Menicon Progent Large Diameter Contact Lens Case is only intended for use with the Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Contact Lenses.

The Menicon Progent Large Diameter Contact Lens Case provides an alternative lens case to hold large diameter lenses (11 mm to 23 mm) during the Menicon Progent Protein Remover treatment. The case is not intended for disinfection (chemical, heat or peroxide). The case is not intended for lens storage.

Device Description

The Menicon Progent Large Diameter Contact Lens Case is a non-vented barrel style contact lens case. It consists of a clear polycarbonate (PC) cylinder with acrylonitrilebutadiene-styrene (ABS) copolymer non-vented screw cap and lens holder/basket. Each lens basket is molded with a letter, "L" or "R", for ease in proper lens identification. The left lens basket is also colored grey to assist patients who are not currently wearing their contact lenses. The lens case is capable of holding the 10 mL of Menicon Progent Protein Remover A/B mixed solution for effective protein removal.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Menicon Progent Large Diameter Contact Lens Case) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, the submission details are focused on demonstrating substantial equivalence to predicate devices. This is a common pathway for Class II medical devices, where the manufacturer asserts that their new device is as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval.

Here's a breakdown of why this document doesn't fit the request and what it does contain:

Why the Request Cannot Be Fulfilled from this Document:

No Acceptance Criteria: The document does not define specific performance metrics or thresholds (e.g., accuracy, sensitivity, specificity, or physical durability standards) for the Menicon Progent Large Diameter Contact Lens Case.
No "Study" in the sense of performance evaluation: There isn't a study described that measures the device's performance against predefined criteria. Instead, it relies on a comparison of characteristics to predicate devices.
Focus on Substantial Equivalence: The entire submission's purpose is to show that the new device is "substantially equivalent" to existing, legally marketed devices, rather than proving it meets novel acceptance criteria through new testing.

What the Document Does Provide (Relevant to the request in a broader sense):

A table of characteristics (not acceptance criteria):

Characteristic	Menicon Progent Large Diameter Contact Lens Case (New Device)	Bonasse Barrel Style Lens Case (Predicate 1)	Progent SP Vial (Predicate 2)
Manufacturer	Menicon Pharma	Bonasse Enterprise Company, Ltd.	Bonasse Enterprise Company, Ltd.
Device Name	Contact Lens Case	Contact Lens Case	Contact Lens Case
Model Name	Not Applicable	BC 790	BC 760-1
Trade Name	Menicon Progent Large Diameter Contact Lens Case	Bonasse Barrel Style Lens Case BC 760-1	Barrel Style Lens Case
Classification	Ophthalmic (Class II, LRX, 21 CFR 886.5918)	Ophthalmic (Class II, LRX, 21 CFR 886.5918)	Ophthalmic (Class II, LRX, 21 CFR 886.5918)
Intended Use	For Storage of RGP Contact Lenses during lens treatment (protein removal), Not for use with heat, chemical or peroxide disinfection systems.	For Storage of soft, hard and RGP contact lenses during lens treatment (chemical disinfection), Not for use with heat or peroxide disinfection systems.	For Storage of RGP contact lenses during lens treatment (protein removal), Not for use with heat, chemical or peroxide disinfection systems.
Materials	Clear Plastic Vial (PC), White Plastic screw top lid (ABS), White and Grey plastic lens baskets/holder (ABS)	Clear Plastic Vial, White Plastic screw top lid (ABS), White plastic lens baskets/holder (ABS)	Clear Plastic Vial, Green Plastic screw top lid, Clear plastic lens holder
Volume	10 mL	10 mL	10 mL
Biocompatibility	Components used in this lens case 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.	Biocompatibility testing by a third-party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.	Biocompatibility testing by a third-party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.

No sample size for test set / data provenance / experts / adjudication for this comparative study. The "study" here is a comparison of characteristics to established predicate devices, not a new performance study with a test set.
No MRMC comparative effectiveness study. This type of study (evaluating human reader improvement with AI) is irrelevant for this device, which is a physical contact lens case and not an AI-powered diagnostic tool.
No standalone performance evaluation. The submission relies on the established safety and effectiveness of the predicate devices and demonstrates that the new device's characteristics are similar enough.
Ground Truth Type: Not applicable in the context of this 510(k) submission. The ground truth for the predicate devices' safety and effectiveness was established through their own prior clearances and clinical use. For the new device, the "ground truth" is that its materials and design are comparable to those already deemed safe and effective.
Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
How ground truth for training set was established: Not applicable.

In summary, this document demonstrates that the Menicon Progent Large Diameter Contact Lens Case is substantially equivalent to predicate devices, primarily through a comparison of physical characteristics, materials, intended use, and general safety (biocompatibility). It does not present a de novo study with acceptance criteria and performance data for the device itself.

Summary

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

K130285

510(k) Summary

MENICON PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE CONTACT LENSES

February 22, 2013

1. Applicant Information

Lagado Corporation
Contact Person:	Mark Allen
Telephone No.:	(303) 789-0933
Fax No.:	(303) 789-4506
E-mail:	mark@lagadocorp.co
Date Prepared:	February 22, 2013

2. Device Information

Classification name:	Rigid gas permeable contact lens care products
Device classification:	Class II
Regulation number:	21 CFR 886.5918
Product code:	LRX
Proprietary name:	Menicon Large Diameter Contact Lens CaseFor Rigid Gas Permeable Contact Lenses

3. Predicate Devices

Lagado Corporation claims substantial equivalence to K991206 Bonasse Non-Vented Barrel Style Contact Lens Case and the Progent SP Vial cleared in 510(k) K122273.

4. Description of Device

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

5. Indications for Use

Menicon Progent Large Diameter Contact Lens Case is only intended for use with the Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Contact Lenses.

6. Substantial Equivalence

The claim of substantial equivalence to the previously cleared K991206 Bonasse Non-Vented Barrel Style Contact Lens Case is supported by the following Comparison of Characteristics in Table 1.

The Progent Large Diameter Contact Lens Case is also equivalent to the cleared Progent SP Vial cleared in K122273.

Based upon the comparison the Menicon Progent Large Diameter Contact Lens Case is substantially equivalent to the predicate devices. The contact lens cases are similar in design and volume. The lens cases are manufactured from similar materials that have been proven to be safe for use. The lens cases can be used for lens treatments, such as chemical disinfection for predicate device or protein removal for the Menicon . Progent Cases.

Therefore, Progent Large Diameter Contact Lens Case is substantially equivalent to the predicate devices.

Menicon Progent Large Diameter Lens Case 510(k) K 130285

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

Table 1 Comparison of Characteristics
Manufacturer	Bonasse Enterprise Company, Ltd.	Bonasse Enterprise Company, Ltd.	Menicon Pharma

Device Name	Contact Lens Case	Contact Lens Case	Contact Lens Case
Model Name	BC 790	BC 760-1	Not Applicable
Trade Name	Menicon Progent Large DiameterContact Lens Case	Bonasse Barrel Style Lens CaseBC 760-1	Barrel Style Lens Case
510(k)	To Be Determined	K991206	K122273
Classification	Ophthalmic	Ophthalmic	Ophthalmic
Product Code	LRX	LRX	LRX
RegulationNumber	21 CFR 886.5918	21 CFR 886.5918	21 CFR 886.5918
Class	II	II	II
Intended Use	For Storage of RGP Contact Lensesduring lens treatment (proteinremoval), Not for use with heat,chemical or peroxide disinfectionsystems.	For Storage of soft, hard and RGPcontact lenses during lenstreatment (chemical disinfection),Not for use with heat or peroxidedisinfection systems.	For Storage of RGP contact lensesduring lens treatment (proteinremoval), Not for use with heat,chemical or peroxide disinfectionsystems.
Materials	Clear Plastic Vial (PC)White Plastic screw top lid* (ABS)White and Grey plastic lensbaskets/holder (ABS)	Clear Plastic Vial,White Plastic screw top lid* (ABS)White plastic lens baskets/holder(ABS)	Clear Plastic Vial, GreenPlastic screw top lid* Clearplastic lensholder
Volume	10 mL	10 mL	10 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	Biocompatability testing by a thirdparty laboratory demonstrated thematerials are safe for use incontact lens storage anddisinfection**	Biocompatability testing by a thirdparty laboratory demonstrated thematerials are safe for use incontact lens storage anddisinfection
*Non Vented Screw Top Lids
**Source K991206 Summary of Safety and Effectivenes
PC - Polycarbonate, ABS- acrylonitrile-butadiene-styrene copolymer

Menicon Progent Large Diameter Lens Case 510(k) K130285

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

April 3, 2013

Public Health Service

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

The Lagado Corporation % Ms. Ellen M. Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street. Suite 180 Wilmington, MA 01887-4461

Re: K130285

Trade/Device Name: Menicon Progent Large Diameter Contact Lens Case Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: LRX Dated: January 31, 2013 Received: February 5, 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 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 complies with other requirements of the Act

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

Page 2 - Ms. Ellen M. Beucler

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K130285

Device Name: Menicon Progent Large Diameter Contact Lens Case

Indications for Use:

Menicon Progent Large Diameter Contact Lens Case is only intended for use with the Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Contact Lenses.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Digitally signed by Mridulika Virmani-

Mridulika

Virmani

DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=13000903
1.2.840.113549.1.9.1=Mridulika.Virmani -S
Date: 2013.04.01 11:14:17 -04'00'

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

510(k) Number K130285

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.”