OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION

• K Number: K981574
• Device Name: OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
• Manufacturer: ALCON
• Date Cleared: 1998-07-06 ( 63 days)
• Product Code: LPN
• Regulation Number: 886.5928
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K974723
• Predicate For: N/A

Intended Use

For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

OPTI-FREE® Express® Multi-Purpose Solution can be used to dissolve OPTI-FREE® and OPTI-ZYME® Enzymatic Cleaning Tablets.

Device Description

OPTI-FREE® Express® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing sodium citrate and sodium chloride, with edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.001% as preservatives.

AI/ML Overview

The requested information is not available in the provided text. The document refers to the safety and effectiveness of the device, OPTI-FREE® Express® Multi-Purpose Solution, through a series of studies. However, it does not provide specific acceptance criteria or detailed study results in the format requested.

The document states:

• "A series of studies were conducted to demonstrate the ability of citrate in OPTI-FREE® Express Multi-Purpose Solution to continue to remove protein from lenses while they are being stored."
• "Laboratory deposited and human worn lenses were divided and soaked in OPTI-FREE® Express® Multi-Purpose Solution and ReNu MultiPlus Multi-Purpose Solution."
• "These studies demonstrate that OPTI-FREE® Express® Multi-Purpose Solution continues to remove protein while lenses are stored and that significantly more protein is removed during soaking in OPTI-FREE® Express® Multi-Purpose Solution than in ReNu MultiPlus Multi-Purpose Solution."

This indicates that studies were performed, and they showed a positive outcome regarding protein removal. However, specific details such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

are not present in the provided text. The document is a 510(k) summary and an FDA clearance letter, which typically summarizes findings without detailing the full study methodology and results.

Regulation Number and Section

§ 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.”