(50 days)
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.
Disposable Vitrectomy Lens
This document is a 510(k) clearance letter from the FDA for a Disposable Vitrectomy Lens. It does not contain information about acceptance criteria or a study proving the device meets them. The letter simply states that the FDA has reviewed the 510(k) notification and found the device to be substantially equivalent to devices marketed prior to May 28, 1976.
Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2001
Ocular Instruments, Inc. c/o Mr. Raymond Graham Director of Engineering & Product Development 2255 116th Ave., N.E. Bellevue, WA 98004-3039
Re: 510(K) Number: K012096 Trade/Device Name: Disposable Vitrectomy Lens Regulation Number: 21 CFR 886.1385 Regulatory Class: Class II Product Code: HJK Dated: July 3, 2001 Received: July 5, 2001
Dear Mr. Graham:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becamed the device is substantially equivalent (for the indications for use above and we and oure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the enorthere) (Device Amendments, or to devices that have been reclassified in enacificant anie of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the device, subject to the general controls provisions of the Act. The general chercedes, mailier the device as lude 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 (1 remarited i Ipproval), it the Code of Federal Regulations, Title 21, Parts 800 to ancecing your don't lee can valent determination assumes compliance with the Current Good 099. It substantially of of a quirements, 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 moponesis) with the GMP regulation may result in regulatory action. In addition, FDA may collips " will one of comments concerning your device in the Federal Register. Please note: publication and caremarket notification submission does not affect any obligation you this response to your premation 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. Raymond Graham
This letter will allow you to begin marketing your device as described in your 510(k) premarker notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The PDF mically of casswation 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 II you distre specific at not ro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please 571-6115. Italiaonal), roompliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information " Misoranonig by reletence to prematics nounceaver (2) virision of Small Manufacturers On your responsibilities and and and and are (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 KOJ 2096
DEVICE NAME Disposable Vitrectomy Lens
INDICATIONS FOR USE
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use __ X
Over-The Counter-Use _ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel W.C. Brown, Ph.D.
ivision of Ophthalmic Devices K012096 510(k) Number
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.