(48 days)
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Progent Vial. Menicon Rinse solution is used once the lens soaking cycle is complete. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
The provided text describes a 510(k) premarket notification for the "Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses." However, it explicitly states that no new clinical or non-clinical studies were performed for this particular submission (K173136).
The device's clearance is based on its prior approvals and the fact that there are no product formulation changes. Therefore, the device's acceptance criteria and the study that proves it meets those criteria are established through substantial equivalence to predicate devices (Boston Cleaner and Boston Advance Cleaner) based on historical data, not new studies presented within this document.
As such, I cannot provide a table of acceptance criteria and reported device performance from a new study conducted for this 510(k) submission, nor can I detail sample sizes, expert qualifications, or adjudication methods for studies not conducted as part of this submission. The document explicitly states:
- "Non-clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no non-clinical studies were required." (Page 4)
- "Clinical studies were unnecessary for this application. Menicon Progent Protein Remover has been cleared in prior applications. There are no product formulation changes made in this application therefor no clinical studies were required." (Page 4)
The "Conclusion" section on page 4 further reinforces this by stating: "Based upon the product history and data presented, the Menicon Progent Protein Remover can be used as safely and as effectively as the Boston Cleaner and the Boston Advance Cleaner."
Therefore, the requested information points regarding new studies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to the immediate content of this 510(k) summary as no such new studies were performed. The acceptance criteria essentially stem from the historical performance and regulatory compliance of the predicate devices and the Menicon Progent Protein Remover's prior clearances.
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”