(216 days)
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.
The provided text describes a 510(k) premarket notification for a contact lens care product, the "Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner." The submission seeks to add an alternative manufacturing site and change packaging resin and raw material suppliers.
However, the document does not contain information about acceptance criteria for a device's performance based on AI/algorithm/software output, nor does it detail a study proving the device meets such criteria. The "Preclinical testing" mentioned is related to biocompatibility and confirms the safety and effectiveness of the product itself, not a software device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information (specifically points 1-9 regarding an AI/algorithm-based device and its validation) is absent from the provided text.
The text focuses on the following:
- Device Type: A contact lens care solution (not an AI/software device).
- Purpose of 510(k) Submission: To add an alternative manufacturing site and modify packaging components, not to introduce or validate a new AI/software feature or performance.
- Testing Mentioned: Biocompatibility, cytotoxicity, and ocular irritation studies related to the chemical solution and its packaging components. These are standard tests for medical devices that come into contact with human tissue, not for evaluating AI performance metrics like sensitivity, specificity, or reader improvement.
§ 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.”