EYE CARE CURE CONTACT LENS CASE

K112832 · Eye Care and Cure · LRX · Dec 5, 2011 · Ophthalmic

Device Facts

• Record ID: K112832
• Device Name: EYE CARE CURE CONTACT LENS CASE
• Applicant: Eye Care and Cure
• Product Code: LRX · Ophthalmic
• Decision Date: Dec 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The storage and disinfection of soft, rigid gas permeable or hard contact lenses. For use during chemical disinfection only. Not to be used with heat.

Device Story

Eye Care and Cure Contact Lens Case is a non-sterile, polyethylene storage container for contact lenses. Device features two adjoining wells with integral hinged self-sealing caps; each well has 1.0ml capacity and 8mm inner height. Used by patients for chemical disinfection of soft, rigid gas permeable, or hard contact lenses. Patient places lenses in wells filled with chemical disinfectant; device provides containment during disinfection process. Not intended for heat disinfection. Distributed by eye care professionals to patients.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence established via material and design comparison to predicate devices.

Technological Characteristics

Material: Dow Chemical Company Low Density Polyethylene (Product #9931). Design: Two adjoining wells with integral hinged self-sealing caps. Capacity: 1.0ml per well. Dimensions: 8mm inner well height. Energy source: None (passive). Sterilization: Non-sterile.

Indications for Use

Indicated for storage and chemical disinfection of soft, rigid gas permeable, or hard contact lenses. Not for use with heat disinfection.

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

• i-Promotions Contact Lens Case (K042578)
• Pelican Contact Lens Case (K030987)

Submission Summary (Full Text)

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K112832

### 510(k) Summary

# DEC - 5 2011

- 1. Date of Preparation: September 21, 2011
#### 2. Applicant Device Information:

Device Name: Eye Care and Cure Contact Lens Case

Common Name: Contact Lens Case

Classification Name: Case, Contact Lens

Device Class: Contact lens carrying cases are considered Class II Medical Devices by the FDA, although not formally classified at this time.

Recommended Classification Regulation Number: 21 CFR §886.5928

Product Code: LRX

#### Predicate Devices:

The following devices have been identified as the predicate devices for the Eye Care and Cure contact lens case:

Predicate Device: i-Promotions Contact Lens Case (K042578) i-Promotions, Inc. 9522 Gravois Rd. St. Louis, MO 63123

Predicate Device: Pelican Contact Lens Case (K030987) Pelican Products, Inc. 2248 Highway 43 North Pelhatchie, MS 39145

#### Non-Sterile:

The Eye Care and Cure Contact Lens Case is a non-sterile device.

#### Packaging/Labeling:

The contact cases will be sold in bags of 100, including 100 individual labels to be distributed by eye care professionals to contact lens case users together with the case.

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#### Device Description and Intended Use:

The Eye Care and Cure Contact Lens Case consists of a lens case base with adjoining dual walls for the containment of fluid and separate integral hinged self-sealing caps.

The Eye Care and Cure Contact Lens Case is intended for storage during disinfection of soft, rigid gas permeable or hard contact lenses. It is to be used for chemical disinfection only. It is not intended to be use with heat disinfection.

#### Material:

Polyethylene 9931 Low Density (2380) is the same material used by predicate i-Promotions (K042578) with an established history of safe and effective use as a non body contacting, non implanted medical device for holding a contact lens.

#### 3. Submitter Information

#### Manufacturer:

Eye Care and Cure Corporation 4646 S. Overland Dr. Tucson, AZ 85714 Establishment Registration: 2085143 Owner/Operator Number: 9044582

#### Contact Person for Submission:

Lindy van Dalen Regional Director Eye Care and Cure 4646 S. Overland Drive Tucson. AZ 85714 Phone: [phone] Email: [e-mail]

#### 5. Device Description

The Eye Care and Cure Contact Lens Case is to be used for the storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. The case is to be used during chemical disinfection only and is not to be used with heat disinfection devices.

The Eye Care and Cure Contact Lens Case is polyethylene and consists of a two adjoining wells, with hinged self-sealing caps, in which contact lenses are immersed in fluid. Rub and rinse your contact lenses as directed by your eye care professional. The two adjoining wells of the Eye Care and Cure Contact Lens Case each have a capacity of 1.0ml. This is sufficient capacity to fully immerse a contact lens when the well is filled with chemical under normal use conditions. The inner height of the well measures 8mm.

The Eye Care and Cure Contact Lens Case is made of Dow Chemical Company Low Density Polyethylene, Dow Product #9931. No colorant will be added.

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## 6. Substantial Equivalence Determination

| | Applicant<br>Device | Predicate<br>Device | Predicate Device |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Classification | | | |
| Device Name | Eye Care and<br>Cure Contact<br>Lens Case | i-Promotions<br>Contact Lens Case<br>K042578 | Pelican Products,<br>Inc. #500/600<br>(deep well lens<br>case with integral<br>lids)<br>K030987 |
| Classification<br>Name | Case, Contact<br>Lens | Case, Contact<br>Lens | Case, Contact Lens |
| Product Code | LRX | LRX | LRX |
| Comparison<br>Statement | The applicant device has the same classification as<br>the predicate devices. | | |
| 2. Intended Use | | | |
| Intended Use | The applicant<br>device is to be<br>used for the<br>storage during<br>disinfection of<br>soft, rigid gas<br>permeable or<br>hard contact<br>lenses. The<br>case is to be<br>used during<br>chemical<br>disinfection<br>only and is not<br>to be used<br>with heat. | The predicate<br>device is intended<br>for storage during<br>disinfection of<br>soft, rigid gas<br>permeable or<br>hard contact<br>lenses. Not to be<br>used with heat<br>disinfection. Use<br>only with<br>chemical<br>disinfection. | The predicate<br>device is intended<br>for the storage of<br>soft<br>(hydrophilic)/rigid<br>gas permeable and<br>hard contact<br>lenses during<br>chemical<br>disinfection. Not to<br>be used for heat<br>disinfection. |
| Indications | Storage and<br>disinfection of<br>soft, rigid gas<br>permeable or<br>hard contact<br>lenses | Storage and<br>disinfection of<br>soft, rigid gas<br>permeable or<br>hard contact<br>lenses | Storage of soft<br>(hydrophilic)/rigid<br>gas permeable and<br>hard contact<br>lenses during<br>chemical<br>disinfection |
| Comparison<br>Statement | The applicant device has the same intended use as<br>the predicate devices. | | |
| 3. Design/Material | | | |
| Design | Two adjoining<br>wells with | Two adjoining<br>wells with | Two adjoining<br>wells with integral |
| | | | |
| | integral<br>hinged caps,<br>into which<br>lenses are<br>immersed. | integral hinged<br>cap into which<br>respective lenses<br>are immersed. | lids into which<br>lenses are<br>immersed. |
| Material | Dow Chemical<br>Company Low<br>Density<br>Polyethylene,<br>Dow Product<br>#9931 | Dow Chemical<br>Company Low<br>Density<br>Polyethylene,<br>Dow Product<br>#9931 | |
| Comparison<br>Statement | The applicant device has a similar product design<br>and is made of the same material as the predicate<br>devices. | | |
| 4. Effectiveness | | | |
| Effectiveness | The applicant<br>device has two<br>adjoining<br>wells with<br>sufficient<br>capacity to<br>allow for a<br>contact lens to<br>be fully<br>immersed. | The predicate<br>device has two<br>adjoining wells<br>into which<br>respective lenses<br>are immersed. | The predicate<br>device has two<br>adjoining wells<br>into which lenses<br>are immersed |
| Comparison<br>Statement | The applicant device has the same performance<br>effectiveness as the predicate devices. | | |
| 5. Safety | Applicant | Predicate Device | |

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KI12832

| 5. Safety | Applicant Device | Predicate Device |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Dow Chemical<br>Company Low<br>Density<br>Polyethylene,<br>Dow Product<br>#9931 | Dow Chemical<br>Company Low<br>Density<br>Polyethylene,<br>Dow Product<br>#9931 |
| | No tests<br>conducted as<br>material is the<br>same as the<br>material used<br>by the<br>predicate<br>device. | 1. In Vitro Cyto-<br>Toxicity: No<br>Cyto-toxicity<br>2. Delayed-Type<br>Hypersensitivity:<br>No delayed<br>dermal contact<br>sensitization<br>3. Eye Irritation:<br>No<br>intracutaneous<br>reactivity<br>4. Systemic<br>Toxicity: No<br>systemic toxicity |
| Comparison<br>Statement | The applicant device is made of the same material as the predicate device and therefore has the same performance safety as the predicate device. | |
| 6. Labeling &<br>Packaging | Applicant<br>Device | Predicate Device |
| | Refers to<br>product as Eye<br>Care and Cure<br>contact lens<br>case; instructs<br>patients to<br>clean lens case<br>as<br>recommended<br>by the<br>patient's eye<br>care | Refers to product<br>as<br>i-Promotions<br>contact lens case;<br>instructs patients<br>to clean lens case<br>with disinfecting<br>solution<br>recommended for<br>this purpose. |

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## Conclusion:

The applicant device has the same classification, same intended use and indications, similar product design, same materials, same performance effectiveness and the same performance safety as the predicate device. There are no new changes to raise new issues of safety and effectiveness. Therefore, therefore the applicant device is substantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.

#### Public Health Service

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

DEC - 5 2011

Eye Care and Cure Corp. c/o Lindy van Dalen Regional Director 4646 S. Overland Dr. Tucson, AZ 85714

Re: K112832

Trade/Device Name: Eye Care and Cure Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: September 21, 2011 Received: September 29, 2011

Dear Ms. van Dalen:

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 premaiket 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. Ilisting 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 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

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807); labeling (21 CFR Part 801); medical device 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Director Division of Ophthalmic, Neurological 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: ______________________________________________________________________________________________________________________________________________________________

Device Name: Eye Care and Cure Contact Lens Case

Indications for Use:

The storage and disinfection of soft, rigid gas permeable or hard contact lenses. For use during chemical disinfection only. Not to be used with heat.

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

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:_ (per 21 CFR 801.109) Over-The-Counter Use__

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Division of Ophthalmic, Neurological and ENT Devices 510(k) Number