I-PROMOTIONS CONTACT LENS CASE

K042578 · I-Promotions, Inc. · LRX · Jan 25, 2005 · Ophthalmic

Device Facts

• Record ID: K042578
• Device Name: I-PROMOTIONS CONTACT LENS CASE
• Applicant: I-Promotions, Inc.
• Product Code: LRX · Ophthalmic
• Decision Date: Jan 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

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

Device Story

i-Promotions Contact Lens Case provides storage for soft, rigid gas permeable, or hard contact lenses during chemical disinfection. Device consists of base with two adjoining wells and integral hinged self-sealing caps. Used by patients in home setting. Patient places lenses into wells containing chemical disinfecting solution; caps are closed to contain fluid. Device facilitates lens disinfection; helps maintain lens hygiene. Not for use with heat disinfection.

Clinical Evidence

Bench testing only. Cytotoxicity testing performed by NAMSA on six samples (various colorants and uncolored) per USP XXII standards. Results demonstrated product safety for intended use.

Technological Characteristics

Materials: Dow Chemical Company Low Density Polyethylene (Product #9931) and Carolina Color Corporation colorants. Design: Dual-well container with integral hinged self-sealing caps. Non-powered, passive device.

Indications for Use

Indicated for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable, and hard contact lenses. Contraindicated 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

• Pelican Contact Lens Case (K030987)
• OptiLens™ Contact Lens Case (K920064)

Submission Summary (Full Text)

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## Amended 510(k) K042578 Page #5 January 14, 2005

:

#### XII. Summary of Safety and Effectiveness

| Date of Preparation: | September 20, 2004 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | i-Promotions Contact Lens Case |
| Classification Name: | Contact Lens Case |
| Manufacturer: | i-Promotions, Inc.<br>9522 Gravois Rd.<br>St. Louis, MO 63123 |
| Contact: | Charlotte Slankard<br>President<br>i-Promotion, Inc. |
| Predicate Device: | Pelican Contact Lens Case K030987<br>And OptiLens™ Contact Lens Case K920064 |
| Device Description<br>And Intended Use: | The i-Promotions Contact Lens Case consists of a lens case base with adjoining dual wells for the containment of fluid, and separate integral hinged self-sealing caps.<br><br>The i-Promotions Contact Lens Case is intended for storage during disinfection of soft, rigid gas permeable or hard contact lenses. Not to be used with heat disinfection. Use only with chemical disinfection. |
| Summary of Safety<br>Testing: | NAMSA preformed cytotoxicity testing on six completed i-Promotions Contact Lens Cases. The six cases tested were created using the correct proportion of Dow Chemical Company Low Density Polyethylene Product #9931 and one of five Carolina Color Corporation (listed on page 15). One case was created using no colorant. Five cases were created using one of each colorant. NAMSA took an equal sampling from each of the six cases and combined the sampling to perform one cytotoxicity test.<br><br>The six completed contact lens cases were tested using the biological and toxicology tests recommended by the USPXXII and the results of these studies show that the product is safe for its intended use. |

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| Table I |
|-----------------------------------------|
| Summary of Equivalences and Differences |
| 510(k) Device and Predicate Devices |
| (Amended 1-14-05) |

| Device Name | 510(k) i-Promotions<br>Contact Lens Case | Pelican Contact<br>Lens Storage Case<br>(K030987)<br>Item #600 | Opti-LensTM<br>Contact Lens Case<br>(K920064) |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Storage and<br>Disinfection of Soft,<br>Rigid Gas<br>Permeable or Hard<br>Lenses | Storage and<br>Disinfection of Soft,<br>Rigid Gas<br>Permeable or Hard<br>Lenses | Storage and<br>Disinfection of Soft,<br>Rigid Gas<br>Permeable or Hard<br>Lenses |
| Disinfection Type | Chemical<br>(Not Heat) | Chemical<br>(Not Heat) | Chemical<br>(Not Heat) |
| Design | Two Adjoining<br>Wells With Integral<br>Hinged Caps Into<br>Which Respective<br>Lenses are<br>Immersed | Two Adjoining<br>Wells With Integral<br>Hinged Caps Into<br>Which Respective<br>Lenses are<br>Immersed | Two Adjoining<br>Wells With Screw<br>Top Caps Into<br>Which Respective<br>Lenses are<br>Immersed |
| Materials | -Dow Chemical<br>Company Low<br>Density<br>Polyethylene<br>Dow Product #9931<br>-One of the Carolina<br>Color Corporation<br>Colorants listed in<br>List of Materials<br>Page15 | -Dow Chemical<br>Company Low<br>Density<br>Polyethylene<br>Dow Product #9931<br>See 510(k)<br>(K030987)<br>Item #600 | -M.A. Industries,<br>Inc. #PO011AL<br>Polypropylene |
| Labeling | Refers to product as<br>i-Promotions<br>contact lens case;<br>instructs patient to<br>clean lens case with<br>a disinfecting<br>solution<br>recommended for<br>this purpose | See 510(k)<br>(K030987)<br>Item #600 | Refers to product as<br>Opti-Lens contact<br>lens case; instructs<br>patient to clean lens<br>case with Opti-Free<br>Daily Cleaner |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized wing or feather shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2005

i-Promotions, Inc. c/o Ms. Charlotte Slankard 9522 Gravois Rd. St. Louis, MO 63123

Re: K042578

Trade/Device Name: i-Promotion Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Contact Lens Storage Case Regulatory Class: Class II Product Code: LRX Dated: December 27, 2004 Received: December 30, 2004

Dear Ms. Slankard:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for acce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered province that 20, 2017 - ) 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such 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 807); labeling (21 CFR Part 801); 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.

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## Page 2 - Ms. Charlotte Slankard

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Ahalpi forentthal

A. Ralph Rosenthal, 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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Amended 510(k) K042578 Page #7 January 14, 2005

### Indications for Use

510 (k) Number: K042578

Device Name: i-Promotions Contact Lens Case

Indications for Use:

For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses.

For use during chemical disinfection only, Not to be used with heat.

Over the Counter Use (21 CFR 801 Subpart C)

**Over-the-Counter Use**

Firdak Lee Cohen, MD

(Division Sign Division of Ophthalmic E Nose and Throat Devise

510(k) Number 042578