SCAR CARE

K971009 · Target Health, Inc. · MDA · Jul 29, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971009
• Device Name: SCAR CARE
• Applicant: Target Health, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For the management of hypertrophic or keloid scars.

Device Story

SCAR CARE™ is a topical dressing for hypertrophic and keloid scars. Device consists of an outer shell of medical-grade silicone sheets sealed together, containing an internal component of medical-grade silicone oil. It is a soft, semi-transparent, rubbery dressing applied topically to the scar site. The device functions as a physical barrier/dressing to manage scar tissue. It is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Topical dressing; materials: medical-grade silicone sheets and medical-grade silicone oil; form factor: soft, semi-transparent, rubbery sheet; non-powered; no software or electronic components.

Indications for Use

Indicated for the management of hypertrophic and keloid scars in patients requiring topical dressing therapy.

Regulatory Classification

Identification

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

Predicate Devices

• TopiGel™ Gel Sheeting (K913140)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Dr. Jules T. Mitchell
Target Health, Inc.
310 Madison Avenue, 22nd Floor
New York, New York 10017

JUL 29 1997

Re: K971009
Trade Name: SCAR CARE™
Regulatory Class: Unclassified
Product Code: MDA
Dated: June 17, 1997
Received: June 17, 1997

Dear Dr. Mitchell:

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 - Dr. Jules T. Mitchell

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,


Enclosure

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K971009

Life Medical Sciences, Inc.
379 Thornall Street
Edison, NJ 08837
JUL 29 1997

SCAR CARE™
510(K) Number: K971009
Amendment 1: March 28, 1997
Amendment 2: June 17, 1997

12.510(k) Summary

SCAR CARE™ FOR THE KELOID SCARS
MANAGEMENT OF HYPERTROPHIC OR

Contact: Target Health, Inc.
310 Madison Avenue, 22nd Floor
New York, NY 10017

Tel: [phone]
Fax: [phone]

Sponsor: Life Medical Sciences, Inc.
379 Thornall Street
Edison, NJ 08837-2227 USA

Dr. Eli Pines

Tel: [phone]
Fax: [phone]

Notice: This document is proprietary and its contents are the exclusive property of Life Medical Sciences, Inc. This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc. 14

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Life Medical Sciences, Inc.
379 Thornall Street
Edison, NJ 08837
SCAR CARE™
510(K) Number: K971009
Amendment 1: March 28, 1997
Amendment 2: June 17, 1997

a. Device Name

SCAR CARE™ is provided as follows:

a. Trade Name - SCAR CARE™
b. Common Name - Topical dressing for hypertrophic and keloid scars
c. Classification Name - Not available

b. Predicate Device/ Company Names and Addresses

The predicate device is listed below with its 510(k) clearance number.

| TopiGel™ Gel Sheeting | K 913140 | CUI Corporation
PO Box 40288
Santa Barbara, CA 93140 |
| --- | --- | --- |

c. Description of Device

SCAR CARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.

d. Intended Use

For the management of hypertrophic or keloid scars.

Notice: This document is proprietary and its contents are the exclusive property of Life Medical Sciences, Inc. This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc. 15
012

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k971009

Life Medical Sciences, Inc.

379 Thornall Street

Edison, NJ 08837

SCAR CARE™

510(K) Number: K971009

Amendment 1: March 28, 1997

Amendment 2: June 17, 1997

# INDICATION FOR USE

SCAR CARE™ is intended for use in the management of hypertrophic and
keloid scars.


(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971009

Prescription Use ☑
(Per 21 CFR 801.109)

Over-the-Counter Use

Notice: This document is proprietary and its contents are the exclusive property of Life Medical Sciences, Inc.

This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc.