OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER

K990480 · Alcon Laboratories · LPN · May 10, 1999 · Ophthalmic

Device Facts

• Record ID: K990480
• Device Name: OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
• Applicant: Alcon Laboratories
• Product Code: LPN · Ophthalmic
• Decision Date: May 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® EXPRESS® Multi-Purpose Solution, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, Bausch & Lomb ReNu® Multi-Purpose Solution or conditioned in OPTI-SOAK® Conditioning Solution.. Use as recommended by your eye care practitioner.

Device Story

OPTI-FREE® SUPRACLENS® Daily Protein Remover is a preservative-free enzymatic solution used by contact lens wearers to clean lenses during the disinfection or conditioning process. The solution contains porcine pancreatin enzymes, propylene glycol, and sodium borate. The user adds the solution to a compatible multi-purpose or conditioning solution while soaking lenses. The enzymes break down protein deposits on the lens surface during the disinfection cycle. This process allows for simultaneous cleaning and disinfection, reducing the steps required for lens maintenance. The device is intended for home use by patients as directed by an eye care practitioner. It benefits patients by maintaining lens cleanliness, comfort, and visual acuity, thereby supporting extended lens wear and reducing potential ocular irritation from protein buildup.

Clinical Evidence

Three-month, open-label, multi-site study with 62 patients (124 eyes) wearing soft (hydrophilic) lenses (Groups I and IV). Compared the subject regimen (OPTI-FREE® SUPRACLENS® + Bausch & Lomb ReNu®) against a historical control regimen. Primary endpoints included lens cleanliness, patient convenience, comfort, corrected visual acuity, and lens wearing time. Results showed the subject regimen provided clinically equivalent cleaning and was clinically acceptable across all efficacy variables. Intolerance rate was 3.2% vs 2.0% for control. No serious adverse events reported.

Technological Characteristics

Preservative-free liquid solution containing porcine pancreatin enzymes, propylene glycol, and sodium borate. Functions as an enzymatic cleaner for soft and rigid gas permeable contact lenses. Compatible with various multi-purpose and conditioning solutions. Non-cytotoxic per agar overlay assay.

Indications for Use

Indicated for users of daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses requiring simultaneous enzymatic cleaning and disinfection/conditioning.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 820001/S18, K974625)

Submission Summary (Full Text)

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MAY 1 0 1999

K990480

May 3, 1999

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510(K) SUMMARY

Submitted by:

Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 [phone] (Phone) [phone] (Fax)

## Device Name:

Contact Lens Cleaning Solution Common Name:

OPTI-FREE® SUPRACLENS® Daily Protein Remover Proprietary Name:

## Indications for Use:

OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in OPTI-FREE® EXPRESS Multi-Purpose Solution, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Bolution, Or ITT FRD - Icansing, Diomisoning and Stering Colution or conditioned in OPTI-SOAK® Conditioning Solution. Use as recommended by your eye care practitioner.

# Description:

OPTI-FREE® SUPRACLENS® Daily Protein Remover is a preservative-free solution which contains propylene glycol, sodium borate, and highly purified porcine pancreatin enzymes as the active cleaning ingredient.

## Substantial Equivalence:

This product is substantially equivalent, in terms of its actions and indications for use, to Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 820001/S18, K974625). OPTI-FREE® SUPRACLENS® Daily Protein Remover meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification (510(k) Guidance Document for Contact Lens Care Products.

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## Safety and Effectiveness:

#### A. Non-Clinical Data

#### Microbiological Studies

The combination OPTI-FREE® SUPRACLENS® Daily Protein Remover in Bausch & Lomb ReNu Multi-Purpose Solution was evaluated for disinfection efficacy using the FDA guidelines for contact lens solutions. The OPTI-FREE® SUPRACLENS® Daily Protein Remover in Bausch & Lomb ReNu® Multi-Purpose Solution regimen meets the FDA criteria for disinfection of contact lenses.

## Preclinical

Since both OPTI-FREE® SUPRACLENS® Daily Protein Remover and Bausch & Lomb ReNu Multi-Purpose Solution have been shown to be safe in FDAaccepted toxicology studies, the preclinical safety evaluation in this submission focused on the cytotoxicity and ocular safety of the products when used together in a soft contact lens care regimen. The cytotoxicity evaluation demonstrated that OPTI-FREE® SUPRACLENS® Daily Protein Remover used with ReNu® Multi-Purpose Solution is not cytotoxic in the agar overlay assay. The fourteen-day ocular irritation evaluation in rabbits of OPTI-FREE® SUPRACLENS® Daily Protein Remover when used with ReNu® Multi-Purpose Solution for the daily simultaneous cleaning and disinfection of soft contact lenses demonstrated that the ocular effects produced were generally confined to the conjunctiva, minimal in nature and were judged to be of no clinical significance.

Based on the result of these studies, OPTI-FREE® SUPRACLENS® Daily Protein Remover is safe for its intended use with Bausch & Lomb ReNu® Multi-Purpose Solution in the simultaneous cleaning and disinfection of soft (hydrophilic) contact lenses (Groups I-IV) and should not present an ocular hazard to the consumer under the recommended lens treatment regimen.

#### Compatibility/Cleaning Efficacy

Product compatibility with soft contact lenses and the product's ability to clean laboratory deposited lens were evaluated. The cleaning study demonstrated the ability of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu Multi-Purpose Solution regimen to satisfactorily clean deposits commonly found on hydrophilic contact lenses. Also, compatibility of the regimen was demonstrated with hydrophilic soft contact lenses (Groups ) through IV) when used daily to concurrently clean and disinfect lenses.

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#### B. Clinical

A clinical study was conducted and demonstrated that the OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu® Multi-Purpose Solution regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses. The study was a three-month, open-label, multi-site study with a descriptive control. The descriptive control was OPTI-FREE® SUPRACLENS® Daily Protein Remover/ OPTI-FREE® Rinsing. Disinfection and Storage Solution/OPTI-FREE® Daily Cleaner. Patients wearing soft (hydrophilic) contact lenses from lens polymer groups I and IV were enrolled on a daily wearing schedule. There were 62 patients/124 eyes. The OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu Multi-Purpose Solution regimen provides clinically equivalent cleaning compared to the historical control regimen in maintaining clinically clean (i.e., visibly clean) lenses. The OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu® Multi-Purpose Solution regimen is clinically acceptable as measured by all efficacy variables including: lens replacements, patient convenience and comfort, corrected visual acuity and lens wearing time. No serious adverse events related or unrelated to the regimen were reported. The incidence of intolerance to the regimen (3.2%) was clinically equivalent to the incidence of intolerance associated with the historical control regimen (2.0%).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 1999

Mr. Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099

Re: K990480

Trade Name: OPTI-FREE® SURPRACLENS® Daily Protein Remover (For use of Bausch & Lomb ReNu® Multi-Purpose Solution as a diluent, indicated for simultaneous enzymatic cleaning and disinfection) Regulatory Class: II Product Code: 86 LPN Dated: February 12, 1999 Received: February 16, 1999

Dear Mr. Larsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket 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 - Mr. Ralph H. Larsen

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _________

Device Name: OPTI-FREE® SUPRACLENS® Daily Protein Remover

Indications for Use:

OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® EXPRESS® Multi-Purpose Solution, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, Bausch & Lomb ReNu® Multi-Purpose Solution or conditioned in OPTI-SOAK® Conditioning Solution.. Use as recommended by your eye care practitioner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Inn Sion-Off sion of Ophthalmic Devices 1990480 (k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X