RIGID GAS PERMEABLE CONTACT LENS SOLUTION

K011945 · Polymer Technology Corp. · HQD · Sep 12, 2001 · Ophthalmic

Device Facts

• Record ID: K011945
• Device Name: RIGID GAS PERMEABLE CONTACT LENS SOLUTION
• Applicant: Polymer Technology Corp.
• Product Code: HQD · Ophthalmic
• Decision Date: Sep 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

BOSTON EQUALENS (itafluorofocon A) and BOSTON EQUALENS II (oprifocon A) RGP Contact Lenses are 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 disinfecting system only.

Device Story

BOSTON EQUALENS and EQUALENS II are fluoro silicone acrylate rigid gas permeable (RGP) contact lenses. Lenses are wet-shipped and stored in Boston Advance Comfort Formula Conditioning Solution for up to 30 days. Intended for daily wear to correct refractive errors. Device provides vision correction through physical lens geometry. Safety established via stability, compatibility, and bioburden testing after 30-day storage in conditioning solution.

Clinical Evidence

Bench testing only. Stability testing evaluated changes in diameter, base curve, and power after 30-day soak in conditioning solution per DRAFT ISO/CD 8321-2. Bioburden testing confirmed colony forming units (CFU) per lens were <10, meeting the acceptance criteria of <100 CFU per lens.

Technological Characteristics

Materials: fluoro silicone acrylate copolymers (itafluorofocon A and oprifocon A). Type: Rigid Gas Permeable (RGP) contact lenses. Energy source: None. Connectivity: None. Sterilization: Not specified (wet-shipped in conditioning solution).

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, astigmatism, and presbyopia in aphakic and non-aphakic persons with nondiseased eyes. Contraindicated for use with non-chemical disinfection systems.

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 XO (hexafocon A) RGP Contact Lenses (K002025)

Submission Summary (Full Text)

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### FOR

# BOSTON® EQUALENS® and BOSTON® EQUALENS® II RGP Contact Lenses Wet Shipped In BOSTON® Advance® Comfort Formula Conditioning Solution And Stored For Up To 30 Days

#### SUBMITTER INFORMATION: 1.

Polymer Technology 1400 N. Goodman Street Rochester, New York 14603-0450

### CONTACT PERSON: 2.

Address:

Fax No .:

1400 North Goodman Street P.O. Box 30450 Rochester, New York 14603-0450 [phone] Telephone No .: [phone] [e-mail] E-mail Address:

Manager, Regulatory Affairs

Debra Ketchum

#### 3. Device Identification:

Rigid Gas Permeable (hydrophobic) Contact Classification Name: Lens Material BOSTON Contact Lens Materials Proprietary Name: fluoro silicone acrylate rigid gas permeable Common Name: contact lens material

#### PREDICATE DEVICE: 4.

BOSTON XO (hexafocon A) RGP Contact Lenses Wet Shipped and up to 30 day storage in Boston Advance Comfort Formula Conditioning Solution, 510(k) K002025 cleared on October 31, 2000.

#### DESCRIPTION OF THE DEVICE: 5.

BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Contact Lenses are composed of fluoro silicone acrylate copolymers wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.

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#### INDICATIONS FOR USE: 6.

BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) RGP Contact Lenses are 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 disinfecting system only.

### DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE: 7.

The applicant performed stability, compatibility, and microbiology testing on BOSTON EQUALENS and BOSTON EQUALENS II RGP Contact Lenses wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.

### Stability/Compatibility:

Silicone acrylate (SA) and fluorosilicone acrylate (FSA) tinted rigid gas permeable contact lenses were subjected to a thirty-day soak in Boston Advance Comfort Formula Conditioning Solution according to the lens compatibility protocol. The average changes for each parameter (diameter, base curve and power), relative to the initial measurements were determined and compared to the DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses- Part 1: Specifications for rigid corneal and scleral contact lenses.

After soaking in the contact lens carrying cases at room temperature for thirty days the silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses were determined to be physically compatible with Boston Advance Comfort Formula Conditioning Solution.

### Microbiology

A bioburden study was completed. A set of test lenses was cleaned with Boston Laboratory Lens Cleaner and subjected to bioburden testing. In this test, two sets of lenses were tested to validate the storage in Boston Advance Comfort Formula after 30 days. One set was stored dry (control) and the other set was stored in Boston Advance Comfort Formula. This established the "cleanliness" of the test samples prior to entering the stability study. Testing showed that the colony forming units (CFU) per lens was less than 10. The acceptance criteria is 100 CFU per lens. Testing showed that the colony forming units (CFU) per lens was less than 10. The acceptance criteria is 100 CFU per lens.

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### SUBSTANTIAL EQUIVALENCE 8.

BOSTON EQUALENS and EQUALENS II RGP Contact Lenses wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days are substantially equivalent to the currently stored for up to of a oo areable Contact Lens Wet Shipped In markets a vance Comfort Formula Conditioning Solution and stored for up to 30 days, 510(k) Premarket Notification No. K002025.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administratio 200 Corporate Boulevard Rockville MD 20850

# SEP 1 2 2001

Polymer Technology c/o Ms. Debra Ketchum 1400 N. Goodman St. P.O. Box 30450 Rochester, NY 14603-0450

Re: K011945

Trade/Device Name: BOSTON® EQUALENS® (itafluorofocon A) and BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses (Wet Shipped and up to 30 day storage in Boston Advance Comfort Formula Conditioning Solution) Regulation Number: 21 CFR 886.5916 Regulatory Class: Class II Product Code: HQD Dated: June 20, 2001 Received: June 21, 2001

Dear Ms. Ketchum:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have here hear four becered the device is substantially equivalent (for the indications for use above and we nevelosure) to legally marketed predicate devices marketed in interstate commerce stated in the encrosary to tegars and date of the Medical Device Amendments, or to devices that pHor to May 26, 1776, the chactions atternent also be the Federal Food, Drug, and Cosmetic nave been reclassined in wefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, the rece. "The general consulacturing 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 Approval), it may be tound in the Code of Federal Regulations, Title 21, Parts 800 to 895. A your 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 mopononio, the I over regulation may result in regulatory action. In addition, FDA may comply with the GHF regulation in a since in the Federal Register. Please note: this publish larger announces 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 I his leter will allow you to begin mancally your device of your device to a legally marked on
notification. The FDA finding of substantial equivalence of your device to pro to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR-Part 801 and If you desire specific at nor ro diagnostic devices), please contact the Office of Compliance at (301) additional Addition Compress (201) 594-400 Aller planet (1) Arter please (1)
Strated in Armere (200) 394-400 Aller personal de metropomante metropomante metropomante mentalia

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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## Polymer Technology 1400 North Goodman Street P.O. Box 30450 Rochester, NY 14603-0450

### Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

## BOSTON® EQUALENS® (itafluorofocon A) RGP Contact Lens BOSTON® EQUALENS® II (oprifocon A) RGP Contact Lens

### Indications for Use:

BOSTON EQUALENS (itafluorofocon A) and BOSTON EQUALENS II (oprifocon A) RGP Contact Lenses are 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 disinfecting system only.

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

OR

Prescription Use

Over-The-Counter-Use_

Myra Smith

ision Sign-Off) · Ision of Ophthalmic Devices . )/k) Number_________________________________________________________________________________________________________________________________________________________________