(287 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is described as "intended to maintain a moist environment that is conducive to healing" for various types of wounds, indicating a therapeutic purpose in wound management.
No
The "Intended Use" states that the device is for "management" of various wounds, and the "Device Description" explains it's a wound dressing that maintains a moist environment and prevents microbial colonization. There is no mention of the device identifying diseases or conditions, which is the function of a diagnostic device.
No
The device description clearly describes a physical wound dressing made of gauze impregnated with an emulsion and containing antimicrobial agents. It is a tangible, physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is 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." This describes a device used directly on the body for wound care, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "sterile, single-use, non-adherent gauze dressing impregnated with an odorless petrolatum-based emulsion." This is a physical dressing applied to a wound.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information. The "in vitro testing" mentioned is related to the dressing's ability to inhibit microbial growth within the dressing itself, not to diagnose an infection in a patient.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic wound dressing applied directly to the wound.
N/A
Intended Use / Indications for 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.
Product codes
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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 | |
| 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 | ||
| dressings changes to soften encrusted | ||
| wound dressings. | 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, diabetic | ||
| ulcers, partial and full thickness wounds, | ||
| donor sites, post-surgical incisions, trauma | ||
| 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 | |
| containing nonwoven gauze impregnated | ||
| with petrolatum-based emulsion |