(381 days)
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.
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.
The provided document is a 510(k) summary for the medical device "Dash-Topic Plus Cream." It is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to a legally marketed predicate device. This type of document focuses on comparing the new device to an existing one, rather than presenting a study of its independent effectiveness against clinical outcomes or a rigorous clinical trial. Therefore, the document does not contain the information required to answer your specific questions about acceptance criteria, detailed study designs, sample sizes, expert ground truth, or comparative effectiveness with human readers.
The document discusses "Performance Data" but this refers to non-clinical testing (biocompatibility, stability, etc.) to ensure safety and functionality, not clinical performance in terms of diagnostic accuracy or impact on human readers.
Here's a breakdown of what can be extracted and why the other information is missing:
1. A table of acceptance criteria and the reported device performance
- Missing from document: The document does not provide a table of acceptance criteria in terms of clinical efficacy or diagnostic performance. The "performance data" section (Section VIII) lists non-clinical tests (biocompatibility, stability) and states the results (e.g., "non-cytotoxic, a negligible irritant and non-sensitizing"), but it doesn't define acceptance criteria for these tests within the narrative. Their acceptance is implied by the "Conclusion" that the device is substantially equivalent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from document: There is no clinical test set described in the sense of a patient cohort or diagnostic images. The "tests" mentioned are laboratory-based assays (e.g., Agar Diffusion Cytotoxicity). Sample sizes for these types of tests typically refer to the number of samples or replicates tested in the lab, not patient populations. No data provenance in terms of country of origin or retrospective/prospective nature is applicable as no clinical study is described.
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)
- Missing from document: Not applicable. No clinical ground truth or expert review is mentioned because no clinical study or diagnostic AI algorithm testing is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from document: Not applicable. No clinical adjudication method is mentioned as there is no clinical test set to adjudicate.
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
- Missing from document: Not applicable. This document pertains to a topical cream, not an AI-powered diagnostic device, and therefore no MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from document: Not applicable. This device is a topical cream, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing from document: Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be the established scientific standards and methods for assessing cytotoxicity, irritation, sensitization, and stability (e.g., ISO standards, USP monographs).
8. The sample size for the training set
- Missing from document: Not applicable. This document is for a medical device (topical cream), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Missing from document: Not applicable. As above, there is no AI algorithm or training set.
Summary of what the document does provide regarding "performance":
The "Performance Data" (Section VIII) describes non-clinical testing to confirm the safety and effective performance in terms of the cream's physical and biological interaction with the body (biocompatibility) and its stability.
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Tests Conducted:
- Agar Diffusion Cytotoxicity (ISO 10993-5: 2009)
- Direct Primary Skin Irritation (ISO 10993-10:2010)
- Kligman Maximization Sensitization (ISO 10993-10:2010)
- Bench performance testing for release and shelf life stability (monitored parameters: Appearance, pH, preservative content, viscosity and package integrity)
- Preservative Effectiveness Testing as per USP<51> (Antimicrobial Effectiveness Testing)
- USP<61> <62> (Microbial Enumeration Tests and Tests for Specified Microorganisms)
- In-use stability testing for opened 450g container (monitored parameters: Appearance, pH, preservative content, viscosity, package integrity, USP<51> and USP<61> <62>)
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Reported Results (Performance):
- Dash-Topic Plus Cream is non-cytotoxic.
- Dash-Topic Plus Cream is a negligible irritant.
- Dash-Topic Plus Cream is non-sensitizing.
- The bench performance data confirmed the physical characteristics, stability, and shelf-life.
The acceptance criteria for these tests are implicitly that the device passes specific thresholds or shows no adverse effects according to the referenced ISO and USP standards. However, the exact numerical acceptance criteria are not explicitly stated in this summary.
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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
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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
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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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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.
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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<51> (Antimicrobial Effectiveness Testing) and USP<61> <62> (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<51> and USP<61> <62>.
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.
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