(115 days)
No
The device is a topical cream and the summary does not mention any AI/ML components or functions.
Yes.
The device is intended for the "dressing and management of minor skin irritations and minor burns," which are therapeutic applications.
No
This device, HylaGuard Moisturizing Cream, is intended for the dressing and management of minor skin irritations and burns, forming a physical barrier to moisturize and protect skin. It is explicitly described as a "topical device product" and its function is therapeutic/protective, not diagnostic.
No
The device is a topical cream, which is a physical product, not software. The description explicitly states it is a "topical device product" and details its physical properties and performance testing related to biocompatibility and stability.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "dressing and management of minor skin irritations and minor burns, including sunburn." This is a topical application for treating the skin directly.
- Device Description: It is described as a "topical device product" that forms a "physical barrier that moisturizes and protects skin." This aligns with a device applied to the body surface.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze these specimens.
Therefore, HylaGuard Moisturizing Cream is a topical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HylaGuard Moisturizing Cream is intended for the dressing and management of minor skin irritations and minor burns, including sunburn.
Product codes
FRO
Device Description
HylaGuard Moisturizing Cream is a non-sterile, off-white, low odor, fragrance free, topical device product. HylaGuard Moisturizing Cream forms a semi-permeable, physical barrier that moisturizes and protects skin. HylaGuard Moisturizing Cream is an over-the-counter (OTC) device. The same device has been cleared for prescription use in K150914 under the name of Dash-Topic Plus Cream.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 HylaGuard Moisturizing 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 HylaGuard Moisturizing cream is non-cytotoxic, a negligible irritant and non-sensitizing. For release and shelf life stability studies, the device had undergone bench performance testing, the following parameters were monitored: Appearance, pH, preservative content, viscosity and package integrity. The device had undergone bench performance 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 uselife 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
October 16, 2017
Founders Science Group, LLC Ronald Gurge, Ph.D. Chief Science Officer 30 Robert W. Boyden Road Suite A1000 Taunton, Massachusetts 02780
Re: K171879
Trade/Device Name: HylaGuard Moisturizing Cream Regulation Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO Dated: October 2, 2017 Received: October 4, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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,
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) K171879
Device Name HylaGuard Moisturizing Cream
Indications for Use (Describe)
HylaGuard Moisturizing Cream is intended for the dressing and management of minor skin irritations and minor burns, including sunburn.
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
Founders Science Group/Puddingstone Pharma Regulatory Affairs 30 Robert W. Boyden Road Suite A1000 Taunton, MA 02780 Contact Person: Ronald M. Gurge Email: rgurge@founderssg.com Date Prepared: October 11, 2017
II. Device Name
Name of Device: HylaGuard Moisturizing Cream Common or Usual Name: Dressing, Wound, Drug Panel: General & Plastic Surgery CFR Number: Unclassified Product code: FRO
III. Predicate Device
MimyX Cream cleared under 510(k) K041342, from Stiefel Laboratories. Inc.
IV. Device Description
HylaGuard Moisturizing Cream is a non-sterile, off-white, low odor, fragrance free, topical device product. HylaGuard Moisturizing Cream forms a semi-permeable, physical barrier that moisturizes and protects skin. HylaGuard Moisturizing Cream is an over-the-counter (OTC) device. The same device has been cleared for prescription use in K150914 under the name of Dash-Topic Plus Cream.
V. Indications for Use
HylaGuard Moisturizing Cream is intended for the dressing and management of minor skin irritations and minor burns, including sunburn.
VI. Comparison of Technological Characteristics with the Predicate Device
The proposed and predicate devices are both semi-viscous oil-in-water emulsions containing humectant and emollient components. These components donate moisture to the skin and form a semi-permeable protective barrier. Both the proposed and predicate device products are non-sterile creams which contain preservatives, and are used topically for management of minor skin irritation or minor burns, including sunburns.
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VII. Substantial Equivalence
HylaGuard Moisturizing Cream is similar in function and intended use when compared to MimyX Cream manufactured by Stiefel Laboratories, Inc. HylaGuard Moisturizing Cream has similar OTC indications for use and similar operating principles as the predicate device. MimyX Cream.
VIII. Performance Data
Non-clinical testing was conducted to confirm the safe and effective performance of HylaGuard Moisturizing 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 HylaGuard Moisturizing cream is non-cytotoxic, a negligible irritant and non-sensitizing. For release and shelf life stability studies, the device had undergone bench performance testing, the following parameters were monitored: Appearance, pH, preservative content, viscosity and package integrity. The device had undergone bench performance 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 uselife 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 non-clinical performance data confirms the physical characteristics, stability and shelflife of the proposed device. The biocompatibility testing data confirms the safety of the proposed device. HylaGuard Moisturizing Cream has similar OTC indications, operating principles and similar functioning components when compared to the predicate. Therefore, HylaGuard Moisturizing Cream is substantially equivalent to MimyX Cream, cleared under 510(k) K041342.