BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT

K011718 · Bausch & Lomb, Inc. · MVN · Jul 25, 2001 · Ophthalmic

Device Facts

• Record ID: K011718
• Device Name: BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
• Applicant: Bausch & Lomb, Inc.
• Product Code: MVN · Ophthalmic
• Decision Date: Jul 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D. The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

Device Story

Hemispherical flexible contact lens; covers cornea and portion of sclera. Material: copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone; 70% water content. Tinted blue (D&C Green #6 or Reactive Blue Dye 246) or clear. Used for daily wear vision correction of refractive ametropia. Prescribed by eye care professionals; patient self-use for daily wear; discarded after each removal. Benefits include vision correction and convenience of single-use disposable format.

Clinical Evidence

Bench testing only. In vitro and in vivo preclinical toxicology testing performed per FDA 1994 guidance. Studies conducted in compliance with GLP. Results demonstrated no toxicity or irritation and physicochemical equivalence to the predicate.

Technological Characteristics

Material: hilafilcon A (copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone). Water content: 70%. Refractive index: 1.38. Oxygen permeability (Dk): 33 x 10^-11. Diameter: 13.5-15.0mm. Base curve: 7.8-9.5mm. Sterilization: sterile saline solution. Manufacturing: cast molding.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes, with astigmatism ≤ 2.00 diopters. Powers: +20.00D to -20.00D. Single-use disposable.

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 (hilafilcon A) Visibility Tinted Contact Lens (K011718)

Submission Summary (Full Text)

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K011718

# 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens

#### SUBMITTER INFORMATION 1.

Bausch & Lomb Incorporated 1400 North Goodman Street P.O. Box 0450 Rochester, NY 14692-0450

Contact Person: Debra Ketchum Manager, Regulatory Affairs [phone] Telephone No .:

#### DEVICE NAME 2.

Classification Name: Soft (hydrophilic) contact lens

Proprietary Name: BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens

### PREDICATE DEVICE 3.

The BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens has been selected as the predicate devices for the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens produced with the monomer diluent.

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#### DESCRIPTION OF DEVICE 4.

The BAUSCH & LOMB® SofLens™ one day disposable (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)phenylamino]anthraquinone). 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: | 1.068 |
|---------------------------|------------------------------------------------------------------------------|
| 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 SofLens™one day disposable (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 |

Each BAUSCH & LOMB SofLens™ one day disposable (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 ধন

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20,00D to -20.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

### DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALIENCE 6.

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Contact Lens. A summary of results from the preclinical tests is provided below.

## Preclinical Testing:

A series of in vitro and in vivo preclinical toxicology testing was performed to assess the safety and effectiveness of the contact lens device. Testing was performed in accordance with FDA guideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. All non-clinical laboratory studies were conducted in compliance with the GLP regulation.

The results of the preclinical testing on the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens produced with the monomer diluent demonstrate that:

The physicochemical properties of the BAUSCH & LOMB® SofLens™ one day (hilafilcon A) disposable Visibility Tinted Contact Lens are equivalent to the currently marketed predicate device, BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens.

The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens material demonstrated no toxicity or irritation.

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# Substantial Equivalence

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The DITO bess produced with the monomer diluent is similar to the currently marketed BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens, in that both fall into the same FDA material classification grouping (Group II) and both are manufactured by the same manufacturing process (cast molding). (Group II) CH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The Driver Lens is different from the BAUSCH & LOMB® SofLens™ one day Disposable (hilafileon A) Visibility Tinted Contact Lens in that it is manufactured using a monomer (imamoon is) visioningerol is not included in the weight or mole percentages of the monomer mix, as it does not become part of the lens material. The difference between these two lenses will not have any negative effect on the safety and effectiveness of the device.

All product will be sold as sterile medical devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**JUL 2 5 2001**

Bausch & Lomb, Inc. c/o Ms. Debra Ketchum Manager, Regulatory Affairs 1400 N. Goodman Street P.O. Box 30450 Rochester, NY 14603-0450

Re: K011718

Trade Name: Bausch & Lomb® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulatory Class: Class II Product Code: 86 MVN Dated: June 1, 2001 Received: June 4, 2001

Dear Ms. Ketchum:

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 - Ms. Debra Ketchum

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,
A. Ralph Rosenthal

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

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

## Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Device Name: Visibility Tinted Contact Lens

## Indications for Use:

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The DAOSCAT & LOND - Bollers
Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and Comact Lelis is indroased for t-sphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may astEmatists of inspherical powers ranging from +20.00D to -20.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

## Claims:

- The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility l. Tinted Contact Lens provides vision correction in powers ranging from +20.00D to -20.00D.
- The BAUSCH & LOMB® Sofilens™ one day disposable (hilafilcon A) Visibility 2. Tinted Contact Lens is for single-use disposable wear.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter-Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

Daniel W.C. Brown, Ph.D.

(Division Sign-Off)

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K011718