BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES

K053124 · Bausch & Lomb, Incorporated · HQD · Jan 30, 2006 · Ophthalmic

Device Facts

• Record ID: K053124
• Device Name: BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
• Applicant: Bausch & Lomb, Incorporated
• Product Code: HQD · Ophthalmic
• Decision Date: Jan 30, 2006
• 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, and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

Device Story

Rigid gas permeable contact lenses; materials include aliphatic fluoroitaconate siloxanyl methacrylate copolymer (ES/EO) or siloxanyl fluoromethacrylate copolymer (XO); includes UV absorber. Used for daily wear correction of refractive errors and management of irregular corneal conditions. Prescribed by eye care professionals for patients with non-diseased eyes. Lenses require chemical disinfection. Provides optical correction for ametropia and physical corneal surface management for irregular conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on physical/optical property comparisons and previously cleared indications.

Technological Characteristics

Rigid gas permeable contact lenses; materials: aliphatic fluoroitaconate siloxanyl methacrylate copolymer or siloxanyl fluoromethacrylate copolymer; includes UV absorber; color additives per 21 CFR 73/74; water content <1%; oxygen permeability (Dk) varies by material; chemical disinfection required.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic/non-aphakic persons with non-diseased eyes; also for management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, or post-refractive surgery).

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

• Dyna Intra-Limbal Lens (K020006)
• Rose K Post Graft (K013646)

Submission Summary (Full Text)

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## JAN 3 0 2006

# 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

# BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND DOSTON 20 - (Smidloodl A), DOSTON EO - (ennutocon 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: Lisa Graney Manager, Global 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 DEVICES

Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufiocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, have been selected as the predicate devices for the BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses.

#### 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 absorher.

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 lenses may also be supplied clear (no tint).

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lenses for Daily Wear

| Property | BOSTON ES | BOSTON EO | BOSTON XO |
|-----------------------------|-------------|-------------|---------------|
| Specific Gravity | 1.22 | 1.23 | 1.27 |
| Refractive Index | 1.443 | 1.429 | 1.415 |
| Visible Light Transmittance | > 85% | > 85% | > 92% |
| Water Content | <1% | <1% | <1% |
| Wetting Angle | 52° | 49° | 49° |
| Oxygen Permeability (Dk)*** | 36*<br>18** | 82*<br>58** | 140*<br>100** |

The physical / optical properties of the lenses are:

gas to gas method

**polarographic method (ISO/Fatt) ***(x 101'' (cm³ O₂ • cm)/ (cm² • sec • mmHg) @ 35° C}

# 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, and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

# 6. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE

The safety and efficacy of BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses was demonstrated in 510(k) Premarket Notifications as follows: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively. The most recent Premarket Notification for all three materials (Boston ES, EO, and XO) was 510(k) K013762, cleared April 3, 2002, for a new indication for keratoconus.

BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, including an indication for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplastv.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2006

Bausch and Lomb Incorporated c/o Ms. Lisa Graney Manager, Global Regulatory Affairs 1400 North Goodman St. Rochester, NY 14609

Re: K053124

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: HOD Dated: November 4, 2005 Received: November 15, 2005

Dear Ms. Graney:

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, True, 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 (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. Lisa Graney

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Malvina B. Eydelman, M.D.

Acting Division 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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Image /page/4/Picture/0 description: The image shows the logo and address of Bausch & Lomb. The address is 1400 North Goodman Street, Rochester, NY 14609. The logo is a stylized version of the company name.

# Indications for Use Statement

510(k) Number (if known): K 05 3124

BOSTON ES (enflufocon A), BOSTON EO® (enflufocon B) and Device Name: 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 (mynpia, hyperopia, astigmatism, presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

Prescription Use √ AND/OR Over-The-Counter Use **__**
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Myna Smith

(Division Sign-Off)

ivision of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K053124