Menicon Saline Rinse Solution

K151768 · Menicon Co, Ltd. · LPN · Aug 28, 2015 · Ophthalmic

Device Facts

• Record ID: K151768
• Device Name: Menicon Saline Rinse Solution
• Applicant: Menicon Co, Ltd.
• Product Code: LPN · Ophthalmic
• Decision Date: Aug 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

Device Story

Menicon Saline Rinse Solution is a sterile, non-preserved 0.9% NaCl (normal saline) solution provided in single-use 5 mL plastic containers. It is used by contact lens wearers to rinse soft, rigid gas permeable, or hard contact lenses after disinfection and before insertion. It also serves as an insertion solution for scleral lenses, a rinse for lens cases, and for mid-day lens rinsing. By providing a preservative-free environment, it avoids potential irritation from osmolarity agents or preservatives found in multipurpose solutions when held against the cornea. The device is intended for over-the-counter use by patients.

Clinical Evidence

No clinical data. Bench testing only. The solution is a standard 0.9% saline meeting USP requirements; biocompatibility was established via adherence to ISO 10993 and FDA guidance for contact lens care products.

Technological Characteristics

0.9% NaCl (normal saline) solution; non-preserved; sterile; single-use 5 mL plastic resin container with twist-off cap. Biocompatibility evaluated per ISO 10993 and FDA guidance for contact lens care products.

Indications for Use

Indicated for users of soft (hydrophilic), rigid gas permeable, and hard contact lenses, including large diameter (scleral) lenses, requiring a sterile, non-preserved saline rinse for lens insertion, case rinsing, or mid-day rinsing following proper disinfection.

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

• Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution (K093367)
• Optics Laboratory, Inc. Eye-Cept Sterile Saline Solution (K110221)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 28, 2015

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

Re: K151768

Trade/Device Name: Menicon Saline Rinse Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: June 30, 2015 Received: June 30, 2015

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.

{1}------------------------------------------------

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -A

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K151768

Device Name Menicon Saline Rinse Solution

#### Indications for Use (Describe)

The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

Type of Use (*Select one or both, as applicable*)

| <input type="checkbox"/> <span>Research Use (Part 21 CFR 601. Subpart D)</span> | <input checked="" type="checkbox"/> <span>Compassionate Use (21 CFR 601 Subpart E)</span> |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for Menicon. The logo consists of a red and green circular graphic to the left of the company name. The company name "Menicon" is written in a stylized, black font.

Page 1 of 3

# K 151768

#### 510(k) Summary

#### MENICON SALINE RINSE SOLUTION

## 1. Applicant Information

Menicon Co., Ltd. 21-19, Aoi 3-Chome, Naka-ku Nagoya 460-0006 Japan

| Contact Person: | Tohru Kawaguchi, Ph.D. |
|-----------------|-------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| email: | [e-mail] |
| Date Prepared: | July 8, 2015 |

#### 2. Device Information

| Classification name: | Contact Lens Care Products |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Device classification: | Class II |
| Regulation number: | 21 CFR 886.5918 (Rigid Gas Permeable Contact Lens Care Products)<br>21 CFR 886.5928 (Soft (hydrophilic) Contact Lens Care Products) |
| Product code: | LPN |
| Proprietary name: | Menicon Saline Rinse Solution |

#### 3. Predicate Devices

Menicon Co., Ltd. claims substantial equivalence to K093367, Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution and K110221, Optics Laboratory, Inc. Eye-Cept Sterile Saline Solution.

#### 4. Description of Device

The Menicon Saline Rinse Solution is a sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution indicated for rinsing soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for Menicon. The logo consists of a circular graphic on the left and the word "Menicon" on the right. The circular graphic is divided into two halves, with the top half being red and the bottom half being green. A white curved line runs through the center of the circle, separating the two halves. The word "Menicon" is written in a black, sans-serif font.

Page 2 of 3

This sterile, normal saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time.

# 5. Indications for Use

The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses. as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

## 6. Performance Data

#### Non-Clinical Data

Biocompatibility tests were unnecessary for this application. The solution is a 0.9 % saline solution that meets the requirements of USP saline therefore testing was not required. The components are safe for the intended use.

## Clinical Data

Clinical studies involving the saline rinse solution were unnecessary for this application. Lens care solutions used with this Saline Rinse Solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses.

## Conclusion

Based upon the composition of the saline rinse solution and previous test data presented, the Menicon Saline Rinse Solution is as safe, as effective and performs as well as the predicate devices. A comparison of the new device and the predicate devices is presented in Table 1.

## 7. Substantial Equivalence

The claim of substantial equivalence to the previously cleared to K093367, Cachet Pharmaceuticals Pvt. Ltd Sterile Saline Solution and K110221, Optics Laboratory, Inc. Eye-Cept Sterile Saline Solution, is supported by the following Comparison of Characteristics in Table 1.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Menicon. The logo consists of a red and green circular symbol on the left, followed by the word "Menicon" in a stylized, cursive font. The symbol appears to be a stylized eye or lens, with the red portion on top and the green portion on the bottom.

Page 3 of 3

The Menicon Saline Rinse Solution and the predicates are similar in composition and intended use. Therefore, Menicon Saline Rinse Solution is substantially equivalent to the predicate device.

| Table 1<br>Comparison of Characteristics | | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | Menicon Saline Rinse Solution | Cachet Pharmaceuticals<br>Sterile Saline Solution | Optics Laboratory Inc.<br>Eye-Cept Sterile Saline Solution |
| Device Name | Contact Lens Care Product | Contact Lens Care Product | Contact Lens Care Product |
| Trade Name | Menicon Saline Rinse Solution | Sterile Saline Solution | Eye-Cept Sterile Saline Solution |
| Document Number | K151768 | K093367 | K110221 |
| Classification | Ophthalmic | Ophthalmic | Ophthalmic |
| Product Code | LPN | LPN | LPN |
| Regulation Number | 21 CFR 886.5918<br>21 CFR 886.5928 | 21 CFR 886.5928 | 21 CFR 886.5928 |
| Class | II | II | II |
| Intended Use | For use following proper lens disinfection<br>as recommended by the eye care<br>practitioner. The Menicon Saline Rinse<br>Solution is for rinsing soft (hydrophilic),<br>rigid gas permeable and hard contact<br>lenses prior to lens insertion. This solution<br>may also be used as an insertion solution<br>for large diameter (scleral) contact lenses,<br>as a rinse for contact lens cases, and may<br>be used as needed throughout the day to<br>rinse contact lenses. | For rinsing and wetting of soft<br>(hydrophilic) contact lenses | For rinsing soft contact lenses after<br>cleaning and for wetting soft contact<br>lenses after disinfection before use. |
| Volume | 5 mL | - | 10 mL |
| Preservative Free | yes | yes | yes |
| Container Usage | single use | single use | single use |
| Sterility | Sterile | Sterile | Sterile |
| Materials | Plastic resin container<br>with twist off cap | Plastic resin container<br>with twist off cap | Plastic resin container<br>with twist off cap |
| Biocompatibility | Components used in this lens case have<br>been evaluated in accordance with Part<br>10993 of the ISO standard for Biological<br>Evaluation and the FDA Guidance for<br>Contact Lens Care Products | Components used for this product<br>have been evaluated in accordance<br>with FDA Guidance for Contact Lens<br>Care Products | Components used for this product<br>have been evaluated in accordance<br>with FDA Guidance for Contact Lens<br>Care Products |