(86 days)
Acrylic (PMMA) or Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), or the space left after the removal of the contents of the eye ball (evisceration). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for Eye Sphere Implants. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed devices and can be marketed subject to federal regulations.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Oculo Plastik, Inc. c/o Mr. Jean-Francois Drette 200 Sauvé West Montreal, Québec, Canada H3L 1 Y9
Re: K040689 Trade/Device Name: Eye Sphere Implants Regulation Number: 21 CFR 807.81 Regulatory Class: Class II Product Code: HPZ Dated: March 1, 2004 Received: March 29, 2004
Dear Mr. Drette :
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(K) promained is substantially equivalent (for the indications for referenced above and nave decemined the are devices marketed in interstate commerce use stated in the encrosure) to regally hats of the Medical Device Amendments, or to devices that prob to May 26, 1970, the endominent aan the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with are proval application (PMA). You may, Act (Act) that do not require upproval or a provisions of the Act. The general therefore, market the device, sabject to ans genirements for annual registration, listing of devices, good controls provisions of the rise necessarist misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device Is classified (Sec above) into existing major regulations affecting your device can be
may be subject to such additional controls. Existing major regulations may be subject to such additional controls. Title 21, 2005
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Sous onts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 177A s issualled of a vace with other requirements of the Act or that FDA has made a decemination that your celling of the Federal agencies. You must comply with ally rederal statutes and regulations assist not limited to: registration and listing - (21 CFR Part all the Act s requirements, mending, but nection in the requirements as set forth in the 807); labeling (21 CFR Fart 601); good manatations and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if and TFR 1980 (1958 quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in you to organization of substantial equivalence of your device to a legally premarket notinoation: The Press 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 rr you atem office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal masternational and Consumer 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 Kalgi 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
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K040689
Eye Sphere Implants Device Name:
Indications For Use:
Acrylic (PMMA) or Silicone eye sphere implants are permanent implants that occupy Acrylic (FinitiArol Silleone eye spreasary to surgically remove the eye (enucleation), the eye cavity when it becomes nobobal) to be space left after the removal of another ine contents of the eye bas (onisoviann), It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ausaurace Inz
Division Sign Off
{Division Sign-Off}
Division of Ophthalmic Ear,
Nose and Throat Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K040689
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.