(163 days)
Aqua Naina Plus Sterile Saline Solution: The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may 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 Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner.
Aqua Naina Sterile Saline Solution: The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.
Aqua Naina Plus Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Plus Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in single dose 1 fl oz (30 ml) high density polyethylene (HDPE) container with a tamper evident seal. Aqua Naina Plus Sterile Saline Solution is for single use only.
Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in a multidose 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.
The provided text is a 510(k) summary for a medical device (Aqua Naina Sterile Saline Solution and Aqua Naina Plus Sterile Saline Solution). This document outlines the device's characteristics and its substantial equivalence to existing predicate devices, but it does not contain information about acceptance criteria or specific performance studies as would be typically found for AI/ML-based diagnostic devices.
The relevant section, "VII. PERFORMANCE DATA," explicitly states:
"The package volume change was validated using the same methods identified in K193441. No other performance data (clinical or non-clinical) are required for this special 510(k) submission."
This indicates that for this specific type of device (saline solution), comprehensive performance studies with acceptance criteria, sample sizes, ground truth establishment, expert reviews, and MRMC studies, as typically requested for AI/ML medical devices, were not required by the FDA for this submission. The submission relies on establishing substantial equivalence to previously cleared predicate devices based on chemical composition, intended use, and production methods, rather than demonstrating performance against specific clinical metrics.
Therefore, I cannot provide the requested information in the format of acceptance criteria and study details because such data is not present in the provided document.
§ 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.”