Sil-K is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars. Sil-K is designed to be used only after the skin has completely healed and is non invasive.

AI/ML Overview

This document is a 510(k) summary for Degania Silicone Sil-K, a silicone elastomer sheet used to treat hypertrophic or keloid scars. It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested elements for a study proving device meets acceptance criteria cannot be extracted because such a study is not detailed in the provided text.

Here's a breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text, as this is a 510(k) for substantial equivalence, not a performance study against specific criteria. The core acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
Reported Device Performance: Not detailed in terms of measurable outcomes (e.g., scar height reduction, pain relief) from a clinical study. The document states the device "is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars," implying its intended function, but no performance metrics are provided.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No test set or clinical study is described.
Data Provenance: Not applicable. No study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set or ground truth establishment by experts is described.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a silicone sheet, not an AI-powered diagnostic tool. MRMC studies are irrelevant in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used:

Not applicable. No ground truth is established as no performance study is detailed.

8. The sample size for the training set:

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Key Information from the Document Regarding "Acceptance Criteria" for a 510(k):

The primary "acceptance criteria" for a 510(k) submission is to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device.

Predicate Device: "We are Substantially Equivalent to ourselves." This statement indicates that Degania Silicone is submitting for a new Premarket Notification for a device (Sil-K) that is deemed substantially equivalent to a previous version of their own device that was already cleared (510(k) number K914701).
Basis for SE: The document states: "The Sil-K is manufactured from the same raw materials, from the same vendors and using the same manufacturing processes as our previous 510(k)." This is the justification for claiming substantial equivalence.

In essence, the "study" proving the device meets 510(k) acceptance criteria (i.e., substantial equivalence) is the comparison of the manufacturing process, raw materials, and intended use of the new Sil-K device to its previously cleared predicate device, and finding them identical or sufficiently similar. There is no performance study against specific clinical outcomes detailed in this document.

Summary

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Image /page/0/Picture/0 description: The image shows a circular logo with the text "ISO 9001" in the center. The logo is surrounded by the text "Standardization of Israel". The image is black and white and appears to be a scan or photocopy. The logo is slightly distorted and the text is not perfectly clear.

Image /page/0/Picture/1 description: The image shows the words "Degania Silicone" in a bold, sans-serif font. The word "Degania" is in black, while the word "Silicone" is in white with a black outline. The words are next to each other, with "Degania" on the left and "Silicone" on the right.

JUN 2 4 1997

Degania Silicone Ltd. Degania Bet 15130, Israel. Tel: 972-6-755712, Fax: 972-6-709182

TÜV

APPENDIX E

510 (k) SUMMARY

K971482

Trade Name: Degania Silicone Sil-K

Common Name: Silicone Elastomer Sheet

Device Class: Unclassified

Classification Panel: General & Restorative Devices

Establishment Registration Number: 8030107

This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 JER 807:92.

DEVICE DESCRIPTION AND USE:

Sil-K is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars.

Sil-K is designed to be used only after the skin has completely healed and is non invasive.

MANUFACTURING:

The Sil-K is manufactured from the same raw materials, from the same vendors and using the same manufacturing processes as our previous 510(k).

SUBSTANTIAL EQUIVALENCE:

We are Substantially Equivalent to ourselves.

selta

Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone

16 april 1997
Date

2 Y/29

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Image /page/1/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUM. SERVICES - USA". The symbol in the center appears to be three stylized human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1997

Ms. Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone Ltd. ························································································································································ Degania Bet 15130 Israel

Re: K971482 Trade Name: Degania Silicone Sil-K Regulatory Class: Unclassified Product Code: MDA Dated: April 16, 1997 Received: April 21, 1997

Dear Ms. Lubin:

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.

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Page 2 - Ms. Bette Lubin

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,

Celia M. Witten. P.

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

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Image /page/3/Picture/0 description: The image shows the words "Degania Silicone" in a split-screen format. The word "Degania" is in white letters on a black background, while the word "Silicone" is in black outline letters on a white background. The two words are side-by-side, creating a visually contrasting effect.

Image /page/3/Picture/1 description: The image shows a black and white seal with the text "ISO 9002" in the center. The text "The Standards Institution of Israel" is written around the circle. The seal appears to be stamped or printed, as the edges are not perfectly clean and there are some smudges around the perimeter.

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Degania Silicone Ltd. Degania Bet 15130, Israel. Tel: 972-6-755712, Fax: 972-6-709182

长971482

INDICATIONS FOR USE

Device Name: Degania Silicone Sil-K

Indications For Use: The Sil-K is designed and indicated for treating thick painful, itchy, red and raised hypertrophic or keloid scars.

Degania Silicone Ltd. is submitting a new Premarket Notification begania birreone noa. It banketery of the previous 510(k) number is K 914701.

Orvision Sign-Off) Division of General Restorative Devices K971482 510(k) Number _

FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use: (Fer 21 CFR 801:109) Over-The-Counter :

(Optional Format 1-2-96)

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.