(123 days)
Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, and radiation dermatiis. Hexagen Derm helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Hexagen Derm is an amorphous, odorless, petrolatum-based emollient consisting of petrolatum (95%), water, and the antimicrobial preservatives Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK). Hexagen Derm's petrolatum base locks in moisture at the skin surface to keep wounded skin moist. Hexagen Derm is non-sterile, RX only, and available in 30 and 90 gram low density polyethylene tubes.
The provided text is a 510(k) summary for a medical device called Hexagen Derm. However, it does not contain specific acceptance criteria, detailed study results, or information about the performance of a device against numerical acceptance criteria.
The "Performance Testing" section is very brief and states: "The product is non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials. USP 51 trials confirm that the preservatives are effective." This indicates that some testing was performed, but it doesn't provide the level of detail requested in your prompt (e.g., acceptance criteria for non-cytotoxicity, sensitivity, irritation, or specific results).
Furthermore, the document describes Hexagen Derm as a "topical emulsion" and lists its ingredients. It's a "Wound Dressing, Drug Product" and its indications for use involve treating dry skin conditions and managing burning and itching associated with various dermatoses. This type of device is typically evaluated based on its biocompatibility, stability, and effectiveness of its components, rather than performance metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML or diagnostic devices.
Therefore, I cannot populate the table or provide answers to most of your questions as the document does not contain the required information for a study proving device performance against detailed acceptance criteria for an AI/ML or diagnostic device.
Here's a breakdown of why I can't fulfill your request based on the provided input:
- Acceptance Criteria & Reported Performance: The document only vaguely mentions "non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials" and "USP 51 trials confirm that the preservatives are effective." It doesn't provide numerical acceptance criteria or specific numerical results.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Size, Training Set Ground Truth: All these questions are geared towards the evaluation of AI/ML or diagnostic devices with specific performance metrics (e.g., accuracy, sensitivity, specificity, reader studies). The Hexagen Derm is a topical emulsion, and its evaluation for a 510(k) primarily focuses on safety (biocompatibility) and equivalence to predicates, not on the type of performance study you're asking about.
In summary, the provided content describes the regulatory submission for a topical dermatological product, not a device that would typically undergo the kind of performance studies you're inquiring about for AI/ML or diagnostic tools.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Global Health Solutions, LLC Bradley Burnam Founder 1360 Redmond Circle Rome, Georgia 30165
Re: K171191
Trade/Device Name: Hexagen Derm Regulatory Class: Unclassified Product Code: FRO Dated: July 28, 2017 Received: July 28, 2017
Dear Bradley Burnam:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
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/MedicalDevices/ResourcesforYou/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) K171191
Device Name Hexagen Derm
Indications for Use (Describe)
Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, and radiation dermatiis. Hexagen Derm helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K Summary for Hexagen Derm
1. Submission Sponsor:
Global Health Solutions, LLC (Owner/Operator: 10050298) 1360 Redmond Circle NW, Rome GA, 30165
Submission Contact: 2.
Bradley Burnam, Founder/ CEO Phone: 818-312-6621 Email: brad@globalhealthrx.com eFax: 818-302-2424
3. Date Prepared: April 23, 2017
4. Device Identification:
Trade Name: Hexagen Derm Common Name: Topical Emulsion Classification Name: Dressing, Wound, Drug Product Code: FRO Device Class: Unclassified
5. Predicate Device:
PolyPlex Wound Dressing (K160872) Epiceram Skin Barrier Emulsion (K052643)
6. Description of Proposed Device:
Hexagen Derm is an amorphous, odorless, petrolatum-based emollient consisting of petrolatum (95%), water, and the antimicrobial preservatives Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK). Hexagen Derm's petrolatum base locks in moisture at the skin surface to keep wounded skin moist. Hexagen Derm is non-sterile, RX only, and available in 30 and 90 gram low density polyethylene tubes.
7. Indications for Use Statement:
Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. Hexagen Derm helps to relieve dry, waxy, skin by maintaining a moist wound and skin environment, which is beneficial to the healing process
8. Performance Testing:
The product is non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials. USP 51 trials confirm that the preservatives are effective.
9. Substantial Equivalence Discussion:
Hexagen Derm is identical in formulation to the predicate product, PolyPlex WoundDressing (K160872). Hexagen Derm keeps wounded skin moist in an equivalent manner to the predicate product, Epiceram (K052643), which is beneficial to the healing process. Hexagen Derm also incorporates equivalent indications to Epiceram. The product is determined to be substantially equivalent to the predicate devices.
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