Protego Antimicrobial Wound Dressing

K183681 · Global Health Solutions (Dba Turn Therapeutics) · FRO · Oct 11, 2019 · SU

Device Facts

• Record ID: K183681
• Device Name: Protego Antimicrobial Wound Dressing
• Applicant: Global Health Solutions (Dba Turn Therapeutics)
• Product Code: FRO · SU
• Decision Date: Oct 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the management of a healthcare professional, Protego Antimicrobial Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions.

Device Story

Sterile, single-use, non-adherent gauze dressing impregnated with odorless petrolatum-based emulsion containing Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK). Applied by healthcare professionals to wounds to maintain moist healing environment; antimicrobial agents inhibit microbial colonization within dressing for up to 24 hours. Packaged in single-use LDPE tear pouches. Benefits patient by providing protective barrier and preventing microbial growth within dressing.

Clinical Evidence

Bench testing only. In vitro testing demonstrates inhibition of microbial growth within the dressing for up to 24 hours. Biocompatibility testing per ISO 10993 confirms product is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

Non-woven gauze impregnated with petrolatum-based emulsion containing PHMB and BZK. Sterile (gamma irradiation). Dimensions: 4"x4", 1"x8", 2"x2". Single-use. LDPE pouch packaging.

Indications for Use

Indicated for management of first/second degree burns, venous stasis ulcers, diabetic ulcers, partial/full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions. For use under healthcare professional management.

Predicate Devices

• PolyPlex Wound Dressing (K160872)

Submission Summary (Full Text)

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October 11, 2019

Global Health Solutions (DBA Turn Therapeutics) Bradley Burnam Official Correspondent 2362 Calabasas Road #100 Calabasas, California 91302

Re: K183681

Trade/Device Name: Protego Antimicrobial Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 10, 2019 Received: September 12, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Cynthia J. Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183681

Device Name Protego Antimicrobial Wound Dressing

### Indications for Use (Describe)

Under the management of a healthcare professional, Protego Antimicrobial Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions.

Type of Use (Select one or both, as applicable)

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510k Summary

# 1. SubmissionSponsor:

Global Health Solutions (DBA Turn Therapeutics) 23632 Calabasas Road, #100 Calabasas, CA 91302

#### SubmissionContact: 2.

Bradley Burnam Phone: [phone] Email: [e-mail]

#### Date Prepared: September 2,2019 3.

#### 4. DeviceIdentification:

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

#### PredicateDevices: 5.

PolyPlex Wound Dressing (K160872)

#### Description of Proposed Device: 6.

Protego Antimicrobial Wound Dressing is a sterile, single-use, non-adherent gauze dressing impregnated with an odorless petrolatum-based emulsion. The impregnated gauze is placed in a sealed pouch. The product contains Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK) to prevent microbial colonization within the dressing. Protego Antimicrobial Wound Dressing is intended to maintain a moist environment that is conducive to healing. Protego Antimicrobial Wound Dressingis packaged in single-use, LDPE tear pouches. Protego Antimicrobial Wound Dressing comes in three sizes, including 4"x 4," 1"x 8," and 2"x 2," with no differencein materials among the different sizes.

#### Indications for UseStatement: 7.

Under the management of a healthcare professional, Protego Antimicrobial Wound Dressing is intended for the managementof first and second degree burns,venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, post-surgical incisions,traumawounds,and abrasions.

#### 8. PerformanceTesting:

Results of in vitro testing indicate that Protego Antimicrobial Wound Dressing effectively inhibits the growth of microorganisms within the dressing for up to 24 hours. The product is non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials.

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# 9. Substantial Equivalence Discussion:

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

| Device | PolyPlex Wound Dressing | Protego Antimicrobial Wound Dressing |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K160872 | K183681 |
| Pro code | FRO | FRO |
| Manufacturer | Global Health Solutions | Turn Therapeutics |
| Indications | Under the management of<br>a healthcare professional, PolyPlex<br>Wound Dressing is intended for the<br>management of first and second degree<br>burns, venous stasis ulcers, diabetic<br>ulcers, partial and full thickness<br>wounds, donor sites, post-surgical<br>incisions, trauma wounds, and<br>abrasions. It can be used during wound<br>dressings changes to soften encrusted<br>wound dressings. | Under the management of a healthcare<br>professional, Protego Antimicrobial<br>Wound Dressing is intended for the<br>management of first and second degree<br>burns, venous stasis ulcers, diabetic<br>ulcers, partial and full thickness wounds,<br>donor sites, post-surgical incisions, trauma<br>wounds, and abrasions. |
| Sterility | Non-Sterile | Sterile |
| Prescription | Prescription | Prescription |
| Ingredients | Petrolatum, water, PHMB, BZK | Petrolatum, water, PHMB, BZK, non-woven |
| Use Duration | 72h | 24h |
| Shelf Life | No shelf life | No shelf life |
| Comparison | | sterilized by gamma irradiation, pouch<br>containing nonwoven gauze impregnated<br>with petrolatum-based emulsion |