Menicon Nect Contact Lens Case is indicated for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. This case is for use during chemical disinfection only. Not to be used with heat disinfection.

Device Description

The Menicon Nect Contact Lens Case consists of a molded dual compartment base unit and two screw caps. Both the base unit and screw caps are made from Polypropylene resin. The right screw cap is marked "R" and has a blue tint to assist patients who are not currently wearing their contact lenses. The lens compartments are of sufficient volume to allow contact lenses to be fully immersed during lens disinfection. The case is available in two models, one with ribs in the lens case wells and one without ribs in the lens case wells.

AI/ML Overview

The provided 510(k) summary for the Menicon Nect Contact Lens Case (K131875) does not describe an active device that utilizes AI or machine learning, and therefore, does not have conventional "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic or predictive performance.

This submission is for a medical device (a contact lens case) that is seeking clearance based on substantial equivalence to a predicate device. The primary "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate device, primarily through material biocompatibility and functional equivalence.

Here's a breakdown based on the information provided, framed to address your questions as best as possible given the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are not performance metrics like sensitivity or specificity. Instead, they relate to compliance with standards and equivalence to the predicate.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (Menicon Nect Contact Lens Case)
Biocompatibility: Safe for contact with the eye/lens.	Components evaluated in accordance with ISO 10993 Biological Evaluation of Medical Devices. Test results indicate components meet ISO standard (Cytotoxicity, Systemic Toxicity, Ocular Irritation).
Intended Use: Suitable for storage and chemical disinfection.	Indicated for storage during chemical disinfection of soft, rigid gas permeable, and hard contact lenses. Not for heat disinfection. (Same as predicate)
Material: Made from safe and suitable materials.	Polypropylene resin used for base and caps. (Same as predicate)
Design: Similar to predicate device, allowing proper immersion.	Molded dual compartment base, two screw caps (R marked, blue tint). Available with or without ribs. Similar in design to predicate.
Volume: Sufficient to immerse lenses.	3.6 mL. (Predicate: 3.8 mL; considered similar).
Disinfection Type: Chemical, not heat.	Chemical; Not Heat. (Same as predicate)
Sterilization: Not sold sterile.	Not Sold Sterile. (Same as predicate)
Overall Safety and Effectiveness: As safe and effective as predicate.	"Based upon the test data presented, the Menicon Nect Contact Lens Case is as safe, as effective and performs as well as the predicate device."

2. Sample size used for the test set and the data provenance:

Test Set: Not applicable for a traditional "test set" in the context of an AI/ML device. For biocompatibility, general testing (Cytotoxicity, Systemic Toxicity, Ocular Irritation) was done on representative plastic components. The document does not specify the number of samples or animals used for these tests.
Data Provenance: The biocompatibility tests were conducted according to ISO 10993, which are international standards. The country of origin for the data is not explicitly stated but implies testing by a certified lab. The studies were likely prospective in nature (i.e., designed specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not an AI/ML device requiring expert-established ground truth. Biocompatibility testing is typically performed by trained laboratory personnel following established protocols, and evaluation is against ISO standards.

4. Adjudication method for the test set:

Not applicable. Biocompatibility tests are objective measurements against defined pass/fail criteria from ISO standards, not subjective expert adjudication.

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:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

For biocompatibility: Ground truth is established by adherence to and passing criteria of ISO 10993 Biological Evaluation of Medical Devices standards.
For substantial equivalence: Ground truth is the predicate device (K121030 Sacks Holdings, Inc. Contact Lens Storage Case). The new device is compared feature-by-feature to the cleared predicate.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or associated ground truth establishment process for this type of device.

In summary: The submission demonstrates the Menicon Nect Contact Lens Case meets its "acceptance criteria" by showing it is substantially equivalent to a legally marketed predicate device (K121030) and that its materials are biocompatible according to international standards. Clinical studies were deemed unnecessary because the device's function is well-understood, and the lens care solutions used with it are already cleared.

Summary

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510(k) Summary MENICON NECT CONTACT LENS CASE July 17, 2013

1. Applicant Information

Menicon Nect Co., Ltd:	12-7, Biwajima 3, Nishi-ku,
	Nagoya 451-0053, JAPAN
Contact Person:	Mr. Shinji Tanaka
Telephone No.:	+81-52-908-2472
Fax No.:	+81-52-529-2465
E-mail:	stanaka@meniconnect.co.jp
Date Prepared:	July 17, 2013

AUG 06 2013

2. Device Information

Classification name:	Contact Lens Care Products
Device classification:	Class II
Regulation number:	21 CFR 886.5918 (Rigid Gas Permeable Contact Lenses)21 CFR 886.5928 (Soft (hydrophilic) Contact Lenses)
Product code:	LRX
Proprietary name:	Menicon Nect Contact Lens Case

3. Predicate Devices

Menicon Nect claims substantial equivalence to K121030 Sacks Holdings, Inc. Contact Lens Storage Case cleared by the Food and Drug Administration on July 6, 2012.

4. Description of Device

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K131875

5. Indications for Use

6. Performance Data

Non-Clinical Data

Biocompatibility tests were conducted on the plastic components in accordance with ISO Part 10993 Biological Evaluation of Medical Devices. Testing included Cytotoxicity, Systemic Toxicity and Ocular Irritation. The test results indicate the components are safe for the intended use.

Clinical Data

Clinical studies were unnecessary for this application. Lens care solutions used with this contact lens case are already cleared for use as cleaning, rinsing, disinfection and storage solutions for soft (hydrophilic), rigid gas permeable and hard contact lenses.

Conclusion

Based upon the test data presented, the Menicon Nect Contact Lens Case 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

The claim of substantial equivalence to the previously cleared K121030 Sacks Holdings, Inc. Contact Lens Storage Case is supported by the Comparison of Characteristics in Table 1.

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7. Substantial Equivalence (continued)

Based upon the comparison the Menicon Nect Contact Lens Case is substantially equivalent to the K121030 Sacks Holdings, Inc. Contact Lens Storage Case. The contact lens cases are similar in design and volume. Both lens cases are manufactured from similar materials that have been proven to be safe for use. Both lens cases can be used for lens chemical disinfection treatments.

Therefore, Menicon Nect Contact Lens Case is substantially equivalent to the predicate device.

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Table 1 Comparison of Characteristics
	Menicon Nect Co., Ltd.	Sacks Holdings, Inc.
Device Name	Contact Lens Case	Contact Lens Storage Case
Trade Name	Menicon Nect Contact Lens Case	Contact Lens Case
510(k)	K131875	K121030
Classification	Ophthalmic	Ophthalmic
Product Code	LRX	LRX
Regulation Number	21 CFR 886.591821 CFR 886.5928	21 CFR 886.5928
Class	II	II
Intended Use	For storage duringchemical disinfection of soft(hydrophilic), rigid gas permeableand hard contact lenses.This case is for use duringchemical disinfection only.Not to be used with heat disinfection.	For storage duringchemical disinfection of soft(hydrophilic), rigid gas permeableand hard contact lenses.This case is for use duringchemical disinfection only.Not to be used with heat disinfection.
Disinfection Type	Chemical; Not Heat	Chemical; Not Heat
Design	Case Bottom with screw on capsThe letter "R" embossed on the rightcap. Right and Left caps arecontrasting colors.	Case Bottom with screw on capsThe letter "R" embossed on the rightcap. Right and Left caps arecontrasting colors.
Sterilization	Not Sold Sterile	Not Sold Sterile
Materials	Polypropylene resin used for thelens case base and screw top caps	Polypropylene resin used for thelens case base and screw top caps
Volume	3.6 mL	3.8 mL
Biocompatability	Components used in this lens casehave been evaluated in accordancewith Part 10993 of the ISO standardfor Biological Evaluation. Test resultsindicate the test articles meet theISO standard	Components used in this lens casehave been evaluated in accordancewith Part 10993 of the ISO standardfor Biological Evaluation. Test resultsindicate the test articles meet theISO standard

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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 6, 2013

Menicon Nect Co., Ltd. c/o Ms. Ellen Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvalle Street, Suite 180 Wilmington, MA 01887-4461

Rc: K131875

Trade/Device Name: Menicon Nect Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LR X Dated: July 17, 2013 Received: July 19, 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 10 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 complics 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 (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 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" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -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

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Menicon Nect Co., Ltd

Indications for Use

K131875 510(k) Number (if known): __

Device Name: Menicon Nect Contact Lens Case

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jeffrey M. Broclous -S 2013.08.23 10:03:48 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

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510(k) Number: K131875

Menicon Nect Contact Lens Case 510(k)

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.”