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 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.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request. The summary explicitly states: "No new data have been submitted in this application. All information is contained in K050517." and "Based on the identity of the solution to the previously cleared solutions, no clinical data was required." Therefore, the document is a resubmission for new labeling for products already cleared, and as such, it does not detail new acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment for a new device.

However, based on the provided text, I can infer some information relevant to the substantial equivalence determination.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in this document for the current submission. The acceptance criteria would have been established during the original clearance (K050517) or for the predicate devices. For a contact lens solution, this typically involves microbiological disinfection efficacy, cleaning efficacy, lens material compatibility, and biocompatibility in relevant in-vitro and in-vivo models.
Reported Device Performance: Not reported in this document. The document states that no new data (nonclinical or clinical) were submitted for this application, as the product formulation is identical to a previously cleared device (K050517).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not applicable/not provided. No new studies were conducted for this submission.
Data Provenance: Not applicable/not provided. No new data were generated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/not provided. No new studies requiring expert ground truth establishment were conducted for this submission. The substantial equivalence is based on the identical formulation to a previously cleared device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/not provided. No new studies requiring adjudication were conducted for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a contact lens solution and eyedrop, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a contact lens solution and eyedrop, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable/not provided. For the original clearance of the identical formulation (K050517), the "ground truth" would have been established through a combination of in-vitro chemical and microbiological testing, as well as potentially in-vivo biocompatibility and clinical user studies, against established standards and predicate device performance.

8. The sample size for the training set:

Not applicable/not provided. This is not an AI/machine learning device. The "training" for a contact lens solution involves formulation development and testing against various performance parameters.

9. How the ground truth for the training set was established:

Not applicable/not provided. Not an AI/machine learning device.

Overall Study Information (as inferable from the document):

Study Intent: To establish substantial equivalence for new labeling of existing formulations, rather than to prove safety and effectiveness of a new formulation.
Basis of Equivalence: The products (JSZ MultiAction GP Contact Lens Solution and JSZ Wetting/Rewetting Eyedrop) are "identical in composition" to the JSZ-Multipurpose Solution previously cleared under K050517, which is also identical to Sauflon Delta Plus Multiaction Solution.
Predicates:
- JSZ MultiAction GP Contact Lens Solution: Optimum Cleaning, Disinfecting and Storage Solution, Boston Simplus Multiaction Solution, and Sauflon Delta Plus Multiaction Solution.
- JSZ Wetting/Rewetting Eyedrop: Complete Blink-n-Clean Lens Drops.
Data Submitted for Current K060924: "No new data have been submitted in this application." All relevant technical information was contained in the prior submission K050517.
Clinical Data Requirement: "Based on the identity of the solution to the previously cleared solutions, no clinical data was required."

In summary, this 510(k) pertains to a change in labeling for devices that were already determined substantially equivalent, and therefore, it does not include new study data or criteria. All performance and acceptance criteria would have been addressed in the previous 510(k) submission (K050517) for the identical formulation.

Summary

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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 312-553-0828 FAX 312-553-0611

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:

(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/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.

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 (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,

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

(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

(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

ર્દેન

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.”