(38 days)
The bifocal/multifocal designs of the HYDRO2 (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.
Bifocal/Multifocal HYDRO2 (filofocon A) Daily Wear RGP Contact Lens
The provided document is a 510(k) clearance letter from the FDA for a contact lens, not a study report or a document describing acceptance criteria and device performance. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert qualifications.
The document states that the FDA reviewed a "Section 510(k) notification of intent to market the device" and found it to be "substantially equivalent" to a legally marketed predicate device. This process involves comparing the new device to an existing one, but the specific performance data and criteria used for that comparison are not detailed in this clearance letter.
Therefore, I cannot extract the requested information from the provided text.
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JUL 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
c/o Mr. Don M. Woodford Vice President Innovision, Inc. 3125 South 61st. Ave. Omaha, NE 68106
Re: K011914
K011711
Trade Name: Bifocal/Multifocal HYDRO2 (filofocon A) Daily Wear RGP Contact Lens Regulation Number: 21 CFR 886.5916 Regulatory Class: Class II Product Code: HQD Dated: June 14, 2001 Received: June 19, 2001
Dear Mr. Woodford:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becally a substantially equivalent (for the indications for use above and we have acterimled in interstate commerce prior to May 28, 1976, the stated in the enotical Device Amendments, or to devices that have been reclassified in encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provinents siect to the general controls provisions of the Act. The general cherelots, mainor are are are as a contrements for annual registration, listing of devices, eone on provisions or noveling, 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 Current Good 079. I subtained - oguirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may oublish 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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Page 2 - Mr. Don M. Woodford
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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. 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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510(k) Number K011914
Bifocal/Multifocal HYDRO2 (filofocon A) DEVICE NAME Daily Wear RGP Contact Lens
INDICATIONS FOR USE
The bifocal/multifocal designs of the HYDRO2 (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use X
OR Over-The Counter-Use ______________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel W. B. Brown, M.D.
ivision Sign-O Division of Ophthalmic Devices
510(k) Number K011914
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.