EYE SPHERE IMPLANTS

K040689 · Oculo Plastik, Inc. · HPZ · Jun 10, 2004 · Ophthalmic

Device Facts

• Record ID: K040689
• Device Name: EYE SPHERE IMPLANTS
• Applicant: Oculo Plastik, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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.

Device Story

Eye sphere implants consist of acrylic (PMMA) or silicone spheres; surgically implanted into the eye cavity following enucleation or evisceration; function as volume replacement to maintain orbital structure; provide a base to impart motion to a subsequent ocular prosthesis; used by ophthalmologists in surgical settings; permanent implant.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Acrylic (PMMA) or Silicone. Form factor: Spherical. Function: Permanent orbital volume replacement. Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing enucleation or evisceration requiring volume replacement in the eye cavity and potential motion for an ocular prosthesis.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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

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**Division of Ophthalmic Ear,
Nose and Throat Devices**

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510(k) Number K040689