BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS

K022128 · Bausch & Lomb, Incorporated · HQD · Aug 22, 2002 · Ophthalmic

Device Facts

• Record ID: K022128
• Device Name: BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
• Applicant: Bausch & Lomb, Incorporated
• Product Code: HQD · Ophthalmic
• Decision Date: Aug 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The BOSTON® EQUALENS® II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Device Story

Rigid gas permeable (RGP) contact lens; material composed of methyl methacrylate fluoroitaconate siloxanyl copolymer with UV absorber. Corrects refractive errors (myopia, hyperopia, astigmatism, presbyopia) in aphakic/non-aphakic patients. Daily wear; chemical disinfection only. Prescribed by eye care professionals. Benefits include vision correction via rigid lens optics.

Clinical Evidence

Safety and efficacy established via Premarket Application P860022 and subsequent supplements (S007, S016, S054). No new clinical data provided in this 510(k).

Technological Characteristics

Material: methyl methacrylate fluoroitaconate siloxanyl copolymer with UV absorber. Specific gravity: 1.24. Refractive index: 1.423. Water content: <1%. Oxygen permeability (Dk): 127 (gas to gas) or 85 (ISO/Fatt). Designs: spherical, aspherical, toric, bifocal/multifocal.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic and non-aphakic persons with non-diseased eyes.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• BOSTON® EQUALENS® (itafluorofocon A) Rigid Gas Permeable Contact Lens (P860022)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 2 2 2002

K022/28

### 510(k) SUMMARY

FOR

BOSTON® EQUALENS® II (oprifocon A) RIGID GAS PERMEABLE CONTACT TENSES

### 1. SUBMITTER INFORMATION

Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609

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

# 2. DEVICE NAME

Classification Name: Rigid Gas Permeable (hydrophobic) Contact Lens

Proprietary Name: BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses

#### PREDICATE DEVICE 3.

The BOSTON® EQUALENS® (itafluorofocon A) Rigid Gas Permeable Contact Lens approved in Premarket Application, P860022, on November 30, 1987, has been selected as the predicate device for the BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses.

{1}------------------------------------------------

### DESCRIPTION OF DEVICE 4.

The BOSTON® EQUALENS® II (oprifocon A) is a Rigid Gas Permeable Contact Lens material composed of methyl methacrylate fluoroitaconate siloxanyl copolymer with an ultraviolet absorber.

The color additives conform to 21 CFR Part 74. The lens may also be supplied clear (no tint).

The physical / optical properties of the lens are:

| Property | BOSTON EQUALENS II |
|---------------------------------------------|-----------------------|
| Specific Gravity | 1.24 |
| Refractive Index | 1.423 |
| Light Absorbance<br>(Absorbance Units/Inch) | 9.4 Blue<br>4.8 Green |
| Water Content | <1% |
| Oxygen Permeability (Dk) | 127*<br>85** |

*gas to gas **ISO/Fatt

#### 5. INDICATIONS FOR USE

The BOSTON® EQUALENS® II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes.

The lens may be disinfected using a chemical disinfection system only.

{2}------------------------------------------------

#### DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE 6.

The safety and efficacy of BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses was demonstrated in Premarket Application P860022 approved for daily wear in Supplement S007 on April 12, 1989.

BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to BOSTON® EQUALENS® (itafluorofocon A) Rigid Gas Permeable Contact Lenses approved in Premarket Application, P860022, on November 30, 1987. BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses for daily wear aspheric, bifocal/multifocal and toric designs are substantially equivalent to BOSTON® EQUALENS® (itafluorofocon A) Rigid Gas Permeable Contact Lenses subsequently approved in Supplements S007 on April 12, 1989, S016 on December 27, 1989, and S054 on May 6, 2002, respectively.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**AUG 22 2002**

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

Re: K022128

Trade/Device Name: Boston® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear

(Spherical, Aspherical, Toric & Bifocal/Multifocal with UV absorber)

Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: August 6, 2002 Received: August 7, 2002

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, 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 (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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

### Page 2 - Ms. Debra L.B. 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/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

{5}------------------------------------------------

Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609

# Indications for Use Statement

510(k) Number (if known): _

BOSTON® EQUALENS® II (oprifocon A) RGP Contact Lens Device Name:

Indications for Use:

The BOSTON® EQUALENS® II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes.

The lens may be disinfected using a chemical disinfection system only.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter-Use

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number: K022/28