EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION

K051104 · Lapis Lazuli, NV · LPN · May 31, 2006 · Ophthalmic

Device Facts

• Record ID: K051104
• Device Name: EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
• Applicant: Lapis Lazuli, NV
• Product Code: LPN · Ophthalmic
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.

Device Story

EYE SEE™ Multipurpose Contact Lens Solution is a sterile, isotonic, buffered solution for soft (hydrophilic) contact lens care. Ingredients include boric acid, sodium chloride, HPMC (lubricant), poloxamer 407 (surfactant), disodium edetate (chelating agent), and polyhexanide (preservative). Packaged in plastic bottles with dropper tips for consumer use. Users apply solution to lenses for daily cleaning, protein removal, rinsing, chemical disinfection, and storage. Regimen requires rubbing and rinsing. Solution maintains lens hygiene and comfort; prevents microbial contamination; supports lens longevity.

Clinical Evidence

Clinical study involved 60 subjects over one month. Results demonstrated non-inferiority to predicate devices. Non-clinical evidence includes lens compatibility cycling, cleaning efficacy via Critical Micelle Concentration (CMC) determination, microbial disinfection effectiveness per FDA guidance, preservative efficacy testing, and cytotoxicity/eye irritation studies showing no evidence of toxicity.

Technological Characteristics

Sterile, isotonic, buffered aqueous solution. Ingredients: Boric acid, sodium chloride, HPMC, poloxamer 407, disodium edetate, polyhexanide. Form factor: Plastic bottle with controlled dropper tip. No electronic components or software.

Indications for Use

Indicated for daily cleaning, protein removal, rinsing, chemical disinfection, and storage of soft (hydrophilic) contact lenses for users as recommended by an eye care practitioner.

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

• Complete® brand Multi-purpose solution (K030092)
• NRC07 Multi-purpose solution (K033854)

Submission Summary (Full Text)

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## MAY 3 1 2006

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K051104 |
|--------------------------------|---------|
|--------------------------------|---------|

Applicant information:

| Date Prepared: | May 22, 2006 |
|-------------------------|-----------------------------------------------------|
| Name: | Lapis Lazuli International NV |
| Address | Damsluisweg 48<br>1332 ED Almere<br>The Netherlands |
| Contact Person: | Mark Berkouwer<br>Executive Officer |
| Phone number: | [phone] |
| US Firm: | MedVice Consulting, Inc. |
| Official Correspondent: | Mr. Martin Dalsing |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Email address: | [e-mail] |

Device Information:

| Device Classification: | Class II |
|------------------------|----------------------------------------------------------------------------------|
| Classification Number: | LPN 886.5928 |
| Classification Name: | Accessories, soft lens products Soft<br>(hydrophilic) contact lens care products |
| Trade Name: | EYE SEE™ Multipurpose Contact Lens Solution |

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#### Purpose of 510(k) Submission

NEW DEVICE ~

Lapis Lazuli International NV proposes to market and sell in United States interstate commerce, The EYE SEE™ Multipurpose Solution. Data supporting substantial equivalency to the predicate devices, performance, and safety & efficacy of the EYE SEE™ Multipurpose Solution is contained in this submission.

#### Device Description

The EYE SEE™ Multipurpose Solution is a sterile, isotonic, buffered, solution containing boric acid, sodium chloride, Hydroxypropyl Methylcellulose (HPMC) as a lubricant, poloxamer 407 as a surfactant, disodium edetate as chelating agent, purified water and preserved with polyhexanide.

The EYE SEE™ Multipurpose Solution is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

#### Intended Use

The EYE SEE™ Multipurpose Solution is indicated for use in the daily cleaning. removing protein deposits, rinsing, chemical (not heat) disinfecting, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.

## Description of Safety and Substantial Equivalence

Data to demonstrate all indications: daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfecting, and storage of soft (hydrophilic) contact lenses, of the EYE SEE™ Multipurpose Solution have been included in this submission.

A series of non-clinical and clinical studies were completed on this product. The following studies have been completed:

> Lens Compatibility: Lens compatibility studies were undertaken after cycling lenses in the solution. The results indicated that all soft (hydrophilic) contact lenses were compatible with the solution.

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Cleaning Effectiveness: The cleaning efficacy of the solution was evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants.

Microbial Testing: Disinfection effectiveness was evaluated according to the FDA guidance document. The results indicate satisfactory levels of disinfection efficacy. Preservative efficacy testing with rechallenge was evaluated. All results were satisfactory.

Toxicology Testing: A series of cytotoxicity and eye irritation studies were performed. In these studies there was no evidence of toxicity

Clinical Study: Following an approved FDA clinical protocol, a 60-subject, one-month clinical study has been conducted and results indicate that the solution is non-inferior to the predicate devices.

The EYE SEE™ Multipurpose Solution is substantially equivalent in terms of its actions and indications for use to the following predicate devices:

PREDICATE DEVICES ~

"Complete®" brand Multi-purpose solution by Advanced Medical Optics K030092 "NRC07" Multi-purpose solution by Bausch & Lomb K033854

The EYE SEE™ Multipurpose, Contact Lens Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.

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## SUBSTANTIAL EQUIVALENCY CHART

| Substantial<br>Equivalency | EYE SEETM<br>MULTIPURPOSE<br>SOLUTION | COMPLETE BRAND<br>MULTI-PURPOSE<br>SOLUTION<br>K030092 | NRC07 MULTIPURPOSE<br>SOLUTION<br>K033854 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | Lapis Lazuli International | Advanced Medical Optics | Bausch & Lomb |
| INTENDED<br>USE | The EYE SEETM<br>MULTIPURPOSE<br>SOLUTION<br>is indicated for use in the daily<br>cleaning,<br>removing protein deposits,<br>rinsing, chemical<br>(not heat) disinfecting, and<br>storage of soft<br>(hydrophilic) contact lenses, as<br>recommended by your eye care<br>practitioner. | The COMPLETETM BRAND<br>MULTI-PURPOSE<br>SOLUTION<br>is indicated for the care of soft<br>hydrophilic contact lenses. Use<br>this product as recommended by<br>our eye care practitioner to:<br>Chemically (NOT HEAT)<br>Disinfect, Clean, Rinse, Store,<br>Remove Protein | The NRC07 MULTIPURPOSE<br>SOLUTION is indicated for use<br>in the daily<br>cleaning, removal of protein<br>deposits, rinsing, chemical (not<br>heat) disinfection<br>and storage of soft (hydrophilic)<br>contact lenses as recommended<br>by your eye care practitioner |
| Active<br>Ingredient | Hydroxypropyl<br>Methylcellulose (HPMC) | Hydroxypropyl<br>Methylcellulose (HPMC) | Hydranate<br>(hydroxyalkylphosphonate) |
| Surfactant | poloxamer 407 | poloxamer 237 | poloxamer 407 |
| Preservative | Polyhexanide 0.00015%, | Polyhexamethylene<br>biguanide<br>0.0001% | Alexidine dihydrochloride<br>(0.00045%). |
| Chelating Agent | Disodium edetate | Disodium edetate | Disodium edetate |
| Tears<br>Simulation<br>Additive | Sodium chloride<br>Boric Acid | Sodium chloride<br>Potassium chloride | Boric acid, Sodium chloride,<br>Sodium phosphate |
| Lens Care<br>Regimen | Rub and Rinse | No Rub | No Rub |
| Sterility Claim | Sterile | Sterile | Sterile |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, symbolizing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 1 2006

Lapis Lazuli International, NV c/o Mr. Martin Dalsing Official Correspondent Medvice Consulting, Inc. 2214 Sanford Dr., Suite #B7 Grand Junction, CO 81505

Re: K051104

Trade/Device Name: EYE SEE™ Multipurpose Contact Lens Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: May 22, 2006 Received: May 23, 2006

Dear Mr. Dalsing:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 - Mr. Martin Dalsing

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/industry/support/index.html.

Sincerely yours,
Evert A. Been, PhD

Marvina B. 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: K051104

Device Name: EYE SEE™ Multipurpose Contact Lens Solution

#### INDICATIONS FOR USE:

EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use *X*
21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mona Smith

Division Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K051104