(84 days)
COMPLETE® brand 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 .
- Condition .
COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal.
The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
The provided text is a 510(k) summary for COMPLETE® brand Multi-Purpose Solution (K030092). This document focuses on demonstrating substantial equivalence to a predicate device for a contact lens care solution, rather than providing detailed acceptance criteria and a study design for evaluating a novel medical device's performance against specific metrics. Therefore, many of the requested categories are not directly applicable or explicitly stated in the document.
However, based on the information provided, here's an attempt to address your request:
Acceptance Criteria and Device Performance for COMPLETE® brand Multi-Purpose Solution (K030092)
Note: The document describes in-vitro and clinical studies to support substantial equivalence for a contact lens solution, not a medical imaging or diagnostic device. As such, the typical metrics for device performance (e.g., sensitivity, specificity, accuracy) are not relevant here. Instead, the focus is on physical, chemical, and subjective user experience.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from Study Goals) | Reported Device Performance (COMPLETE® brand Multi-Purpose Solution) |
|---|---|---|
| In-Vitro - Physical Properties | Viscosity Equivalence: Viscosity of COMPLETE® Solution with HPMC should be comparable to original COMPLETE® without HPMC and other multipurpose solutions. | "In Vitro Studies were conducted to compare the physical and chemical properties of COMPLETE® Solution with other multi-purpose solutions in order to evaluate the effects of adding hydroxypropyl methylcellulose (HPMC)." (General statement; no specific numeric values are provided in this summary.) |
| In-Vitro - Lens Interaction | HPMC Uptake & Release: Demonstrate uptake of HPMC onto the lens surface during soak and subsequent release in saline over time. | "The studies show uptake of HPMC onto the lens surface during the soak period, and its subsequent release, over time, in saline. This layer of adsorbed HPMC appears to enhance the lens' ability to retain moisture and remain more wettable." (Positive finding, indicating the desired mechanism of action.) |
| In-Vitro - Surface Wetting | Surface Fluid Retention: Comparable effect on surface fluid retention compared to B&L's ReNu® MultiPlus® and Alcon's OPTI-FREE® Express. | "Compare the effect of three COMPLETE® Solution formulations to B&L's ReNu® MultiPlus® and Alcon's OPTI-FREE® Express on surface fluid retention." (Study was conducted, results are implied to be satisfactory for substantial equivalence, but specific comparative data is not provided.) |
| In-Vitro - Wetting Angle | Receding Contact Angle: Comparable effect on receding contact angle (as a measure of wetting) to various multipurpose solutions. | "Examine the effect of various multipurpose solutions on receding contact angle as a measure of wetting." (Study was conducted, results are implied to be satisfactory for substantial equivalence, but specific comparative data is not provided.) |
| Clinical - Subjective Comfort | Comfort & Acceptability Equivalence: Subjective comfort and acceptability of COMPLETE® with HPMC should be substantially equivalent to original COMPLETE® without HPMC and competitor regimens. | "This subjective data shows that COMPLETE® Solution, used with a rub regimen, has comfort substantially equivalent to other marketed contact lens care multipurpose solutions." (Positive finding, demonstrating equivalence in user experience.) |
| Clinical - Rub vs. No-Rub Efficacy | Functional Equivalence (Rub vs. No-Rub): COMPLETE® Solution used in a "no-rub" regimen should demonstrate substantial equivalence to its use in a "rub" regimen. | "Objective data from an additional clinical study demonstrate the substantial equivalence of COMPLETE® Solution used in a 'no-rub' regimen, with COMPLETE® Solution used in a 'rub' regimen." (Positive finding, supporting the flexibility of use with equivalent performance.) |
2. Sample Size and Data Provenance for Test Set
- Clinical Studies: "Study subjects in three clinical studies" were used for subjective comfort and acceptability. An "additional clinical study" provided objective data for rub vs. no-rub regimens.
- Sample Size: Not explicitly stated. The number of participants in each study is not provided.
- Data Provenance: Not explicitly stated. However, given the context of a US regulatory submission (510(k)), it is highly probable the data originated from studies conducted in the United States and were prospective in nature, as they were designed to evaluate the new formulation.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable directly. This is a contact lens solution, not an interpretive device. The "ground truth" for subjective comfort comes from the study subjects themselves via questionnaires. For objective data (rub vs. no-rub), unspecified "objective data" was collected, likely related to lens cleanliness or disinfection efficacy, which would be measured by laboratory techniques rather than expert consensus on interpretation.
4. Adjudication Method for Test Set
- Not applicable. There is no "adjudication" in the sense of multiple experts independently reviewing and then resolving discrepancies for medical image interpretation. Clinical subjective data was gathered via questionnaires, and objective data via laboratory methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is relevant for diagnostic imaging systems where human readers interpret cases. The provided document concerns a contact lens solution.
6. Standalone (Algorithm Only) Performance
- Not applicable. The device is a chemical solution, not an algorithm.
7. Type of Ground Truth Used
- Clinical Studies:
- Subjective Data: User-reported comfort and acceptability via questionnaires.
- Objective Data: Unspecified objective measures related to contact lens care performance (e.g., disinfection, cleaning, protein removal efficacy) for the rub vs. no-rub regimen comparison. This would typically be laboratory-based measurements.
- In Vitro Studies: Laboratory measurements of physical (viscosity, surface fluid retention, receding contact angle) and chemical (HPMC uptake/release) properties.
8. Sample Size for Training Set
- Not applicable. This isn't a machine learning model, so there isn't a "training set" in that sense. The studies described are for validation of the product's performance and equivalence.
9. How Ground Truth for Training Set was Established
- Not applicable. See 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.”