ORBITAL RECONSTRUCTIVE IMPLANT II

K083342 · Evera Medical, Inc. · HPZ · Mar 12, 2009 · Ophthalmic

Device Facts

• Record ID: K083342
• Device Name: ORBITAL RECONSTRUCTIVE IMPLANT II
• Applicant: Evera Medical, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Mar 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORI II is intended for augmentation or restoration in the craniofacial region.

Device Story

Non-absorbable, inert, sterile, porous implant for craniofacial/orbital augmentation; composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). Available in various lengths/widths. Implanted by surgeons during procedures to restore orbital volume or correct enophthalmos following trauma or tumor excision. Provides structural support to orbital tissues. Bench testing confirms mechanical performance (tensile, shear, compression) and biocompatibility per ISO-10993.

Clinical Evidence

Bench testing only. Evaluated tensile load/elongation at break, elastic/shear modulus, compression deflection, suture pullout, and shear strength. Standards used: ASTM-D624, ASTM-D1777, ASTM-F88, ASTM-D412, ASTM-D3787. Biocompatibility confirmed via ISO-10993 long-term implant testing.

Technological Characteristics

Materials: porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). Mechanical properties tested per ASTM-D624, ASTM-D1777, ASTM-F88, ASTM-D412, ASTM-D3787. Sterile, non-absorbable, inert polymeric implant.

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, or correction of enophthalmos.

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

• Orbital Reconstructive Implant (K070130)
• Medpor Plus Orbital Volume Replacement Implant (K021357)
• Oculo-Plastik Universal-ePTFE (K934834)
• Solid Silicone and Silicone Foam Implants (K950806)

Submission Summary (Full Text)

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KD83342

MAR 1 2 2009

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

#### Submission Date: November 7, 2008

# Submitter Information:

| Company Name: | Evera Medical, Inc. |
|------------------|---------------------------------------------------------------|
| Company Address: | 353 Vintage Park Drive<br>Suite F<br>Foster City, CA 94404 |
| Contact Person: | Randy Kesten<br>650-287-2884<br>[e-mail] |

# Device Information:

| Trade Name: | Orbital Reconstructive Implant II (ORI II) |
|--------------|--------------------------------------------|
| Common Name: | Orbital Implant |

Classification Name: 21 CFR § 886.3320

Classification Code: HPZ

Device Class: Class II

# Predicate Device(s):

| Trade Name: | Orbital Reconstructive Implant |
|---------------|------------------------------------------------|
| Manufacturer: | Evera Medical, Inc. |
| K Number: | K070130 |
| Product Code: | HPZ |
| Trade Name: | Medpor Plus Orbital Volume Replacement Implant |
| Manufacturer: | Porex Surgical, Inc. |
| K Number: | K021357 |
| Product Code: | HPZ |
| Trade Name: | Oculo-Plastik Universal-ePTFE |
| Manufacturer: | Oculo-Plastik, Inc. |
| K Number: | K934834 |

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| Product Code: | HPZ |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name:<br>Manufacturer:<br>K Number:<br>Product Code: | Solid Silicone and Silicone Foam Implants<br>MIRA, Inc.<br>K950806<br>HQX |
| Device Description: | The Orbital Reconstructive Implant II (ORI II) is a non-<br>absorbable, inert, sterile, porous, implant composed of<br>porous silicone elastomer and expanded<br>polytetrafluoroethylene (ePTFE). This polymeric implant is<br>available in a range of lengths and widths to accommodate<br>the surgical application and the needs of the individual<br>surgeon practicing medicine. |
| Intended Use: | The ORI II is intended for augmentation or restoration in<br>the craniofacial region. |
| Indications for Use: | The ORI II is indicated as an implant for augmentation,<br>reconstruction, or restoration in and around the orbit of the<br>eye, such as in reconstruction following orbital trauma or<br>tumor excision, to treat orbital volume deficiencies, or in<br>the correction of enophthalmos. |
| Comparison to<br>Predicate Device: | The ORI II has the same intended use and technological<br>characteristics as the predicate devices. Slight differences<br>in design and performance from the cited predicates do not<br>affect either the safety and/or effectiveness of the ORI II<br>for its intended use. As compared to the ORI predicate<br>(K070130), ORI II uses the same materials in its<br>construction: polydimethylsiloxane elastomer ("silicone<br>elastomer") and expanded polytetrafluoroethylene. The<br>slight design difference between ORI II and the ORI<br>predicate is that the silicone elastomer is processed to form<br>a porous core layer of the implant, while in ORI the<br>silicone was formed into a film core of the implant. The<br>slight performance difference between ORI II and the ORI<br>predicate is that ORI II exhibits approximately 50% greater<br>tensile strength than ORI, while the elongation at break of<br>ORI II is approximately 25% of that of ORI. |

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Non-clinical performance data demonstrated in bench testing of ORI II are substantially equivalent to those of the predicates. The following testing was performed to measure the performance of ORI II as compared to the predicate devices: Tensile load at break; Tensile elongation at break; Elastic (Young's) modulus; Compression deflection; Uniaxial compressive modulus; Compressive set; Suture pullout; Shear modulus; Ultimate shear strength; and Shear load at break. Where applicable, test methods used the following testing standards: ASTM-D624; ASTM-D1777; ASTM-F88; ASTM-D412; and ASTM-D3787. The results of this testing showed that ORI II was demonstrated to be safe and effective for its intended use. ORI II will be manufactured in accordance with the product performance specifications derived from these test results.

The biocompatibility of ORI II was evaluated based on the long-term implant section of the ISO-10993 standard and shown to be biocompatible.

The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the ORI II is substantially equivalent to the cited predicate devices.

### Conclusion:

The results of these evaluations of the ORI II support the conclusion that it is safe and effective for its intended use and that it is substantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2009

Evera Medical, Inc. c/o Randy Kesten Chief Technical Officer 1191 Chess Drive, Suite G Foster City, CA 94404

Re: K083342

Trade/Device Name: Orbital Reconstructive Implant II (ORI II) Regulation Number: 21 CFR 886.3320 Regulation Name: Implant, Eye Sphere Regulatory Class: II Product Code: HPZ Dated: February 10, 2009 Received: February 12, 2009

### Dear Mr. Kesten:

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, Trug, 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 devive con be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA move 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 aft 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 eestonic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Malvina B. Egleston, M.D.

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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#### 1.0 STATEMENT OF INDICATIONS FOR USE

KO83342 510(k) Number (if known):

Device Name:

Orbital Reconstructive Implant II

Indications for Use:

The Orbital Reconstructive Implant II 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.

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)

Daryl L. Caubna

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

CONFIDENTIAL

510(k) Number_k 08334 2