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K Number
K042176
Device Name
AQUIFY LENS COMFORT DROPS
Manufacturer
CIBA VISION CORPORATION
Date Cleared
2004-11-03

(84 days)

Product Code
LPN
Regulation Number
886.5928
Type
Traditional
Panel
OP
Reference & Predicate Devices
K013204
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.

Device Description

AQuify Lens Comfort Drops is a sterile solution containing sodium hyaluronate, sodium chloride, sodium phosphate and sodium perborate stabilized with phosphoric acid as a preservative.

AI/ML Overview

The provided text is a 510(k) summary for AQuify Lens Comfort Drops. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

Therefore, I cannot fulfill your request for:

  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 used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. MRMC comparative effectiveness study results
  6. Standalone performance details
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document explicitly states:

  • "Non-clinical: No new studies performed. Non-clinical data from K013204 should be referenced."
  • "Discussion of Clinical Data: Clinical data ." (This line is incomplete in the original document, suggesting no new clinical data is presented here).
  • "The purpose of this application is to provide a more descriptive "action to the package insert for AQuify Lens Comfort Drops. There were no changes to the product formulation. Application, K013204 has already established the substantial equivalence of the product. The clinical data provide in the application supports that AQuify Lens Comfort Drops is substantially equivalent to Complete Blink-N-Clean."

This indicates that K042176 is primarily focusing on a labeling change and relies on previously submitted data (K013204) for establishing substantial equivalence. The detailed study information you're asking for would likely be found in the K013204 submission, not in this 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.”