(131 days)
K 913140
Not Found
No
The device description and the lack of mentions of AI, ML, or related concepts indicate it is a physical silicone-based scar management device without AI/ML components.
Yes
The intended use states it is "For the management of hypertrophic or keloid scars," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as being "intended for use in the management of hypertrophic and keloid scars," and its description as a "soft, semi-transparent rubbery device" made of silicone sheets and oil suggests a physical treatment or management device, not one that identifies or diagnoses a condition.
No
The device description explicitly states it is composed of physical components: an outer shell of silicone sheets and an internal component filled with silicone oil. This indicates it is a hardware device, not software-only.
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 "management of hypertrophic or keloid scars." This is a therapeutic or management purpose, not a diagnostic one.
- Device Description: The device is described as a physical object made of silicone sheets and oil, applied externally. This is consistent with a topical or physical therapy device, not a device used to test samples from the body (which is the core of IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
For the management of hypertrophic or keloid scars. / SCAR CARE™ is intended for use in the management of hypertrophic and keloid scars.
Product codes (comma separated list FDA assigned to the subject device)
MDA
Device Description
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.
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.
K 913140
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
Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
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 2 9 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 (OS) 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.
1
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 (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,
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Life Medical Sciences, Inc. 379 Thornall Street Edison, NJ 08837
JUL 2 9 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: 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. 14 This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc.
3
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 propriety and its contents are the exclusive property of Life Medical Sciences, Inc. 15 This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc.
4
97,009
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 keloid scars.
management of hypertrophic and
coole
Division Division of 510(k) Numb
X Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use_
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.
008