(199 days)
Use REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to insertion on the eye.
REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride hexahydrate, potassium chloride, purified water, PURITE® (stabilized oxychloro complex), sodium borate decahydrate, and sodium citrate dihydrate. This formula does not contain chlorhexidine, thimerosal, or any other mercury-containing ingredients.
The provided text describes REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops and its 510(k) submission (K083812). However, it does not contain details about specific acceptance criteria, a corresponding study, or the performance metrics that would typically be found in an Acceptance Criteria table.
Instead, the document focuses on:
- Substantial Equivalence: The primary claim is substantial equivalence to a predicate device (Allergan REFRESH® Contacts Lubricating and Rewetting Drops).
- Testing Performed: It mentions that the sponsor performed "stability, compatibility, toxicology and microbiology testing and a clinical study" to support the claim of substantial equivalence.
- Indication for Use: The main application of the device is to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses to relieve dryness, discomfort, and irritation.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These types of details are usually found in comprehensive clinical study reports or detailed performance data sections of a 510(k) submission, which are not present in this summary.
The document states: "The sponsor performed stability, compatibility, toxicology and microbiology testing and a clinical study with this formulation to support the claim of substantial equivalence." This is a high-level statement that a clinical study was done, but no details about the study design, acceptance criteria, or results are provided.
In summary, the provided text lacks the detailed information required to answer your request.
§ 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.”