PolyPlex Wound Dressing

K160872 · Global Health Solutions, LLC · FRO · Nov 23, 2016 · SU

Device Facts

• Record ID: K160872
• Device Name: PolyPlex Wound Dressing
• Applicant: Global Health Solutions, LLC
• Product Code: FRO · SU
• Decision Date: Nov 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the management of a healthcare professional, PolyPlex Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, postsurgical incisions, trauma wounds, and abrasions. It can be used during wound dressing changes to soften encrusted wound dressings.

Device Story

PolyPlex Wound Dressing is an amorphous, odorless, petrolatum-based emulsion; maintains moist wound environment conducive to healing. Contains preservatives polyhexamethylene biguanide (PHMB) and benzalkonium chloride (BZK) to prevent microbial colonization within dressing. Applied topically by healthcare professionals to manage various wound types; also used to soften encrusted dressings during changes. Benefits include moisture maintenance and microbial colonization prevention.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards; results indicate the product is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

Amorphous, petrolatum-based emulsion. Contains preservatives: polyhexamethylene biguanide (PHMB) and benzalkonium chloride (BZK). Biocompatibility verified per ISO 10993.

Indications for Use

Indicated for management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions in patients requiring professional wound care management.

Predicate Devices

• Prontosan Wound Gel (K10882)
• Copa AMD Antimicrobial Wound Dressing (K082296)
• SuileOIntment Wound DRessing (K041013)

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

November 23, 2016

Global Health Solutions, LLC Mr. Bradley Burnam Founder 1360 Redmond Circle Rome. GA 30165

Re: K160872

Trade/Device Name: PolyPlex Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 18, 2016 Received: October 18, 2016

Dear Mr. 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 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.

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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 [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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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) K160872

Device Name PolyPlex Wound Dressing

Indications for Use (Describe) Rx Only:

Under the management of a healthcare professional, PolyPlex Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, postsurgical incisions, trauma wounds, and abrasions. It can be used during wound dressing changes to soften encrusted wound dressings.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510 Summary for PolyPlex Wound Dressing

#### Submission Sponsor: 1.

Global Health Solutions, LLC (Owner/Operator: 10050298) 1360 Redmond Circle NW, Rome GA, 30165

#### 2. Submission Contact:

Bradley Burnam, Founder Phone: [phone] Email: [e-mail] eFax: 818-302-2424

#### 3. Date Prepared: September 18, 2016

#### 4. Device Identification:

Trade Name: PolyPlex Wound Dressing Common Name: Wound Dressing Classification Name: Dressing, Wound, Drug Product Code: FRO Device Class: Unclassified

#### 5. Predicate Device:

Prontosan Wound Gel (K10882) Copa AMD Antimicrobial Wound Dressing (K082296) SuileOIntment Wound DRessing (K041013)

#### 6. Description of Proposed Device:

PolyPlex Wound Dressing is an amorphous, odorless, petrolatum-based emulsion intended to maintain a moist environment that is conducive to healing. The product contains the preservatives polyhexamethylene biguanide (PHMB) and benzalkonium chloride (BZK) to prevent microbial colonization within the dressing.

#### 7. Indications for Use Statement:

Under the management of a healthcare professional, PolyPlex Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions. It can be used during wound dressing changes to soften encrusted wound dressings.

#### 8. Performance Testing:

The product is non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials.

#### 9. Substantial Equivalence Discussion:

It has been shown that the technological/formulaic differences between PolyPlex Wound Dressing and the predicate device do not raise concerns regarding the safety and/or efficacy of the proposed product. PolyPlex Wound Dressing is determined to be substantially equivalent to the predicate device.