AQUIFY LENS COMFORT DROPS

K013204 · Ciba Vision Corporation · MRC · Apr 3, 2002 · Ophthalmic

Device Facts

• Record ID: K013204
• Device Name: AQUIFY LENS COMFORT DROPS
• Applicant: Ciba Vision Corporation
• Product Code: MRC · Ophthalmic
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5918
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

AQuify Lens Comfort Drops is a sterile ophthalmic solution used to provide temporary relief from dryness and irritation associated with contact lens wear. The solution contains sodium hyaluronate, sodium chloride, sodium phosphate, and sodium perborate stabilized with phosphoric acid. It is intended for over-the-counter use by contact lens wearers. The user applies the drops directly to the eyes while wearing lenses to moisten, cushion, and refresh them. The device functions by lubricating the lens surface, thereby reducing discomfort and irritation. Clinical and preclinical studies demonstrate that the solution is biocompatible, non-cytotoxic, and non-irritating, with performance comparable to existing marketed contact lens rewetting solutions.

Clinical Evidence

A one-month clinical study evaluated safety and performance. Results showed no differences in biomicroscopy findings, symptoms, or vision safety between the test group (AQuify) and control treatment groups. No adverse differences were noted in lens surface ratings. Bench testing included comprehensive cytotoxicity studies (non-cytotoxic, non-irritant) and microbiological testing (met ISO/FDA Preservative Effectiveness Test criteria). Lens compatibility testing confirmed optical and physical properties remained within ANSI specifications.

Technological Characteristics

Sterile ophthalmic solution. Ingredients: sodium hyaluronate, sodium chloride, sodium phosphate, and sodium perborate stabilized with phosphoric acid. Form factor: liquid eye drops. Intended for use with soft (hydrophilic) and rigid gas permeable contact lenses. No electronic or software components.

Indications for Use

Indicated for contact lens wearers experiencing dryness and irritation to moisten, cushion, and refresh lenses.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Bausch and Lomb - ReNu Multiplus Lubricating and Rewetting Drops
• Pfizer - Visine for Contacts
• Biomatrix - Hylashield CL Lubricating Eye Drops

Submission Summary (Full Text)

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# APR 0 3 2002

## 510(k) SUMMARY 2010 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

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

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR AQuify Lens Comfort Drops

- Submitter Information 1. CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person:Steven Dowdley Telephone No. 678-415-3897
- Device Name 2. Soft (hydrophilic) Contact Lens Solution Classification Name: AQuify Lens Comfort Drops Proprietary Name:
- 3. Predicate Devices Bausch and Lomb - ReNu Multiplus Lubricating and Rewetting Drops Pfizer - Visine for Contacts Biomatrix - Hylashield CL Lubricating Eye Drops

#### Description of the Devices 4.

AQuily Lens Comfort Drops is a sterile solution containing sodium hyalvronate, sodium chloride, a AQuify Lens Comfort Drops is a stenle solution containing bouldn't phosphoric acid as a preservative.
sodium phosphate and sodium perborate stabilized with phosphoric acid as

#### Indications for Use 5.

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

Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies were completed to demonstrate the substantial A selles of precimied and olinion station of the predicate device(s). All testing described equivalence of AQuily Lens Obmort Drops to the productions. Results demonstrate the in accordance with and biocompatible, and is comparable to other currently marketed soft -Sontact lens solutions. Results from all tests demonstrate the substantial equivalence to previously FDA approved predicate device.

### Lens Compatibility Data:

There was no significant difference between AQuify Lens Comfort Drops and the control rnloro with respect to optical (power, base curve and diameter) and physical (visual Solution with respool to option (porchanges in the measured properties of lenses. The results further showed that the changes observed in lens power and diameter were within ANSI specifications. The proposed solution was found to be substantially equivalent to the control solution

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#### Cytotoxicity

A series of comprehensive cytotoxicity studies were conducted to evaluate the safety of AQuify A denos of comprehensive of the testing demonstrated that AQuify Lens Comfort Drops is noncvtotoxic and is a non-irritant.

#### Microbiological

Microbiogical
AQuify Lens Comfort Drops tested for microbiological safety and effectiveness using the FDA AQuily Lens Contact lens solution. The solution met the acceptance criteria for the ISO/FDA Preservative Effectiveness Test.

#### Clinical Testing

A one month clinical study was conducted to evaluate the substantial equivalence of AQuify Lens A one mont offinitured. Stay the Jurpose Lubricating and Rewetting Drops. The results of the study demonstrated no differences in biomicroscopy findings, symptoms, or vision safety Study demonotration no afficients Comfort Drops (HAM) and the control treatment groups. In addition, there were no adverse differences for shown in the test cell for lens surface addition, there were no advertive ratings. The findings of this study demonstrate the substantial equivalence of AQuify Lens Comfort Drops.

### 7. Substantial Equivalence

Stantial Equivalence
The data provided in this 510(k) submission concludes that AQuify Lens Comfort Drops is The data provided in this of to(t) bubiniscion is submission (ReNu Multiplus Substantially equivalent to the predicate devices and Hylashield CL Lubricating Eye Drops).
Lubricating and Rewetting Drops, Visine for Contacts, and Hylashield CL Lubricatin

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 0 3 2002

Re: K013204

Trade/Device Name: AQuify Lens Comfort Drops Regulation Number: 886.5928 Regulatory Class: Soft (hydrophilic) contact lens care products Product Code: LPN Regulation Number: 886.5918 Regulatory Class: Rigid gas permeable contact lens care products Product Code: MRC Dated: January 24, 2002 Received: January 30, 2002

Dear Mr. Dowdley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

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

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K0/3204

# [PART ]]]. INDICATIONS FOR USE STATEMENT . CONSULTION CONSULTION CONSULTION CANAL CONSULTION

This is a new 510 (k) Notification. (Number to be assigned) 510(k) Number:

Device Name: AQuify Lens Comfort Drops

# Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | ☐ or over-the-counter: ☑ |
|-------------------|--------------------------|
|-------------------|--------------------------|

(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devices

| 510(k) Number | K013204 |
|---------------|---------|
|---------------|---------|