MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS

K122273 · Menicon Co, Ltd. · MRC · Jan 2, 2013 · Ophthalmic

Device Facts

• Record ID: K122273
• Device Name: MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
• Applicant: Menicon Co, Ltd.
• Product Code: MRC · Ophthalmic
• Decision Date: Jan 2, 2013
• Decision: SESE
• Submission Type: Abbreviated
• 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 and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.

Device Story

Menicon Progent is a two-part chemical protein removal system for RGP contact lenses. It consists of two sterile solutions: Progent A (sodium hypochlorite) and Progent B (potassium bromide). The user mixes these solutions in a Menicon SP Vial and soaks the lenses for 30 minutes. The treatment is typically performed every two weeks, or as directed by an eye care professional (maximum frequency every 5 days). The device functions by chemically breaking down protein deposits on the lens surface. After soaking, the lenses must be rinsed; the device supports the use of sterile normal saline as a rinsing agent. The system is intended for use by contact lens wearers to maintain lens hygiene and comfort, potentially extending the useful life of the lenses by preventing protein buildup.

Clinical Evidence

Bench testing only. Residual Progent testing was conducted to compare the rinsing effectiveness of sterile normal saline against the predicate's sterile purified water. Results confirmed that active chlorine concentrations and pH values of the rinsing solutions were equivalent, demonstrating that the new rinsing protocol does not affect the safety or efficacy of the protein removal system.

Technological Characteristics

Two-part chemical solution system: Progent A (sodium hypochlorite) and Progent B (potassium bromide). Requires a Menicon SP Vial for mixing. Rinsing agent: sterile normal saline. Class II medical device (21 CFR 886.5918).

Indications for Use

Indicated for cleaning and removing protein deposits from fluorosilicone acrylate rigid gas permeable (RGP) 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 (RGP) Lenses (K002140)
• Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Lenses (K082855)

Submission Summary (Full Text)

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## 510(k) Summary For K122273 MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES

JAN 0 2 2013

:

November 30, 2012

#### 1. Applicant Information

| Menicon Co., Ltd. | |
|--------------------------|--------------------------|
| 3-21-19, Aoi, | |
| Naka-ku, Nagoya 460-0006 | |
| JAPAN | |
| Contact Person: | Takahiro Ochi |
| Telephone No .: | [phone] |
| Fax No.: | [phone] |
| E-mail: | [e-mail] |
| Summary prepared on: | November 30, 2012 |

## 2. Device Information

| Classification name: | Rigid gas permeable contact lens care products |
|------------------------|---------------------------------------------------------------------------|
| Device classification: | Class II |
| Regulation number: | 21 CFR 886.5918 |
| Product code: | MRC |
| Proprietary name: | Menicon Progent Protein Remover for<br>Rigid Gas Permeable Contact Lenses |

#### 3. Predicate Devices

Menicon claims substantial equivalence to Menicon Progent Protein Remover for Rigid Gas Permeable Contact (RGP) Lenses previously cleared under K002140 and K082855.

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K12273 2/3

## 4. Description of device

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minutes. Soaking for longer than 30 minutes is not recommended. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).

#### 5. Indications for use

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

#### 6. Substantial equivalence

The claim of substantial equivalence to the previously cleared Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is based on the fact that the active components of the protein remover system (Progent Solution A and Progent Solution B) are the same formulation as the predicate devices. The only change is the addition of an alternative rinsing solution, sterile normal saline, versus sterile purified water cleared in 510(k) K082855..

In support of this application, nonclinical testing (Residual Progent Testing) was done to prove that the rinsing effectiveness of the new rinsing solution, sterile normal saline, was equivalent to the rinsing solution used in the previously cleared 510(k) K0828 55, sterile purified water.

Residual Progent Testing was performed to determine the amount of residual Progent Solution that remains following the lens rinsing process. Rinsing solutions were collected and measure to determine the remaining active chlorine concentration and pH of the rinsing solutions.

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### 6. Substantial equivalence (continued)

This test was originally performed in 2009 with the sterile purified water used as a rinsing solution in K082855. In support of this application the test was repeated with sterile normal saline as a rinsing solution. A comparison of the two sets of data was completed and based on active chlorine concentrations and pH values it was confirmed that the rinsing efficacy of sterile normal saline was equal to the rinsing efficacy of the sterile purified water.

Based on these results the Menicon Progent Protein Remover for RGP Contact Lenses with sterile saline rinse is substantially equivalent to the Menicon Progent Protein Remover for RGP Contact Lenses with sterile purified water rinse.

In addition the Progent solutions may be manufactured at an alternate manufacturing site, Gujo Factory, Menicon Nect, Co., Ltd.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# JAN 0 2 2013

Menicon Co., Ltd. % Ms. Ellen M. Beucler Foresight Regulatory Strategies, Inc. 187 Ballardvale Street. Suite 180 Wilmington, MA 01887

Re: K122273

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

Regulation Number: 21 CFR 886.5918

Regulation Name: Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: MRC Dated: November 30, 2012 Received: December 6, 2012

Dear Ms. Beucler:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Ms. Ellen Beucler

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

# Deborah L. Falls

Malvina B. Eydelman, M.D. 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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#### Indications for Use

510(k) Number (if known): ___ K 122273_

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 and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

10 mm ------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

ia Ngg

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

K 122273 510(k) Number_