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 Description

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.

AI/ML Overview

The provided text is related to the FDA 510(k) clearance for the PolyPlex Wound Dressing. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.

The document does not contain information about:

A table of acceptance criteria and reported device performance in the context of a diagnostic or algorithmic device.
Sample sizes for test sets, data provenance, or details about training sets.
The number or qualifications of experts used to establish ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or human-in-the-loop performance.
Standalone algorithmic performance.
Specific types of ground truth (e.g., pathology, outcomes data).

Instead, the document focuses on biocompatibility testing to demonstrate safety, which is typical for a wound dressing.

Here's what the document does provide relevant to "acceptance criteria" and "study":

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit for safety)	Reported Device Performance
Non-cytotoxic	Product is non-cytotoxic
Non-sensitizing	Product is non-sensitizing
Non-irritating	Product is non-irritating

2. Sample size used for the test set and the data provenance: Not applicable to the type of testing performed (biocompatibility). The document refers to "biocompatibility trials" per ISO 10993. These trials involve specific protocols for in vitro and in vivo testing on biological systems, not a "test set" of clinical data in the context of an AI/diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biocompatibility testing relies on standardized laboratory procedures and scientific assessment, not expert consensus for ground truth on clinical images/data.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used: For biocompatibility, the "ground truth" is defined by the specific biological responses observed in standardized tests, such as cell viability (for cytotoxicity), skin reaction (for sensitization/irritation), as per ISO 10993 standards.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

Study that proves the device meets the acceptance criteria:

The study referenced is "biocompatibility trials" conducted "per ISO 10993." This refers to a series of international standards for the biological evaluation of medical devices. These standards specify how to assess cytotoxicity, sensitization, irritation, and other biological effects to ensure a device is safe for patient contact. The document states that the product passed these tests, meaning it was found to be non-cytotoxic, non-sensitizing, and non-irritating.

In summary, this document is a 510(k) clearance for a physical wound dressing, not an AI or diagnostic device. Therefore, many of the typical questions regarding AI/ML performance studies, expert ground truth, and clinical test sets are not relevant to this submission. The core performance evaluation here is focused on the device's biocompatibility and safety, demonstrated through adherence to ISO 10993 standards.

Summary

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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 (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 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 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:

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 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: 818-312-6621 Email: bradburnam@me.com 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:

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.

Regulation Number and Section

N/A