MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT

K962013 · Mentor Corp. · MDA · Aug 22, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962013
• Device Name: MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
• Applicant: Mentor Corp.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Aug 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Mentor H/S Silicone Gel Sheeting for Scar Management is indicated for treatment of hypertrophic and keloid scars. This therapy does not remove the scar but will flatten and soften the scar tissue as well as return a more natural palor to the scar area.

Device Story

Mentor H/S Silicone Gel Sheeting treats hypertrophic and keloid scars; flattens/softens scar tissue; improves scar color. Device consists of silicone sheets reinforced with polyester mesh; supplied sterile. Used by patients or physicians; sheets cut to size to fit treatment area. Applied topically to scar site. Benefits include improved scar appearance and texture.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone elastomer sheeting reinforced with polyester mesh. Supplied sterile. Form factor: cuttable sheets.

Indications for Use

Indicated for treatment of hypertrophic and keloid scars. Contraindicated for patients unable to properly use/clean dressing, open wounds, known silicone elastomer allergy, or if rash develops.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Predicate Devices

• DermaSof by McGhan Medical Corp.
• Epi-Derm Silicone Gel Sheeting by Biodermis Corp.
• TopiGel by CUI Corp.
• Sil-K by Degania Silicone

Submission Summary (Full Text)

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AUG 22 1996
K962013
Page 1 of 2

# SUMMARY OF SAFETY AND EFFECTIVENESS

## MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT

### 510(k) SUMMARY

1. Submitter's Data
Mentor Corporation
5425 Hollister Avenue
Santa Barbara, CA 93111

Contact Person(s): Byron Wickett or Lynn Breckenridge

Telephone: [phone]

Date Prepared: February, 1996

2. Device Name, Classification
Name: Mentor H/S Silicone Gel Sheeting for Scar Management
FDA Classification: Class II, Elastomer, Silicone, for Scar Management (FDA Code 79MDA)

3. Identification of Substantially Equivalent Devices
DermaSof by McGhan Medical Corp.
Epi-Derm Silicone Gel Sheeting by Biodermis Corp.
TopiGel by CUI Corp.
Sil-K by Degania Silicone

4. Device Description
The Mentor H/S Silicone Gel Sheeting for Scar Management is designed to treat hypertropic and keloid scars. This therapy does not remove the scar, but will flatten and soften the scar tissue as well as return a more natural palor to the scar area. The material will be supplied sterile in sheets of silicone reinforced with polyester mesh. The sheets may be cut by the patient and/or the physician to a desired size to fit the scar treatment area.

**MENTOR CONFIDENTIAL**
**TRADE SECRET**
000070

20°d 7009 189 508
S81676 80167638-80167638
SP:TT 966T-11-7n

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TOTAL P. 03
K962013
Page 2 of 2

The Mentor H/S Silicone Gel Sheeting for Scar Management is indicated for treatment of hypertrophic and keloid scars. This therapy does not remove the scar but will flatten and soften the scar tissue as well as return a more natural palor to the scar area.

## 6. Contraindications for Use

Clinical contraindications for use of the Mentor H/S Silicone Gel Sheeting for Scar Management may include use by patients with medical conditions that would prevent them from using and cleaning the dressing properly. This product should not be applied over an open wound. The product should not be used if the patient is known to be allergic to silicone elastomers or if a rash develops.

## 7. Warnings, Precautions

Possible complications include:

- skin rashes attributed to poor or insufficient hygiene
- skin rashes attributed to the gel sheeting being applied too tightly
- superficial maceration of the skin associated with an occlusive dressing
- pruritis

MENTOR CONFIDENTIAL TRADE SECRET
000071
JUL-11-1996 11:46
MENTOR-REGULATORY AFFAIRS
805 681 6004 P. 03