← Product Code FRO · K241809 # coactiv+™ Antimicrobial Wound Gel (K241809) _Kane Biotech, Inc. · FRO · Jul 19, 2024 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K241809 ## Device Facts - **Applicant:** Kane Biotech, Inc. - **Product Code:** FRO - **Decision Date:** Jul 19, 2024 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds and surgical incisions for adult populations. OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations. ## Device Story coactiv+ Antimicrobial Wound Gel is a white, odorless hydrogel dressing providing a moist environment to facilitate wound healing and debridement. It contains 0.1% PHMB as a preservative to inhibit microbial colonization within the gel during storage. The device is supplied in polypropylene tubes and is intended for use by clinicians (Rx) or patients (OTC) for various wound types. The gel is applied topically to the wound site. By maintaining a moist environment, it supports the natural healing process. The recent modification removed a previous usage restriction (21g/week), supported by a toxicological risk assessment. The device does not require complex operation or electronic integration. ## Clinical Evidence No human clinical trials were conducted. Evidence includes non-clinical biocompatibility testing (ISO 10993 series: cytotoxicity, sensitization, reactivity, implantation, systemic toxicity, pyrogenicity, genotoxicity), USP preservative effectiveness testing, and stability testing. A porcine model study was performed to evaluate the effect on full-thickness wound healing, demonstrating no negative impact on normal healing. ## Technological Characteristics Hydrogel dressing containing water, Poloxamer 407, Glycerol, Trisodium citrate, 0.1% PHMB, Citric acid, and Disodium EDTA. Supplied in polypropylene tubes. Biocompatibility per ISO 10993-1. Performance testing per USP <51>, <71>, <912>, <3>, and <61>. ## Predicate Devices - coactiv+TM Antimicrobial Wound Gel ([K223259](/device/K223259.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION". July 19, 2024 Kane Biotech, Inc. % Valerie Acosta Principal Consultant - Regulatory Affairs Acostar Limited 69 Cherryblossom Pvt Ottawa, K2H0C4 Canada Re: K241809 Trade/Device Name: coactiv+TM Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: June 21, 2024 Received: June 21, 2024 Dear Valerie Acosta: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 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, Mustafa A. Mazher - S For Yu-chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241809 Device Name coactiv+TMAntimicrobial Wound Gel ### Indications for Use (Describe) Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds and surgical incisions for adult populations. OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations. | 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." {4}------------------------------------------------ #### 510(k) Summary (5) #### SUBMITTER l Kane Biotech Inc. 290-100 Innovation Drive Winnipeg, Manitoba Canada R3T 6G2 Phone: 204-453-1301 Contact Person: Lori Christofalos = DEVICE coactiv+™Antimicrobial Wound Gel Name of Device: Dressing, Wound, Drug Common Name: Classification Name: Unclassified Regulatory Class: Unclassified Product Code: FRO #### lll PREDICATE DEVICE coactiv+TM Antimicrobial Wound Gel (K223259) #### IV DEVICE DESCRIPTION The coactiv+™ Antimicrobial Wound Gel is a white, odorless gel that provides a moist wound environment conducive to wound healing. The coactiv+™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The coactiv+™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment. The coactiv+™ Antimicrobial Wound Gel contains water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA. The coactiv+™ Antimicrobial Wound Gel dressing will be supplied in 0.7 oz. (21 g) white/opaque polypropylene (19 x 100 mm) screw cap tubes. The device will be available as both a Rx and OTC product. {5}------------------------------------------------ #### V INDICATIONS FOR USE Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations. OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor skin scrapes, minor cuts, minor lacerations, minor burns (155 degree burns) and abrasions for adult populations. #### VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES | Summary of the technological characteristics compared to the predicate device [21 CFR 807.92(a)(6)] | | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Characteristics | Subject Device:
coactiv+™ Antimicrobial Wound Gel | Primary Predicate Subject Device:
coactiv+™ Antimicrobial Wound Gel
(K223259) | | Classification | Unclassified | Same | | Indicated wounds
(Rx) | ulcers (including diabetic foot and leg
ulcers and pressure ulcers), 1st and 2nd
degree burns, partial & full thickness
wounds, large surface area wounds and
surgical incisions | Same | | Indicated
wounds (OTC) | minor skin scrapes, minor cuts, minor
lacerations, minor burns (1st degree
burns) and abrasions | Same | | Technology | Hydrogel dressing | Same | | Preservative | 0.1% Polyaminopropyl Biguanide
(Polyhexanide [PHMB]), | Same | | Performance | USP <51> Preservative effectiveness
testing | Same | | Biocompatibility
Assessment | Biocompatibility according to ISO
10993-1 surface device with prolonged
contact on breached or compromised
surfaces. | Same | coactiv+™ Antimicrobial Wound Gel (K223259), the proposed predicate device, is the same as the subject device as described by Special 510(K) program - a change to the submitter's own legally marketed device. All technological and performance data remain the same. {6}------------------------------------------------ #### VII SUMMARY OF MODIFICATION The labeling has been revised to eliminate the previous restriction on usage to 21g/week (90 g/month). This was supported by a Toxicological Risk Assessment providing assurance of the safety of the coactiv+. #### VIII PERFORMANCE DATA The following performance data continue to support and were provided in support of the substantial equivalence determination. # Non-Clinical Testing The biocompatibility evaluation for coactiv+™ Antimicrobial Wound Gel was conducted in accordance with the FDA Blue Book Memorandum #G95-l "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests: - Cytotoxicity ISO 10993-5: 2009 - Sensitization ISO 10993-10:2010 - Intracutaneous reactivity ISO 10993-10:2010 - Implantation ISO 10993-6:2016 - · Acute Systemic toxicity ISO 10993-11:2017 - · Pyrogenicity ISO 10993-11:2017 - · Genotoxicity ISO10993-3:2014 ## Performance Testing USP <51> preservative effectiveness testing demonstrates the chosen preservative is performing as intended and appropriate for product formulation. The results of real-time and accelerated aging study indicate the product is stable and maintains performance for the proposed shelf-life of 2 years. Testing includes the following: - pH - · Viscosity - Appearance - TAMC/TYMC - · Preservative Effectiveness ## Animal Testing The effect of the coactiv+™ Antimicrobial Wound Gel on full thickness wound healing was evaluated using a porcine model to demonstrate that it does not negatively impact normal wound healing. #### IX CONCLUSIONS Based on the information presented, Kane Biotech Inc, concludes that the updated label for coactiv+™ Antimicrobial Wound Gel is substantially equivalent to previously cleared 510(k) predicate devices as it has the same indication for use, technological characteristics, intended uses, and demonstrates that it is as safe and effective as legally marketed predicate devices. --- **Source:** [https://fda.innolitics.com/device/K241809](https://fda.innolitics.com/device/K241809) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com