MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND

K014162 · Lobob Laboratories, Inc. · MRC · Jan 15, 2002 · Ophthalmic

Device Facts

• Record ID: K014162
• Device Name: MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
• Applicant: Lobob Laboratories, Inc.
• Product Code: MRC · Ophthalmic
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5918
• Device Class: Class 2

Intended Use

To clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses

Device Story

Optimum Cleaning, Disinfecting and Storage Solution is a sterile chemical solution for maintenance of rigid gas permeable (RGP) and hard contact lenses. Formulation includes lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol, and benzyl alcohol preservative. Used by patients for lens cleaning, disinfection, and storage. Solution removes debris and contaminants from lens surfaces; maintains lens hygiene to support ocular health. No complex instrumentation or electronic processing involved.

Technological Characteristics

Sterile aqueous solution containing lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol, and benzyl alcohol preservative. Designed for chemical cleaning and disinfection of RGP and hard contact lenses.

Indications for Use

Indicated for cleaning, disinfecting, and storing fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses.

Regulatory Classification

Identification

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

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

• Lobob Optimum™ Cleaning, Disinfecting and Storage Solution (K001964)

Submission Summary (Full Text)

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K 014162

## 510(k) Summary

JAN 1 5 2002

Daniel J. Manelli Submitted by: Manelli, Denison & Selter, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036

100 02 102 2000 000

"

202-261-1000

On behalf of Lobob Laboratories, Inc.

510(k) Submission: Optimum™ Cleaning, Disinfecting and Storage Solution

January 10, 2002

Optimum Cleaning, Disinfecting and Storage Solution is intended to clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses. The product is a sterile solution containing lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.

The product is substantially equivalent to the currently marketed Lobob Optimum™ Cleaning, Disinfecting and Storage Solution (K001964). The product formulation, solubility, cleaning effectiveness and disinfection properties are similar to the predicate product. Labeling and indications for use are identical.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2002

Lobob Laboratories, Inc. c/o Mr. Daniel J. Manelli Manelli Denison & Selter PLLC 2000 M Street, N.W. 7th Floor Washington, D.C. 20036-3307

Re: K014162

Trade/Device Name: Optimum Cleaning, Disinfecting and Storage Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC; HPX Dated: December 19, 2001 Received: December 19, 2001

Dear Mr. Manelli:

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 your 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogin maxioung of substantial equivalence of your device to a legally premaired notification: "The PDF missification 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 If you desire specific acrise to for in vitro diagnostic devices), please contact the Office of additionally 21 CF F at 607.10 for questions on the promotion and advertising of Compliance at [phone] Times of Compliance at [phone]. Also, please note the your deviol, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Ingulation entities, "Pisoralians of responsibilities under the Act may be obtained from the Division Official 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

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Exhibit D

Page __ 1 __ of __ 1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Lobob Optimum Cleaning, Disinfecting and Storage Solution Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

To clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device evaluation (ODE)

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

510(k) Number k014162

**Prescription Use** ***_*****_**

OR

Over-The-Counter Use

(Per 21 CFR 801.109)