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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the clinical study mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on non-clinical and clinical studies demonstrating the overall safety and efficacy for all intended uses. While specific quantitative acceptance criteria for each test are not explicitly detailed in the summary, the overall outcome of the clinical study is described.

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
All Indications	Demonstrate safety and efficacy for: daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfecting, and storage of soft (hydrophilic) contact lenses.	A series of non-clinical and clinical studies were completed, indicating the solution meets these requirements. Specific details on non-clinical test results (e.g., microbial, toxicology) were described as "satisfactory."
Clinical Performance	Non-inferiority to predicate devices.	Results indicate that the solution is non-inferior to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 60 subjects
Data Provenance: Not explicitly stated (e.g., country of origin). The study was conducted "Following an approved FDA clinical protocol," suggesting it was likely conducted in the US or under US regulatory oversight. It is a prospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. The clinical study investigated effectiveness in subjects, likely relying on direct observations and patient-reported outcomes rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This information is not provided in the summary. For a clinical study involving subject outcomes, adjudication might involve blinded assessment of adverse events or efficacy endpoints by clinicians.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No, an MRMC comparative effectiveness study, typically seen in imaging for diagnostic accuracy, was not performed. The study was a clinical trial comparing the new solution to predicate devices with human subjects.
Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted diagnostic device study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? Not applicable. This device is a contact lens solution, not an algorithm, so a standalone algorithm performance study was not relevant. The "standalone" performance here refers to the device's inherent efficacy in its intended uses. Non-clinical tests like cleaning effectiveness, microbial testing, and toxicology could be considered "standalone" as they evaluate the solution itself.

7. Type of Ground Truth Used

For the clinical study: The "ground truth" would be established through clinical assessments, patient complaints/symptoms, and potentially objective measures relevant to soft contact lens wear (e.g., ocular health exams, comfort ratings, adverse event monitoring). The summary states "results indicate that the solution is non-inferior," implying a comparison of these clinical outcomes between the test and predicate solutions.

8. Sample Size for the Training Set

Not applicable. This is a contact lens solution, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is a physical product, not an AI/ML algorithm.

Summary

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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
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Applicant information:

Date Prepared:	May 22, 2006
Name:	Lapis Lazuli International NV
Address	Damsluisweg 481332 ED AlmereThe Netherlands
Contact Person:	Mark BerkouwerExecutive Officer
Phone number:	+31 (0) 36 547 6020
US Firm:	MedVice Consulting, Inc.
Official Correspondent:	Mr. Martin Dalsing
Phone number:	(970) 243-5490
Fax number:	(970) 243-5501
Email address:	marty@FDApproval.com

Device Information:

Device Classification:	Class II
Classification Number:	LPN 886.5928
Classification Name:	Accessories, soft lens products Soft(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 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

SubstantialEquivalency	EYE SEETMMULTIPURPOSESOLUTION	COMPLETE BRANDMULTI-PURPOSESOLUTIONK030092	NRC07 MULTIPURPOSESOLUTIONK033854
Manufacture	Lapis Lazuli International	Advanced Medical Optics	Bausch & Lomb
INTENDEDUSE	The EYE SEETMMULTIPURPOSESOLUTIONis indicated for use in the dailycleaning,removing protein deposits,rinsing, chemical(not heat) disinfecting, andstorage of soft(hydrophilic) contact lenses, asrecommended by your eye carepractitioner.	The COMPLETETM BRANDMULTI-PURPOSESOLUTIONis indicated for the care of softhydrophilic contact lenses. Usethis product as recommended byour eye care practitioner to:Chemically (NOT HEAT)Disinfect, Clean, Rinse, Store,Remove Protein	The NRC07 MULTIPURPOSESOLUTION is indicated for usein the dailycleaning, removal of proteindeposits, rinsing, chemical (notheat) disinfectionand storage of soft (hydrophilic)contact lenses as recommendedby your eye care practitioner
ActiveIngredient	HydroxypropylMethylcellulose (HPMC)	HydroxypropylMethylcellulose (HPMC)	Hydranate(hydroxyalkylphosphonate)
Surfactant	poloxamer 407	poloxamer 237	poloxamer 407
Preservative	Polyhexanide 0.00015%,	Polyhexamethylenebiguanide0.0001%	Alexidine dihydrochloride(0.00045%).
Chelating Agent	Disodium edetate	Disodium edetate	Disodium edetate
TearsSimulationAdditive	Sodium chlorideBoric Acid	Sodium chloridePotassium chloride	Boric acid, Sodium chloride,Sodium phosphate
Lens CareRegimen	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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

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

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

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mona Smith

Division Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K051104

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.”