EPICERAM® is a skin barrier emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, radiation dermatitis. EPICERAM® helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Apply Epiceram® in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover Epiceram® with a dressing of choice.

Device Description

EPICERAM™ is a non-sterile, viscous, lipid-rich emulsion presented for prescription use.

AI/ML Overview

The provided text focuses on the 510(k) submission for the EPICERAM® Skin Barrier Emulsion and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific device performance metrics, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), or comparative effectiveness studies (MRMC).

The document states:

"Functional and performance testing has been conducted to assess the safety and effectiveness of EPICERAM™ Skin Barrier Emulsion and the results are satisfactory." However, it does not detail what those tests were, what the acceptance criteria were, or what the specific "satisfactory" results entail.
The FDA's letter confirms substantial equivalence based on the provided information but does not elaborate on the underlying performance data.

Therefore, I cannot fulfill most of the requested points based on the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "Functional and performance testing has been conducted... and the results are satisfactory," but it does not list specific acceptance criteria or report quantitative device performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document makes no mention of study design, sample sizes, or data provenance for any testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. There is no mention of independent experts, ground truth establishment, or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. There is no mention of any adjudication method.

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

Cannot be provided. This document is for a topical skin emulsion, not an AI-assisted diagnostic device. Therefore, an MRMC study as described (comparing human readers with/without AI assistance) is not applicable and not mentioned.

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

Cannot be provided. As explained above, this is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. There is no information regarding how "satisfactory" results were defined or validated, or what type of ground truth (if any formal one was used beyond clinical observation) was applied.

8. The sample size for the training set

Cannot be provided. This is not an AI/machine learning device that would require a "training set."

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

Cannot be provided. Not applicable for this type of device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices for a topical skin barrier emulsion, not on detailed clinical trial results with specific acceptance criteria or performance metrics typically seen for diagnostic devices or AI algorithms.

Summary

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K052643

APR 1 1 2006

510(k) Summary

1. Submission Applicant & Correspondent

Ceragenix Corporation Name: 1444 Wazee Street Address: Suite 210 Denver, Colorado 80202

Phone No. (720) 946-6440

Carl Genberg, J.D. Contact Person:

EPICERAM® Skin Barrier Emulsion 2. Name of Device:

Trade/Proprietary/Model Name: EPICERAM®

Skin Barrier Emulsion Common or Usual Name:

Classification Name:

Dressing, Wound & Burn, Hydrogel w/Drug or Biologic .

Devices to Which New Device is Substantially Equivalent:

Sinclair Wound and Skin Emulsion™ Sinclair Pharmaceuticals, Ltd � (K024367, July 28, 2003);
Biafene Wound Dressing Emulsion (Radiodermatitis Emulsion) Medix . Pharmaceuticals Americas, Inc. (K964240, Jan. 22, 1997);
Carrasyn® Hydrogel Wound Dressing, which is also marketed under the . name RadiaCare Gel Hydrogel Wound Dressing - Carrington Laboratories, Inc. (K961758, July 11, 1996); and
Mimyx™ Cream Steifel Laboratories, Inc. (K041342, July 19, 2005) �

3. Device Description:

EPICERAM™ is a non-sterile, viscous, lipid-rich emulsion presented for prescription use.

4. Intended Use of the Device:

The device is intended to be used as a topical skin care preparation applied at least twice daily to affected areas of the skin to improve dry skin conditions and to relieve and to manage the burning, itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment.

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All products referenced are non sterile emulsion/gel types that are applied All products releve the symptoms of various dermatoses, including, but not limited to atopic dermatitis, irritant contact dermatitis and radiation dermatitis.

6. Tests and Conclusions:

Functional and performance testing has been conducted to assess the safety and Functiveness of EPICERAM™ Skin Barrier Emulsion and the results are satisfactory.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

APR 1 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ceragenix Corporation c/o Mr. Carl Genberg Senior Vice President, R&D 1444 Wazee Street Denver, Colorado 80202

Re: K052643

Trade/Device Name: EPICERAM™ Skin Barrier Emulsion Regulatory Class: Unclassified Product Code: FRO Dated: January 17, 2006 Received: January 17, 2006

Dear Mr. Genberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Carl Genberg

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Page 1 of 1

K052643 510(k) Number:

Device Name:

EPICERAM™ Skin Barrier Emulsion

Indications for Use:

FOR TOPICAL DERMATOLOGICAL USE ONLY

Apply Epiceram® in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover Epiceram® with a dressing of choice.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) 00 MD Division of General, Restorative, and Neurological Devices

510(k) Number_K052643

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use

(Per 21 C.F.R. § 801.109)

Regulation Number and Section

N/A