JSZ MULTIACTION GP CONTACT LENS SOLUTION

K060924 · Szabocsik and Associates · LPN · Jun 28, 2006 · Ophthalmic

Device Facts

• Record ID: K060924
• Device Name: JSZ MULTIACTION GP CONTACT LENS SOLUTION
• Applicant: Szabocsik and Associates
• Product Code: LPN · Ophthalmic
• Decision Date: Jun 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The JSZ MultiAction GP Contact Lens Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfection, storage and conditioning of rigid gas permeable contact lenses, including fluorosilicone acrylate and silicone acrylate lenses, as recommended by your eye care practitioner. JSZ Wetting/Rewetting Eyedrop is indicated to rewet soft (hydrophilic) and to cushion and wet rigid gas permeable contact lenses, including fluoro-silicone acrylate and silicone acrylate lenses, before application and during lens wear. The product may be used with daily wear or extended wear lenses and with disposable lenses or lenses prescribed for frequent replacement.

Device Story

JSZ MultiAction GP Contact Lens Solution and JSZ Wetting/Rewetting Eyedrop are sterile, isotonic ophthalmic solutions. Solutions contain poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyquaternium-1 (0.0001%). Products are used by contact lens wearers to clean, disinfect, store, or rewet lenses. No mechanical or electronic components; no software or algorithms. Products are identical in formulation to previously cleared device (K050517).

Clinical Evidence

No clinical data required; substantial equivalence established based on formulation identity to previously cleared devices.

Technological Characteristics

Sterile, isotonic aqueous solution. Ingredients: poloxamer, sodium phosphate buffer, sodium chloride, disodium edetate. Preservative: polyquaternium-1 (0.0001%). No chlorhexidine, thimerosal, or mercury-containing products. Packaging: 2oz/4oz bottles (solution) and 0.5oz/1oz bottles (eyedrop).

Indications for Use

Indicated for users of rigid gas permeable (fluoro-silicone acrylate and silicone acrylate) contact lenses for cleaning, rinsing, disinfection, storage, and conditioning. Also indicated for users of soft (hydrophilic) and rigid gas permeable contact lenses (including daily, extended, disposable, and frequent replacement wear) for rewetting and cushioning before application and during wear.

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

• Optimum Cleaning, Disinfecting and Storage Solution
• Boston Simplus Multiaction Solution
• Sauflon Delta Plus Multiaction Solution
• Complete Blink-n-Clean Lens Drops
• JSZ-Multipurpose Solution (K050517)

Submission Summary (Full Text)

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# JUN 2 8 2006

FOI Summary K060924

Júne 6, 2006

## 510(k) SUMMARY

## K060924 JSZ MultiAction GP Contact Lens Solution JSZ Wetting/Rewetting Eyedrop

This summary uses the format provided in 21 CFR 807.92:

(a)(1). Submitter:

John M. Szabocsik, PhD President SZABOCSIK AND ASSOCIATES INC 203 N WABASH AVE STE 1200 CHICAGO IL 60601

Phone [phone] FAX [phone]

June 6, 2006

Summary prepared:

(a)(2) Device Trade Name:

Device Common Name:

Rigid Gas Permeable contact lens solution Contact lens Wetting/Rewetting Eyedrop

JSZ Wetting/Rewetting Eyedrop

JSZ MultiAction GP Contact Lens Solution

### Device Classification Name:

## JSZ MultiAction GP Contact Lens Solution:

Products, Contact Lens Care, Rigid Gas Permeable (MRC)

# JSZ Wetting/Rewetting Eyedrop:

Accessories Soft Lens Products (LPN) and Products, Contact Lens Care, Rigid Gas Permeable (MRC)

### (a)(3) Identification of Predicate Device:

The JSZ MultiAction GP Contact Lens Solution product is substantially equivalent to other currently marketed rigid gas permeable (GP) contact lens care multipurpose solutions, such as Optimum Cleaning, Disinfecting and Storage Solution, Boston Simplus Multiaction Solution, and Sauflon Delta Plus Multiaction Solution.

The JSZ Wetting/Rewetting Eyedrop is substantially equivalent to other currently marketed wetting/rewetting drops for use with contact lenses, such as Complete Blink-n-Clean Lens Drops.

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Both the JSZ MultiAction GP Contact Lens Solution and the JSZ Wetting/Rewetting Eyedrop are identical in composition to the JSZ-Multipurpose Solution previously cleared for market in K050517, which is also identical to Sauflon Delta Plus Multiaction Solution.

### (a)(4) Device Description:

Both products are sterile, isotonic solutions that contain poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polydum ide 0.0001%. Contain no chlorhexidine, no thimerosal, nor any other mercury containo products.

The products are packaged in sizes appropriate to their intended uses: JSZ MultiAction GP Contact Lens Solution in 2oz (60ml) and 4oz (120ml) bottles, JSZ Wetting/Rewetting Eyedrop in 0.5oz (15ml) and 1oz (30ml) bottles.

# (a)(5) Intended Use (Indications for Use):

The JSZ MultiAction GP Contact Lens Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfection, storage and conditioning of rigid gas permeable contact lenses, including fluoro-silicone acrylate and silicone acrylate lenses, as recommended by your eye care practitioner.

JSZ Wetting/Rewetting Eyedrop is indicated to rewet soft (hydrophilic) and condition and wet rigid gas permeable contact lenses, including fluoro-silicone acrylate and silicone acrylate lenses, before application and during lens wear. The product may be used with daily wear or extended wear lenses and with disposable lenses or lenses prescribed for frequent replacement.

# (a)(6) Comparison of Technological Characteristics:

No changes have been made to the product formulation subject to this application. All technical information is contained in K050517.

#### b)(1) Discussion of Nonclinical:

No new data have been submitted in this application. All information is contained in K050517.

### (b)(2) Discussion of Clinical Data:

No new data have been submitted in this application. Based on the identity of the solution to the previously cleared solutions, no clinical data was required.

# (b)(3) Conclusions Drawn from Data Supporting Equivalence Determination:

This application presents new labeling for the product. There were no changes in

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FOI Summary K060924

June 6, 2006

the product formulation and no new data were presented. The products are substantially equivalent to the predicate devices.

:

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head facing to the right, with three stylized lines representing the eagle's feathers.

JUN 2 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Szabocsik and Associates c/o Mr. John M. Szabocsik 203 North Wabash Ave., Suite 1200 Chicago, IL 60601

Re: K060924

Trade/Device Name: JSZ MultiAction GP Contact Lens Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: II Product Code: MRC

Trade/Device Name: JSZ Wetting/Rewetting Eyedrop Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: II Product Code: LPN; MRC Dated: June 7, 2006 Received: June 8, 2006

Dear Mr. 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 (11.1 The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misburanti, 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. IDA max 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 not me . . ct

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Page 2 - Mr. John M. Szabocsik

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. 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,

J. Soveta

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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FOI Summary K060924

June 6, 2006

Page 1 of 2

# INDICATIONS FOR USE STATEMENT

# 510(k) NUMBER (IF KNOWN) K060924

# Device Name: JSZ MultiAction GP Contact Lens Solution

Indications for Use

The JSZ MultiAction GP Contact Lens Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfection, storage and conditioning of rigid gas permeable contact lenses, including fluorosilicone acrylate and silicone acrylate lenses, as recommended by your eye care practitioner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mig. Vinn Shiz
Division Sign-Off

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number

Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter-Use

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### FOI Summary K060924

June 6, 2006

Page 2 of 2

# INDICATIONS FOR USE STATEMENT

# 510(k) NUMBER (IF KNOWN) K060924

# Device Name: JSZ Wetting/Rewetting Eyedrop

Indications for Use

JSZ Wetting/Rewetting Eyedrop is indicated to rewet soft (hydrophilic) and to cushion and wet rigid gas permeable contact lenses, including fluoro-silicone acrylate and silicone acrylate lenses, before application and during lens wear. The product may be used with daily wear or extended wear lenses and with disposable lenses or lenses prescribed for frequent replacement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mei-Ann Shih i

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

Prescription Use ાર (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter-Use

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