(381 days)
Not Found
No
The summary describes a topical cream and its performance testing, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section states that the cream is "indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses" and "helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process," indicating a therapeutic purpose.
No.
The device description and intended use indicate that Dash-Topic Plus Cream is a topical product used to manage and relieve symptoms like burning, itching, and pain associated with dermatoses, and to maintain a moist wound/skin environment. It does not perform any diagnostic function.
No
The device description clearly states it is a "topical product" and a "cream," indicating a physical substance applied to the skin, not software. The performance studies also focus on biocompatibility and stability of a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage and relieve symptoms of various dermatoses by topical application to the skin. This is a therapeutic and symptomatic treatment applied directly to the patient's body.
- Device Description: It is described as a "topical product" and a "prescription device" that forms a "physical barrier" on the skin.
- Mechanism of Action: It works by maintaining a moist wound and skin environment, which is a physical effect on the skin surface.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is applied in vivo (on the body).
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, Dash-Topic Plus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dash-Topic Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Dash-Topic Plus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. Dash-Topic Plus Cream forms a physical barrier that helps to maintain a moist wound and skin environment. Dash-Topic Plus Cream is 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 Dash-Topic Plus Cream. Agar Diffusion Cytotoxicity (ISO 10993-5: 2009). Direct Primary Skin Irritation (ISO 10993-10:2010) and Kligman Maximization Sensitization (ISO 10993-10:2010) Tests were performed on the proposed device. The results of the biocompatibility tests demonstrate that Dash-Topic Plus Cream is non-cytotoxic, a negligible irritant and non-sensitizing. For release and shelf life stability studies, the device product had undergone bench performance testing, the following parameters were monitored: Appearance, pH, preservative content, viscosity and package integrity. The device product had undergone Preservative Effectiveness Testing as per USP (Antimicrobial Effectiveness Testing) and USP (Microbial Enumeration Tests and Tests for Specified Microorganisms). In-use stability testing was conducted to determine the shelf-life of the opened 450g container, the following parameters were monitored during the study: Appearance, pH, preservative content, viscosity, package integrity, USP and USP .
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of human profiles facing right, with three distinct faces layered on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
Founders Science Group, LLC Ronald M Gurge, Ph.D. Chief Science Officer 400 Highland Corporate Drive Cumberland, RI 02864
Re: K150914
Trade/Device Name: Dash-Topic Plus Cream Regulatory Class: Unclassified Product Code: FRO Dated: March 18, 2016 Received: March 21, 2016
Dear Dr. Gurge:
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 does 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 vours.
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150914
Device Name Dash-Topic Plus Cream
Indications for Use (Describe)
Under the supervision of a healthcare professional, Dash-Topic Plus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dash-Topic Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summary
I. Submitter
Puddingstone Pharma Regulatory Affairs 400 Highland Corporate Drive Cumberland, RI 02864 Contact Person: Robert Munroe Email: puddingstone@founderssg.com Date Prepared: March 31, 2015
II. Device Name
| Name of Device: | Dash-Topic Plus Cream |
|---|---|
| Common or Usual Name: | Dressing, Wound, Drug |
| Classification Name: | Dressing, Wound, Drug |
| Panel: | General & Plastic Surgery |
| CFR Number: | Unclassified |
| Product code: | FRO |
III. Predicate Device
HylatopicPlus Cream cleared under 510(k) K110727, from PreCision Dermatology Inc.
IV. Device Description
Dash-Topic Plus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. Dash-Topic Plus Cream forms a physical barrier that helps to maintain a moist wound and skin environment. Dash-Topic Plus Cream is a prescription device.
V. Indications for Use
Under the supervision of a healthcare professional, Dash-Topic Plus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dash-Topic Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
VI. Comparison of Technological Characteristics with the Predicate Device
Both the proposed and predicate device are oil-in-water emulsions containing humectant and emollient components which donate moisture to the skin, and form a semi-permeable protective barrier. Both products are non-sterile creams containing similar preservative systems, and are used topically to relieve symptoms of various dermatoses.
4
VII. Substantial Equivalence
Dash-Topic Plus Cream is similar in function and intended use to HylatopicPlus Cream manufactured by PreCision Dermatology Inc., and includes identical components, indicated uses and operating principles.
VIII. Performance Data
Non-clinical testing was conducted to confirm the safe and effective performance of Dash-Topic Plus Cream. Agar Diffusion Cytotoxicity (ISO 10993-5: 2009). Direct Primary Skin Irritation (ISO 10993-10:2010) and Kligman Maximization Sensitization (ISO 10993-10:2010) Tests were performed on the proposed device. The results of the biocompatibility tests demonstrate that Dash-Topic Plus Cream is non-cytotoxic, a negligible irritant and non-sensitizing. For release and shelf life stability studies, the device product had undergone bench performance testing, the following parameters were monitored: Appearance, pH, preservative content, viscosity and package integrity. The device product had undergone Preservative Effectiveness Testing as per USP (Antimicrobial Effectiveness Testing) and USP (Microbial Enumeration Tests and Tests for Specified Microorganisms). In-use stability testing was conducted to determine the shelf-life of the opened 450g container, the following parameters were monitored during the study: Appearance, pH, preservative content, viscosity, package integrity, USP and USP .
IX. Conclusion
The bench performance data confirms the physical characteristics, stability and shelf-life of the proposed device product. The biocompatibility testing data confirms the safety of the proposed device product. Dash-Topic Plus Cream has identical indicated uses, operating principles and component composition when compared to the predicate. Therefore, Dash-Topic Plus Cream is substantially equivalent to HylatopicPlus Cream, cleared under 510(k) K110727.