(126 days)
COMPLETE® (and Private Label) brand Multi-Purpose Solution is indicated for use in the chemical (NOT HEAT) disinfection, cleaning, rinsing, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
COMPLETE® brand Multi-Purpose Solution is a sterile, isolonic solution containing hydroxypropyl methylcellulose as a lubricant, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, ederate disodium as a chelating agent, sodium chloride, and purified water. COMPLETE® brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.
Private label brand Multi-Purpose Solution is a sterile, isotonic solution containing purified water, sodium chloride, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, and edetate disodium as a chefating agent. Private label brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.
The provided text describes a 510(k) submission for "COMPLETE® brand Multi-Purpose Solution" and a "Private label brand Multi-Purpose Solution." This is a medical device submission for a contact lens care solution, which acts as a disinfectant, cleaner, and storage solution. The submission focuses on demonstrating substantial equivalence to previously approved devices, rather than a novel device requiring extensive de novo studies. Therefore, the traditional format of acceptance criteria and a study proving a device meets them (as would be applicable for a diagnostic or therapeutic device with measurable performance metrics) is not directly presented in the provided text.
Instead, the submission leverages previous approvals and existing FDA criteria to establish the safety and effectiveness of the updated or rebranded solutions.
Here's an interpretation based on the provided text, aligning with the requested categories where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from FDA Standards) | Reported Device Performance (Summary from K980775) |
|---|---|
| Microbiological Performance: | |
| FDA criteria for disinfection against bacteria, yeast, and molds. | "Both products meet the current FDA criteria for disinfection of contact lenses against bacteria, yeast, and molds." |
| FDA standards for preservation. | "Both products are effectively preserved by FDA standards." |
| USP sterility requirements. | "Both products conform to USP sterility requirements." |
| Preclinical Safety: | |
| Safety for use in cleaning, rinsing, chemical disinfection, and up to 30-day storage of soft contact lenses. | "These products are safe for use in cleaning, rinsing, chemical disinfection and up to 30 day storage of all soft contact lenses." |
| Absence of ocular hazard when used as directed. | "COMPLETE® brand Multi-Purpose Solution and private label brand should not present an ocular hazard to the contact lens wearer when used as directed in the labeling for soft contact lenses." |
| Compatibility/Cleaning Efficacy: | |
| Compatibility with all soft contact lenses. | "COMPLETE® brand Multi-Purpose Solution and private label brand Multi-Purpose Solution were demonstrated previously... to be compatible with all soft contact lenses." |
| Ability to remove non-protein deposits. | "able to remove non-protein deposits from the surface of the contact lens." |
| Ability to remove protein deposits. | "An additional study was performed that demonstrated the ability of COMPLETE® brand Multi-Purpose Disinfecting Solution and private label brand Multi-Purpose Solution to remove protein deposits on the contact lens surface and in the lens matrix during disinfection compared to Bausch & Lomb's ReNu@ MultiPlus Multi-Purpose Solution." |
| Clinical Safety and Effectiveness: | |
| Clinical safety and effectiveness for intended use. | "COMPLETE® brand Multi-Purpose Solution and private label brand Multi-purpose Solution were proven clinically safe and effective under P910075 and are substantially equivalent to Bausch & Lomb's ReNu@ Multi-Plus Multi-Purpose Solution (P860023/S12)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a new, standalone study. The primary "testing" relies on previous approvals (P910075 and P860023/S12).
- For the additional protein removal study, the sample size is not specified.
- Data Provenance: The studies referenced (P910075 and P860023/S12) would have been conducted by the manufacturers (Allergan and Bausch & Lomb respectively) according to FDA guidelines applicable at the time. The country of origin and whether they were retrospective or prospective are not detailed in this 510(k) summary. These would be found in the original PMA (P910075, P860023/S12) documentation. The "additional study" on protein removal would presumably be prospective research commissioned by Allergan.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable in the context of this 510(k) submission. The "ground truth" for the performance claims (disinfection, preservation, safety, cleaning) is established by adherence to recognized FDA and USP standards and the results of laboratory tests and clinical trials conducted during the original PMA approvals (P910075 and P860023/S12). Expert consensus, as typically applied in diagnostic imaging, is not relevant here.
4. Adjudication Method for the Test Set
- This is not applicable. The data presented is from laboratory tests and clinical outcomes, not expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic algorithms with human readers. This submission is for a medical device (contact lens solution) evaluated through microbiological, preclinical, and clinical trials, not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- This is not applicable. This is not an AI algorithm. The device's performance is inherently "standalone" in the sense that it performs its chemical function (disinfection, cleaning) independently, but its safety and efficacy are evaluated through biological and chemical tests, not an algorithm's output.
7. The Type of Ground Truth Used
- Microbiological Studies: Ground truth is established by quantitative microbiological methods based on FDA and USP standards for log reduction of specific microorganisms (bacteria, yeast, molds) and sterility.
- Preclinical (Biocompatibility/Toxicity): Ground truth is established by in vitro and in vivo animal and potentially human irritation/toxicity studies (implied from the P910075 approval for safety).
- Cleaning Efficacy: Ground truth is established by laboratory assays/methods to quantify the removal of protein and non-protein deposits from contact lenses.
- Clinical Studies: Ground truth is established by clinical endpoints and adverse event monitoring in human subjects, demonstrating safety and effectiveness as a contact lens care solution.
8. The Sample Size for the Training Set
- This is not applicable. The concept of a "training set" is for machine learning models. This submission references previous approvals (P910075, P860023/S12) which included their own study populations, but these are not "training sets" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there is no "training set" for an AI model being discussed. The ground truth for the performance studies (as described in point 7) was established through established scientific and regulatory methods for evaluating medical devices of this type.
§ 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.”