(188 days)
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.
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The provided text is a 510(k) clearance letter from the FDA for a medical device called Aquify® Multipurpose Solution. This document is related to regulatory approval for a contact lens care product and does not contain information about the performance of an AI/ML powered device, its acceptance criteria, or any associated studies.
Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
(Division Sign-Off)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K0502250
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§ 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.”