(61 days)
TRADE NAME Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:
- Chemically (NOT HEAT) Disinfect
- Clean
- Rinse
- Store
- Remove Protein
TRADE NAME Multipurpose Solution is a sterile, isotonic, buffered, aqueous solution containing sodium chloride, potassium chloride, phosphate buffer, edetate disodium, and Poloxamer 237 with polyhexamethylene biguanide 0.0001% as a preservative. As with COMPLETE® brand Multi-Purpose Solution, this product is a clear, coloriess solution, packaged in the same plastic bottles with controlled dropper tips.
Acceptance Criteria and Study for Allergan TRADE NAME Multipurpose Solution
The provided document describes the acceptance criteria and supporting studies for Allergan's "TRADE NAME Multipurpose Solution," which is a soft (hydrophilic) contact lens care product. The submission is a 510(k) premarket notification, seeking substantial equivalence to predicate devices (COMPLETE® brand Multi-Purpose Solution, K003252 and K013479). The key change in the new product is the removal of the lubricant HPMC, leading to the deletion of the "conditioning" claim. Therefore, the studies primarily focus on demonstrating that removing HPMC does not negatively impact the remaining indicated uses and that the new formulation is comparable to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a non-clinical device (not an AI/ML medical device as would typically have performance metrics like sensitivity/specificity), the "acceptance criteria" are based on demonstrating equivalence to the predicate device. The performance is assessed through various nonclinical studies.
| Acceptance Criteria (Demonstrate Equivalence to Predicate) | Reported Device Performance (TRADE NAME Multipurpose Solution) |
|---|---|
| Solution Compatibility: Maintain lens diameter, power, basecurve, integrity, and visual appearance with Group I and IV soft contact lenses. | Results were comparable to or better than COMPLETE® brand Multi-Purpose Solution. |
| Cleaning Studies (Surface deposits & general cleanliness): Maintain clean Group I and IV lenses over a 30-day/30-cycle period including artificial tears soak. | Comparable to the predicate device/regimen and an effective cleaner for soft (hydrophilic) contact lenses. |
| Cleaning Studies (Passive protein removal): Remove lysozyme protein adsorbed to contact lens surfaces and within the lens matrix. | Comparable to the predicate device formulation and significantly (2 times) better than a competitive product. |
| Microbiological Studies (Antimicrobial efficacy): Meet predefined standards for antimicrobial efficacy. | All results were satisfactory, using methods from predicate 510(k)s (K003252 and K013479). |
| Toxicological Studies (In-vitro cytotoxicity): Not cytotoxic. | Not cytotoxic and comparable to COMPLETE® brand Multi-Purpose Solution. |
| Toxicological Studies (Ocular effects in vivo): No ocular toxicity or clinically significant regimen-related ocular toxicity findings in rabbit study. | No ocular toxicity observed and no clinically significant regimen-related ocular toxicity findings associated with the modified disinfecting solution. |
2. Sample Size and Data Provenance
The document does not specify exact sample sizes for each study, but provides the following details:
- Solution Compatibility: Used FDA Group I and IV soft contact lenses for 30 cycles.
- Cleaning Studies: Used Group I and IV lenses over a 30-day/30-cycle period.
- Toxicological Studies (In-vivo): A 21-day rabbit study was performed.
- Data Provenance: The studies were conducted by Allergan, presumably in the USA. Given the submission date (2002), these are retrospective studies on the newly formulated product.
3. Number of Experts and Qualifications for Ground Truth
This type of product (contact lens solution) does not typically involve human expert adjudication for ground truth in the way a diagnostic AI/ML device would. The "ground truth" for the non-clinical studies is based on objective measurements and established laboratory protocols.
- Solution Compatibility/Cleaning: Assessment of lens parameters (diameter, power, basecurve), integrity, visual appearance, and presence of deposits would be performed by lab technicians or scientists following standardized procedures.
- Microbiological Studies: Efficacy against microorganisms assessed via standardized microbiological assays.
- Toxicological Studies: In-vitro cytotoxicity assessed by laboratory techniques. In-vivo rabbit study would involve veterinarians or toxicologists assessing ocular effects, but the document doesn't specify a "number of experts" or their specific qualifications beyond what implied for such studies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this submission concerns non-clinical performance of a contact lens solution, not an AI/ML diagnostic system requiring human adjudication of results. The results are based on objective laboratory measurements and observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device, and no human reader performance is being evaluated or compared with or without AI assistance. The studies assess the intrinsic properties and performance of the contact lens solution itself.
6. Standalone (Algorithm Only) Performance
Not applicable. This is not an algorithm based device. The "device" is a chemical solution. The studies describe the standalone performance of the solution as a product.
7. Type of Ground Truth Used
The ground truth for these studies is based on:
- Objective measurements: E.g., lens diameter, power, basecurve changes, protein removal percentages, cytotoxicity levels.
- Standardized protocols and assays: E.g., for microbiological efficacy, cleaning effectiveness.
- Veterinary/Toxicological observations: For the in-vivo rabbit study regarding ocular effects.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The "formulation" is the "design" of the product, which is then tested.
9. How 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.”