(78 days)
K(953420)
Not Found
No
The device description and intended use clearly describe a physical silicone-based product for scar management, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the "topical management of hypertrophic and keloid scars," which is a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" states that SKAR-KARE™ is "indicated for use in the topical management of hypertrophic and keloid scars," which describes a therapeutic or management function, not a diagnostic one.
No
The device description clearly states it is composed of physical components: medical grade silicone sheets and medical grade silicone oil. This indicates it is a physical medical device, not software-only.
Based on the provided information, SKAR-KARE™ is not an IVD (In Vitro Diagnostic) device.
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. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical object made of silicone sheets and oil, designed to be applied topically. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological specimens (like blood, urine, tissue, etc.).
Therefore, SKAR-KARE™ falls under the category of a topical medical device for scar management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SKAR-KARE™ is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
Product codes
MDA
Device Description
SKAR-KARE™ 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.
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)
K(953420)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Life Medical Sciences, Inc. 379 Thornall Street Edison, NJ 08837
・・
SKAR-KARE™ 510(K) Premarket Notification Dated: August 19, 1997
13. 510(k) Summary
over-the-counter use of SKAR-KARE™ FOR THE TOPICAL MANAGEMENT OF HYPERTROPHIC OR KELOID SCARS
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: 908 494 0444 Fax: 908 494 6252
Notice: This document is propriety and its contents are the exclusive property of Life Medical Sciences, Inc. 18 Nollce. This document is propriety and its ochtente are the crosses of the Medical Sciences, Inc.
1
13.1 Device Name
ﻟ
SKAR-KARE™ is provided as follows:
-
Trade Name SKAR-KARE™ a.
・・ -
Common Name Topical dressing for hypertrophic and keloid scars b.
-
Classification Name Not available C.
13.2 Predicate Device/ Company Names and Addresses
The predicate device is listed below with its 510(k) clearance number.
| REJUVENESS™
(formerly known as
Silk*Skin) | K(953420) | RichMark International
Corporation 100 Saratoga Village
Blvd. Ballston Spa, NY 12020 |
| ------------------------------------------------- | ----------- | -------------------------------------------------------------------------------------------- |
|---|
13.3 Description of Device
SKAR-KARE™ 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.
13.4 Intended Use
SKAR-KARE™ 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. 19 Notice. This document is proprior, and its somethe art and the specific permission of Life Medical Sciences, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1997
Life Medical Sciences. Inc. ·c/o Dr. Jules T. Mitchel Target Health, Inc. 310 Madison Avenue, 22nd Floor New York, New York 10017
Re: K973271 Trade Name: SKAR-KARETM Regulatory Class: Unclassified Product Code: MDA Dated: August 29, 1997 Received: September 2, 1997
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 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.
3
Page 2 - Dr. Jules T. Mitchel
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.
A. Ottebo
Cena M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ of _
510(k) Number (if Known): K973271
Device Name: SKAR-KARE™
Indications For Use:
"SKAR-KARE™ is indicated for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds."
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off Division of General Rea 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter UseX
(Optional Format 1-2-96)