MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES

K020930 · Menicon Co, Ltd. · MRC · May 2, 2002 · Ophthalmic

Device Facts

• Record ID: K020930
• Device Name: MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
• Applicant: Menicon Co, Ltd.
• Product Code: MRC · Ophthalmic
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5918
• Device Class: Class 2

Intended Use

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses. This product is for professional in-office use only.

Device Story

Device consists of two chemical solutions, Progent A (sodium hypochlorite, sodium carbonate) and Progent B (potassium bromide, sodium carbonate), packaged in separate low-density polyethylene ampoules. Used in professional clinical settings; practitioner mixes solutions in a cleaning vial (SP Vial) containing a lens holder cap. Rigid gas permeable lenses are soaked in the mixture for 30 minutes. Process removes protein deposits and disinfects lenses; facilitates maintenance of lens hygiene; supports clinical lens care workflows.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical stability, toxicology, and microbiology bench testing.

Technological Characteristics

Chemical solution system. Components: Progent A (sodium hypochlorite, sodium carbonate), Progent B (potassium bromide, sodium carbonate). Packaging: Natural low-density polyethylene (USP Class VI) ampoules. No electronic or software components.

Indications for Use

Indicated for professional in-office cleaning, disinfection, and protein deposit removal from fluorosilicone acrylate rigid gas permeable 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

• Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K002140)

Submission Summary (Full Text)

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# MAY 0 2 2002

Page 1 of 2

## 510(k) Summary

K020930

Menicon Co., Ltd. Applicant's Name and Address: 21-19, Aoi 3-Chome Naka-ku, Nagoya 460-0006 Japan

#### Tohru Kawaguchi Contact Person: Phone 011 81 (52) 935-1676 011 81 (52) 935-1633 Fax

March 2002 Summary Prepared

Trade Name:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Classification Name:

rigid gas permeable contact lens solution

Common/Usual Name

periodic cleaner; disinfecting solution

Predicate Device:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K002140).

Device Description:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses consists of two solutions, Progent A and Progent B, which are mixed together when used. They are packaged separately in natural low density polyethylene (USP classification :VI) ampoules, type "Bottle Pack", containing 5.5 ml of solution, (5 ml being usable). Each package consists of 7 pairs of ampoules.

Progent A contains sodium hypochlorite and sodium carbonate; Progent B contains potassium bromide and sodium carbonate. Rigid Gas Permeable Contact Lenses are placed into the lens holder cap of the cleaning vial (SP Vial). Progent A, then Progent B are poured into the case receptacle, then the lenses are soaked in the Progent mixture for 30 minutes.

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# Indication for Use:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.

# Substantial Equivalence:

The claim of substantial equivalence to Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is based on the fact that the product is the same formulation. Only the indications and directions for use have been modified.

The applicant performed non-clinical stability, toxicology and microbiology testing which supports the claim of substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

#### Public Health Service

**MAY 02 2002**

Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850

Menicon Co., Ltd. c/o Beverly D. Venuti, Ph.D., RAC. Foresight Regulatory Strategies, Inc. 269A Ballardvale St. Wilmington, MA 01887

Re: K020930

Trade/Device Name: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenes

Regulation Number: 21 CFR 886.5918 Regulation Name: RGP Contact Lens Solution Regulatory Class: Class II Product Code: MRC Dated: March 20, 2002 Received: March 22, 2002

Dear Dr. Venuti:

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, 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 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 - Beverly D. Venuti, Ph.D., RAC

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 vours,

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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### Indications for Use

K020930 510(k) Number (if known):

Device Name:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

Indications for Use:

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.

This product is for professional in-office use only.

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Daniel W. C. Brown, PHD.

510(k) Number_K020930

Prescription Use x
(Per 21 CFR 80.109)

Over-The-Counter Use

(Optional Format 1-2-96)