DURETTE OCULAR IMPLANT

K123764 · Oculo-Plastik, Inc. · HPZ · Jan 31, 2013 · Ophthalmic

Device Facts

• Record ID: K123764
• Device Name: DURETTE OCULAR IMPLANT
• Applicant: Oculo-Plastik, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Jan 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

Device Story

Durette ocular implant is a quasi-spherical, permanent PMMA device used in ophthalmology. It replaces volume in the eye cavity following enucleation, evisceration, or secondary implantation. The device features a smooth surface with 20 interconnected anterior tunnels to facilitate muscle suturing and tissue integration/ingrowth, providing motion and stability to an eventual ocular prosthesis. It is available in 4 models. The device is used in hospitals and clinics by ophthalmologists. It is supplied non-sterile and requires sterilization by the user via ethylene oxide (EO) prior to implantation. The current version utilizes an ultrasonic welding process, replacing a previous liquid-based welding method, to eliminate potential biocompatibility concerns associated with the welding agent. The device is purely mechanical; it does not involve energy delivery, software, or electrical components.

Clinical Evidence

Bench testing only. No clinical data provided. Validation focused on the new ultrasonic welding manufacturing process, sterilization validation (conforming to AAMI TIR12:2010), and adherence to ISO standards (ISO 10993-5, ISO 10993-7, ISO 11135-1, ISO 14971, ISO 15223-1, AAMI ST72, AAMI ST81).

Technological Characteristics

Material: PMMA (acrylic). Form factor: Quasi-spherical with 20 interconnected anterior tunnels for muscle suturing. Energy: None. Connectivity: None. Sterilization: Non-sterile (user-sterilized via ethylene oxide). Standards: ISO 10993-5, ISO 10993-7, ISO 11135-1, ISO 14971, ISO 15223-1, AAMI ST72, AAMI ST81.

Indications for Use

Indicated for patients requiring ocular volume replacement following enucleation, evisceration, or secondary implantation due to birth defects, diseases (e.g., cancer, glaucoma, retinal detachment), trauma, or ocular socket complications.

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

• Durette Implant (K073293)

Submission Summary (Full Text)

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K123764

page lot 4

## 5- 510(k) Summary

JAN 3 1 2013

# OCULOPLASTIK

200, rue Sauvé ouest, Montreal, Quebec H3L 1Y9 Canada Tel [phone] Fax [phone] Toll-free Tel [phone] Fax [phone]

Jan-16, 2013

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 USA

#### RE: Premarket notification -- Traditional 510(k)

Device name: Regulation number: Regulatory Class: Product code: Establishment reg: Contact person:

Durette ocular implant 21 CFR 886.3320 Class II HPZ 8022166 Sylvain Desrosiers, QM [phone] [e-mail]

#### To the reviewer:

This is a submission for a 510(k) for the Durette Implant, which were previously cleared by FDA in 2008 (K073293). The basis for this submission is change of welding process, packaging, and labeling. The predicate device was welded using a liquid that was remaining in a dry form after welding; the new process does not require that liquid anymore. The proposed packaging is simpler and clearer for the user. The instructions for use (labeling) has been revised to minimize risk for the user. According to guidance "Deciding When to submit a 510(k) for a Change to an Existing Device" (CDRH, 1997), we determined that this change must be submitted to FDA prior to market in USA (paragraph C3). This change does not affect the indication for use, and does not alter the fundamental scientific technology of the device.

As there is no addition of any other component, the Durette implant is 100% made of acrylic clearing any possible biocompatibility issue. The previous 510(k) submission K073293 was cleared based on our own implants made of the same material grade.

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This new welding process has been validated to ensure safety and effectiveness over a long period of time.

#### Indication for use

The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

### Description

The Durette implant is a quasi-spherical ocular implant made in 4 models for variations in anterior surface. Each has a permanent smooth surface and many tunnels to allow direct suturing of the muscles. These 20 interconnected tunnels, all situated in the anterior 3rd of the implant, allow tissue integration or ingrowth to help stabilize the implant. Each has an off-center elongation. Please refer to Article published in the Journal of Ophthalmic Prosthetics and AAO_ASO Joint Scientific Session for more complete explanations on the Durette implant.

| Areas | Predicate Durette implant (laser welding) | Durette implant (ultrasonic welding) |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 510(k) number | K073293 | K123764 |
| FDA Product Class | Class II | Same |
| Intended use | Enucleation, evisceration and secondary implantation | Same |
| Indications for use | Birth defects and diseases (cancer, glaucoma, retinal<br>detachment, Etc.) or trauma and ocular socket<br>complications. | Same |
| Target population | Total population | Same |
| Anatomical sites | Ocular | Same |
| Where used | Hospitals and clinics | Same |
| Compatibility with the<br>environment and other<br>devices | Compatible. | Same |
| Human factors | Used by Ophthalmologists. Permanent and safe<br>implants | Same |
| Materials | PMMA and liquid for welding | PMMA only. |

#### Device comparison table identifying relevant similarities and differences

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## 1123764

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| Design | Image: Durette 1, Durette 2, Durette 3, Durette 4 | Same |
|---------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Biocompatibility | PMMA is biocompatible. The liquid for welding is<br>documented biocompatible. | PMMA is<br>biocompatible. No<br>other component. |
| Sterility | Sold non-sterile | Same |
| Performance | Effective and safe. No performance standards<br>applicable to SPHERE, EYE IMPLANT has been<br>assigned by FDA. | Same |
| Size Range | 4 models (1, 2, 3, 4)<br>6 sizes (16, 18, 19, 20, 21, 22 mm) | 4 models (1, 2, 3, 4)<br>1 size (20 mm) |
| Chemical safety | PMMA is well documented in ophthalmology | Same |
| Mechanical safety | Solid devices | Same |
| Energy used and/or<br>delivered | No energy involved for this type of procedure. | Same |
| Standards met | None | ISO 10993-5<br>ISO 10993-7<br>ISO 11135-1<br>ISO 14971<br>ISO 15223-1<br>AAMI ST72<br>AAMI ST81 |
| Electrical safety | No electricity involved for this type of procedure. | Same |
| Thermal safety | Not applicable | Same |
| Radiation safety | No radiation involved for this type of procedure. | Same |
| Color additives | Non applicable. No color additives used in the<br>manufacturing process. | Same |
| Software | Non applicable. No software involved for this device. | Same |

## Discussion of the nonclinical tests submitted

We are providing assurance that our manufacturing process yields a product within specifications (e.g., bioburden, endotoxin) by the tests performed on the finished product. The device (Durette implant) is a single use device sold Non Sterile. Since it is new and sold non sterile, we include instructions as to how it should be processed to become patient ready (handling and sterilization).

The IFU recommends only sterilization by ethylene oxide (EO), and are based on sterilization

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validation for Durette implant. Selected parameters conform with AAMI TIR12:2010.

## Conclusion

Based on the proposed changes and results of nonclinical tests, this device has been determined as substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is enclosed in a circle, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

January 31, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Oculo Plastik, Inc. % Mr. Sylvain Desrosiers Quality Manager 200, Rue Sauvé Ouest Montréal, Québec Canada H3L 1Y9

Re: K123764

Trade/Device Name: Durette Implant Regulation Number: 21 CFR 886.3320 Regulation Name: Sphere, Eye Implant Regulatory Class: Class II Product Code: HPZ Dated: December 4, 2012 Received: December 7, 2012

Dear Mr. Desrosiers:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia Y. Alexander -S

for 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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KI23764

# 4- Indications for Use

510(k) Number (if known):

Device Name: Durette Implant

The Durette ocular acrylic (PMMA) implants in 4 models are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac (evisceration), or space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and to impart motion and stability to the eventual ocular prosthesis.

AND/OR Over-The-Counter Use Prescription Use _ X _ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Ophthalmic and Ear, Nose
and Throat Devices
510(k) Number K123764