(96 days)
SKAR-KARE™-SHEET is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
SKAR-KARE™-SHEET is a soft, durable and washable elastic device for topical patient use over intact skin. It is not sterile. It is composed of a standard silicone sheeting (inert) in a flexible-link, ionic, micro-patterned appearance.
The provided text is a 510(k) Premarket Notification for the SKAR-KARE™-SHEET. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.
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SKAR-KARE™-SHEET 510(K) Premarket Notification Dated: February 11, 1998
510(k) Summary 13.
SKAR-KARE™-SHEET FOR THE TOPICAL MANAGEMENT OF HYPERTROPHIC OR KELOID SCARS
MAY 2 0 1998
Contact: Target Health Inc. 310 Madison Avenue, 22nd Floor New York, NY 10017
Tel: 212 681 2100 Fax: 212 682 0151
Sponsor: Life Medical Sciences, Inc. 379 Thornall Street Edison, NJ 08837-2227 USA
Dr. Eli Pines
Tel: 732 494 0444 Fax: 732 494 6252
Notice: This document is propriety 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. 16
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13.1. Device Name
SKAR-KARE™-SHEET is provided as follows:
- a. Trade Name SKAR-KARE™-SHEET
- b. Common Name Topical d for hypertrophic and keloid scars
- c. Classification Name 21 CFR 880.5075 ELASTIC BANDAGE
13.2. Predicate Device/ Company Names and Addresses
The predicate device is listed below with its 510(k) clearance number.
| REJUVENESSTM | RichMark International |
|---|---|
| (formerly known as | Corporation 100 Saratoga Village |
| Silk*Skin) | Blvd. Ballston Spa, NY 12020 |
13.3. Description of Device
SKAR-KARE™-SHEET is a soft, durable and washable elastic device for topical patient use over intact skin. It is not sterile. It is composed of a standard silicone sheeting (inert) in a flexible-link, ionic, micro-patterned appearance.
13.4. Intended Use
SKAR-KARE™-SHEET is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
Notice: This document is propriety 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. 17
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Jules T. Mitchel, Ph.D. Target Health, Inc. Representing Life Medical Sciences, Inc. 310 Madison Avenue, 22nd Floor New York, New York 10017
Re: K980563 SKAR-KARE™ Sheet Trade Name: Regulatory Class: Unclassified Product Code: MDA Dated: April 13, 1998 April 14, 1998 Received:
Dear Dr. Mitchel:
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 Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes.compliance..................................................................................................................... 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 Frod and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.
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Page 2 - Jules T. Mitchel, Ph.D.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Cel Director Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Life Medical Sciences, Inc. 379 Thomall Street Edison, NJ 08837
SKAR-KARE™-SHEET 510(K) Premarket Notification Dated: February 11, 1998
INDICATION FOR USE
SKAR-KARE™-SHEET is indicated for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
Biodee
PRESCRIPTION
SE
OVER THE COUNTRY X
Notice: This document is propriety 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.
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.