophilic contact lens; material: copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone; 70% water content. Refractive index 1.38; oxygen permeability (Dk) 33 x 10^-11. Tinted with D&C Green #6 or Reactive Blue Dye 246. Dimensions: 13.5-15.0mm diameter, 0.05-0.75mm center thickness, 7.8-9.5mm base curve. Powers: +20.00D to -20.00D; Toric cylinder 0 to 10D.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism up to 10.00D) in aphakic and non-aphakic persons with non-diseased eyes. Prescribed for frequent/planned replacement wear.

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

• BAUSCH & LOMB SofLens one day disposable (hilafilcon A) Visibility Tinted Contact Lens (K974780)

Submission Summary (Full Text)

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# K 983 894

# 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

# BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens

#### Submitter Information: 1.

Bausch & Lomb Incorporated Global Vision Care Division 1400 North Goodman Street Rochester, NY 14692-0450

Contact Person: Dennis Hahn Manager, Regulatory Affairs Telephone No .: [phone]

#### 2. Device Name:

Classification Name: Soft (hydrophilic) contact lens

Proprietary Name: BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens

#### 3. Predicate Device:

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens has been selected as the predicate device.

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#### Description of Device 4.

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylaminolanthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).

The physical / optical properties of the lens are:

| Specific Gravity: | 1.075 |
|---------------------------|-------------------------------------------------------------------------------|
| Refractive Index: | 1.38 |
| Light Transmittance: | C.I.E. Y value - at least 97% |
| Water Content: | 70% |
| Oxygen Permeability (Dk): | 33 x10-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C<br>(Polarographic Method) |

The BAUSCH & LOMB Phoenix (hilafilcon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:

| • Diameter: | 13.5mm to 15.0mm |
|-----------------------|--------------------|
| • Center Thickness: | 0.05mm to 0.75mm |
| • Base Curve: | 7.8mm to 9.5mm |
| • Powers (Spherical): | +20.00D to -20.00D |
| • Toric (Cylinder): | 0 to 10 diopters |
| • Toric Axis: | 0° to 180° |

Each BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date.

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#### INDICATIONS FOR USE ળં

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eves, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

The BAUSCH & LOMB Phoenix (hilaffilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

#### 6. Description of Safety and Substantial Equivalence

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens has the same technological characteristics as the predicate device, the BAUSCH & LOMB® Soft ens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens. The established safety profile (toxicology, physicochemical properties, manufacturing / chemistry) of the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is equivalent to the predicate device.

The SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens was cleared on March 11, 1998, File Number K974780. File K974780 included test data from studies in which hilafilcon A visibility tinted contact lenses were subjected to care system testing, specifically 1) Compatibility testing of the lens care regimens recommended for use in the proposed labeling, and 2) Clinical performance testing.

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is therefore substantially equivalent to the predicate device, the BAUSCH & LOMB® Soft ens TM one day disposable (hilafilcon A) Visibility Tinted Contact Lens, and does not raise new questions of safety or effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

BAUSCH & LOMB Dennis Hahn Manager, Regulatory Affairs 1400 North Goodman St. Rochester, NY 14692

Re: K983894 Trade Name: Bausch & Lomb Phoenix (hilafilcon A ) Visibility Tinted Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: October 30, 1998 Received: November 3, 1998

Dear Mr. Hahn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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## Page 2 - Mr. Dennis Hahn, Manager, Regulatory Atlairs

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450

# Indications for Use Statement

510(k) Number (if known): K983894

BAUSCH & LOMB Phoenix (hilafilcon A)Visibility Tinted Contact Lens Device Name:

Indications for Use:

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

### Claims:

- The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact provides vision 1. correction in powers ranging from +20.00D to -20.00D.
- 2. The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact provides vision correction of refractive astigmatism of up to 10.00 diopters.
- 3. The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact may be disinfected using a chemical disinfection system.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span>✓</span> |
|------------------|----------------|
|------------------|----------------|

| | <i>(Division Sign-Off)</i> |
|--|--------------------------------|
| | Division of Ophthalmic Devices |

| 510(k) Number | K983894 |
|---------------|---------|
|---------------|---------|

| Over-The-Counter-Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|