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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.

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.

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.

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JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses.

JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses.

JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.

JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.

Cleaning, Disinfecting and Storing Solutions; and Wetting, Lubricating and Rewetting Solutions for Rigid Gas Permeable Contact Lenses.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with quantified performance metrics to be considered "met" in the traditional sense for a medical device. Instead, the approach taken for these contact lens solutions is a demonstration of substantial equivalence to existing legally marketed predicate devices. The "performance" is implicitly deemed acceptable if the new products exhibit comparable chemical, toxicological, and microbiological characteristics to the predicates.

   Test Category	Acceptance Criteria (Implied)	Reported Device Performance
   Chemistry	Compatibility with RGP lenses; effective daily cleaner	JSZ-Stat-Tree/JSZ-Wet-Tree and JSZ-Stat-Or/JSZ-Wet-Or systems were compatible with all groups of RGP lenses. Both JSZ-Stat-Tree and JSZ-Stat-Or were shown to be effective daily cleaners.
   Toxicology	Comparable to or passing established safety tests for predicates	- Cytotoxicity: NA (cleaning solutions), Passed (wetting solutions)

• Acute Oral Toxicity: Passed
• Ocular Irritation (21d rabbit): Passed
• Ocular Irritation (72hr rabbit): Passed
• Anesthetic Effect: NA (cleaning solutions), Passed (wetting solutions)
• Guinea Pig Maximization: Passed
• Corneal Epithelial Wound Healing: Passed
• Corneal Penetration: Passed |
  | Microbiology | Acceptable disinfection efficacy, neutralizer efficacy, preservative efficacy, and sterility/stability | - Disinfection Efficacy: Passed (JSZ-Stat-Tree, JSZ-Stat-Or), NA (wetting solutions)
• Neutralizer Efficacy: Passed (JSZ-Stat-Tree, JSZ-Stat-Or), NA (wetting solutions)
• Preservative Efficacy: Passed (all products)
• Sterility/Stability: Passed (all products) |
  | Clinical Studies | Not required if formulations are identical to previously approved devices | No clinical data included; explicitly stated "Clinical data is not required for solutions using the same active ingredients at the same concentrations as currently marketed products." |
  | Substantial Equivalence | Identical to or substantially equivalent to predicate devices with similar formulations and indications | Solutions are identical to DeStat-3, DeStat-4, Stay-Wet 3, and Stay-Wet-4 solutions; substantially equivalent to Optimum by Lobob and Claris Cleaning and Soaking Solution. |

2. Sample size used for the test set and the data provenance:
   The document does not specify discrete "test sets" in the context of a typical clinical study. The toxicology and microbiology tests were likely conducted on laboratory samples of the solutions themselves, not on human subjects or clinical data sets. The provenance of the data is from laboratory testing of the JSZ products, and comparisons to legally marketed predicate devices in the US market. The study is not a clinical study; it's a pre-market notification (510(k)) relying on substantial equivalence to existing products, with supportive lab data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A). This submission relies on laboratory testing and comparison to predicate devices, not on expert consensus for a "ground truth" in the diagnostic sense. The regulatory body (FDA) reviews the submitted data.

4. Adjudication method for the test set:
   N/A. There was no clinical test set requiring adjudication in the context of this 510(k) 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:
   N/A. This is a submission for contact lens solutions, not an AI-powered diagnostic device. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   N/A. This is not an algorithm or AI device. The "performance" refers to the solutions' chemical, toxicological, and microbiological properties.

7. The type of ground truth used:
   The "ground truth" for demonstrating safety and effectiveness relies on established scientific methods for toxicology (e.g., rabbit ocular irritation, acute oral toxicity) and microbiology (e.g., disinfection efficacy, preservative efficacy), as well as the prior regulatory acceptance of chemically identical or substantially equivalent predicate devices. There is no single "ground truth" in the context of pathology or outcomes data as would be found in a diagnostic study.

8. The sample size for the training set:
   N/A. There is no "training set" in the context of an AI/ML algorithm or a traditional clinical trial here. The submission is based on laboratory tests of the formulated solutions.

9. How the ground truth for the training set was established:
   N/A. As there is no training set for an AI/ML model, there is no ground truth established for such a set.

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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

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.

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The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is indicated for use in chemical (not heat) disinfection, daily cleaning, rinsing and storage of daily and extended wear soft contact lenses as recommended by the eye care practitioner.

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. Cleans, loosens and removes accumulations of films, deposits and debris from soft contact lenses. Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewets lenses before the lenses are placed on the eye.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution are primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices (specifically, Bausch and Lomb ReNu Multipurpose Solution). This means the device must perform as safely and effectively as the predicate device. The summary doesn't explicitly state quantitative acceptance criteria for each test in a pass/fail format with specific numerical thresholds. Instead, it reports outcomes which, upon review, were deemed to meet the substantial equivalence standard.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Trial):

  • Test Group: 246 subjects
  • Control Group: 117 subjects (59 using a commercially available multipurpose solution, 58 using a commercially available two-step peroxide system).
  • Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. However, the submitter's address is in the UK and the official agent is in the US, suggesting a potential international or multi-site study, but no definitive statement is made. The study is prospective as it involved tracking subjects using the product over a period of at least three months.

• Test Set (Toxicological & Microbiological):

  • Agar Overlay Cytotoxicity: Representative lenses from all four groups of soft (hydrophilic) lens types.
  • Systemic Toxicity: Healthy mice, 50ml/kg body weight. (Specific number of mice not given).
  • Acute Oral Toxicity: Healthy rats, 5ml/kg body weight. (Specific number of rats not given).
  • Acute Ocular Irritation: Three rabbits.
  • USP Class VI Testing: Not specified, but involved extracts from bottles.
  • Sterility, Preservative Efficacy, Disinfection Efficacy: Not specified, but likely involved laboratory samples and standardized media.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Study: The clinical trial involved 12 investigators. Their specific qualifications (e.g., ophthalmologist, optometrist, years of experience) are not specified in the provided summary. They reported symptoms, problems, complaints, and performed slit lamp examinations.
• Toxicological/Microbiological Studies: Not applicable in the same sense as clinical ground truth. These are laboratory tests with objective endpoints.

4. Adjudication Method for the Test Set

• Clinical Study: The summary does not describe a formal adjudication method for the clinical observations (slit lamp findings, symptoms). The data appears to be collected directly by the 12 investigators. However, the "Analysis of the discontinuations among the various groups...showed that the differences in the incidence of discontinuations for cause...were not statistically significant," suggesting a statistical comparison was performed.
• Laboratory Tests: Not applicable, as these are objective laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described. The clinical study was a comparison of a single product (Sauflon Multipurpose Solution) against two control product types, as used by subjects under the supervision of investigators. It was not a study evaluating human readers' diagnostic accuracy with or without AI assistance.

6. Standalone Performance

• Yes, standalone (algorithm only without human-in-the-loop performance) was implicitly done for the toxicological and microbiological tests. The solution itself was tested for its inherent properties (cytotoxicity, systemic toxicity, ocular irritation, sterility, preservative efficacy, disinfection efficacy, stability) independent of human interpretation of its effects on patients in the clinical study.

7. Type of Ground Truth Used

• Clinical Study: The "ground truth" for the clinical study was based on clinical observations and reported symptoms by human subjects and medical personnel (the 12 investigators). This includes slit lamp findings, adverse reactions, and subjective reports of discomfort or issues. Comparison was made to control groups using established products, indicating a comparative clinical "truth."
• Toxicological & Microbiological Tests: The ground truth for these tests was based on standardized, objective laboratory assays with predefined endpoints and pass/fail criteria (e.g., absence of cell lysis, no difference from control animals, reduction in microbial count).

8. Sample Size for the Training Set

• Training Set (for the reported clinical trial) NA: There is no explicit mention of a separate "training set" for the clinical study or any AI/algorithmic development. The clinical trial described in the submission served as the primary validation study for human use. The toxicological and microbiological studies would have been performed on laboratory samples, not human "training sets." This product is a chemical solution, not an AI/ML-driven device, so the concept of a "training set" for an algorithm as typically understood in AI is not directly applicable here. The product's formulation and design may have been informed by prior R&D data, but that's distinct from an AI training set.

9. How Ground Truth for Training Set Was Established

• As the device is a contact lens solution and not an AI or algorithm, the concept of a "training set" with established ground truth in the AI context does not directly apply. The formulation of the solution would have been developed based on chemical principles, known antimicrobial agents, surfactants, and buffers, guided by an understanding of ocular compatibility and cleaning efficacy. The various laboratory tests (cytotoxicity, microbiology, etc.) serve more as validation steps for the R&D, rather than "ground truth establishment" for an AI model.

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