Hexagen Derm

K171191 · Global Health Solutions, LLC · FRO · Aug 25, 2017 · SU

Device Facts

• Record ID: K171191
• Device Name: Hexagen Derm
• Applicant: Global Health Solutions, LLC
• Product Code: FRO · SU
• Decision Date: Aug 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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.

Device Story

Hexagen Derm is a topical, petrolatum-based emollient emulsion; contains 95% petrolatum, water, and antimicrobial preservatives (PHMB, BZK). Device functions by creating a moisture-locking barrier at the skin surface to maintain a moist wound/skin environment; supports healing process; relieves burning/itching associated with dermatoses. Supplied in non-sterile 30g and 90g low-density polyethylene tubes. Intended for prescription use; applied topically by patient or caregiver as directed by clinician. Benefits include symptom relief and maintenance of optimal skin hydration for wound healing.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 confirmed the product is non-cytotoxic, non-sensitizing, and non-irritating. Preservative effectiveness confirmed via USP 51 trials.

Technological Characteristics

Amorphous, petrolatum-based (95%) topical emulsion. Contains water, PHMB, and BZK. Packaging: low-density polyethylene tubes. Non-sterile. No electronic or software components.

Indications for Use

Indicated for patients with dry skin conditions, atopic dermatitis, irritant contact dermatitis, and radiation dermatitis to manage and relieve burning and itching. Prescription use only.

Predicate Devices

• PolyPlex Wound Dressing (K160872)
• Epiceram Skin Barrier Emulsion (K052643)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Email: [e-mail] 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.