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.

Device Description

The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric implant is available in a range of lengths and widths to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

AI/ML Overview

The Orbital Reconstructive Implant II (ORI II) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through
non-clinical performance testing and biocompatibility evaluation.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test)	Reported Device Performance (ORI II)	Basis for Equivalence
Tensile load at break	Approximately 50% greater than the ORI predicate.	Demonstrates improved mechanical strength compared to a predicate device, supporting safety and effectiveness.
Tensile elongation at break	Approximately 25% of that of the ORI predicate.	Demonstrates different mechanical properties compared to a predicate, assessed as not affecting safety/effectiveness for intended use.
Elastic (Young's) modulus	Performed. Results support substantial equivalence.	Compared to predicate devices.
Compression deflection	Performed. Results support substantial equivalence.	Compared to predicate devices.
Uniaxial compressive modulus	Performed. Results support substantial equivalence.	Compared to predicate devices.
Compressive set	Performed. Results support substantial equivalence.	Compared to predicate devices.
Suture pullout	Performed. Results support substantial equivalence.	Compared to predicate devices.
Shear modulus	Performed. Results support substantial equivalence.	Compared to predicate devices.
Ultimate shear strength	Performed. Results support substantial equivalence.	Compared to predicate devices.
Shear load at break	Performed. Results support substantial equivalence.	Compared to predicate devices.
Biocompatibility	Evaluated based on the long-term implant section of the ISO-10993 standard and shown to be biocompatible.	Direct compliance with recognized standards for implantable medical devices, ensuring biological safety.
Material Composition	Polydimethylsiloxane elastomer ("silicone elastomer") and expanded polytetrafluoroethylene (ePTFE). These are the same materials as the ORI predicate (K070130).	Use of established, biocompatible materials found in predicate devices.
Processing (core layer)	Silicone elastomer processed to form a porous core layer. (Differs from ORI predicate which had a film core).	Design difference from predicate, but overall performance shown to maintain safety and effectiveness.
Intended Use & Indications for Use	Same as predicate devices: augmentation, reconstruction, or restoration in and around the orbit of the eye (e.g., following orbital trauma, tumor excision, to treat orbital volume deficiencies, or correction of enophthalmos).	Maintenance of the same clinical applications and patient population as currently marketed, cleared predicate devices, minimizing new clinical risks. The slight differences in design and performance from the predicate devices do not affect the safety and/or effectiveness for its intended use.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified. The study involved bench testing of the Orbital Reconstructive Implant II (ORI II). This refers to a series of laboratory tests conducted on the device itself, rather than testing on biological samples or human patients.
Data Provenance: The data is from non-clinical performance testing (bench testing) and biocompatibility evaluation. There is no information regarding the country of origin of the data as it's not clinically collected patient data. It is inherently prospective in the sense that the device was manufactured and then tested according to established protocols.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the study is based on laboratory bench testing and biocompatibility assessment, not interpretation of clinical data or images by experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for mechanical properties is typically derived directly from the physical measurements themselves. Biocompatibility ground truth is established by standardized toxicity tests.

4. Adjudication Method for the Test Set:

This information is not applicable as the study does not involve human readers interpreting data or making subjective judgments that would require adjudication. The testing methods are objective measurements of physical and chemical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is an implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is an implant, not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" in this context is based on objective measurements of physical properties (e.g., tensile strength, elongation, modulus) obtained through standardized engineering test methods (e.g., ASTM-D624, ASTM-D1777, ASTM-F88, ASTM-D412, ASTM-D3787).
For biocompatibility, the ground truth is established by adherence to the ISO-10993 standard, specifically the long-term implant section, which involves standardized biological assessments to determine the device's compatibility with living tissues.

8. The sample size for the training set:

This information is not applicable as the device is an implant and does not involve machine learning or an algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as above; there is no training set for this type of device submission.

Summary

{0}------------------------------------------------

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 DriveSuite FFoster City, CA 94404
Contact Person:	Randy Kesten650-287-2884randy.kesten@everamedical.com

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

{1}------------------------------------------------

Product Code:	HPZ
Trade Name:Manufacturer:K Number:Product Code:	Solid Silicone and Silicone Foam ImplantsMIRA, Inc.K950806HQX
Device Description:	The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed ofporous silicone elastomer and expandedpolytetrafluoroethylene (ePTFE). This polymeric implant isavailable in a range of lengths and widths to accommodatethe surgical application and the needs of the individualsurgeon practicing medicine.
Intended Use:	The ORI II is intended for augmentation or restoration inthe craniofacial region.
Indications for Use:	The ORI II is indicated as an implant for augmentation,reconstruction, or restoration in and around the orbit of theeye, such as in reconstruction following orbital trauma ortumor excision, to treat orbital volume deficiencies, or inthe correction of enophthalmos.
Comparison toPredicate Device:	The ORI II has the same intended use and technologicalcharacteristics as the predicate devices. Slight differencesin design and performance from the cited predicates do notaffect either the safety and/or effectiveness of the ORI IIfor its intended use. As compared to the ORI predicate(K070130), ORI II uses the same materials in itsconstruction: polydimethylsiloxane elastomer ("siliconeelastomer") and expanded polytetrafluoroethylene. Theslight design difference between ORI II and the ORIpredicate is that the silicone elastomer is processed to forma porous core layer of the implant, while in ORI thesilicone was formed into a film core of the implant. Theslight performance difference between ORI II and the ORIpredicate is that ORI II exhibits approximately 50% greatertensile strength than ORI, while the elongation at break ofORI II is approximately 25% of that of ORI.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

{5}------------------------------------------------

1.0 STATEMENT OF INDICATIONS FOR USE

KO83342 510(k) Number (if known):

Device Name:

Orbital Reconstructive Implant II

Indications for Use:

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

Regulation Number and Section

§ 886.3320 Eye sphere implant.

(a)
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.(b)
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.