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510(k) Data Aggregation
(200 days)
The Clued Up 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
Clued Up 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.
Clued Up Multipurpose Solution remains unchanged from the previously approved product in K980147, except for the revised directions for use.
The provided text describes a 510(k) submission for the "Clued Up Multipurpose Solution", a soft contact lens solution. It details pre-clinical testing and a clinical study to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, formatted as requested:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for its pre-clinical or clinical studies. Instead, it states that the device "meets the requirements" or demonstrates "substantial equivalence." For the purpose of this response, I will interpret the "acceptance criteria" as meeting the regulatory requirements for various tests and then report the finding as the "reported device performance."
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Pre-clinical Testing | ||
| Solution Compatibility | Compatibility with contact lenses | Details of compatibility study are contained in K980147 (implicitly, it met requirements as K030910 was approved). |
| Toxicology | Safety profile | Toxicological testing is contained in K980147 (implicitly, it met requirements as K030910 was approved). |
| Container Requirements | USP for ophthalmic preparations | Container components meet the requirements of USP for containers and closures for ophthalmic preparations, confirmed by cytotoxicity, ocular irritancy, and systemic toxicity tests. |
| Microbiology - Sterility | Sterility testing requirements | Meets the requirements of sterility testing as per K980147. |
| Microbiology - Preservative Efficacy | Preservative efficacy test with rechallenge at 14 days | Meets the requirements of the preservative efficacy test with rechallenge at 14 days as per K980147. |
| Microbiology - Disinfection Efficacy | Stand-alone with organic load disinfection test | Meets the requirements of the stand-alone with organic load disinfection test. |
| Microbiology - Disinfection Efficacy | Regimen test | Meets the requirements of the regimen test. |
| Clinical Studies | ||
| Safety and Acceptability | Safety, acceptability, and substantial equivalence to predicate device for intended use (3-month usage) | Demonstrated safety, acceptability, and substantial equivalence to the AMO Complete Brand Multi-Purpose Solution - No Rub (predicate device) in a 3-month clinical trial. |
| Overall Conclusion | Substantial Equivalence to Predicate Device | The Clued Up Multipurpose Solution for use in a no rub regimen for lenses replaced in 30 days or less is substantially equivalent to the AMO Complete Brand Multi-Purpose Solution - No Rub. The FDA's 510(k) clearance confirms this finding ["device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices"]. |
Study Details
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 50 subjects for the test device (Clued Up Multipurpose Solution) and 21 control subjects for the predicate device (AMO Complete Brand Multi-Purpose Solution - No Rub).
- Data Provenance: The document does not explicitly state the country of origin. Given the submitting company's address (Egham, Surrey, UK) and the regulatory body (FDA, USA), it's likely a multinational study or initiated from the UK for US market approval. The study was prospective, as it involved "3 months usage of the Multipurpose Solution by 50 subjects... compared to 21 control subjects."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. The assessment of "safety, acceptability and substantial equivalence" would typically involve eye care practitioners, but the specific details are not provided.
4. Adjudication method for the test set
The document does not specify an adjudication method for the clinical study's test set.
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
- Was an MRMC study done? No. This device is a contact lens solution, not an AI-powered diagnostic or imaging device.
- Effect size of human readers with/without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Was a standalone performance study done? Yes, in a sense. The pre-clinical tests (Microbiology - Disinfection Efficacy, Preservative Efficacy, Sterility, etc.) evaluate the solution's performance as an "algorithm only" in a controlled environment, without human intervention in the efficacy measurement itself. These tests demonstrate the inherent functional capabilities of the solution.
7. The type of ground truth used
- For pre-clinical microbiology tests (disinfection, sterility, preservative efficacy): Ground truth is established by microbiological standards and quantitative measurements of microbial reduction/elimination against defined challenge organisms and accepted performance thresholds within the specified test protocols.
- For the clinical study: Ground truth for safety and acceptability would be based on clinical observations, patient reported outcomes, and examinations by eye care practitioners, likely against established clinical endpoints for ocular health and contact lens wear. The "substantial equivalence" is the primary ground truth, meaning its performance metrics (implicitly safety and effectiveness) were comparable to a legally marketed predicate device.
8. The sample size for the training set
The document does not mention or imply a training set. This is not an AI/ML device where a separate training set would be defined. The information provided describes a traditional medical device (contact lens solution) and its evaluation.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device submission.
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