(267 days)
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
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.
The provided document is a 510(k) summary for a medical device called Dermiseb Cream. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical performance study for an AI/ML medical device would.
The document primarily focuses on establishing substantial equivalence to an already cleared predicate device (Promiseb® Topical Cream). This means that the device is considered safe and effective because it is similar to a legally marketed device, not necessarily because it has met specific, quantifiable performance metrics in a new clinical study.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text, as this type of information is typically part of a clinical trial or performance study, which is not detailed here for this specific 510(k) submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states that "Non-clinical testing was conducted to confirm the safe and effective performance of Dermiseb Cream," but it does not provide specific acceptance criteria or performance metrics. The basis for clearance is substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. No specific clinical test set or study data are presented.
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)
- Not available. No ground truth establishment is described as there is no detailed clinical study presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. No adjudication method 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 topical cream, not an AI/ML diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a topical cream, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. No ground truth is described.
8. The sample size for the training set
- Not applicable. This is a topical cream, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a regulatory submission for a medical device (topical cream) seeking clearance based on substantial equivalence. It does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment that would be associated with the development and validation of an AI/ML diagnostic device.
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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 AveP.O. Box 687Buena, NJ 08310 |
|---|---|
| Contact Person | Frederick WeissDirector, QA/QC/Analytical/RATel: (856) 697-1441, ext 360Fax: (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 Descriptionand Comparison | Both the proposed and referenced predicate devices are oil-in-water emulsions, which add moisture to the skin, and form a physical barrier. |
| SubstantialEquivalence | 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-clinicalPerformance | 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.
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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.
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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
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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
N/A