DERMISEB CREAM

K123724 · Igi Laboratories, Inc. · FRO · Aug 28, 2013 · SU

Device Facts

• Record ID: K123724
• Device Name: DERMISEB CREAM
• Applicant: Igi Laboratories, Inc.
• Product Code: FRO · SU
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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 Story

Dermiseb Cream is a non-sterile, steroid-free, fragrance-free, oil-in-water topical emulsion. Applied topically by patients under healthcare professional supervision, it functions as a physical barrier to maintain a moist skin environment. This moisture management relieves symptoms of seborrhea and seborrheic dermatitis, including itching, erythema, scaling, and pain, while aiding in the relief of dry, waxy skin. The device is supplied in 30g tubes.

Clinical Evidence

Non-clinical testing was conducted to confirm the safe and effective performance of the device. No clinical trial data provided.

Technological Characteristics

Oil-in-water emulsion topical cream. Steroid-free and fragrance-free formulation. Packaged in 30g tubes. Non-sterile.

Indications for Use

Indicated for patients with seborrhea or seborrheic dermatitis experiencing itching, erythema, scaling, and pain, or dry, waxy skin. Use under supervision of a healthcare professional.

Predicate Devices

• Promiseb® Topical Cream (K050158)

Submission Summary (Full Text)

{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.<br>105 Lincoln Ave<br>P.O. Box 687<br>Buena, NJ 08310 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Frederick Weiss<br>Director, QA/QC/Analytical/RA<br>Tel: [phone], ext 360<br>Fax: [phone] |
| 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<br>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<br>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<br>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 [phone] or [phone] 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 [phone] or [phone] 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(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