EYE SPHERES

K082850 · Product and Educational Services, LLC · HPZ · Feb 27, 2009 · Ophthalmic

Device Facts

• Record ID: K082850
• Device Name: EYE SPHERES
• Applicant: Product and Educational Services, LLC
• Product Code: HPZ · Ophthalmic
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration) Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process

Device Story

Eye spheres and conformers are ocular implants/devices used following enucleation or evisceration. Eye spheres are permanent implants occupying the eye cavity; conformers are temporary devices maintaining eye shape and preventing adhesion during healing. Both are manufactured from polymethylmethacrylate (PMMA). Eye spheres are available in 10mm-22mm diameters; conformers are available in small, medium, and large sizes, with or without holes. Devices are used in clinical settings by ophthalmologists/surgeons. The device provides structural support to the eye socket post-surgery, facilitating proper healing and preparation for future prosthetic fitting.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Polymethylmethacrylate (PMMA). Form factor: Spheres (10-22mm) and conformers (small, medium, large). Sterilization: Gamma sterilization. Connectivity: None. Software: None.

Indications for Use

Indicated for pediatric and adult patients requiring ocular implants following enucleation or evisceration, or temporary conformers to maintain eye shape and prevent adhesion during post-surgical healing.

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

• Gulden Ophthalmics Eye Sphere and Conformer (K972661)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Product and Educational Services LLC. The logo consists of the letters "PES" in a stylized font, with the words "Product and Educational Services LLC" written to the right of the letters. The text is in black and the background is white.

3 2 2009

## 510(k) Summary

Submitter's Name

Address

Product and Educational Services LLC

Bucks County Biotechnology Center 3805 Old Easton Road Doylestown, PA 18902 Phone: [phone] Facsimile: [phone]

Edward T. Griffith President

## Date of Summary:

Contact Person

26 September 2008

Proprietary Name of Device:

None

Common/Usual Name:

Classification Name:

Eye Sphere

Conformer

Implant, Eye Sphere

Conformer, Ophthalmic

Legally Marketed Equivalent Devices:

Gulden Ophthalmics Eye Sphere and Conformer (K972661)

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Image /page/1/Picture/0 description: The image shows the logo for Product and Educational Services LLC. The logo consists of the letters "PES" in a stylized font, with the words "Product and Educational Services LLC" to the right of the letters. The text is in black and the background is white.

## Summary of Device:

When an eye is severely damaged by trauma or disease, it may be necessary to remove it surgically. The most common procedures are evisceration (removal of the contents of the eye) or enucleation (removal of the eye itself). Eye spheres are permanent implants to occupy the cavity that results from surgery. Conformers are temporary devices, which maintain the shape of the eye and prevent closure or adhesion during the healing process. When healing is complete, conformers are replaced with prosthesis. Eye Spheres and Conformers are made of polymethylmethacrylate (PMMA), a hard, clear plastic that is lightweight, inert and virtually unbreakable. Eye spheres are available in even diameters from 10mm through 22mm. Conformers are available in three sizes: small, medium, large. Conformers may be ordered with or without holes. Eye spheres and Conformers are FDA Class II products.

#### Intended Use:

Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration)

Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process

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Product and
Educational Services LLC

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echnological Characteristics of the Device Compared to the Predicate Devices

| Manufacturer | Gulden Ophthalmics<br>Eye Spheres - Non Sterile<br>Conformers - Non Sterile<br>Gulden Ophthalmics | Gulden Ophthalmics<br>Eye Spheres – Sterile<br>Conformers – Sterile<br>Gulden Ophthalmics | Product and Educational<br>Services LLC<br>Eye Spheres - Sterile<br>Conformers - Non Sterile<br>Product and Educational<br>Services LLC |
|---------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | Pre-amendment | K972661 | New |
| FDA Product Class | Class II | Class II | Class II |
| Intended Population | Pediatric and Adult | Pediatric and Adult | Pediatric and Adult |
| Material | Polymethylmethacrylate<br>(PMMA) | Polymethylmethacrylate<br>(PMMA) | Polymethylmethacrylate<br>(PMMA) |
| Size Range (mm) –<br>Eye Sphere | 10, 12, 14, 16, 18, 20, and<br>22 mm | 10, 12, 14, 16, 18, 20, and<br>22 mm | 10, 12, 14, 16, 18, 20, and<br>22 mm |
| Size Range –<br>Conformers | Small, Medium, Large<br>(with and without holes) | Small, Medium, Large<br>(with and without holes) | Small, Medium, Large<br>(with and without holes) |
| Method of<br>sterilization | None | EtO (100%) and Gamma<br>Sterilization | Gamma Sterilization only |

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Image /page/3/Picture/0 description: The image shows the logo for Product and Educational Services LLC. The logo consists of the letters 'FES' in a stylized font, with the words 'Product and Educational Services LLC' to the right of the letters. The text is in a simple, sans-serif font and is black in color. The logo is simple and professional in appearance.

## Non-Clinical Tests:

Product and Educational Services LLC (PES) Eye Spheres and Conformers are the same Eye Spheres and Conformers manufactured and marketed by Gulden Ophthalmics as "non sterile". The only difference is that PES will be providing the same Eye Spheres and Conformers as sterile, single use devices. Gulden Ophthalmics Eye Spheres and Conformers are "preamendment" devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Product and Educational Services, LLC PA Biotechnology Center of Bucks County Mr. Edward T. Griffith President 3805 Old Easton Road Doylestown, PA 18902

FEB 2 7 2009

Re: K082850

Trade Name: Eye Spheres and Conformers Regulation Number: 21 CFR 886.3320 Regulatory Class: II Product Code: HPZ, HQN Dated: February 12, 2009 Received: February 17, 2009

Dear Mr. Griffith:

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 -- Mr. Edward T. Griffith

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 1 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 vours.

M.B. Egleston, MD

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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# Indications for Use

510(k) Number (if known): K082850

Device Name: Eye Spheres and Conformers

Indications for Use:

Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration)

Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Qoncurrence of CDRH, Office of Device Evaluation (ODE)

Z

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

KO 82850 510(k) Number

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