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 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.

AI/ML Overview

This FDA 510(k) summary describes the coactiv+™ Antimicrobial Wound Gel and its substantial equivalence to a previously cleared predicate device (K223259). The submission is a special 510(k) for a change to the submitter's own legally marketed device, specifically a labeling change to remove a usage restriction.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating the continued safety and effectiveness of the device after a labeling change. The "performance" in this context refers to the device maintaining its original safety and functional characteristics despite the change.

Acceptance Criteria (based on predicate device performance)	Reported Device Performance (after labeling change)
Biocompatibility: Meet ISO 10993 standards for surface devices with prolonged contact on breached or compromised surfaces.	Met: A biocompatibility evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Testing included Cytotoxicity, Sensitization, Intracutaneous reactivity, Implantation, Acute Systemic toxicity, Pyrogenicity, and Genotoxicity. (No specific results provided, but the statement implies compliance).
Preservative Effectiveness: Demonstrate that the 0.1% PHMB preservative is effective and appropriate for the product formulation (USP <51>).	Met: USP <51> preservative effectiveness testing was performed and demonstrates the chosen preservative is performing as intended and appropriate for product formulation. (No specific numerical results provided).
Stability: Maintain product stability and performance for a 2-year shelf-life (e.g., pH, viscosity, appearance, microbial limits).	Met: Real-time and accelerated aging studies were conducted, indicating the product is stable and maintains performance for the proposed shelf-life of 2 years. Testing included pH <USP 71>, Viscosity <USP 912>, Appearance <USP 3>, TAMC/TYMC <USP 61>, and Preservative Effectiveness <USP 51>. (No specific numerical results provided).
Non-negative impact on wound healing: Demonstrate that the gel does not negatively affect normal wound healing.	Met: 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. (No specific numerical results or direct comparison to a control group provided).
Safety and Effectiveness after increased usage (due to label change): A Toxicological Risk Assessment should provide assurance of safety for increased usage.	Met: The labeling restriction on usage (21g/week, 90 g/month) was eliminated, supported by a Toxicological Risk Assessment providing assurance of the safety of the coactiv+. (No details of the risk assessment or specific safety metrics are provided, but the conclusion is that safety is assured).

Study Details:

Sample size for the test set and data provenance:
- Biocompatibility Testing: Not specified, but standard ISO 10993 tests for cytotoxicity, sensitization, intracutaneous reactivity, implantation, acute systemic toxicity, pyrogenicity, and genotoxicity are usually performed on representative samples of the final device material. No human subjects are involved.
- Performance Testing (USP <51>, stability): Not specified. These are laboratory-based tests on product batches.
- Animal Testing (Wound Healing): A "porcine model" was used. The exact number of animals or wounds tested is not specified. This is a preclinical study.
- Toxicological Risk Assessment: This is a theoretical assessment based on chemical composition and potential exposure, not directly a "test set" with a sample size in the traditional sense. It would utilize existing toxicological data for the components. The provenance is internal to the manufacturer.
Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable in the conventional sense for these types of non-clinical, laboratory, and animal studies. Ground truth is established by the accepted scientific standards and methodologies (e.g., ISO, USP guidelines).
- The Toxicological Risk Assessment would be performed by qualified toxicologists, but the number of "experts" to establish a ground truth for a test set is not relevant here.
Adjudication method for the test set:
- Not applicable. The studies mentioned are laboratory tests, animal studies, and toxicological assessments. These do not typically involve human adjudication of results in the way clinical studies or diagnostic AI algorithms do. Results are based on direct measurement and interpretation against predefined criteria.
Multi-reader multi-case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study was not done. This device is a wound gel, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, the concept of human readers improving with AI assistance is not relevant.
Standalone (i.e., algorithm only without human-in-the-loop performance) study:
- No, this is not an AI/algorithm-based device. It is a medical device (wound gel). Therefore, a standalone algorithm performance study is not applicable.
Type of ground truth used:
- Biocompatibility: Established scientific standards and methodologies (ISO 10993 series).
- Performance Testing: Pharmacopoeial standards (USP <51>, <71>, <912>, <61>, <3>).
- Animal Testing: Physiological wound healing as observed and measured in a porcine model.
- Toxicological Risk Assessment: Toxicology databases, literature, and expert knowledge on chemical safety.
Sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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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).

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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.

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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

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Indications for Use

510(k) Number (if known) K241809

Device Name coactiv+TMAntimicrobial Wound Gel

Indications for Use (Describe)

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)

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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 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.

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V INDICATIONS FOR USE

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 legulcers and pressure ulcers), 1st and 2nddegree burns, partial & full thicknesswounds, large surface area wounds andsurgical incisions	Same
Indicatedwounds (OTC)	minor skin scrapes, minor cuts, minorlacerations, minor burns (1st degreeburns) and abrasions	Same
Technology	Hydrogel dressing	Same
Preservative	0.1% Polyaminopropyl Biguanide(Polyhexanide [PHMB]),	Same
Performance	USP <51> Preservative effectivenesstesting	Same
BiocompatibilityAssessment	Biocompatibility according to ISO10993-1 surface device with prolongedcontact on breached or compromisedsurfaces.	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.

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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 <USP 71>
· Viscosity <USP 912>
Appearance <USP 3>
TAMC/TYMC <USP 61>
· Preservative Effectiveness <USP 51>

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.

Regulation Number and Section

N/A