(287 days)
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.
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.
This document is a 510(k) premarket notification for a medical device, specifically a wound dressing. It outlines the regulatory clearance for the Protego Antimicrobial Wound Dressing. However, it does not contain any information about the acceptance criteria or a study that proves the device meets those criteria, as typically described for software or AI/ML-based medical devices.
The document focuses on demonstrating substantial equivalence to a predicate device (PolyPlex Wound Dressing, K160872) based on the device's physical properties, chemical composition, indications for use, and basic in vitro performance.
Therefore, I cannot provide the requested information from the provided text. The document does not discuss:
- A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven outcome.
- Sample sizes for test sets, data provenance, or retrospective/prospective study design.
- Number of experts, their qualifications, or ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
- Standalone algorithm performance.
- Types of ground truth (expert consensus, pathology, outcomes data).
- Training set sample size or how its ground truth was established.
This is a traditional medical device clearance document for a physical product (a wound dressing) that does not involve AI or complex diagnostic performance evaluation as would be seen for imaging software or AI-powered diagnostics. The "Performance Testing" section only mentions "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." These are standard biocompatibility and antimicrobial efficacy tests for a physical wound dressing, not acceptance criteria for an AI/ML device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 818-312-6621 Email: brad@turntherapeutics.com
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 ofa healthcare professional, PolyPlexWound Dressing is intended for themanagement of first and second degreeburns, venous stasis ulcers, diabeticulcers, partial and full thicknesswounds, donor sites, post-surgicalincisions, trauma wounds, andabrasions. It can be used during wounddressings changes to soften encrustedwound dressings. | Under the management of a healthcareprofessional, Protego AntimicrobialWound Dressing is intended for themanagement of first and second degreeburns, venous stasis ulcers, diabeticulcers, partial and full thickness wounds,donor sites, post-surgical incisions, traumawounds, 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, pouchcontaining nonwoven gauze impregnatedwith petrolatum-based emulsion |
N/A