JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,

K052074 · Szabocsik and Associates · MRC · Sep 1, 2005 · Ophthalmic

Device Facts

• Record ID: K052074
• Device Name: JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
• Applicant: Szabocsik and Associates
• Product Code: MRC · Ophthalmic
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5918
• Device Class: Class 2

Intended Use

JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses. JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses. JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye. JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.

Device Story

Chemical solutions for RGP contact lens care; includes cleaning, disinfecting, and storage solutions (Stat-Tree/Stat-Or) and wetting, lubricating, and rewetting drops (Wet-Tree/Wet-Or). Solutions applied by patient to RGP lenses; cleaning/disinfecting performed during storage; wetting drops applied prior to insertion or while lens is on eye. Formulations identical to previously marketed predicate devices. No clinical data required due to established safety of active ingredients. Benefits include maintenance of lens hygiene, comfort, and ocular lubrication.

Clinical Evidence

No clinical data included. Evidence based on bench testing: cytotoxicity, acute oral toxicity, ocular irritation, guinea pig maximization, corneal wound healing, corneal penetration, disinfection efficacy, and preservative efficacy. All tests passed.

Technological Characteristics

Chemical solutions for RGP lens care. Formulations contain active ingredients identical to predicate devices. Stability and sterility verified via real-time testing. No electronic or software components.

Indications for Use

Indicated for cleaning, chemical disinfection, and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses; wetting, lubricating, and rewetting of RGP lenses prior to insertion and while on the eye.

Regulatory Classification

Identification

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

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

• DeStat-3
• DeStat-4
• Stay-Wet 3
• Stay-Wet 4

Reference Devices

• Optimum by Lobob Cleaning, Disinfecting and Storage Solution
• Optimum by Lobob Wetting and Rewetting Drops
• Claris Cleaning and Soaking Solution

Submission Summary (Full Text)

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SEP 0 1 2005

K052074

JSZ-Stat-Tree, JSZ-Stat-Or, JSZ-Wet-Tree, JSZ-Wet Or 510(k)

### SUMMARY, FREEDOM OF INFORMATION

# JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS;

# AND JSZ-WET-TREE AND JSZ-WET-OR, WETTING, LUBRICATING AND REWETTING SOLUTIONS

### FOR RIGID GAS PERMEABLE CONTACT LENSES

| 1. Common/Usual Names | JSZ-Stat-Tree, and JSZ-Stat-Or, Cleaning, Disinfecting and Storing Solutions;<br>and JSZ-Wet-Tree and JSZ-Wet-Or, Wetting, Lubricating and Rewetting Solutions |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Trade/Proprietary | JSZ-Stat-Tree, and JSZ-Stat-Or, Cleaning, Disinfecting and Storing Solutions;<br>and JSZ-Wet-Tree and JSZ-Wet-Or, Wetting, Lubricating and Rewetting Solutions |
| 3. FDA Classification | Class II<br>(Performance Standards)<br>21 CFR 886.5918<br>Rigid Gas Permeable (RGP) contact lens solutions |
| 4. Performance standards | None established under section 514 |

5. Substantial equivalence

These products are substantially equivalent to several currently marketed products, such as DeStat-3 and Destat 4 Cleaning, Disinfecting and Storage Solutions, Stay-Wet 3 and Stay-Wet 4 Wetting and Rewtting Drops. Optimum by Lobob Cleaning, Disinfecting and Storage Solution, Wetting and Rewetting Drops, and Claris Cleaning and Soaking Solution.

### 6. Indications for Use

JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses.

JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses.

JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.

JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.

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# SUMMARY

Contained in this submission are comparisons of the products to the predicate devices, information on the chemistry and manufacturing, toxicology and microbiology. Because the predicate devices, with identical formulations, have been previously approved for market, and have been marketed over the last decade, no clinical data is included in this submission.

- I. Chemistry
The JSZ-Stat-Tree/JSZ-Wet-Tree and the JSZ-Stat-Or/JSZ-Wet-Or systems were compatible with all groups of RGP lenses. Both ISZ-Stat-Tree and JSZ-Stat-Or were shown to be effective daily cleaners.

Toxicology II.

> The toxicological testing of the the JSZ-Stat-Tree/JSZ-Wet-Tree, and JSZ-Stat-Or/JSZ-Wet-Or systems for the cleaning, disinfecting and storing, and wetting, lubricating and rewetting of rigid gas permeable lenses is summarized below.

| Test | DeStat-3/DeStat-4 | Stay-Wet-3/Stay-Wet 4 |
|-------------------------------------|-------------------|-----------------------|
| Cytotoxicity | NAa | passed |
| Acute Oral Toxicity | passed | passed |
| Ocular Irritation (21d rabbit) | passedb | |
| Ocular Irritation (72hr rabbit) | passedb | |
| Anesthetic Effect | NAa | passed |
| Guinea Pig Maximization | passedc | |
| Corneal Epithelial Wound<br>Healing | passedc | |
| Corneal Penetration | passedc | |

a NA - test not applicable to cleaning solutions

b Test used JSZ-Stat-Tree/JSZ-Wet-Tree, or JSZ-Stat-Or/JSZ-Wet-Or

° Tests on benzyl alcohol

#### III. Microbiology

The microbiological testing of the the JSZ-Stat-Tree/JSZ-Wet-Tree, and JSZ-Stat-Or! JSZ-Wet-Or systems for the cleaning, disinfecting and storing, and wetting, lubricating and rewetting of rigid gas permeable lenses is summarized below.

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# JSZ-Stat-Tree, JSZ-Stat-Or, JSZ-Wet-Tree, JSZ-Wet Or 510(k)

| Test | JSZ-Stat-Tree | JSZ-Stat-Or | JSZ-Wet-Tree | JSZ-Wet-Or |
|---------------------------------------------|---------------|-------------|--------------|------------|
| Disinfection Efficacy<br>(microbial, viral) | passed | passed | NAa | NA |
| Neutralizer Efficacy | passed | passed | NA | NA |
| Preservative Efficacy | passed | passed | passed | passed |
| Sterility/Stabilityb | passed | passed | passed | passed |

ª NA - Not applicable to rewetting solutions

6 Protocol for real-time stability of JSZ products included

# IV. Clinical Studies

Clinical data is not required for solutions using the same active ingredients at the same concentrations as currently marketed products.

V. Substantial Equivalence

The solutions are identical to the DeStat-3, DeStat-4, Stay-Wet 3, and Stay-Wet-4 solutions previously approved, and substantially equivalent to the Optimum by Lobob Cleaning, Disinfecting and Storage Solution, Optimum by Lobob Wetting and Rewetting Drops, and Claris by Menicon Cleaning and Soaking Solution.

VI. Manufacturing

Manufacturing details are included in the manufacturing section.

VII. Shelf Life

The shelf life is assumed to be the same as in the predicate filings and a protocol for on-going real time shelf-life is included.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 1 2005

John Szabocsik, Ph.D. President SZABOCSIK AND ASSOCIATES 203 North Wabash Avenue Chicago, Illinois 60601

Re: K052074

Trade/Device Name: JSZ-Stat-Tree, and JSZ-Stat-Or, Cleaning, Disinfecting and Storing Solutions; and JSZ-Wet-Tree and JSZ-Wet-Or, Wetting, Lubricating and Rewetting Solutions

Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable (RGP) contact lens solutions Regulatory Class: Class II Product Code: MRC Dated: July 29, 2005 Received: August 1, 2005

Dear Dr. Szabocsik :

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 - John Szabocsik, Ph.D.

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,

David M. Whipple

David M. Whipple Acting 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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JSZ-Stat-Tree, JSZ-Stat-Or, JSZ-Wet-Tree, JSZ-Wet Or 510(k)

510(k) NUMBER (IF KNOWN) K052074

DEVICE NAME

JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution

JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops.

# INDICATIONS FOR USE

JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution is indicated for use in the JSZ-Stat-Tree Cleaning, Disameeting, Sessings of Stages
cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses.

JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution is indicated for use in the JSZNal-Of Cleaning, Districting, Stellige Beer ago Bearther and silicone acrylate (RGP) contact lenses.

JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops are indicated for use to wet JSZ-Wel-Tree Wetting. Dubrieading acrylate rigid gas permeable (RGP) contact lenses Indord/sincolle act yiate and barrest and lubricate the lens while on the eye.

JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops are indicated for use to wet JSZ-Wel-Or Welting: Edwrieauing, songlate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.

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

Amilham

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter-Use U (Per 21 CFR 801.109) OR Prescription Use _ (Optional Format 1-2-96)

stmlest

ision of Ophthalm

10(k) Number K052074