(77 days)
AQuify Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, storing for soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multi-Purpose Solution is also indicated for taily protein removal of lenses replaced in 30 days or less.
AQuify Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, dexpanthnol, edetate disodium dihydrate and preserved with polyhexanide 0.0001.
The provided text describes the 510(k) summary for the Aquify Multi-Purpose Solution (K033608). It references prior studies submitted under K021635 to demonstrate substantial equivalence to currently marketed products.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document speaks to general efficacy and safety rather than explicit, quantified acceptance criteria with specific thresholds for "performance." However, it states that the product met both the secondary stand alone criteria and the regimen test criteria for disinfection efficacy and that Results showed that AQuify MPS is substantially equivalent to currently marketed products in terms of daily protein removal.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate for cleaning, rinsing, chemical (not heat) disinfecting, storing, and daily protein removal. | AQuify MPS is substantially equivalent to currently marketed products in terms of daily protein removal. and The data provided...concludes that AQuify Multi-Purpose Solution is substantially equivalent to currently cleared KARATS Multi-Purpose Solution for all indicated uses. |
| Non-toxicity and biocompatibility. | Results demonstrate the solution is non-toxic and biocompatible, and is comparable to other currently marketed soft contact lens solutions. |
| Non-cytotoxicity and non-irritancy. | Results of the testing demonstrated that AQuify MPS is non-cytotoxic and is a non-irritant. |
| Microbiological efficacy (disinfection). | met both the secondary stand alone criteria and the regimen test criteria for disinfection efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in K033608. The document refers to studies previously submitted under K021635, which would contain this detail.
- Data Provenance: Not explicitly stated in K033608. The studies were conducted by CIBA Vision Corporation. It's common for such studies to be conducted internally or by contract research organizations, but specific country of origin or retrospective/prospective nature is not detailed here. It refers to "clinical studies" implying prospective testing, but without further detail.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The studies are in vitro (microbiological, cleaning, cytotoxicity) and clinical. For in vitro studies, "ground truth" would be objective measurements. For clinical studies, the "ground truth" would relate to patient outcomes or physiological assessments, typically by eye care professionals, but the number and qualifications are not listed.
4. Adjudication Method for the Test Set
- This information is not provided in the document, as the studies are not described in this level of detail. Such methods are more relevant for subjective assessments, which are not explicitly detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This is not applicable. The device is a multi-purpose contact lens solution, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable for a contact lens solution. However, the
secondary stand alone criteriafor microbiological efficacy can be interpreted as a standalone performance test for the solution's disinfectant properties, independent of a full regimen (which usually involves user handling). This refers to the solution's inherent killing power in a laboratory setting.
7. The Type of Ground Truth Used
- For in vitro studies (cleaning efficacy, enzyme compatibility, cytotoxicity, microbiological efficacy): The ground truth would be based on objective laboratory measurements, standardized testing protocols (e.g., ISO or FDA/ASTM standards for disinfection), and established scientific methods.
- For clinical studies: The ground truth would likely be clinical endpoints related to ocular health, comfort, adverse events, and lens performance as assessed by eye care practitioners and patient feedback.
8. The Sample Size for the Training Set
- This is not applicable, as the Aquify Multi-Purpose Solution is a chemical solution, not a machine learning or AI-based device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as point 8.
§ 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.”