(267 days)
Not Found
No
The 510(k) summary describes a topical cream and its intended use for treating skin conditions. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device description focuses on the physical properties and function of the cream as a barrier.
Yes.
The device is intended to "manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis" and "aids to relieve dry, waxy skin by maintaining a moist wound and skin environment," directly indicating its therapeutic purpose.
No
The given text describes a topical cream for managing symptoms of seborrhea and seborrheic dermatitis. Its function is to relieve symptoms and maintain a moist skin environment, not to diagnose a condition.
No
The device description clearly states it is a "topical cream," which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Dermiseb Cream is a topical cream applied to the skin to manage and relieve symptoms of seborrhea and seborrheic dermatitis. This is a direct treatment applied to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description confirms it's a topical cream forming a physical barrier on the skin.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Dermiseb Cream does not fit this description.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, Dermiseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Dermiseb Cream also aids to relieve dry, waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.
Dermiseb Cream in indicated for use in:
- Seborrhea ●
- · Seborrheic Dermatitis
Product codes
FRO
Device Description
Non-sterile, off-white to slight pale-yellow colored, low odor, steroid-free, fragrance free, topical cream. Dermiseb Cream forms a physical barrier to relieve dry waxy skin by maintaining a moist wound and skin environment, and will be marketed in a 30 g tube as a prescription 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
healthcare professional
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)
Non-clinical testing was conducted to confirm the safe and effective performance of Dermiseb Cream.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for IGI Laboratories. The logo is black and white and features the letters "IGI" in a stylized font. Below the letters is the word "LABORATORIES" in a smaller font. The logo has a modern and professional look.
AUG 2 8 2013
123724
510(k) Summary
| Submitter | IGI Laboratories, Inc.
105 Lincoln Ave
P.O. Box 687
Buena, NJ 08310 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Frederick Weiss
Director, QA/QC/Analytical/RA
Tel: (856) 697-1441, ext 360
Fax: (856) 697-2259 |
| Date Prepared | November 29, 2012 |
| Trade Name | Dermiseb Cream |
| Common Name | Dressing, Wound & Burn, Hydrogel w/drug and/or biologic |
| Classification Name | Dressing, Wound & Burn, Hydrogel w/drug and/or biologic |
| Predicate Device | Promiseb® Topical Cream; marketed by Promius Pharma, LLC 510(k) K050158 |
| Description | Non-sterile, off-white to slight pale-yellow colored, low odor, steroid-free, fragrance free, topical cream. Dermiseb Cream forms a physical barrier to relieve dry waxy skin by maintaining a moist wound and skin environment, and will be marketed in a 30 g tube as a prescription device. |
| Indications for Use | Under the supervision of a healthcare professional, Dermiseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Dermiseb Cream also aids to relieve dry, waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process. |
| Device Description
and Comparison | Both the proposed and referenced predicate devices are oil-in-water emulsions, which add moisture to the skin, and form a physical barrier. |
| Substantial
Equivalence | The product is similar in function and intended use to Promiseb® Topical Cream marketed by Promius Pharma LLC and includes identical ingredients, indicated uses, and operating principles. |
| Non-clinical
Performance | Non-clinical testing was conducted to confirm the safe and effective performance of Dermiseb Cream. |
| Conclusion | Dermiseb Cream is substantially equivalent to the currently cleared and marketed Promiseb® Topical Cream |
IGI Laboratories Inc.,
105 Lincoln Ave.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2013
Frederick Weiss Vice President, Quality IGI Labs Incorporated 105 Lincoln Avenue. P.O Box 687 Buena, New Jersey 08310
Re: K123724 Trade/Device Name: Dermiseb Cream Regulatory Class: Unclassified Product Code: FRO Dated: July 23, 2013 Received: July 25, 2013
Dear Mr. Weiss:
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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however. that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 vour 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Frederick Weiss
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 12 3+24
page 1 of 1
Statement of Indications for Use
510(k) Number (if known):
Device Name: Dermiseb Cream
Indications for Use:
Under the supervision of a healthcare professional, Dermiseb Cream is indicated to manage and relieve the signs and symptoms of seborthea and sebortheic dermatitis such as itching, erythema, scaling and pain. Dermiseb Cream also aids to relieve dry, waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.
Dermiseb Cream in indicated for use in:
- Seborrhea ●
- · Seborrheic Dermatitis
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off)
Division of Surgical Devices
510(k) Number: K123724