SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS

K950806 · Mira, Inc. · HQX · Jun 5, 1996 · Ophthalmic

Device Facts

• Record ID: K950806
• Device Name: SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
• Applicant: Mira, Inc.
• Product Code: HQX · Ophthalmic
• Decision Date: Jun 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.

Device Story

Molded extruded silicone devices; used as scleral buckling implants in retinal reattachment surgery. Implants occupy space and provide compression to the sclera. Used by ophthalmic surgeons in clinical settings. Device function remains unchanged from predicate; modification limited to silicone material source.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per FDA Tripartite Guidance and Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials. Results confirmed devices are non-toxic and biocompatible.

Technological Characteristics

Molded extruded silicone; provided sterile. Physical properties equivalent to original Dow Corning material. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients undergoing retinal reattachment surgery requiring scleral buckling.

Regulatory Classification

Identification

An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

Predicate Devices

• Solid Silicone (preamendment)
• Silicone Sponge Implants (K780987A)

Submission Summary (Full Text)

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K950806

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Solid Silicone and Silicone Sponge Implants
JUN - 5 1995

## 1. APPLICANT

MIRA, Inc.
87 Rumford Avenue
Waltham, MA 02154
Contact Person: Michael A. Warren
Telephone: [phone] (In MA, 617-894-2200)
Facsimile: 617-647-1855
Date of Summary Preparation: February 21, 1995

## 2. DEVICE NAME

Proprietary Name: Solid Silicone and Silicone Sponge Implants
Common/Usual Name: Scleral Buckling Device
Classification Name: Extraocular Orbital Implants

## 3. PREDICATE DEVICE

MIRA, Inc. claims substantial equivalence of the Solid Silicone and Silicone Sponge Implants to currently marketed Solid Silicone (preamendment) and Silicone Sponge Implants (K780987A) manufactured and marketed by MIRA, Inc.

## 4. DEVICE DESCRIPTION

Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.

MIRA, Inc. 510(k) for Change in Silicone Material 2/21/95 Page F-1

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MIRA, Inc. 510(k) for Change in Silicone Material 2/21/95 Page F-2

# 5. INTENDED USE

The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.

# 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF THIS DEVICE TO THE PREDICATE

- Operational Principles

The general operational principles are identical. Buckling implants are used to occupy space and provide compression for retinal reattachment. The change in materials has no impact on the function of these implants.

- Materials of Construction

The only difference between the modified Solid Silicone and Silicone Sponge Implants is the silicone material. This difference is minor and does not affect safety or effectiveness.

- Models Available

The models of Solid Silicone and Silicone Sponge Implants is unchanged.

- Sterility Status

The Solid Silicone and Silicone Sponge Implants, like the currently marketed devices, are provided sterile.

# 7. TESTING

- Non-clinical Testing

Non-clinical testing was performed to show that the new material used for the manufacture of MIRA Solid Silicone and Silicone Sponge Implants is not substantially

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different from that of the original Dow Corning material. Physical testing was performed by the material supplier with results provided in FDA Master Files.

- Biocompatibility

There is no change in biocompatibility. Sterilized finished devices manufactured with new silicone material were tested for biocompatibility according to FDA "Tripartite Guidance" and according to "Table IV. Confirmatory Biological Testing" referenced in FDA "Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials. Testing demonstrated that the implants were non-toxic and biocompatible.

MIRA, Inc. 510(k) for Change in Silicone Material 2/21/95 Page F-3