(197 days)
Not Found
No
The document describes a topical skin barrier emulsion and does not mention any AI or ML components in its intended use, device description, or performance studies.
No
The product is described as a "skin barrier emulsion" (a topical cream/lotion) which is used for treating dry skin conditions and relieving associated symptoms. This function aligns with the definition of a drug or cosmetic rather than a therapeutic device, especially considering it helps maintain a "moist wound & skin environment, which is beneficial to the healing process" and is covered with a "dressing of choice" if the skin is broken. Its classification as a "Drug/Biologic" device type in the K024367 predicate, specifically a "Barrier, Topical" further solidifies this.
No
Explanation: This device is described as a skin barrier emulsion for treating dry skin conditions and managing symptoms of dermatoses. There is no mention of it being used to diagnose conditions or process any kind of diagnostic information.
No
The device description clearly states it is a "viscous, lipid-rich emulsion," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical dermatological application to treat dry skin conditions and manage symptoms associated with various dermatoses. This is a direct application to the body surface for therapeutic and symptomatic relief.
- Device Description: It's described as a "skin barrier emulsion" for "topical dermatological use only."
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality. IVDs are used in vitro (outside the body) for diagnostic purposes.
Therefore, EPICERAM® is a topical medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
FOR TOPICAL DERMATOLOGICAL USE ONLY
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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
EPICERAM™ is a non-sterile, viscous, lipid-rich emulsion presented for prescription use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Functional and performance testing has been conducted to assess the safety and Functiveness of EPICERAM™ Skin Barrier Emulsion and the results are satisfactory.
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.
K024367, K964240, K961758, K041342
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
N/A
0
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.
1
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.
2
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.
3
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
4
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
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) 00 MD Division of General, Restorative, and Neurological Devices
510(k) Number_K052643
OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-the-Counter Use
(Per 21 C.F.R. § 801.109)