SILICONE SPHERES

K112176 · Oculo Plastik, Inc. · HPZ · Sep 15, 2011 · Ophthalmic

Device Facts

• Record ID: K112176
• Device Name: SILICONE SPHERES
• Applicant: Oculo Plastik, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Silicone eye sphere implants 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 the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

Device Story

Silicone eye sphere implants are permanent, solid silicone elastomer spheres used to occupy the eye cavity following enucleation or evisceration; they replace lost volume and may facilitate motion of an eventual ocular prosthesis. The device is provided non-sterile and must be steam-autoclaved by the ophthalmologist prior to surgical implantation in a hospital setting. The device is available in sizes ranging from 12mm to 22mm. The current submission reflects a change in material grade and supplier compared to the predicate, with no changes to the fundamental scientific technology, intended use, or clinical application. The device is inert, biocompatible, and intended for single use.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by biocompatibility testing of the new silicone resin grade and comparison of physical/mechanical properties to the predicate device.

Technological Characteristics

Solid silicone elastomer spheres; sizes 12-22mm. Inert, biocompatible material. Non-sterile; requires user-performed steam autoclave sterilization. No electrical, electronic, or software components. Complies with ISO 14971 risk management standards.

Indications for Use

Indicated for patients of all ages requiring ocular volume replacement following enucleation, evisceration, or as a secondary implant after removal of a previous ocular implant.

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

• Silicone Eye sphere implants (K040689)

Submission Summary (Full Text)

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Premarket Notification (510k)

## 5- 510(k) Summary

SEP 1 5 2011

# OCULOPLASTIK

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

July 26th, 2011

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 modification - Special 510(k)

Device name: Requlation number: Regulatory Class: Product code: Establishment reg:

Silicone Eye sphere implants 21 CFR 886.3320 Class II HPZ 8022166

Contact person:

Sylvain Desrosiers, QM [phone] [e-mail]

This is a submission for a special 510(k) for our Silicone Eye sphere implants, which were previously cleared by FDA in 2004 (K040689). The basis for this submission is change of material grade and supplier, as the resin's manufacturer is discontinuing the current silicone grade. There is also a change for labeling and packaging. 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 material change does not affect the intended use, and does not alter the fundamental scientific technology of the device, therefore we are eligible to Special 510(k) approach.

We have determined that both silicone elastomers are equivalent and do not represent additional risk for the user.

## Description of the device

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#### Intended use

Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surqically remove the eye (enucleation), the contents of the eve sac (evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

Image /page/1/Picture/4 description: The image shows a circle with the word "SILICONE" written around the top of the circle. There is a curved shape inside the circle. The circle has a shadow on the bottom right.

Silicone eye spheres have been used for decades and still are. As for any implant, spheres are single use. Users are ophthalmologists who are very qualified to use eve spheres. Furthermore, we provide instructions for use with each device. These instructions include:

- · Description
- · Appearance
- · Indications
- · Silicone sphere
- · Mode of action
- · Contra-indications
- · Adverse effects
- Recommendation for use
- · Precautions for use

They are available by units in a wide range of sizes, from 12 to 22mm.

| Radius | Vol. | Weight | Product no |
|--------|-------|--------|------------|
| 12mm | 0.9cc | 1.0 g | 11-212E |
| 13mm | 1.2cc | 1.3 g | 11-213E |
| 14mm | 1.4cc | 1.7 g | 11-214E |
| 15mm | 1.8cc | 2.0 g | 11-215E |
| 16mm | 2.1cc | 2.5 g | 11-216E |
| 17mm | 2.6cc | 3.0 g | 11-217E |
| 18mm | 3.1cc | 3.5 g | 11-218E |
| 19mm | 3.6cc | 4.1 g | 11-219E |
| 20mm | 4.2cc | 4.8 g | 11-220E |
| 21mm | 4.8cc | 5.6 g | 11-221E |
| 22mm | 5.6cc | 6.4 g | 11-222E |

## Intended use

#### Intended use

Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), the contents of the eye sac

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(evisceration), or the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

The new device is substantially equivalent to the predicate device. The comparison is established against our previous 510(k). The following comparison table shows similarities and differences between both devices.

| | Predicate device | New device |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K040689 | K112176 |
| FDA Product<br>Class | Class II | Same. |
| Indications for<br>use | For enucleation, evisceration,<br>or as secondary implant. | Same. |
| Target<br>population | All ages. | Same. |
| Design | Silicone elastomer Eye<br>Sphere | Same. |
| Material | Medical grade | Medical too but different grade |
| Performance | No performance standards<br>applicable to SPHERE, EYE<br>IMPLANT has been assigned<br>by FDA. | Same. |
| Size Range | 12, 13, 14, 15, 16, 17, 18 and<br>19mm | 12 to 22mm |
| Sterility | Non sterile. | Same. Must be sterilized by steam<br>autoclave by the user. |
| Biocompatibility | The silicone manufacturer<br>has done many<br>biocompatibility tests on their<br>resin. | Equivalent. The silicone manufacturer<br>has done same biocompatibility tests<br>with same results. In addition, we have<br>performed 2 other tests on finished<br>device. |
| Mechanical<br>safety | Silicone in its solid state is<br>well documented by<br>manufacturers of silicon<br>resins, and well known by<br>ophthalmologists. | Same. |
| Chemical<br>safety | Silicone is an inert material. | Same. |
| Anatomical<br>sites | Ocular globe replacement or<br>filling. | Same. |
| Human factors | Users are ophthalmologists. | Same. |
| Energy used<br>and/or<br>delivered | No energy involved for this<br>type of procedure. | Same. |
| Compatibility<br>with<br>environment<br>and other<br>devices | In use for decades. | Same. |
| Where used | Operating rooms in hospitals. | Same. |
| Standards met | None. | ISO 14971 |
| Electrical<br>safety | No electricity involved for this<br>type of procedure. | Same. |
| Thermal safety | Can be autoclaved or gassed<br>(ETO) | Same. Highly resistant. |
| Radiation<br>safety | No radiation involved for this<br>type of procedure. | Same. |
| Color additives | Non applicable. No color<br>additives used in the<br>manufacturing process. | Same. |
| Software | Non applicable. No software<br>involved for this device. | Same. |

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No performance standards applicable to SPHERE, EYE IMPLANT has been assigned by FDA. However, a risk assessment has been performed against ISO 14971.

## Sterility

Silicone spheres are sold «Non Sterile». The labels clearly mention that they are not sterilized. Sterilization of these implants is required before surgery.

## Pyrogens

Non applicable. These devices are labeled as non-sterile and need to be sterilized by the user.

## Sterilization by User

The standard accepted sterilization method is to be performed in the hospitals that will purchase the implants. We provide detailed validated steam sterilization instructions in our labeling for the silicone spheres.

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Image /page/4/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and elevation. Encircling the bird is text, which appears to be part of the logo's official branding. The text is arranged in a circular fashion, following the contour of the logo.

l ood and Dag Admin. Cahon 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Oculo -Plastik, Inc. c/o Mr. Sylvain Desrosiers Quality Manager 200 rue Sauvé ouest Montreal, Quebec H3L LY9 Canada

Re: K112176

Trade/Device Name: Silicone Spheres Regulation Number: 21 CFR 886.3320 Regulation Name: Eye Sphere Implant Regulatory Class: Class II Product Code: HPZ Dated: August 25, 2011 Received: September 6. 2011

ccp 15 2011

Dear Mr. Derosiers:

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 contractly and this 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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.html 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/ReportalProblem/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 Alexander

Image /page/5/Picture/7 description: The image shows a handwritten word, "for", in cursive script. The "f" is elongated with a loop extending below the baseline, and the "o" and "r" are connected with a smooth stroke. The writing appears to be done with a pen or fine-tipped marker, and the overall impression is one of casual, flowing handwriting.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological and Ear. Nose and Throat Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K112176

## 4- Indication for use statement

510(k) Number (if known):

Device Name: Silicone Eye Sphere Implants

Indication for use

Silicone eye sphere implants 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 the space left after the removal of another ocular implant (used as a secondary implant). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denise Hampton

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

510(k) Number K112176