AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.

Device Description

AQuify Multi-Purpose Solution is a sterile aqueous solution containing dexpanthenol, preserved with polyhexanide 0.0001%. pluronic F127, edetate disodium dehydrate, sorbitol, tromethamine, sodium phosphate dihydrogren, and purified water.

AI/ML Overview

The provided text describes the safety and effectiveness studies for AQuify Multipurpose Solution, comparing it to predicate devices, particularly ReNu Multipurpose Solution. Here's an analysis of the acceptance criteria and study details based on the input:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes studies and their findings, concluding that AQuify Multipurpose Solution is "substantially equivalent" to the predicate device. The performance is reported in terms of statistical significance and preference compared to the control.

Here's a table summarizing the findings as they relate to implied acceptance:

Acceptance Criteria (Implied)	Reported Device Performance (AQuify MPS vs. ReNu Multiplus)
Cleaning Capacity (Daily protein removal)	AQuify MPS is substantially equivalent in terms of daily protein removal to previously submitted and reviewed predicate devices (K021635).
Dehydration Effect / Water Holding Capabilities	Statistically better than control lens multipurpose solution at increasing the steady-state water content within a lens group after 60 minutes at 50% relative humidity. AQuify had a higher water content.
Microbiological Efficacy (Disinfection)	Meets the stand-alone criteria of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. Meets USP Modified criteria for Preservative Effective Testing and USP Sterility Test requirements (studies reviewed under K021635).
Toxicology	Toxicology studies completed, submitted, and reviewed under K021635. (Implied acceptable if approved).
Clinical Safety (Symptoms)	No significant differences in symptoms between AQuify MPS and the control solution.
Clinical Efficacy (Overall Comfort - 2 weeks)	Statistically significant differences in favor of AQuify MPS for overall comfort (1-10 scores), overall dryness, and overall lens awareness 1-10 scores. Statistically significant for lens awareness preference. Strong trends for overall comfort and lens awareness.
Clinical Efficacy (Overall Comfort - 1 month)	Statistically significant differences in favor of AQuify MPS for overall comfort and dryness (1-10 scores) and for overall comfort, dryness, and lens awareness preferences.
Clinical Efficacy (Overall Comfort - 3 months)	Statistically significant differences in favor of AQuify MPS for insertion and overall comfort (1-10 scores) and for insertion comfort, overall comfort, dryness, and lens awareness preferences. Overall comfort 1-10 scores and preferences were consistently statistically significantly better with AQuify MPS. AQuify MPS was also statistically significantly preferred for less dryness. AQuify MPS increasingly preferred, reaching almost a 4:1 ratio (42% vs 11%) by the final visit.
Clinical Efficacy (Lens Cleanliness - Deposits/Wetting)	No statistically significant differences in investigator appraisal of lens deposits, front surface wetting, and objective dark-field image analysis of lenses worn for 90 days. Both test and control provided clinically acceptable lens cleanliness.
Overall Substantial Equivalence to Predicate Device	AQuify Multipurpose Solution is substantially equivalent to ReNu Multiplus Multipurpose Solution for cleaning, rinsing, chemical disinfecting, and storing soft contact lenses.

Study Details

The primary study mentioned for clinical evaluation is a "three-month prospective, randomized, single masked trial."

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number. The text mentions "over 50% of the subjects expressing a preference" by the final visit, suggesting a sizable cohort was involved, but the exact N is not provided.
- Data Provenance: Prospective. The study was a "three-month prospective, randomized, single masked trial." Country of origin is not specified but implicitly in the USA as it's a 510(k) submission to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes a clinical trial where subjects reported symptoms and efficacy scores, and an "investigator appraisal" for lens deposits and wetting.
- Number of Experts: Not specified.
- Qualifications of Experts: The "investigator" who performed appraisals would likely be an eye care professional (e.g., optometrist or ophthalmologist), but specific qualifications (e.g., years of experience) are not provided. The subjects themselves provided "ground truth" for subjective measures like comfort and dryness.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert interpretations of images or findings. This study primarily relies on direct subject reporting of subjective measures and investigator appraisal for objective measures.
- Adjudication Method: Not applicable/Not mentioned. The study design ("single masked trial," "contra-lateral basis") means subjects compared the products on their own eyes, minimizing the need for adjudication of differing subjective experiences. Objective appraisals (e.g., dark field image analysis) would have predefined criteria.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, this was not an MRMC study. This study evaluated the performance of a contact lens solution, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a contact lens solution, not an algorithm. Its performance is evaluated through direct use (cleaning, disinfection, clinical comfort/dryness) or laboratory testing (microbiology, water content).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Clinical Efficacy/Safety: Subjective self-reported data from study participants (e.g., comfort scores, dryness scores, preferences) and objective investigator appraisal (lens deposits, front surface wetting, dark-field image analysis).
- For Microbiology/Cleaning/Dehydration: Laboratory standard tests, likely with pre-defined pass/fail criteria from regulatory guidance (e.g., FDA guidance, USP standards).
The sample size for the training set:
- Not applicable. This is a medical device (contact lens solution), not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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OCT 2 8 2004

Image /page/0/Picture/2 description: The image shows the logo for CIBA Vision, a Novartis company. The logo is in black and white and features the word "CIBA" in large, bold letters above the word "Vision". The "i" in "Vision" is replaced with an eye symbol. Below the word "Vision" is the text "A Novartis Company" in a smaller font.

510(k) SUMMARY

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

510(k) SUMMARY for AQuify Multipurpose Solution

1. Submitter Information CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley Telephone No. 678-415-3897
1. Proprietary Name: AQuify Multipurpose Solution Classification Name: Soft (hydrophilic) Contact Lens Solution

ന് Predicate Device(s)

KARATS Multipurpose Solution (for lenses replaced in less than 30 days) ReNu Multipurpose Solution Complete Comfort Plus Multipurpose Solution Opti-Free Express Multipurpose Solution

4. Description of the Device

5. Indications for Use

6. Description of Safety and Substantial Equivalence

Cleaning Studies

Previous studies have demonstrated the cleaning capacity of AQuify Multipurpose Solution with soft contact lenses. The study previously submitted and reviewed under K021635 demonstrated that AQuify MPS is substantially equivalent in terms of daily protein removal.

Dehydration Effect

Using a dynamic vapor sorption system, lenses treated with AQuify Multipurpose Solution showed an effect on the steady state water content at a relative humidity of 50%. AQuify

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MPS was statistically better than control lens multipurpose solution tested at increasing the steady-state water content within a lens group. All groups of lenses indicate that AQuify had a higher water content after 60 minutes at a relative humidity of 50%. This demonstrates that AQuify increased the water holding capabilities of the hydrogel lenses tested.

Microbiology

A series studies were also completed to demonstrate the microbiological efficacy of AQuify Multipurpose Solution. These studies were submitted and reviewed under K021635. These studies demonstrate that AQuify Multipurpose Solution meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. The product also meets the USP Modified criteria for Preservative Effective Testing and USP Sterility Test requirements.

Toxicology

A series toxicology studies were completed, submitted and reviewed under K021635.

Clinical Evaluation

The trial was a three-month prospective, randomized, single masked trial consisting of baseline, two-week, one-month and final three-month visits. Subjects compared the Aquify Multipurpose Solution and ReNu Multipurpose Solution on a contra-lateral basis. Study participants were all randomized for which eye used the test and which eye used the control product.

The primary objective of this clinical trial was to evaluate safety, efficacy, and preference between AQUIFY Multipurpose Solution and ReNu Multipurpose Solution. Both solutions used a pre-rinse and a minimum 4 hour to overnight soak.

Symptoms

There were no significant differences in the AQUIFY Multipurpose Solution and control solution with regards to symptoms.

Efficacv at Two Weeks

Statistically significant differences in favor of AQuify MPS were found for overall comfort and particularly overall dryness and overall lens awareness 1-10 scores and for lens awareness preference at the two-week visit. There were also strong trends that were almost statistically significant for overall comfort and lens awareness in favor of AQuify MPS.

Efficacy at One Month

Statistically significant differences in favor of AQuify MPS were found for overall comfort and dryness 1-10 scores and for overall comfort, dryness, and lens awareness preferences.

Efficacy at 3 Months

Statistically significant differences in favor of AQuify MPS were found for insertion and overall comfort 1-10 scores and for insertion comfort, overall comfort, dryness, and lens awareness preferences

Efficacy Conclusions

Overall comfort 1-10 scores and preferences were consistently statistically significantly better with AQuify MPS over ReNu Multiplus throughout the trial. AQuify MPS was also statistically significantly preferred for less dryness throughout the trial having higher mean 1-10 scores for all subjective categories for all visits over ReNu Multiplus. AQuify

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MPS was increasingly preferred as the trial progressed to almost a 4:1 ratio (42% versus 11%) by the final visit with over 50% of the subjects expressing a preference.

Dark Field Image Analysis

With reqards to dark field image analysis, there were no statistically significant differences in the investigator appraisal of lens deposits, front surface wetting and objective dark-field image analysis of lenses worn for 90 days. Both the test and control product provided clinically acceptable lens cleanliness when used according to their directions for use as measured by dark filed image analysis of the returned lenses.

7. Conclusion Drawn from Data Supporting Equivalence Determination:

We conclude that AQUIFY Multipurpose Solution is substantially equivalent to ReNu Multiplus Multipurpose Solution when used to clean, rinse, chemical (not heat) disinfect and store soft (hydrophilic) contact lenses on a conventional replacement schedule of three months or longer

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2004

CIBA Vision Corporation c/o Mr. Steven Dowdley 11460 Johns Creek Parkway Duluth, Georgia 30097

Re: K031753

Trade/Device Name: AQuify Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Solution Regulatory Class: Class II Product Code: LPN Dated: September 7, 2004 Received: September 8, 2004

Dear Mr. Dowdley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Steven Dowdley

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A kalgi korenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K031753

Device Name: AQuify Multi-Purpose Solution

Indications for Use:

AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuity Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: or over-the-counter: 内 Avision Sign-Off Division of Ophthalmi Nose and Throat De 510(k) Number

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.”