(53 days)
PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
The PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations.
The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.
This submission describes a 510(k) for a contact lens solution, PuriLens Plus Preservative Free Saline, and argues for its substantial equivalence to a predicate device based on similar formulation, manufacturing, and packaging, and expands its indications for use.
Since this is a submission for substantial equivalence based on a predicate device and there have been no changes to the device design, formulation, or manufacturing, no performance data or studies are presented. Therefore, I cannot provide information on acceptance criteria, specific study details, sample sizes, ground truth establishment, or expert involvement as these were not required or reported in this 510(k) summary.
The summary states: "Because the subject is identical to the predicate in terms of formulation, manufacturing, and packaging, no bench-testing is required to demonstrate substantial equivalence." (Page 5)
As such, for all the requested points regarding acceptance criteria, performance data, sample sizes, ground truth, expert involvement, and comparative effectiveness studies, the answer is that this information is not applicable or not provided in this 510(k) summary due to the nature of the submission (substantial equivalence based on an identical product with expanded indications, requiring no new bench testing).
§ 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.”