PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS

K130285 · The Lagado Corp. · LRX · Apr 3, 2013 · Ophthalmic

Device Facts

• Record ID: K130285
• Device Name: PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
• Applicant: The Lagado Corp.
• Product Code: LRX · Ophthalmic
• Decision Date: Apr 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

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. 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 Story

Non-vented barrel-style contact lens case; holds large diameter RGP lenses (11-23 mm) during protein removal treatment. Input: RGP lenses and Menicon Progent Protein Remover A/B solution (10 mL). Operation: manual placement of lenses into labeled baskets ('L'/'R'); immersion in protein remover solution. Output: cleaned lenses after treatment. Used by patients in home setting. Benefits: facilitates protein removal for large diameter lenses; provides secure containment during treatment process.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993 standards; results indicate materials are safe for use in contact lens treatment applications.

Technological Characteristics

Non-vented barrel-style case. Materials: Polycarbonate (PC) cylinder, Acrylonitrile-butadiene-styrene (ABS) copolymer screw cap and lens baskets. Volume: 10 mL. Dimensions: configured for 11 mm to 23 mm diameter lenses. Biocompatibility: tested per ISO 10993. No energy source, software, or connectivity.

Indications for Use

Indicated for patients using Rigid Gas Permeable (RGP) contact lenses (11 mm to 23 mm diameter) requiring protein removal treatment. Not for use with chemical, heat, or peroxide disinfection systems; not for lens storage.

Regulatory Classification

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.

Special Controls

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

Predicate Devices

• Bonasse Non-Vented Barrel Style Contact Lens Case (K991206)
• Progent SP Vial (K122273)

Submission Summary (Full Text)

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### 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.: | [phone] |
| Fax No.: | [phone] |
| E-mail: | [e-mail] |
| 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 Case<br>For 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

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.

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#### 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.

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.

# 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

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| 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 Diameter<br>Contact Lens Case | Bonasse Barrel Style Lens Case<br>BC 760-1 | Barrel Style Lens Case |
| 510(k) | To Be Determined | K991206 | K122273 |
| Classification | Ophthalmic | Ophthalmic | Ophthalmic |
| Product Code | LRX | LRX | LRX |
| Regulation<br>Number | 21 CFR 886.5918 | 21 CFR 886.5918 | 21 CFR 886.5918 |
| Class | II | II | II |
| Intended Use | For Storage of RGP Contact Lenses<br>during lens treatment (protein<br>removal), Not for use with heat,<br>chemical or peroxide disinfection<br>systems. | For Storage of soft, hard and RGP<br>contact lenses during lens<br>treatment (chemical disinfection),<br>Not for use with heat or peroxide<br>disinfection systems. | For Storage of RGP contact lenses<br>during lens treatment (protein<br>removal), Not for use with heat,<br>chemical or peroxide disinfection<br>systems. |
| Materials | Clear Plastic Vial (PC)<br>White Plastic screw top lid* (ABS)<br>White and Grey plastic lens<br>baskets/holder (ABS) | Clear Plastic Vial,<br>White Plastic screw top lid* (ABS)<br>White plastic lens baskets/holder<br>(ABS) | Clear Plastic Vial, Green<br>Plastic screw top lid* Clear<br>plastic lens<br>holder |
| Volume | 10 mL | 10 mL | 10 mL |
| Biocompatability | Components used in this lens case<br>have been evaluated in accordance<br>with Part 10993 of the ISO standard<br>for Biological Evaluation. Test results<br>indicate the test articles meet the<br>ISO standard | Biocompatability testing by a third<br>party laboratory demonstrated the<br>materials are safe for use in<br>contact lens storage and<br>disinfection** | Biocompatability testing by a third<br>party laboratory demonstrated the<br>materials are safe for use in<br>contact lens storage and<br>disinfection |
| *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

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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

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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 [phone] or [phone] 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

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#### 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.

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.

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