SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

K080755 · Bausch & Lomb, Inc. · MVN · Jun 10, 2008 · Ophthalmic

Device Facts

• Record ID: K080755
• Device Name: SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
• Applicant: Bausch & Lomb, Inc.
• Product Code: MVN · Ophthalmic
• Decision Date: Jun 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 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

Soft hydrophilic contact lens for correction of refractive ametropia and astigmatism. Material: hilafilcon B (copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone); 59% water content; tinted with Reactive Blue Dye 246. Cast-molded design. Prescribed by eye care professionals for daily wear; patient discards lens after each single use. Provides visual correction for patients with astigmatism up to 5.00 diopters. Benefits include convenience of daily disposable modality combined with toric design for astigmatism correction.

Clinical Evidence

No new clinical data provided. Safety and effectiveness of hilafilcon B material established in K994125; safety and effectiveness of daily disposable modality established in K061157; toric design performance established in K941370.

Technological Characteristics

Material: hilafilcon B (hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone). Water content: 59%. FDA Group II (high water/non-ionic). Manufacturing: Cast-molded. Design: Toric, aspheric optics. Diameter: 14.2mm. Base curve: 8.6mm. Tint: Reactive Blue Dye 246. Sterilization: Sterile saline solution.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism (≤5.00D) in non-aphakic, non-diseased eyes. Prescription range: +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

• SofLens daily disposable (hilafilcon B) (K061158)
• SofLens59 (hilafilcon B) (K994125)
• SofLens Toric (alphafilcon A) (K941370)

Submission Summary (Full Text)

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080755

## JUN 1 0 2008

510(K) SUMMARY Bausch & Lomb, Inc. 510(k) Premarket Notification Bausch & Lomb® SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens

#### Applicant's Name and Address 1.

Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609

Susan Pate 2. Contact Person Associate Manager Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 [phone] [e-mail]

#### 3. Identification of Device

| Common Name: | soft contact lens (hydrophilic) |
|------------------------|---------------------------------------------------------------------|
| Trade Name: | SofLens® daily disposable toric (hilafilcon B)<br>Visibility Tinted |
| Classification: | Daily Wear Contact Lens |
| Device classification: | Class II (21 CFR 886.5925) |
| Product Code: | MVN |

Predicate Devices:

The predicate devices, SofLens daily disposable (hilafilcon B) and SofLens59 (hilafilcon B) Contact Lenses, were selected to demonstrate substantial equivalence of the lens material, hilafilcon B, and replacement modality, singleuse disposable lens. The predicate device SofLens toric (alphafilcon A) Contact Lenses was selected to demonstrate substantial equivalence to the Bausch & Lomb toric lens design.

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The SofLens daily disposable toric (hilafilcon B) Visibility Contact Lens is substantially equivalent to the currently marketed SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in 510(k) Premarket Notification No. K061158 on June 22, 2006, SofLens59 (hilafilcon B) Visibility tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000 and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification No. K941370 cleared on April 2,1994.

The differences between the devices follow.

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| Feature | SofLens daily disposable toric | SofLens daily disposable | SofLens59 | SofLens Toric |
|------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| FDA Group | Group II<br>(high water/non-ionic) | Group II<br>(high water/non-ionic)<br>Castmolded | Group II<br>(high water/non-ionic)<br>Castmolded | Group II<br>(high water/non ionic)<br>Castmolded |
| Manufacturing<br>Process | Castmolded | Castmolded | Castmolded | Castmolded |
| USAN Name | hilafilcon B | hilafilcon B | hilafilcon B | alphafilcon A |
| Indications | Toric<br>Daily Wear | Spherical<br>Daily Wear | Spherical<br>Daily Wear | Toric<br>Daily Wear |
| Modality | Single-use disposable | Single-use disposable | Frequent replacement | Single-use disposable or<br>Frequent replacement |
| Design Properties | | | | |
| Diameter | 14.2mm | 14.2mm | 14.2mm | 14.5mm |
| Center Thickness<br>(-3.00D) | 0.125mm | 0.090mm | 0.140mm | 0.190mm |
| Base Curve | 8.6mm | 8.6mm | 8.6mm | 8.5mm |
| Sphere powers | Plano to -6.00D in 0.25D<br>steps<br>-6.50D to -9.00D in 0.50D<br>steps | +6.50D to -6.50D in 0.25D<br>steps<br>-7.00D to -9.00D in 0.50D<br>steps | +6.50D to -6.50D in 0.25D<br>steps<br>-7.00D to -9.00D in 0.50D<br>steps | +6.00D to -6.00D in 0.25D<br>steps<br>-6.50D to -9.00D in 0.50D<br>steps |
| Cylinder Powers | -0.75D, -1.25D, -1.75D | n/a | n/a | -0.75D, -1.25D, -1.75D,<br>-2.25D and -2.75D |
| Axis | 0° to 180° in 10°<br>Increments | n/a | n/a | 0° to 180° in 10°<br>Increments |
| Aspheric Optics | Yes | Yes | No | No |

SIMILARITIES and DIFFERENCES

Section 5, Page 4

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### 4. Description of device

The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is a soft hydrophilic contact lens which is available in a toric lens design for the correction of astigmatism. The lens is made from the hilafilcon B material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246.

### 5. Intended use

The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eves, exhibiting astigmatism of 5.00 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 Equivalence

A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941370.

### Non-Clinical Laboratory Testing:

A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens material, hilafilcon B. Testing was performed in accordance with FDA quideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. The non-clinical testing can be found in the currently marketed SofLens®59 (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000.

Stability testing has demonstrated a five vear expiration date for the sterile lenses.

### Clinical Testing:

The clinical performance to confirm safety and effectiveness of the lens material, hilafilcon B, was conducted on the SofLens59 (hilafilcon B) Visibility Tinted Contact Lens and cleared in the Premarket Notification K994125 on March 3. 2000. The clinical performance to confirm the safety and effectiveness of the lens modality, daily disposable, was conducted on the SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens cleared under Premarket

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Notification K061157 on June 22, 2006. The Bausch & Lomb toric contact lens design was cleared in the SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens Premarket Notification K941370 on April 2, 1994.

#### 7. Substantial Equivalence

The SofLens daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is substantially equivalent to the currently marketed SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K061157 cleared on June 22, 2006; SofLens59 (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000; and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification K941370 cleared on April 2, 1994. The lenses are similar in that all lenses fall into FDA Group II for soft (hydrophilic) contact lenses because the ionic content is less than 1% (nonionic polymer material), the water content is greater than 50% (hilafilcon B - 59% and alphafilcon A - 66%) and are manufactured with the same manufacturing process (cast molding).

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Image /page/5/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 0 2008

Bausch & Lomb, Inc. c/o Ms. Debra Ketchum Manager, Global Regulatory Affairs 1400 North Goodman St. Rochester, NY 14609

Re: K080755

Trade/Device Name: Bausch & Lomb® SofLens® Daily Disposable Toric (hilafilcon B) Visibility Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: MVN Dated: March 14, 2008 Received: March 18, 2008

Dear Ms. Ketchum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Ilsting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Debra Ketchum

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M. B. Egerlton, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):
K080755

Device Name:

SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens

Indication for Use

The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 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.

Prescription Use X

Over-the -counter-use_ ાર

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Njudiet

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K080755

Section 4, Page 2