EYE SPHERE, CONFORMERS

K972661 · Gulden Ophthalmics · HPZ · Oct 3, 1997 · Ophthalmic

Device Facts

• Record ID: K972661
• Device Name: EYE SPHERE, CONFORMERS
• Applicant: Gulden Ophthalmics
• Product Code: HPZ · Ophthalmic
• Decision Date: Oct 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Eye Spheres: To occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration). Conformers: To maintain the shape of the eye and prevent closure or adhesion during the healing process.

Device Story

Eye Spheres are permanent implants for eye cavity occupation post-enucleation or evisceration; Conformers are temporary devices for maintaining eye shape and preventing adhesion during healing. Both devices are manufactured from Polymethylmethacrylate (PMMA). They are provided sterile via Ethylene Oxide (EtO) or Gamma radiation. Devices are used in clinical settings by ophthalmologists during or after surgical procedures. The devices provide structural support to the eye socket; they do not involve electronic processing, software, or algorithms.

Clinical Evidence

No clinical data. Products have been in commercial distribution since before July 1976 and are generally regarded as safe.

Technological Characteristics

Material: Polymethylmethacrylate (PMMA). Form factor: Eye spheres (8-22 mm) and conformers (Small, Medium, Large). Sterilization: 100% Ethylene Oxide (EtO) or Gamma radiation validated per ANSI/AAMI/ISO 11737-1-1995.

Indications for Use

Indicated for pediatric and adult patients requiring eye cavity occupation following enucleation or evisceration (Eye Spheres) or maintenance of eye shape and prevention of adhesion during healing (Conformers).

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

• Eye Sphere - Non Sterile (Pre-amendment)
• Conformers - Non Sterile (Pre-amendment)
• Eye Sphere - Sterile (K921106)
• Conformers - Sterile (K921106)

Submission Summary (Full Text)

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K972661

# 510(k) SUMMARY

OCT - 3 1997

as required per 807.92(c)

2: Submitters Name, Address:

Gulden Ophthamics, Inc 225 Cadwalader Drive Elkins Park, Pa 19027

Date submission was prepared: July 7, 1997 Establishment Registration Number: 2519410

Telephone: [phone] Fax: [phone] Official Correspondent: Mr. Thomas Cockley

#### 3: Trade Name, Common Name and Classification Name:

A. Trade Name:

Eye Sphere - Sterile Conformer - Sterile B. Common Name, Classification Number, Class and Regulation Number,

(

| ommon Name | f<br>t<br>lassification Number | Jase | Number<br>egulation 1 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------|-----------------------|
| Implant<br>Hve<br>Sphere | 86HP7 | | 000 9900<br>600-332 |
| onrormer,<br>ophthalmic<br>A CONSULT LA A LA LE LE LE LE LE LE LE LE LA LA LE LA LE LA LEA LE LA LA LA LEA LE LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA L | 86HON | | 886,3130 |

#### 4: Predicate Device Identification:

Eye Sphere - Non Sterile Eye Sphere - Sterile Conformers - Non Sterile Conformers - Sterile

ﺳﮯ

Gulden Ophthalmics, Elkins Park, PA Storz Instruments, St. Louis, Mo Gulden Ophthalmics, Elkins Park, PA Storz Instruments, St. Louis, Mo

Pre-amendment K921106 Pre-amendment K921106

:

# 5. Device Description:

:

Eye Spheres: 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: Conformers are temporary devices that maintain the shape of the eye and prevent closure or adhesion during the healing process. 1

## 6. Intended Use:

Eye Spheres: To occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).

Conformers: To maintain the shape of the eye and prevent closure or adhesion during the healing process.

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K972661

| | | 7. Table of device similarities and differences to predicate device |
|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 4 (4 ступравленные продавления при при при при приведение при полнение пристементительности по полнение пристементительности по полнением пристем в политические по политическ |

| | Substantial Equivalence<br>Gulden Ophthalmics<br>Eye Spheres - Non Sterile<br>Conformers - Non Sterile | Substantial Equivalence<br>Storz Ophthalmics<br>Eye Spheres - Sterile<br>Conformers - Sterile | Gulden Ophthalmics<br>Eye Spheres - Sterile<br>Conformers - Sterile |
|--------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Manufacturer | Gulden Ophthalmics | Manufactured for Storz<br>Instruments by Gulden<br>Ophthalmics | Gulden Ophthalmics |
| 510K Number | Pre-amendment | K921106 | New |
| FDA Product Class | Class II | Same | Same |
| Intended Population | Pediatric and Adult | Same | Same |
| Material | Polymethylmethacrylate<br>(PMMA) | Same | Same |
| Size Range - Eye spheres | 8, 10, 12, 14, 16, 18, 20<br>and 22 mm | Same | Same |
| Size Range - Conformers | Small, Medium, Large | Same | Same |
| Method of sterilization | None | EtO (88%) | EtO(100%) and<br>Gamma Sterilization |

8. Assessment of non-clinical performance data for equivalence: The Gulden Ophthalmics "sterile" eye spheres and "sterile" conformers are exactly the same as the eye spheres and conformers sold as "non-sterile" by Gulden Ophthalmics. Gulden supplies Storz Instruments with Gulden's "non-sterile" eve spheres and conformers. Storz Instruments sterlizes these products with Ethylene Oxide (EtO) and distributes them as "sterile". Gulden proposes to offer for sale the same eye spheres and conformers as sterile.

9. Assessment of clinical performance data for equivalence: Not applicable. These products have been in commercial distribution since before July 1976 and are generally regarded as safe.

10. Biocompatability: PMMA: Generally Regarded as Safe

Exposure Time

Post Vacuum

Aeration time

#### 11. Sterilization:

A. ETO. 100% Ethylene Oxide 130 +5 °F / + 3 ° C Temperature Pre-Vacuum 24" - 26" inHg / 610 - 660 mmHg Relative Humidity 60 + 10 % RH Humidity Dwell Sterilant Gas EO Concentration

30 - 45 minutes Ethylene Oxide, 100% 600 + 30 mg/l 2 hours + 5 minutes 24" - 26" / 610 - 660 mmHg (2 times) Mechanical Aeration temp. 110 - 124 ° F / 43 - 51° C 48 Hours (minimum) 72 Hours (Recommended)

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K9726le1

、

- B. Gamma Radiation
- Bioburden Studies per ANSI/AAMI/ISO 11737-1-1995, "Sterilization of Medical devicesl . Microbiological Methods-Part 1: Estimation of population of microorganisms on product" AAMI Method 1
- Gamma Sterilization at dose validated by bioburden studies 2.
- Each lot to be validated rather than routine monitoring studies. 3.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines or shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Cockley President Gulden Ophthalmics 225 Cadwalader Avenue Elkins Park, PA 19117-2097

OCT - 3 1997

Re: K972661

Trade Name: Eye Sphere and Conformer Regulatory Class: II Product Code: 86 HPZ and 86 HQN Dated: July 7, 1997 Received: July 16, 1997

Dear Mr. Cockley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Thomas Cockley

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indicated Use Statement

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

Danne lochner

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(Division Sign-Off)

Division of Ophthalmic Devices K972661 510(k) Number _

Prescription Use. (Per 21 CFR 801.109)

# Company Confidential