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 Description

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. 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Menicon Saline Rinse Solution" and does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

The document is for a contact lens care product, which is a saline solution, not an AI/ML device. Therefore, the requested information (table of acceptance criteria and reported device performance for AI/ML, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set) is not applicable to this submission.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on composition, intended use, and existing regulatory standards for saline solutions.

Key information provided in the document related to its performance and regulatory approval includes:

Non-Clinical Data: Biocompatibility tests were deemed "unnecessary" because "The solution is a 0.9 % saline solution that meets the requirements of USP saline." This implies that meeting USP standards for saline is the key acceptance factor, and the components are considered safe for intended use.
Clinical Data: Clinical studies were "unnecessary" because "Lens care solutions used with this Saline Rinse Solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses." This indicates reliance on the known safety and efficacy of similar existing products and the established utility of saline.
Conclusion: The device is considered "as safe, as effective and performs as well as the predicate devices" based on its composition and previous test data (presumably regarding the USP standards and predicate device data).

In summary, for this specific product (Menicon Saline Rinse Solution), the "acceptance criteria" are implied to be adherence to United States Pharmacopeia (USP) standards for saline and its similarity in composition and intended use to already cleared predicate devices. No detailed performance study with specific metrics (like sensitivity, specificity, or AUC) or human reader performance is presented because it's a sterile saline solution, not an AI/ML diagnostic or therapeutic device.

Summary

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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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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Indications for Use

510(k) Number (if known) K151768

Device Name Menicon Saline Rinse Solution

Indications for Use (Describe)

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

Research Use (Part 21 CFR 601. Subpart D)	Compassionate Use (21 CFR 601 Subpart E)
---------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------

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

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

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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:	+81-52-935-1676
Fax:	+81-52-935-1633
email:	tohru@menicon-net.co.jp
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)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

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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.

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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.

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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 1Comparison of Characteristics
	Menicon Saline Rinse Solution	Cachet PharmaceuticalsSterile Saline Solution	Optics Laboratory Inc.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 886.591821 CFR 886.5928	21 CFR 886.5928	21 CFR 886.5928
Class	II	II	II
Intended Use	For use following proper lens disinfectionas recommended by the eye carepractitioner. The Menicon Saline RinseSolution is for rinsing soft (hydrophilic),rigid gas permeable and hard contactlenses prior to lens insertion. This solutionmay also be used as an insertion solutionfor large diameter (scleral) contact lenses,as a rinse for contact lens cases, and maybe used as needed throughout the day torinse contact lenses.	For rinsing and wetting of soft(hydrophilic) contact lenses	For rinsing soft contact lenses aftercleaning and for wetting soft contactlenses 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 containerwith twist off cap	Plastic resin containerwith twist off cap	Plastic resin containerwith twist off cap
Biocompatibility	Components used in this lens case havebeen evaluated in accordance with Part10993 of the ISO standard for BiologicalEvaluation and the FDA Guidance forContact Lens Care Products	Components used for this producthave been evaluated in accordancewith FDA Guidance for Contact LensCare Products	Components used for this producthave been evaluated in accordancewith FDA Guidance for Contact LensCare Products

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
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.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”