BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER

K982562 · Integrated Orbital Implants, Inc. · HPZ · Dec 28, 1998 · Ophthalmic

Device Facts

• Record ID: K982562
• Device Name: BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
• Applicant: Integrated Orbital Implants, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Dec 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bio-eye Hydroxyapatite Ocular Implant is intended to be implanted in the eyeball to occupy space following removal of the contents of the eyeball. The Ophthalmic Conformer is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity during the healing process following surgery.

Device Story

Bio-eye Hydroxyapatite Ocular Implant is a porous sphere implanted into the orbital cavity following enucleation or evisceration to replace lost volume; Ophthalmic Conformer is a temporary insert placed between eyeball and eyelid to maintain orbital space during healing. Implants are manufactured from synthetic hydroxyapatite derived from marine coral via hydrothermal chemical conversion, creating an interconnected porous matrix. Devices are supplied sterile. Used by ophthalmologists in surgical settings. Implants provide structural support for ocular prostheses and improve motility; conformers prevent tissue collapse during post-operative recovery.

Clinical Evidence

No clinical data.

Technological Characteristics

Porous hydroxyapatite synthetic material; interconnected porous matrix derived from marine coral; hydrothermal chemical conversion process. Supplied sterile via gamma radiation. Form factor: ocular sphere implant and ophthalmic conformer.

Indications for Use

Indicated for patients undergoing enucleation or evisceration as a primary implant, or as a secondary implant for poor motility, migration, extrusion, chronic infection, enophthalmos, or lid sag. Indicated for any situation requiring traditional ocular implants. The Conformer is indicated for use in all cases where an orbital implant is used.

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.

Predicate Devices

• Motility Orbital Implant (K891137)
• Ophthalmic Conformer (K945110)
• Interpore 200 Porous Hydroxyapatite (K860983)

Submission Summary (Full Text)

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DEC 28 1998

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INTEGRATED ORBITAL IMPLANTS, INC.

510(k) SUMMARY as required by 807.92(c) Bio-eve® Hydroxyapatite Ocular Implant and Conformer

## SUBMITTER'S NAME, ADDRESS, TELEPHONE AND FAX NUMBER: 1. Integrated Orbital Implants, Inc. 12526 High Bluff Dr., Suite 300 San Diego, CA 92130-2067 Telephone: [phone] Fax: [phone] CONTACT PERSON: Jeanne Dunham, President Bioserv Corporation Telephone: [phone] Fax: [phone] DATE SUMMARY PREPARED: July 10, 1998 2. NAME OF DEVICE: Bio-eye® Hydroxyapatite Ocular Implant and PROPRIETARY NAME: Conformer COMMON/USUAL NAME: Eye sphere implant Ophthalmic Conformer CLASSIFICATION NAME: Eye sphere implant, 21 CFR 886.3320, Class II Ophthalmic conformer, 21 CFR 886.3130, Class II PREDICATE DEVICE: Motility Orbital Implant K891137 3. Ophthalmic Conformer K945110 (510(k) exempt Federal Register 1-21-98) Interpore 200 Porous Hydroxyapatite K860983.

- DESCRIPTION OF DEVICE: Both the Motility Orbital Implant and the Bio-eye 4. Hydroxyapatite Ocular Implant are eye sphere implants manufactured of hydroxyapatite. The Bio-eve Hydroxyapatite Ocular Implant will now be provided sterile. The Ophthalmic Conformer is used in conjunction with the Ocular Implant for ocular prosthesis and will also be supplied sterile.
- 5. INTENDED USE: The Bio-eye Hydroxyapatite Ocular Implant is intended to be implanted in the eyeball to occupy space following removal of the contents of the eyeball. The Ophthalmic Conformer is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity during the healing process following surgery.

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# INTEGRATED ORBITAL IMPLANTS, INC.

# Bio-eve® Hydroxvapatite Ocular Implant and Conformer 510(k) SUMMARY page 2 of 2

- TECHNOLOGICAL CHARACTERISTICS: The technological characteristics of the 6. Ocular Implant are the same as the predicate: Both Implants are manufactured of porous hydroxyapatite. It is a synthetic hydroxyapatite which is similar in composition to the mineral content of human bone. The implant material has a unique interconnected porous matrix derived from specific marine corals. A patented manufacturing process preserves the porous structure of the coral while the calcium carbonate skeleton undergoes a hydrothermal chemical conversion to hydroxyapatite. The Bio-eye Hydroxyapatite Ocular Implant will now be supplied sterile.
The Interpore 200 Porous Hydroxyapatite is identical to the Motility Orbital Implant described above. Interpore is the manufacturer and supplier of the Motility Orbital Implant. The Interpore 200 Porous Hydroxyapatite is sterilized by gamma radiation and is supplied sterile.

The Ophthalmic Conformer, which is now 510(k) exempt (Federal Register 1-21-98), will now be supplied sterile.

- 7. SUMMARY OF PERFORMANCE DATA: Not applicable.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS: Not 8. applicable.

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DEC 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integrated Orbital Implants, Inc. Ms. Jeanne Dunham President Bioserv Corporation 5340 Eastgate Mall San Diego, CA 92121

Re: K982562

Trade Name: Bio-eye ® Hydroxyapatite Ocular Implant and Conformer Regulatory Class: II Product Code: 86 HPZ Dated: November 3, 1998 Received: November 5, 1998

Dear Ms. Dunham:

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 (OS) 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. Jeanne Dunham, President

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,

ARoeyl Rosenthal

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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510(k) Bio-eye Hydroxyapatite Ocular Implant and Conformer Integrated Orbital Implants, Inc. July 1998

No 510(k) Number has been issued

Bio-eve® Hydroxyapatite Ocular Implant and Conformer Device Name:

Indications for Use:

The Bio-eye Hydroxyapatite Ocular Implant is indicated as a primary implant in cases of enucleation and evisceration, and as a secondary implant in cases of poor performance of a primary implant, such as in cases of poor motility, migration, extrusion, chronic infection, enophthalmos, and lid sag. The device is indicated in any situation where silicone, acrylic, polyethylene, glass, or other traditional ocular implants are used.

The Conformer is indicated in all cases in which an orbital implant is used.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Ophthalmic Devices

510(k) Number.

Prescription Use V

OR

Over-The-Counter Use _

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Prescription Use . (Per 21 CFR 801.109)