JSZ MULTIACTION GP CONTACT LENS SOLUTION

• K Number: K060924
• Device Name: JSZ MULTIACTION GP CONTACT LENS SOLUTION
• Manufacturer: SZABOCSIK AND ASSOCIATES
• Date Cleared: 2006-06-28 ( 85 days)
• Product Code: LPN , MRC
• Regulation Number: 886.5928
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K050517

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 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.

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.”