RIGID GAS PERMEABLE CONTACT LENS

K013762 · Bausch & Lomb, Incorporated · HQD · Apr 3, 2002 · Ophthalmic

Device Facts

• Record ID: K013762
• Device Name: RIGID GAS PERMEABLE CONTACT LENS
• Applicant: Bausch & Lomb, Incorporated
• Product Code: HQD · Ophthalmic
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Device Story

Rigid gas permeable contact lenses; composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer (ES/EO) or siloxanyl fluoromethacrylate copolymer (XO); includes UV absorber. Designed for daily wear to correct refractive errors including myopia, hyperopia, astigmatism, presbyopia, and keratoconus. Lenses are worn by patients; chemical disinfection required. Provides vision correction through physical lens properties; no electronic or software components.

Clinical Evidence

No clinical data provided in this summary; safety and efficacy were previously demonstrated in 510(k) notifications K943177, K980741, and K000795.

Technological Characteristics

Materials: aliphatic fluoroitaconate siloxanyl methacrylate copolymer (ES/EO) and siloxanyl fluoromethacrylate copolymer (XO). Includes UV absorber. Color additives conform to 21 CFR 73/74. Water content <1%. Oxygen permeability (Dk) ranges from 36 to 140 (gas-to-gas) depending on material. Rigid, gas-permeable form factor. Chemical disinfection required.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia, keratoconus) 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® II (itafocon A) Rigid Gas Permeable Contact Lens (P820065)

Submission Summary (Full Text)

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

# APR 0 3 2002

## 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

# BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON® XO (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES

### 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 ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses

#### 3. PREDICATE DEVICE

The BOSTON® II (itafocon A) Rigid Gas Permeable Contact Lens approved in Premarket Application, P820065, on November 17, 1983, has been selected as the predicate device for the BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses.

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

#### DESCRIPTION OF DEVICE 4.

The BOSTON ES® (enflufocon A) and BOSTON EO® (enflufocon B) are Rigid Gas Permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.

BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.

The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).

| Property | BOSTON ES | BOSTON EO | BOSTON XO |
|--------------------------|----------------|----------------|----------------|
| Specific Gravity | 1.22 | 1.23 | 1.27 |
| Refractive Index | 1.443 | 1.429 | 1.415 |
| Light Transmittance | C.I.E. Y value | C.I.E. Y value | C.I.E. Y value |
| | - at least % | - at least % | - at least 92% |
| Water Content | <1% | <1% | <1% |
| Oxygen Permeability (Dk) | 36* | 82* | 140* |
| | 18** | 58** | 100** |

The physical / optical properties of the lens are:

*gas to gas

*ISO/Fatt

#### 5. INDICATIONS FOR USE

The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and notaphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

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

The safety and efficacy of BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas PermeableContact Lenses was demonstrated in 510(k) Premarket Notifications: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively.

BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to BOSTON II (itafocon A) Rigid Gas Permeable Contact Lenses approved in Premarket Application, P820065, on November 17, 1983 including an indication for keratoconus.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the caduceus symbol. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra Ketchum Bausch and Lomb Inc. 1400 N. Goodman St. Rochester, NY 14609

# APR 0 3 2002

Re: K013762

Trade/Device Name: Boston ES® (enflufocon A), Boston EO® (enflufocon B) and Boston® XO (hexafocon A) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: February 28, 2002 Received: March 1, 2002

Dear Ms. Ketchum:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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 11 70ar device 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 or any I vith 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.

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

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 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

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

510(K) PREMARKET NOTIFICATION 510(K) PREMARKET NOTIFICATION
BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) RGP Contact Lens

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

### Indications for Use Statement

K013762 510(k) Number (if known):

Device Name:

BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON® XO (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES

### Indications for Use:

The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses 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**

*Mira Smith*
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number: K 013762