KMC Ultra-Sil Scar Management System is a thin, soft silicone sheet designed to be applied externally, in a non-invasive manner to healed keloid and hypertrophic scars. Scar area is to be washed and towel dried before application. KMC Ultra-Sil Scar Management System is applied to scar area with 1/2 inch overlap. Initial application to last 2-3 hours. Successive applications will increase contact by 1 hour each until 8 hour contact is reached. Application time of 20 hours is recommended.

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, or any studies with sample sizes, expert involvement, or statistical analysis. The document is a 510(k) summary for the "KMC Ultra-Sil Scar Management System," which primarily focuses on establishing substantial equivalence to a predicate device (Degania Silicone Sil-K, 510(k) No. K971482).

The 510(k) summary outlines:

Device Description and Use: A thin, soft silicone sheet for external, non-invasive application to healed keloid and hypertrophic scars. It details application instructions (e.g., wash scar area, initial application of 2-3 hours, increasing to 8 hours, with 20 hours recommended).
Manufacturing: States it uses essentially the same silicone materials and manufacturing practices as the predicate device.
Substantial Equivalence: The core claim, stating it's substantially equivalent to the Degania Silicone Sil-K.

Therefore, I cannot populate the requested table or provide details about a study that proves the device meets acceptance criteria. The document does not describe such a study or associated data points. The FDA's letter (Document {1}) confirms the substantial equivalence determination, allowing the device to be marketed, but does not refer to specific performance criteria or a study done by the applicant to prove these criteria were met, beyond the substantial equivalence argument.

Summary

{0}------------------------------------------------

K974143 MAR 2 7 1998

510(k) SUMMARY 510(k) #: K974143

Trade Name: "KMC Ultra-Sil"

Common Name: Silicone Elastomer Sheet

Device Class: Unclassified

Classification Panel: General & Restorative Devices

Establishment Registration No .: To be filled

This summary of 510 (k) safety and effectivencss is submitted in accordance with 21CFR 807.92 and as defined in 21CFR 807.3

DEVICE DESCRIPTION and USE:

MANUFACTURING:

KMC Ultra-Sil Scar Management System is manufactured using essentially the same silicone materials and industry manufacturing practices as re claimed SL product, Degania Silicone Sil-K.

SUBSTANTIAL EQUIVALENCE

KMC Ultr-Sil Scar Management System is substantially equivalent to Degania Silicone Sil-K, 510 (k) No. K971482.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three stylized wing segments, symbolizing health, services, and human needs. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 1998

John Harrison, Ph.D. Technical/Regulatory Consultant KMC International 5662 Calle Real, #331 Goleta, California 93117

Re: K974143 Ultra-Sil Scar Management System Trade Name: Regulatory Class: Unclassified Product Code: MDA February 24, 1998 Dated: Received: March 2, 1998

Dear Dr. Harrison:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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.

{2}------------------------------------------------

Page 2 - Dr. Harrison

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 requlation (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.qov/cdrh/dsmamain.html".

Sincerely yours,

f Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{3}------------------------------------------------

K974143

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: "KMC Ultra-Sil Scar Management System"

Indications For Use:

KMC Ultra-Sil Scar Management System is a thin, soft silicone KMC ofera-SIF Scar handyement application for keloid and hypertrophic scar management.

KMC Ultra-Sil Scar Management System is intended to be used only on healed scars.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __
(Per 21 CFR 801.109)
OR
Over-The-Counter Use $\boxed{✓}$
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: __K974143

Regulation Number and Section

§ 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.