TITANIUM PEG SYSTEM

K980822 · Fci Ophthalmics, Inc. · MQU · Jul 9, 1998 · Ophthalmic

Device Facts

• Record ID: K980822
• Device Name: TITANIUM PEG SYSTEM
• Applicant: Fci Ophthalmics, Inc.
• Product Code: MQU · Ophthalmic
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.

Device Story

Titanium Peg System consists of surgical instruments used to drill hydroxyapatite orbital implants and insert a motility peg. The peg facilitates coupling between the orbital implant and an artificial eye to improve ocular motility. Used by ophthalmologists or ocularists in a clinical or surgical setting. The device provides a mechanical interface for prosthetic eye movement, enhancing cosmetic and functional outcomes for patients with anophthalmia or enucleation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed of titanium. System includes drill bits and motility pegs designed for integration with hydroxyapatite orbital implants. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring hydroxyapatite orbital implant drilling and motility peg placement for artificial eye coupling, or replacement of existing sleeves or pegs.

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1998 JUL

Ms. Anne Bohsack FCI Ophthalmics, Inc. 76 Prospect Street Marshfield Hills, MA 02051

Re: K980822

Trade Name: Titanium Peg System Regulatory Class: II Product Code: 86 MQU Dated: June 22, 1998 Received: June 25, 1992

Dear Ms. Bohsack:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 Manufacturing Practice requirements, 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 publish 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 - Ms. Anne Bohsack

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl forenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 I 0(k) Number (if known):_K980822

Titanium Peg System Device Name:

Indications For Use:

This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="signature" src="signature.png"/> </div> <div>(Division Sign-Off)</div> <div>Division of Ophthalmic Devices</div> |
|---------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K980822 |

| Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: underline;">X</span> |
|---------------------------------------|----------------------------------------------------|
|---------------------------------------|----------------------------------------------------|

OR

| Over-The-Counter Use | ________________ |
|----------------------|------------------|
|----------------------|------------------|

(Optional Format 1-2-96)