(96 days)
Not Found
Not Found
No
The summary describes a silicone sheet for scar management and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as being for "topical management of hypertrophic and keloid scars," which indicates it is used for treatment, thus making it a therapeutic device.
No
Explanation: The device is intended for the topical management of scars, which is a therapeutic purpose, not a diagnostic one. It does not mention any function for identifying, analyzing, or monitoring medical conditions.
No
The device description clearly states it is a "soft, durable and washable elastic device" composed of "standard silicone sheeting," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "topical management of hypertrophic and keloid scars." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical device applied to the skin, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose diseases or conditions. This device is applied to the body for treatment.
N/A
Intended Use / Indications for Use
SKAR-KARE™-SHEET is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
Product codes (comma separated list FDA assigned to the subject device)
MDA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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.