(58 days)
Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner.
Sauflon 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 chlorohexidine or thimerosal.
In the provided text, the device in question is "Sauflon Multipurpose Solution". The purpose of the 510(k) submission is to add the indication for use with Silicone Hydrogel Lenses, with the predicate device being Aquify Multi-Purpose Disinfecting Solution.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome | Reported Device Performance (Sauflon Multipurpose Solution) |
|---|---|---|
| Silicone Hydrogel Lens Compatibility | Compatibility with currently marketed Silicone Hydrogel lenses | "The results of these studies confirm that the Sauflon Multipurpose Solution is compatible with Silicone Hydrogel lenses." Specifically, it is compatible with "4 representative marketed silicone hydrogel lenses." |
| Toxicology | Non-toxic in cytotoxicity, systemic toxicity and ocular irritation testing | "Sauflon Multipurpose Solution was shown to be non-toxic in all cytotoxicity, systemic toxicity and ocular irritation testing." |
| Microbiology | Meet requirements for disinfection efficacy and preservative efficacy | "The Sauflon Multipurpose Solution met the requirements of this testing." |
| Clinical Safety & Acceptability | Safety and acceptability comparable to predicate device (Aquify Multi-Purpose Solution) for intended use | "The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use." |
| Overall Equivalence | Substantially equivalent to Aquify Multi-Purpose Disinfecting Solution | "The data provided in this 510k submission concludes that Sauflon Multipurpose Solution for use in soft contact lenses including silicone hydrogel lenses is substantially equivalent to the Aquify Multi-Purpose Disinfecting Solution." |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Clinical Trial: Circa 250 subjects.
- Data Provenance: Not explicitly stated, but the submission is from a UK company, making it plausible the study was conducted there or internationally. The text does not specify if it was retrospective or prospective, but clinical trials are generally prospective.
- Silicone Hydrogel Lens Compatibility: Tested with "4 representative marketed silicone hydrogel lenses."
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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):
- The document does not mention the use of experts to establish a "ground truth" in the traditional sense. The clinical study compares the new solution to a predicate device, focusing on safety and acceptability based on subject outcomes and observations, rather than expert interpretation of data points.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The clinical trial focused on safety and acceptability, which typically involves collection of adverse events, comfort scores, and other objective measures, rather than subjective adjudication by multiple experts.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiology AI), which is not applicable to a contact lens solution.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a contact lens solution, not an algorithm. The "standalone" performance would refer to the chemical properties and biological effects of the solution, which were tested in pre-clinical (toxicology, microbiology) and clinical studies.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For pre-clinical studies (toxicology, microbiology, lens compatibility): The "ground truth" was established by objective laboratory test results against predefined standards (e.g., cytotoxicity assays, microbial kill rates, material compatibility assessments).
- For clinical studies: The "ground truth" for safety and acceptability was established through clinical observations, reported adverse events, comfort questionnaires, and other objective measures from the 250 subjects, compared against the predicate device. This falls under outcomes data or clinical endpoints.
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The sample size for the training set:
- Not applicable. This is a contact lens solution, not an AI/machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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.”