ORBITAL TISSUE EXPANDER (OTE)

K060151 · Innovia, LLC · NFM · Aug 8, 2006 · Ophthalmic

Device Facts

• Record ID: K060151
• Device Name: ORBITAL TISSUE EXPANDER (OTE)
• Applicant: Innovia, LLC
• Product Code: NFM · Ophthalmic
• Decision Date: Aug 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma. It will facilitate normal growth of orbital soft tissues and bone, in efforts to achieve facial symmetry.

Device Story

Orbital Tissue Expander (OTE) consists of flexible balloon/expander and titanium fixation plate; plate anchored to lateral orbital wall via screws. Slotted arm on plate extends through OTE slot; allows manual positioning. Clinician injects sterile saline via 30-gauge needle into injection port to inflate OTE; exerts pressure on orbit to stimulate bony growth. Used in clinical setting for pediatric patients with anophthalmia/microphthalmia. Size controlled by user; CT scans used to match contralateral eye dimensions. Benefits include facilitated orbital growth and improved facial symmetry.

Clinical Evidence

Animal study compared OTE-expanded sockets to control sockets with anophthalmos. Results showed experimental orbits kept pace with bone growth on contralateral non-enucleated side. Histology confirmed normal tissues without foreign body reaction. Bench testing confirmed repeatable fabrication, volume/diameter maintenance, and fatigue durability.

Technological Characteristics

Materials: Titanium fixation plate, flexible balloon/expander. Principle: Mechanical expansion via saline inflation. Connectivity: None. Sterilization: Not specified. Form factor: Implantable balloon with fixation plate and slotted arm. Software: None.

Indications for Use

Indicated for patients with congenital anophthalmia, congenital microphthalmia, or acquired anophthalmia (e.g., due to childhood ocular tumors or trauma) to facilitate orbital soft tissue and bone growth for facial symmetry.

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

• Osmed Hydrogel Tissue Expander (K010852)

Submission Summary (Full Text)

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AUG - 8 2006

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## 510(k) Summary

| Submitted By: | Innovia LLC |
|---------------|--------------------------|
| | 12415 SW 136 Ave, Unit 3 |
| | Miami, FL 33186 |

- Contact Person: Stewart B. Davis M.D. Assistant Medical Director
- Phone Number: 305-378-2651 Ext. 314 305-378-2652 Fax Number: [e-mail] Email:
- Date Prepared: January 18, 2006
- Orbital Tissue Expander (OTE) Name of Device:
- Osmed Hydrogel Tissue Expander from IOP Inc. (K010852) Equivalent Device:
- The OTE would be used in the case of congenital anophthalmia, Intended Use: congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma. It will facilitate normal growth of orbital soft tissues and bone, in efforts to achieve facial symmetry.
- Device Description: The integrated orbital tissue expander (OTE), consisting of a flexible "balloon/expander" is held in place by means of a titanium fixation plate that is anchored to the lateral orbital wall by screws. A slotted arm attached to the fixation plate, extends through a slot that is formed within the OTE. The OTE can be manually moved along the shaft of the fixation plate to achieve optimal central position in an expanding socket. A 30 gauge disposable hypodermic needle connected to a 1 cc disposable syringe filled with sterile saline is inserted into the OTE through an injection port. Inflation of the OTE will effect pressure on the orbit of the patient.

## Comparison to The OTE is similar to the predicate device in that it can be easily Predicate Device: implanted within the orbit, at a small size, and then increased in size to stimulate orbital bony growth. The predicate device grows on its own, by osmosis. The OTE size is user controlled. CT scans can be used to match up sizes with the contralateral eye, and then saline can be injected to enlarge the OTE.

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Performance Data: Bench testing has shown that orbital tissue expanders can be fabricated in a repeatable and reliable manner. Both in vitro and in vivo testing have shown that the tissue expander maintains adequate volume and diameter over time. Fatigue testing has shown durability.

- The animal study clearly demonstrated a noticeable difference in sockets Animal Data: expanded with the OTE as compared to the control sockets with anophthalmos. The experimental expanded orbits kept pace with bone growth development on the contralateral non-enucleated side. This qualitative difference can be observed on CT scans as well as in gross photos. The histology performed in all animals showed normal tissues, free of foreign body reaction.
- Conclusions: Testing has shown that the OTE can be fabricated in a consistent manner. Animal testing has shown the device to be safe and effective. In-vitro testing has shown the OTE to be durable over time.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a person with outstretched arms, with three wavy lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovia, LLC c/o Stewart B. Davis, M.D. Assistant Medical Director 12415 SW 136 Avenue Unit 3 Miami, FL 33186

Re: k060151

Trade/Device Name: Orbital Tissue Expander Regulation Number: 21 CFR 886.3320 Regulation Name: Eye Sphere Implant Regulatory Class: Class II Product Code: NFM Dated: July 19, 2006 Received: July 25, 2006

Dear Dr. Davis:

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.

AUG - 8 2006

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 Jour de 100 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 r reaso be as nove 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 or any I vith 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 - Stewart B. Davis, M.D.

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/industry/support/index.html.

Sincerely yours,

M.B. Egelman SimD

Malvina B. Eydelman, 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): x060151

Device Name: Orbital Tissue Expander

Indications for Use: The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Olvision Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number KD60

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