Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.

Device Description

The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution system consists of: Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case. The lens case consists of a transparent cup and a lens holder-lens case cap assembly with a neutralizer catalyst disk. Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case must always be used together.

The preservative free, aqueous Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution contains: hydrogen peroxide 3%, phosphonic acid compound (stabilizer), citric acid, polyethylene glycol, sodium chloride, sodium hydroxide, and phosphate (buffer system).

AI/ML Overview

The provided document describes the FDA 510(k) clearance for Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table. Instead, it states that tests were conducted according to established guidance and protocols, and the results "demonstrated" effectiveness or compatibility. The general acceptance criterion for most tests appears to be "similar to the predicate device" or "effective/compatible."

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Lens Compatibility	Compatible with various commercially available hydrogel, silicone hydrogel, and RGP lenses.	"Results demonstrated that the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution was compatible with the test contact lenses."
Neutralization Profile	Similar neutralization profile to the predicate device; neutralizer catalyst disk stability.	"The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution showed a similar neutralization profile to the predicate device. In addition, stability of the neutralizer catalyst disk was confirmed for 90-cycles treatments."
Disinfecting Efficacy	Harmful microorganisms reduced to an ISO level at specified time points.	"Results demonstrated that harmful microorganisms were effectively reduced to an ISO level at 6 and 24 hours and 7 days after neutralization."
Preservative Efficacy	Ensure 3-month open bottle discard date.	"Preservative Efficacy test was conducted to ensure 3-month open bottle discard date of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution."
Cleaning Efficacy	Similar performance to the predicate device in protein and lipid removal.	"Results suggested that both solutions performed similarly in the removal of lens deposition."
Toxicology/Biocompatibility	Non-toxic and non-irritating for the neutralized solution, lens case, and catalyst.	"Results demonstrated that the neutralized solution, the lens case materials and the neutralizer catalyst were non-toxic and nonirritating under the experimental conditions."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (e.g., number of lenses, microorganisms, or test runs) for each non-clinical test. It mentions testing with:

Lens Compatibility: Six commercially available hydrogel/silicone hydrogel soft contact lenses and two commercially available RGP lenses.
The data provenance (country of origin, retrospective/prospective) and specific details about the laboratories conducting these non-clinical tests are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a cleaning and disinfecting solution, not an AI or diagnostic imaging device that requires human expert review for "ground truth." The "ground truth" for its performance is established through objective laboratory tests and scientific protocols that measure chemical properties, microbiological reduction, and material compatibility. Therefore, the concept of "experts establishing ground truth" in the way it applies to AI diagnostic studies is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI diagnostic evaluations where human readers interpret data. This is a non-clinical, laboratory-based performance study for a chemical solution. Therefore, such adjudication methods are not applicable and not mentioned.

5. 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

No MRMC comparative effectiveness study was done. This is a chemical cleaning solution, not an AI-assisted diagnostic device, so comparison with human readers is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an algorithm's performance. As the device is a chemical solution, this concept is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of this device is established through:

Scientific Protocols and Laboratory Measurements: For lens compatibility, neutralization profiles (residual hydrogen peroxide levels), disinfecting efficacy (microbial reduction counts against ISO standards), preservative efficacy, cleaning efficacy (quantification of protein/lipid removal), and toxicology (in-vitro and in-vivo biocompatibility tests based on GLP regulations). This is essentially objective, measurable data generated by laboratory instruments and techniques following validated methods.

8. The sample size for the training set

This device is not an AI algorithm requiring a "training set." Therefore, the concept of a training set sample size is not applicable. The performance studies are validation tests, not machine learning model training.

9. How the ground truth for the training set was established

As there is no training set for an AI algorithm, this question is not applicable.

Summary

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March 2, 2020

Menicon Co., Ltd. Li Haosheng, Ph.D. International Regulatory Affairs Menicon Co., Ltd. 3-21-19, Aoi, Naka-ku, Nagoya, 460-0006 JAPAN

Re: K191872

Trade/Device Name: Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN, MRC Dated: January 29, 2020 Received: February 3, 2020

Dear Dr. Li Haosheng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K191872

Device Name

Menicon 3 % Hydrogen Peroxide Cleaning & Disinfecting Solution

Indications for Use (Describe)

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

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

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510(k) Summary

Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

1. Applicant Information

Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku, Nagoya, Aichi 460-0006 JAPAN

Contact Person:	Tetsuji Kawai
Telephone No.:	+81-52-935-1676
Fax No.:	+81-52-935-1633
E-mail:	t-kawai@menicon.co.jp
Date Prepared:	July 10, 2019

2. Device Information

Device classification:	Class II
Classification name:	21 CFR 886.5928Soft (hydrophilic) Contact Lens Care Product21 CFR 886.5918Rigid Gas Permeable Contact Lens Care Product
Product code:	LPN, MRC
Proprietary name:	Menicon 3% Hydrogen PeroxideCleaning & Disinfecting Solution

3. Predicate Device

Menicon claims substantial equivalence to K142284 Clear Care Plus Cleaning & Disinfecting Solution and K030522 Clear Care Cleaning & Disinfecting Solution.

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4. Description of Device

5. Indications for Use

6. Performance Data

Non-Clinical Data

A series of preclinical tests were performed to demonstrate the substantial equivalence of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution to the predicate devices. All tests were conducted in accordance with the Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (1997) or according to valid scientific protocols.

. Lens Compatibility

Compatibility testing was conducted with six commercially available hydrogel and silicone hydrogel soft contact lenses: Acuvue2 (etafilcon A), Acuvue Oasys (senofilcon A), Biofinity (comfilcon A), Air Optix Aqua (lotrafilcon B), Definitive74 (efrofilcon A) and PureVision2 (balafilcon A), and 2 commercially available RGP lenses: Menicon Z (tisilfocon A) and Boston IV (itafocon B). Results demonstrated that the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution was compatible with the test contact lenses.

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. Neutralization Profile

Tests were conducted to evaluate the effectiveness of the neutralization lens case of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution in terms of residual hydrogen peroxide level. The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution showed a similar neutralization profile to the predicate device. In addition, stability of the neutralizer catalyst disk was confirmed for 90-cycles treatments.

. Disinfecting and Preservative Efficacy

Disinfecting efficacy test was conducted to evaluate the antimicrobial activity of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution as a contact lens disinfection product. Results demonstrated that harmful microorganisms were effectively reduced to an ISO level at 6 and 24 hours and 7 days after neutralization. In addition, Preservative Efficacy test was conducted to ensure 3-month open bottle discard date of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution.

● Cleaning Efficacy

Studies were conducted in an in-vitro system to quantify the ability of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution to remove proteins and lipids from commercially available hydrogel and silicone hydrogel soft contact lenses and RGP lenses, and to compare its performance to the predicate device. Results suggested that both solutions performed similarly in the removal of lens deposition.

● Toxicology

A series of in-vitro and in-vivo biocompatibility tests were conducted in accordance with the GLP regulation (21 CFR Part 58) to ensure the safety of the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution. Results demonstrated that the neutralized solution, the lens case materials and the neutralizer catalyst were non-toxic and nonirritating under the experimental conditions.

Clinical Data

Clinical studies were unnecessary for this application.

Conclusion

Based upon the data presented, the Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is as safe, as effective and performs as well as the predicate devices.

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7. Substantial equivalence

The claim of substantial equivalence to the previously cleared devices is supported by the following Comparison of Characteristics in Table 1.

	Menicon 3% Hydrogen PeroxideCleaning & Disinfecting Solution	Clear Care Plus	Clear Care
510(k) Number	New	K142284	K030522
Product Codes	LPN, MRC	LPN, MRC	LPN
Indications for Use	Indicated for use in cleaning, dailyprotein removal, disinfection, andstoring of soft (hydrophilic) contactlenses (including silicone hydrogellenses) and rigid gas permeable(fluoro silicone acrylate andsilicone acrylate) contact lenses, asrecommended by your eye careprofessional.	Indicated for use in simultaneouscleaning, daily protein removal,disinfection, and storing of soft(hydrophilic) contact lenses(including silicone hydrogellenses) and rigid gas permeable(fluoro silicone acrylate andsilicone acrylate) contact lenses,as recommended by your eyecare professional.	Indicated for use insimultaneous cleaning,daily protein removal,disinfecting, and storing ofsoft (hydrophilic) contactlenses (including siliconehydrogel lenses) contactlenses as recommended byyour eye care practitioner.
Lens Case Design	specially designed lenscase with neutralizing disk	specially designed lenscase with neutralizing disk	specially designed lenscase with neutralizing disk
MinimumDisinfection Time	6 hours	6 hours	6 hours
Color of Bottle Cap	red	red	red
Tamper Resistant	yes	yes	yes

Table 1 Comparison of Characteristics

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.”