JSZ-MULTIPURPOSE SOLUTION

K050517 · Szabocsik and Associates · LPN · Apr 13, 2005 · Ophthalmic

Device Facts

• Record ID: K050517
• Device Name: JSZ-MULTIPURPOSE SOLUTION
• Applicant: Szabocsik and Associates
• Product Code: LPN · Ophthalmic
• Decision Date: Apr 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.

Device Story

JSZ Multipurpose Solution is a sterile, isotonic chemical solution for soft (hydrophilic) contact lens maintenance. It contains poloxamer, sodium phosphate buffer, sodium chloride, disodium edetate, and polyhexanide (0.0001%) preservative; it is free of chlorhexidine and thimerosal. The solution is packaged in plastic bottles with controlled dropper tips. It is used by contact lens wearers at home to clean, rinse, disinfect, and store lenses. The solution acts as a chemical disinfectant and protein remover. By maintaining lens hygiene, it supports comfortable lens wear and reduces the risk of ocular complications associated with contaminated lenses.

Clinical Evidence

Clinical trial of 6 months duration involving 246 subjects wearing representative soft (hydrophilic) contact lenses. The study compared the JSZ-Multipurpose Solution against control groups using currently marketed care products. Results demonstrated the device is substantially equivalent to existing solutions in terms of safety, efficacy, and comfort.

Technological Characteristics

Sterile, isotonic solution. Ingredients: poloxamer, sodium phosphate buffer, sodium chloride, disodium edetate, and polyhexanide 0.0001%. Packaging: plastic bottles (high density polyethylene) with controlled dropper tips. No chlorhexidine or thimerosal. Chemical disinfection principle (non-heat).

Indications for Use

Indicated for daily cleaning, rinsing, chemical disinfection, protein removal, and storage of soft (hydrophilic) contact lenses for patients using such lenses 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.”

Submission Summary (Full Text)

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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2005

John M. Szabocsik, Ph.D. SZABOCSIK AND ASSOCIATES Suite 1200 203 North Wabash Avenue Chicago, IL 60601

Re: K050517 Trade/Device Name: JSZ Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated (Date on orig SE 1tr): February 18, 2005 Received (Date on orig SE Itr): March 1, 2005

Dear Dr. Szabocsik:

This letter corrects our substantially equivalent letter of April 13, 2005 regarding the trade name section of the reference block.

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 (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 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

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Page 2 - John M. Szabocsik, Ph.D.

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 continue 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/dsma/dsmamain.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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# INDICATIONS FOR USE STATEMENT

510(k) NUMBER (IF KNOWN) K 05 05 05 17

Device Name: İSZ Multipurpose Solution

- ﻧ

Indications for Use The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.

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

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K050517 |
|--------------------------|---------------------------------------|
| Prescription Use | OR Over-The-Counter-Use <span></span> |
| (Per 21 CFR 801.109) | |
| (Optional Format 1-2-96) | |

ﺔ ﺍﻟﻤﺘ

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APR 1 3 2005

# 1050517

JSZ-Multipurpose Solution 510(k) FOI Summary

# 510(k) SUMMARY

JSZ-MULTIPURPOSE SOLUTION FOR SOFT (HYDROPHILIC) CONTACT LENSES

This summary uses the format provided in 21 CFR 807.92:

| (a)(1). Submitter: | John M. Szabocsik, PhD<br>President<br>SZABOCSIK AND ASSOCIATES INC<br>203 N WABASH AVE STE 1200<br>CHICAGO IL 60601<br>Phone [phone]<br>FAX [phone] |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary prepared: | February 18, 2005 |
| (a)(2) Device Trade Name: | JSZ-Multipurpose Solution |
| Device Common Name: | Soft (hydrophilic) contact lens solution |

Device Classification Name:

Accessories to Contact Lens Solution (86LPN)

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

This product is substantially equivalent to other currently marketed contact lens care multipurpose solutions.

# (a)(4) Device Description:

The JSZ-Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal.

This product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

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

The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.

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

No changes have been made to the product formulation subject to this application.

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

- I. Chemistry
A. Solution compatibility

The compatibility of the JSZ-Multipurpose Solution was demonstrated by cycling lenses through 30 cycles of simulated use, using the JSZ-Multipurpose Solution for cleaning, rinsing, disinfecting and storing. Parameters of lenses were measured before and after the 30 cycles, and no differences were found.

### B. Cleaning effectiveness

The efficacy of the JSZ-Multipurpose Solution as a daily cleaner was shown by determining the critical micelle concentration.

#### II. Toxicology

The toxicological testing is summarized below, and reports are attached. The solution was shown to be non-toxic in all tests. Additional toxicity testing (cytotoxicity, systemic toxicity and ocular irritation) was done to verify the safety of the solution in the contract manufacturer's bottle.

Agar Overlay Cytotoxicity: A.

Representative lenses from all four groups of soft (hydrophilic) lens types were exposed to the JSZ-Multipurpose Solution for 24 hours, then tested in a direct contact cytotoxicity assay. All test lens types were noncytotoxic.

Systemic Toxicity: B.

The JSZ-Multipurpose Solution was evaluated for systemic toxicity by intraperitoneal (ip) injection in healthy mice, 50ml/kg body weight. The animals were observed over a 72 hour period, and showed no difference from control animals injected with saline. The solution passed the test requirements, that there be no difference between the response of test and control animals.

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C. Acute Oral Toxicity

The JSZ-Multipurpose Solution was evaluated for acute oral toxicity by intubation in healthy rats, 5ml/kg body weight. The animals were observed immediately after intubation, after 2 and 4 hours, then daily for fourteen days. The animals were weighed prior to intubation, at 7 days, and at 14 days. All animals showed no clinical signs of toxicity from test initiation to Day 14, therefore the JSZ-Multipurpose Solution passed the test requirements of no acute oral toxicity.

#### Acute Ocular Irritation: D.

The JSZ-Multipurpose Solution was instilled directly into one eye of each of three rabbits, the other eye receiving sterile water as a control. Examinations over 72 hours showed no differences between test and control eyes, with no evidence of ocular irritation with either the test or control solutions. The JSZ-Multipurpose Solution therefore meets the requirements of the acute ocular irritation test, that it does not cause ocular irritation.

- Full USP Class VI Testing of JSZ-Multipurpose Solution in bottles E. manufactured of PETROTHENE® LR 7320-01 high density polyethylene.
- Cytotoxicity Test: 1.

Under the conditions of this study, the SC test extract showed no evidence of causing cell lysis or toxicity. The negative controls, reagent controls, and the positive controls performed as anticipated. The SC test extract was not cytotoxic and passed this ISO study.

Systemic Toxicity Test: 2. Under the conditions of this study, there was no mortality or evidence of significant systemic toxicity from the extracts. Each test article extract met with

USP requirements.

### Ocular Irritation Study: 3.

Under the conditions of this study, there was no evidence of significant irritation in the test or control eye of any rabbit. The SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbits.

#### Microbiology III.

Sterility A.

Sterility data is included from the contract manufacturer.

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Preservative efficacy B.

The JSZ-Multipurpose Solution solution passed the requirements of the preservative efficacy test.

..

Disinfection Efficacy C.

The JSZ-Multipurpose Solution passed the requirements of the stand-alone of The JSZ-Multipurpose Solution passed the requirements for the multi-item testing.

> Stability D.

Stability data is included from the contract manufacturer.

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

A clinical trial of 6 months usage of the JSZ-Multipurpose Solution by A clinical trial of 6 monuls usage of the 382 mount of soft (hydrophilic)
246 subjects, wearing representative lenses from all marked care 246 subjects, wearing representative rouses using currently marketed care
contact lenses, compared to control groups using currently marketed care contact lenses, compared to control groups asing our unstally
products, showed that the product is substantially equivalent to those current solutions.

(b)(3) Conclusions Drawn from Data Supporting Equivalence Determination:
Conclusions Drawn Barns of States of divised studies supporting the application. sions Drawn from Data Supporting Equites supporting the application, the In view of the in Vitto and cinical starter starter oppose Solution is substantially
safety, efficacy and comfort of the JSZ-Multipurpose Solution is substions safety, efficacy and comfort of the JSZ-Multipurpose Bountillers of any and