Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.

Device Description

Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.

AI/ML Overview

The provided text describes the 510(k) submission for the "Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses." However, it is not a study of a device that uses AI or machine learning. This submission relies on demonstrating substantial equivalence to a predicate device (Alcon RGP Multi-Purpose Solution ID 100136, K000148) by confirming that the new device has:

The same formulation, ingredients, and intended use.
Equivalence in chemical composition to the predicate device.
Satisfactory biocompatibility and shelf-life stability.

Therefore, most of the requested information regarding AI/ML studies, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance, are not applicable to this document. The "Performance Data" section explicitly states that "there were no additional clinical studies required to establish the safety and efficacy of the new device" due to its equivalence to the previously cleared predicate.

However, I can extract the acceptance criteria and performance data as presented for the non-clinical aspects and the general claim of equivalence.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Chemical Composition: Equivalent to predicate device.	Chemical analysis of the Japanese product confirmed equivalence to the product manufactured by Alcon (the predicate device). The composition listed for the new device is identical to the predicate device.
Biocompatibility: Components meet ISO 10993 standard.	"Components used in this product have been evaluated in accordance with Part 10993 of the ISO standard for Biological Evaluation. Test results indicate the test articles meet the ISO standard." (This was done for the predicate and confirmed for the new device's container).
Shelf-life Stability: Satisfactory.	"Shelf life stability tests" were conducted on the new device (implicitly found satisfactory, as substantial equivalence was determined).
Safety and Efficacy: As safe and effective as the predicate.	"Based upon the test data presented, the Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses is as safe, as effective and performs as well as the predicate device." This is based on the new device having the "same formulation, are manufactured by equivalent manufacturing processes and meet the same product release specifications" as the predicate device.
Intended Use: Identical to predicate device.	The "Indications for Use" for the new device are word-for-word identical to those of the predicate device.

Explanation: The "acceptance criteria" here are that the new device must be substantially equivalent to the predicate device across key characteristics. The "reported device performance" is the evidence presented to show this equivalence.

Non-Applicable Information for this type of Submission:

The following information is not present in the provided document because the submission relies on demonstrating substantial equivalence to an existing device rather than presenting a novel AI/ML device study:

Sample size used for the test set and the data provenance: Not applicable as no new clinical study was conducted for this device. The non-clinical testing was comparative/confirmatory.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable in the context of an AI/ML study. The "ground truth" for this submission is the established safety and efficacy of the predicate device.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Menicon Co., Ltd.

K130805

Page 1 of 3

510(k) Summary

JUL 0 3 2013

MENICON UNIQUE pH MULTI-PURPOSE SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES

1. Applicant Information

Menicon Co., Ltd.
3-21-19, Aoi,
Naka-ku, Nagoya 460-0006
JAPAN
Contact Person:	Takahiro Ochi
Telephone No.:	+81-52-935-1676
Fax No.:	+81-52-935-1633
E-mail:	t-ochi@menicon-net.co.jp
Date Prepared:	April 19, 2013

2. Device Information

Classification name:	Rigid gas permeable contact lens care products
Device classification:	Class II
Regulation number:	21 CFR, Subpart F, Section 886.5918
Product code:	MRC
Proprietary name:	Menicon Unique pH Multi-Purpose Solution forRigid Gas Permeable Contact Lenses

3. Predicate Devices

Menicon claims substantial equivalence to Alcon RGP Multi-Purpose Solution ID 100136 for Rigid Gas Permeable Contact Lenses previously cleared under K000148 on April 11, 2000.

4. Description of Device

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Menicon Co., Ltd.

5. Indications for Use

Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.

6. Performance Data

Non Clinical Data

In support of the Alcon Laboratories RGP Multi-Purpose Solution ID 100136 cleared in K000148, a complete set of testing (preclinical, biocompatibility and container tests) was completed to establish the safety and efficacy of the solution.

Testing conducted on the new device consisted of evaluating the solution manufactured in the Japanese facility. Testing included chemical analysis of the Japanese product to confirm equivalence to the product manufactured by Alcon, container biocompatibility tests and shelf life stability tests.

Clinical Data

The safety and efficacy of this solution has been clinically evaluated in the cleared Alcon Laboratories 510(k) application. Alcon RGP Multipurpose Solution K000148.

This application is for the same formulation with the alternate brand name, Menicon Unique pH Multi-Purpose Solution, which will be manufactured in Japan by Menicon Nect. The new device and the predicate device have the same composition, ingredients and intended use. Based upon this fact there were no additional clinical studies required to establish the safety and efficacy of the new device.

Conclusion

Based upon the test data presented, the Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses is as safe, as effective and performs as well as the predicate device. A comparison of the new device and the predicate device is presented in Table 1.

7. Substantial Equivalence

Menicon Co., Ltd claims that the Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses is substantially equivalent to the predicate device. Alcon RGP Multi-Purpose Solution ID 100136 for Rigid Gas Permeable Contact Lenses previously cleared under K000148.

The claim of substantial equivalence is made based upon product testing and the fact that the solutions are the same formulation, are manufactured by equivalent manufacturing processes and meet the same product release specifications.

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: ·

Comparison of CharacteristicsTable 1
New Device		Predicate Device
Manufacturer	Menicon Co., Ltd.	Alcon Laboratories
Device Name	Rigid Gas Permeable ContactLens Care Product	Rigid Gas Permeable ContactLens Care Product
Trade Name	Menicon Unique pHMulti-Purpose Solution	Alcon RGP Multi-PurposeSolution (ID 100136)
510(K)	K130805	K000148
Classification	Ophthalmic	Ophthalmic
Product Code	MRC	MRC
RegulationNumber.	21 CFR 886.5918	21 CFR 886.5918
Class	11	ll
Intended Use	Menicon Unique pH Multi-PurposeSolution is indicated for thecleaning, rinsing, disinfection andconditioning of fluorosiliconeacrylate and silicone acrylate rigidgas permeable contact lenses.	Alcon RGP Multi-Purpose Solutionis indicated for the cleaning,rinsing, disinfection andconditioning of fluorosiliconeacrylate and silicone acrylate rigidgas permeable contact lenses.
Composition	A sterile, buffered aqueoussolution. It contains hydroxypropylguar, polyethylene glycol,poloxamine, boric acid, propyleneglycol, and is preserve withpolyquaternium-1 0.0011%, andedetate disodium 0.01%.	A sterile, buffered aqueoussolution. It contains hydroxypropylguar, polyethylene qlycol,poloxamine, boric acid, propyleneglycol, and is preserve withpolyquaternium-1 0.0011%, andedetate disodium 0.01%.
Biocompatability	Components used in this producthave been evaluated inaccordance with Part 10993 of theISO standard for BiologicalEvaluation. Test results indicatethe test articles meet the ISOstandard	Components used in this producthave been evaluated inaccordance with Part 10993 of theISO standard for BiologicalEvaluation. Test results indicatethe test articles meet the ISOstandard

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DEPARTMENT OF HEALTH & HUMAN SERVICES

July 3, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G60 Silver Spring, MD 20993-002

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

Re: K130805

Trade/Device Name: Menicon Unique oH Multipurpose Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Product Regulatory Class: Class II Product Code: MRC Dated: April 19, 2013 Received: April 22, 2013

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 Requlations, 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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Page 2 - Ms. Ellen Beucler

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

for Malvina 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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Menicon Co. Ltd.

Indications for Use

510(k) Number: K130805

Device Name: Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses

Indications for Use:

Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.

Prescription Use_ (part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leonid Livshitz

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(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices K130805 510(k) Number:_

page I of

Regulation Number and Section

§ 886.5918 Rigid gas permeable contact lens care products.

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