The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft contact lenses during wear.

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the recommendation of your eye care practitioner when disinfecting your lenses.

Device Description

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a sterile, viscous, aqueous solution with an alkaline pH. The cleaner contains no added preservatives. The cleaner contains an amphoteric surfactant to aid in the removal of film, deposits and other debris that accumulates on contact lenses during wear. The cleaner is not meant for use in the eve and must be thoroughly rinsed from the lenses.

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is packaged in a 1 FL OZ plastic bottle (polyethylene) with red dropper tip (polyethylene) and white over-cap (polypropylene). It has an outside cardboard carton. It has an expiration date of two years from the date of bottling.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a soft contact lens cleaning solution. It is not an AI/ML device, therefore, the requested information about acceptance criteria, study details, and AI-specific metrics are not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and includes pre-clinical performance data to support the safety and effectiveness of the Sereine Extra Strength Daily Cleaner.

However, I can extract the information that is available regarding the performance of the device and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (What was tested for)	Reported Device Performance
30-day Silicone Hydrogel Compatibility
Parameter Change (15 days)	No Change (for all tested lens types)
Parameter Change (30 days)	No Change (for all tested lens types)
Color Change	No Change (for all tested lens types)
Cytotoxicity (after 30-day cleaning)	Lenses met ISO requirements for Cytotoxicity.

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

Sample Size: Not explicitly stated as a numerical sample size. The compatibility study tested "Four Silicone Hydrogel contact lens types," namely: senofilcon A (Oasys), lotrafilcon A (Night & Day), comfilcon A (Biofinity), and balafilcon A (Purevision). For cytotoxicity, it refers to "the four Silicone Hydrogel lenses" cleaned over 30 days.
Data Provenance: The studies appear to be pre-clinical, conducted by the applicant or a contract research organization in support of the 510(k) submission. No information on country of origin of data or whether it was retrospective/prospective is provided.

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

This information is not applicable. The studies referenced are laboratory-based compatibility and cytotoxicity tests, not expert-adjudicated clinical studies for AI/ML performance. The "ground truth" here is determined by objective physical and biological measurements against established standards (e.g., ISO standard 81369-2 for lens parameters, ISO requirements for Cytotoxicity).

4. Adjudication Method for the Test Set:

This information is not applicable. There was no human adjudication process described, as the tests involved objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a contact lens cleaning solution.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done:

This information is not applicable. The device is a physical cleaning solution, not an AI algorithm.

7. The Type of Ground Truth Used:

For compatibility: Objective measurements of lens parameters and visual inspection for discoloration/clarity changes, compared against a baseline and established ISO standards (ISO standard 81369-2).
For cytotoxicity: Laboratory assessment of cytotoxicity, meeting "ISO requirements."

8. The Sample Size for the Training Set:

This information is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable. There is no training set for this type of medical device submission.

Summary

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JUN 1 3 2007

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:

1071203

Applicant information:

Date Prepared:

April 25, 2007

Ms. Sally Cook

(303) 936-1137

President

Name: Address Optikem International, Inc. 2172 South Jason Street Denver, CO 80223

Contact Person:

Phone number:

USA Consultant:

Phone number: Fax number: Email address:

MedVice Consulting, Inc. Mr. Martin Dalsing (970) 243-5490 (970) 243-5501 marty@FDApproval.com

Device Information:

Device Classification:

Classification Name:

Class II

Classification Number:

LPN 886.5928

Accessories, soft lens products Soft (hydrophilic) contact lens care products

Trade Name:

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses

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Purpose of 510(k) Submission:

New Device

Optikem International, Inc. proposes to market and sell in United States interstate commerce. The Sereine Extra Strength Daily Cleaner for use with Silicone Hydrogel contact lens material. Data supporting the safety and effectiveness of cleaning Silicon. Hydrogel contact lens materials are included in this submission. The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is the same solution as cleared in 510(k) K011561.

Equivalent Devices:

The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is the same solution as cleared in 510(k) K011561, which is substantially equivalent to the MIRAFLOW cleaner by CIBA Vision. The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is substantially equivalent in terms of its actions, and formulation.

PREDICATE DEVICE ~

The Sereine Extra Strength Daily Cleaner Manufactured by Optikem International, Inc.

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses 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.

Device Description:

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Intended Use:

The intended use of the device is as a daily cleaner or the removal of proteins, lipids and other debris that accumulates on contact lenses during wear. The device is to be used for the removal of this debris immediately after the lenses are removed from the eye. The device is intended for use as a cleaner with Silicone Hydrogel contact lenses. The device is not intended for use in the eye and must be physically rinsed from the lens using either saline solution or multipurpose solution cleared for use on Silicone Hydrogel prior to insertion.

Pre-Clinical Performance Data:

Data to demonstrate the safety and effectiveness of the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses when used to clean Silicone Hydrogel contact lenses are included in this submission and supported by the following studies:

30 day Silicone Hydrogel compatibility study 용

A study was conducted to test the compatibility of Sereine Extra Strength Daily Cleaner on Silicone Hydrogel soft lens parameters. Four Silicone Hydrogel contact lens types were tested: senofilcon A, lotrafilcon A, comfilcon A, and balafilcon A. A baseline of parameters was measured using ISO standard 81369-2, and none of the lenses showed a change in baseline parameters as well as none of the lenses showed discoloration or any change in lens clarity. It was concluded that the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is physically compatible with senofilcon A, lotrafilcon A, comfilcon A. and balafilcon A lenses.

ProductName	Lens Type(USAN)	ParameterChange 15 days	Parameter Change30 days	ColorChange
OASYS	senofilcon A	No Change	No Change	No Change
Night & Day	lotrafilcon A	No Change	No Change	No Change
Biofinity	comfilcon A	No Change	No Change	No Change
Purevision	balafilcon A	No Change	No Change	No Change

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Cytotoxicity studies - ISO Direct Contact Test l

Studies were conducted on the four Silicone Hydrogel lenses after a 30 day regime cleaning period with the Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses. It was concluded that the lenses met ISO requirements for Cytotoxicity.

All other safety and efficacy data can be referenced in previously cleared 510(k) K011561. Permission to reference 510(k) K011561 is included in this 510(k).

Substantial Equivalence:

The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is substantially equivalent to the following predicate devices:

The Sereine Extra Strength Daily Cleaner Manufactured by Optikem l International, Inc.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Optikem International, Inc. c/o Mr. Martin Dalsing MedVice Consulting, Inc. 2214 Sanford Drive, Unit B7 Grand Junction, CO 81505

JUN 1 8 2007

Re: K071203

Trade/Device Name: Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SiHy) Soft Contact Lenses Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: April 25, 2007 Received: May 1, 2007

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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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,

M.B. Eichelman Simd

Malvina 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 STATEMENT

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Device Name: Lenses

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K071203

Prescription Use __
or
Over-The-Counter Use X
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

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.”