EVANESCE SCAR MANAGEMENT SYSTEM

K981387 · Medical Scientific, Inc. · MDA · Jun 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981387
• Device Name: EVANESCE SCAR MANAGEMENT SYSTEM
• Applicant: Medical Scientific, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Jun 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Evanesce Scar Management System is intended for the over the counter, topical treatment and management of hypertrophic and keloid scars. Do not use on open wounds.

Device Story

Evanesce Scar Management System consists of soft, flexible, translucent silicone elastomer sheeting; applied topically to hypertrophic and keloid scars. Device functions as physical barrier for scar management; intended for over-the-counter use by patients. No active components, electronics, or software involved. Clinical benefit derived from topical application to manage scar tissue.

Clinical Evidence

No clinical data provided; device is a silicone elastomer sheet for topical use.

Technological Characteristics

Soft, flexible, translucent silicone elastomer sheeting. Passive device; no energy source or software.

Indications for Use

Indicated for over-the-counter topical management of hypertrophic and keloid scars. Contraindicated for use on open wounds.

Regulatory Classification

Identification

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

Predicate Devices

• SCAR HEAL (K971468)

Submission Summary (Full Text)

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JUN 10 1998

13.

Medical Scientific, Inc. 125 John Hancock Blvd. Taunton, MA 02780

13.1

Evansece Scar Management System 510(k) Premarket Notification April 15, 1998

510(k) SUMMARY: K 981387

over the counter use of Evanesce scar management SYSTEM FOR THE TOPICAL MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS.

CONTACT: Paul Nardella Medical Scientific, Inc. 125 John Hancock Rd. Taunton, MA 02780

> Tel: [phone] Fax: [phone]

- SPONSOR: 13.2
Medical Scientific, Inc. 125 John Hancock Rd. Taunton, MA 02780

Tel: [phone] Fax: [phone]

Paul Nardella

DEVICE NAME: -- 13.3

.

A.) TRADE NAME:

EVANESCE Scar Management System

.

## B.) COMMON NAME:

Silicone Elastomer Sheeting for the treatment and managment of hypertrophic and keloid scars

C.) CLASSIFICATION NAME:

Not Available

Notice: This document is proprietary and its contents are the exclusive property of Medical Scientific, Inc, This document may not be reproduced in any form without the specific permission of Medical Scientific, Inc.

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Medical Scientific, Inc. 125 John Hancock Blvd. Taunton, MA 02780

Evansece Scar Management System 510(k) Premarket Notification April 15, 1998

PREDICATE DEVICE: 13.4

SCAR HEAL

Specialty Systems, Inc. 1312 Veracruz Lane Weston FL 33327

510(k) K971468

## DEVICE DESCRIPTION 13.5

The Evanesce Scar Management System is composed of a sheet of soft, flexible, translucent silicone elastomer.

INTENDED USE: 13.6

The Evanesce Scar Management System is intended for the over the counter, topical treatment and management of hypertrophic and keloid scars. Do not use on open wounds.

## PAGE-11-

Notice: This document is proprietary and its contents are the exclusive property of Medical Scientific, Inc, This document may not be reproduced in any form without the specific permission of Medical Scientific, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1998

Mr. Paul C. Nardella ·Medical Scientific, Incorporated 125 John Hancock Road Taunton, Massachusetts 02780

Re: K981387 Evanesce Scar Management System Trade Name: Regulatory Class: Unclassified Product Code: MDA Dated: April 14, 1998 Received: April 16, 1998

Dear Mr. Nardella:

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 reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and pronibitions 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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## Page 2 - Mr. Paul C. Nardella

This letter will allow you to begin marketing your device as described in your 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 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 device, 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,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known):K981387

Device Name: Evanesce Scar Management System

Indications for Use:

The Evanesce Scar Management System is intended for the over the counter topical management of Hypertrophic and Keloid Scars

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Acedo

ign-Off) on of General Restorative Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter Use

(Optional Format 1-2-96)