(43 days)
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.
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.
This document is a 510(k) summary for the JSZ-Multipurpose Solution, a contact lens care product. It describes the non-clinical and clinical studies conducted to demonstrate its substantial equivalence to legally marketed predicate devices.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| I. Chemistry | |
| A. Solution compatibility: No differences in lens parameters after 30 cycles of simulated use. | Demonstrated: "Parameters of lenses were measured before and after the 30 cycles, and no differences were found." |
| B. Cleaning effectiveness: Efficacy demonstrated by critical micelle concentration. | Demonstrated: "The efficacy of the JSZ-Multipurpose Solution as a daily cleaner was shown by determining the critical micelle concentration." |
| II. Toxicology | |
| A. Agar Overlay Cytotoxicity: Non-cytotoxic to lenses. | Demonstrated: "All test lens types were noncytotoxic." |
| B. Systemic Toxicity (Intraperitoneal injection in mice): No difference from control animals (saline) over 72 hours (50ml/kg body weight). | Passed: "The solution passed the test requirements, that there be no difference between the response of test and control animals." |
| C. Acute Oral Toxicity (Intubation in rats): No clinical signs of toxicity over 14 days (5ml/kg body weight). | Passed: "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." |
| D. Acute Ocular Irritation (Rabbits): No ocular irritation compared to sterile water control over 72 hours. | Meets requirements: "Examinations over 72 hours showed no differences between test and control eyes... The JSZ-Multipurpose Solution therefore meets the requirements of the acute ocular irritation test, that it does not cause ocular irritation." |
| E. Full USP Class VI Testing (PETROTHENE® LR 7320-01 high density polyethylene bottles): | |
| 1. Cytotoxicity Test: No cell lysis or toxicity. | Passed: "The SC test extract was not cytotoxic and passed this ISO study." |
| 2. Systemic Toxicity Test: No mortality or significant systemic toxicity from extracts. | Met USP requirements: "Each test article extract met with USP requirements." |
| 3. Ocular Irritation Study: No significant irritation in test or control eye. | Met requirements: "The SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbits." |
| III. Microbiology | |
| A. Sterility: Product is sterile. | Data included (from contract manufacturer): "Sterility data is included from the contract manufacturer." |
| B. Preservative efficacy: Passed requirements. | Passed: "The JSZ-Multipurpose Solution solution passed the requirements of the preservative efficacy test." |
| C. Disinfection Efficacy: Passed stand-alone and multi-item testing. | Passed: "The JSZ-Multipurpose Solution passed the requirements of the stand-alone of The JSZ-Multipurpose Solution passed the requirements for the multi-item testing." |
| D. Stability: Product is stable. | Data included (from contract manufacturer): "Stability data is included from the contract manufacturer." |
| Acceptance Criteria (Clinical) | Reported Device Performance |
| Clinical Trial: Substantially equivalent to currently marketed care products with respect to safety, efficacy, and comfort over 6 months of usage. | Demonstrated: "A clinical trial of 6 months usage of the JSZ-Multipurpose Solution by 246 subjects... compared to control groups using currently marketed care products, showed that the product is substantially equivalent to those current solutions." |
2. Sample size used for the test set and the data provenance
- Non-Clinical (Toxicology - Animal Studies):
- Systemic Toxicity (mice): An unspecified number of "healthy mice" (often groups of 5-10 per test)
- Acute Oral Toxicity (rats): An unspecified number of "healthy rats" (often groups of 5-10 per test)
- Acute Ocular Irritation (rabbits): Three rabbits.
- USP Class VI Testing (Cytotoxicity, Systemic Toxicity, Ocular Irritation): Sample sizes for ISO/USP tests are standardized, but not explicitly stated here. For example, USP Class VI systemic toxicity often uses 3-5 mice per extract.
- Clinical:
- Sample Size: 246 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was prospective in nature, comparing the JSZ solution to currently marketed care products over a 6-month period.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes performance tests and a clinical trial, not an AI/algorithm study involving expert review for ground truth. Therefore, this information is not applicable in the context of this 510(k) summary. The ground truth for the non-clinical tests was established by direct measurement against scientific and regulatory standards (e.g., lens parameters, animal health, toxicology assays). For the clinical trial, the "ground truth" was derived from clinical observations and patient feedback on safety, efficacy, and comfort, typically assessed by eye care practitioners.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/algorithm study requiring expert adjudication of image interpretations.
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
No. This is a 510(k) submission for a medical device (contact lens solution), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document pertains to a contact lens solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Non-Clinical Studies: The "ground truth" was based on objective measurements and established scientific/toxicological standards. For example, absence of cellular toxicity, no observable systemic or ocular irritation in animal models, measured lens parameters, and compliance with microbiological efficacy tests (sterility, preservative efficacy, disinfection efficacy).
- Clinical Study: The "ground truth" was based on clinical outcomes data collected over a 6-month period from 246 subjects, comparing the JSZ solution to predicate devices. This would involve patient observations, eye examinations, and reported comfort/safety.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning study with a training set.
§ 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.”