FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

K023400 · Fci Ophthalmics, Inc. · HPZ · Aug 22, 2003 · Ophthalmic

Device Facts

• Record ID: K023400
• Device Name: FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
• Applicant: Fci Ophthalmics, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mesh wrapped Bioceramic orbital implants are designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.

Device Story

FCI Mesh Wrapped Bioceramic Orbital Implant is a spherical ocular implant used to restore orbital volume after enucleation or evisceration. The device consists of a bioceramic core wrapped in a mesh material. It is implanted surgically by an ophthalmologist or ocular surgeon into the orbital cavity. The implant provides a structural scaffold for tissue integration, supporting the placement of an ocular prosthesis. It functions as a permanent volume replacement to improve cosmetic outcomes and motility of the overlying prosthesis.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Bioceramic core material; mesh wrapping; spherical form factor; intended for surgical implantation; non-active device; no software or electronic components.

Indications for Use

Indicated for patients requiring orbital cavity volume replacement following enucleation, evisceration, or secondary implantation procedures.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

FCI Ophthalmics, Inc. c/o Hillard W. Welch 344 Annabelle Point Rd. Centerville, MA 02632

Re: K023400

Trade/Device Name: FCI Mesh Wrapped Bioceramic Orbital Implant Regulation Number: 21 CFR 886.3320 Regulation Name: Eve sphere implant Regulatory Class: Class II Product Code: HPZ Dated: May 28, 2003 Received: May 30, 2003

Dear Mr. Welch:

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 application (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 such 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 - Hillard W. Welch

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 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 Manufacturers, International 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. Palagi Fiorentino

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 (if known):________________ | OO

Mesh Wrapped Sioceramic Orbital Implant Device Name:__

Indications for Use:

..

Mesh wrapped Bioceramic orbital implants are designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devises

| 510(k) Number | K023400 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)

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