AQUIFY MULTIPURPOSE SOLUTION

K050250 · Ciba Vision Corporation · LPN · Aug 10, 2005 · Ophthalmic

Device Facts

• Record ID: K050250
• Device Name: AQUIFY MULTIPURPOSE SOLUTION
• Applicant: Ciba Vision Corporation
• Product Code: LPN · Ophthalmic
• Decision Date: Aug 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended 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. AQuify is also indicated for daily protein removal when lenses are soaked for at least 4 hours.

Device Story

AQuify® Multipurpose Solution is a chemical contact lens care product. It functions as a cleaning, rinsing, disinfecting, and storage solution for soft (hydrophilic) and silicone hydrogel contact lenses. The solution performs daily protein removal when lenses are soaked for a minimum of 4 hours. It is intended for use by patients (consumers) at home. The solution is applied directly to the lenses to maintain hygiene and lens performance, supporting patient eye health by preventing microbial contamination and protein buildup.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and regulatory compliance for contact lens care solutions.

Technological Characteristics

Chemical contact lens care solution for soft (hydrophilic) and silicone hydrogel lenses. Non-heat disinfection method. Liquid formulation.

Indications for Use

Indicated for cleaning, rinsing, chemical disinfecting, and storing soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Indicated for daily protein removal via soaking for at least 4 hours. For use by contact lens wearers as recommended by eye care practitioners.

Regulatory Classification

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.

Special Controls

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

Submission Summary (Full Text)

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## JUL 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jerry Land, O.D. Head, Regulatory Affairs - Americas Global Clinical and Regulatory Affairs CIBA Vision Corp. 11460 Johns Creek Parkway Duluth, GA 30097

Re: K050250

Trade/Device Name: Aquify® Multipurpose Solution Regulation Number: CFR886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: II Product Code: LPN Dated: August 10, 2005 Received: February 14, 2005

Dear Dr. Land:

This letter corrects our substantially equivalent letter of August 10, 2005.

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 (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 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 – Jerry Land, O.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Epler, M.D.

Malvina B. Eydelman, M.I 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

510(k) Number: K050250

AQuify® Multipurpose Solution Device Name:

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. AQuify is also indicated for daily protein removal when lenses are soaked for at least 4 hours.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quynh Hoang

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(Division Sign-Off)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

**510(k) Number** K0502250

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