ORBITAL RECONSTRUCTIVE IMPLANT

K070130 · Becker & Associates Consulting, Inc. · HPZ · Apr 19, 2007 · Ophthalmic

Device Facts

• Record ID: K070130
• Device Name: ORBITAL RECONSTRUCTIVE IMPLANT
• Applicant: Becker & Associates Consulting, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Apr 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORI is intended for augmentation or restoration and to separate tissues.

Device Story

The Orbital Reconstructive Implant (ORI) is a non-absorbable, sterile, porous surgical implant used for orbital reconstruction. Composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE), the device is available in various dimensions to suit specific surgical needs. Surgeons may augment the implant's thickness with saline prior to implantation. The device is used by surgeons in clinical settings to restore orbital volume, correct enophthalmos, or maintain ocular shape post-trauma or tumor excision. By providing structural support and tissue separation, the implant aids in anatomical restoration and prevents postoperative adhesions, directly benefiting patients requiring orbital reconstruction.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness were established through biocompatibility and biomechanical performance evaluations.

Technological Characteristics

Non-absorbable, inert, porous surgical implant. Materials: silicone elastomer and expanded polytetrafluoroethylene (ePTFE). Form factor: available in various lengths, widths, and thicknesses. Features: saline-augmentable volume. Sterilization: sterile.

Indications for Use

Indicated for augmentation, reconstruction, or restoration in and around the orbit of the eye, including reconstruction following orbital trauma or tumor excision, treatment of orbital volume deficiencies, and correction of enophthalmos. Also indicated as a temporary device to maintain eye shape and prevent closure or adhesion postoperatively.

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

• Medpor Plus Orbital Volume Replacement Implant (K021357)
• Eye Sphere Conformer (K972661)
• Orbital Tissue Expander (K060151)
• Oculo-Plastik Universal-ePTFE (K934834)

Submission Summary (Full Text)

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K070130

# APR 1 9 2007

#### 510(K) SUMMARY FOR THE ORBITAL RECONSTRUCTIVE IMPLANT 2.0

Submission Date: January 16, 2006

### Submitter Information:

| Company Name: | Evera Medical, Inc. |
|------------------|------------------------------------------------------------|
| Company Address: | 353 Vintage Park Drive<br>Suite F<br>Foster City, CA 94404 |
| Contact Person: | Michael D. Lesh, MD<br>650-525-9750 |

# Device Information:

| Trade Name: | Orbital Reconstructive Implant (ORI) |
|----------------------|--------------------------------------|
| Common Name: | Orbital Implant |
| Classification Name: | 21 CFR § 886.3320 |
| Classification Code: | HPZ |
| Device Class: | Class II |

[e-mail]

# Predicate Device(s):

| Trade Name: | Medpor Plus Orbital Volume Replacement Implant |
|---------------|------------------------------------------------|
| Manufacturer: | Porex Surgical, Inc. |
| K Number: | K021357 |
| Product Code: | HPZ |
| Trade Name: | Eye Sphere Conformer |
| Manufacturer: | Gulden Ophthalmics |
| K Number: | K972661 |
| Product Code: | HPZ / HQN |

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| Trade Name: | Orbital Tissue Expander |
|---------------|-------------------------|
| Manufacturer: | Innovia LLC |
| K Number: | K060151 |
| Product Code: | NFM |

| Trade Name: | Oculo-Plastik Universal-ePTFE |
|---------------|-------------------------------|
| Manufacturer: | Oculo-Plastik, Inc. |
| K Number: | K934834 |
| Product Code: | HPZ |

| Device Description: | The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Intended Use: | The ORI is intended for augmentation or restoration and to separate tissues. |
|---------------|------------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------------|

| Indications for Use: | The ORI is indicated as an implant for augmentation, re- construction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative pe- riod. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Comparison to Predicate Device: | The ORI has the same intended use and technological char- acteristics as the predicate devices. Slight differences in design and performance from the cited predicates do not af- fect either the safety and/or effectiveness of the ORI for its intended use. The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the ORI is substantially equivalent to the cited predicate devices. |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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| Conclusion: | The results of these evaluations of the ORI support the conclusion that it is safe and effective for its intended use and that it is sub- stantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness. |
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KOTOI30

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Becker & Associates Consulting, Inc. c/o Ms. Campbell Tuskey Project Manager 2001 Pennsylvania Ave NW Washington DC 20006

APR 1 9 2007

Re: K070130

> Trade Name: Orbital Reconstructive Implant (ORI) Regulation Number: 21 CFR 886.3320 Regulation Name: eye sphere implant Regulatory Class: Class II Product Code: HPZ Dated: March 26, 2007 Received: March 26, 2007

Dear Ms. Tuskey:

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 - Ms. Campbell L. Tuskey

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 Eglemu SimUD

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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Page 3 - Ms. Campbell L. Tuskey

#### STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K070130

Device Name:

Orbital Reconstructive Implant

Indications for Use:

The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.

Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.

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)

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

K070130

**510(k) Number**