Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

K173136 · Menicon Co, Ltd. · MRC · Nov 16, 2017 · Ophthalmic

Device Facts

• Record ID: K173136
• Device Name: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
• Applicant: Menicon Co, Ltd.
• Product Code: MRC · Ophthalmic
• Decision Date: Nov 16, 2017
• 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 and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.

Device Story

Menicon Progent Protein Remover is an over-the-counter RGP contact lens care product. It consists of two sterile solutions, Progent A (sodium hypochlorite) and Progent B (potassium bromide), which are mixed in a dedicated vial. The user soaks the RGP lenses in the mixture to remove protein deposits, followed by a rinse with Menicon Rinse solution. Treatment is recommended every two weeks, or as directed by an eye care professional (maximum every 5 days). The device provides a chemical cleaning process to maintain lens hygiene and performance for the patient.

Clinical Evidence

No clinical data. The device has been cleared in prior applications and no formulation changes were made.

Technological Characteristics

Chemical cleaning solution consisting of sodium hypochlorite (Progent A) and potassium bromide (Progent B). Supplied in a plastic resin single-use container. Sterile. No electronic or mechanical components.

Indications for Use

Indicated for cleaning and removing protein deposits from fluorosilicone acrylate rigid gas permeable (RGP) contact lenses in patients using such 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

• Boston Cleaner (P860029)
• Boston Advance Cleaner (K923437)
• Boston Advance Cleaner (K974466)

Submission Summary (Full Text)

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November 16, 2017

Menicon Co., Ltd. % Ellen Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street, Suite A250 Wilmington, MA 01887

Re: K173136

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: September 28, 2017 Received: September 29, 2017

Dear Ellen 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.

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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 devicerelated adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Denise L. Hampton -S

for 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) K173136

#### Device Name

Menicon Progent Protein Remover

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|--|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |
| <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |

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K173136

Image /page/3/Picture/2 description: The image shows the text "Menicon Co., Ltd." in a bold, sans-serif font. The text is arranged on a single line, with the company name followed by the abbreviation "Co." and "Ltd.". The text is black against a white background.

## 510(k) Summary Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

#### 1. Applicant Information

#### Menicon Co., Ltd.

| Contact Person: | Kenichi Tanaka |
|-----------------|------------------------------|
| Telephone No.: | [phone] |
| Fax No .: | [phone] |
| E-mail: | [e-mail] |
| Date Prepared: | November 7, 2017 |

#### 2. Device Information

| Proprietary name: | Menicon Progent Protein Remover |
|------------------------|---------------------------------|
| Device classification: | Class II |
| Common Name: | RGP Contact Lens Care Product |
| Classification name: | RGP Contact Lens Care Product |
| Regulation number: | 21 CFR 886.5918 |
| Product code: | MRC |

#### 3. Predicate Devices

The predicate devices are the RGP contact lens cleaners, Boston Cleaner (P860029) and Boston Advance Cleaner (K923437 and K974466). These products are sold over the counter without prescription.

#### 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 Progent Vial. Menicon Rinse solution is used once the lens soaking cycle is complete. 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).

Image /page/3/Picture/13 description: The image shows a logo with a red semi-circle on top and a green semi-circle on the bottom. A white line runs through the middle of the circle, creating a wave-like pattern. The logo is simple and modern, with a focus on color and shape.

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## 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. Performance Data

### Non-Clinical Data

Non-clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no non-clinical studies were required.

### Clinical Data

Clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no clinical studies were required.

### Conclusion

Based upon the product history and data presented, the Menicon Progent Protein Remover can be used as safely and as effectively as the Boston Cleaner and the Boston Advance Cleaner.

### 7. Substantial Equivalence

The claim of substantial equivalence to the previously approved Boston Cleaner and cleared Boston Advance Cleaner for rigid gas permeable contact lenses is based on the fact that both products are contact lens cleaners for rigid gas permeable contact lenses and when used as directed, can be used safely and effectively to remove protein deposits from the surface of rigid contact lens materials.

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#### Table 1 Device Comparison

| | Menicon Progent | Boston Cleaner | Boston Advance |
|-------------------|------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| Product Code | MRC | LPN, MRC | LPN, MRC |
| Class | II | II | II |
| Regulation Number | 21 CFR 886.5918 | 21 CFR 886.5918 | 21 CFR 886.5918 |
| Action | Cleans and removes protein<br>deposits from contact lenses | Cleans and removes deposits<br>from contact lenses | Cleans and removes deposits<br>from contact lenses |
| Indicated for | RGP Contact Lenses | RGP Contact Lenses | RGP Contact Lenses |
| Primary Container | Plastic resin container with twist<br>off cap | Plastic resin container with<br>screw cap | Plastic resin container with<br>screw cap |
| Container | Single Use | Multi Use | Multi Use |
| Sterile | Yes | Yes | Yes |