Who is the manufacturer of coactiv+ Antimicrobial Wound Gel?

Kane Biotech, Inc. filed the 510(k) submission for coactiv+ Antimicrobial Wound Gel (K223259).

What is the FDA product code for coactiv+ Antimicrobial Wound Gel?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for coactiv+ Antimicrobial Wound Gel?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like coactiv+ Antimicrobial Wound Gel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

coactiv+ Antimicrobial Wound Gel

Q: What are the predicate devices for coactiv+ Antimicrobial Wound Gel?

Prontosan Wound Gel X (K130857); Rochal Antimicrobial Wound Gel (K192527).

K223259 · Kane Biotech, Inc. · FRO · May 24, 2023 · SU

Device Facts

Record ID	K223259
Device Name	coactiv+ Antimicrobial Wound Gel
Applicant	Kane Biotech, Inc.
Product Code	FRO · SU
Decision Date	May 24, 2023
Decision	SESE
Submission Type	Traditional
Device Class	Class U
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, large surface area 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

White, odorless hydrogel dressing; provides moist wound environment; facilitates debridement; contains PHMB (0.1% w/w) as preservative to inhibit microbial colonization during shelf storage. Applied topically to wound site; used in clinical or home settings; intended for adult patients. Facilitates healing by maintaining moisture; preservative prevents gel contamination. Supplied in polypropylene tubes.

Clinical Evidence

Bench testing only. Includes USP <51> preservative effectiveness, real-time/accelerated aging (shelf-life), and biocompatibility per ISO 10993 (cytotoxicity, sensitization, intracutaneous reactivity, implantation, acute systemic toxicity, pyrogenicity, genotoxicity). Porcine model animal study evaluated impact on full-thickness wound healing.

Technological Characteristics

Hydrogel dressing; ingredients: water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA. Supplied in 0.7 oz (21 g) polypropylene tubes. Biocompatibility per ISO 10993-1. Performance testing per USP <51>, <71>, <912>, <3>, <61>.

Indications for Use

Indicated for adult populations for management of ulcers (diabetic foot, leg, pressure), 1st/2nd degree burns, partial/full thickness wounds, large surface area wounds, surgical incisions (Rx); and minor lacerations, minor burns (1st degree), and abrasions (OTC).

Predicate Devices

Prontosan Wound Gel X (K130857)
Rochal Antimicrobial Wound Gel (K192527)

Related Devices

K252028 — LUOFUCON® Antimicrobial Wound Gel · Huizhou Foryou Medical Co., Ltd. · Mar 11, 2026
K173911 — Medline Burn and Wound Dressing · Medline Industries, Inc. · Jul 19, 2018
K241809 — coactiv+ Antimicrobial Wound Gel · Kane Biotech, Inc. · Jul 19, 2024
K192527 — Rochal Antimicrobial Wound Gel · Rochal Industries, LLC · Feb 7, 2020
K231057 — Antibacterial Gel Wound Dressing · Winner Medical Co., Ltd. · Dec 1, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. May 24, 2023 Kane Biotech, Inc. % Albert Rego Consultant Albert Rego, PhD, Inc 24501 Cabot Road, Suite 122 Laguna Hills, California 92653 Re: K223259 Trade/Device Name: coactiv+TM Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: October 18, 2022 Received: October 24, 2022 Dear Albert Rego: 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 {1}------------------------------------------------ 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 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, # Julie A. Morabito -S Julie Morabito 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) K223259 Device Name coactiv+TM Antimicrobial 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, large surface area 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) | |----------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input checked="" type="checkbox"/> 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}------------------------------------------------ #### 510(k) Summary (5) #### SUBMITTER l Kane Biotech Inc. 290-100 Innovation Drive Winnipeg, Manitoba Canada R3T 6G2 Phone: 204-453-1301 Contact Person: #### = DEVICE | Name of Device: | coactiv+™ Antimicrobial Wound Gel | |----------------------|-----------------------------------| | Common Name: | Dressing, Wound, Drug | | Classification Name: | Unclassified | | Regulatory Class: | Unclassified | | Product Code: | FRO | #### PREDICATE DEVICE 000 Prontosan Wound Gel X (K130857) Rochal Antimicrobial Wound Gel (K192527) #### IV DEVICE DESCRIPTION The coactiv+™ Antimicrobial Wound Gel is a white, odorless hydrogel 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. {4}------------------------------------------------ #### 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 20d 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 (1* degree burns) and abrasions for adult populations. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES VI | 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 Prontosan Wound Gel X (K130857) | Secondary Predicate Rochal Antimicrobial Wound Gel (K192527 | | Classification | Unclassified | Unclassified | Unclassified | | 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 | 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 | 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 | | Indicated wounds (OTC) | minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns) and abrasions | minor cuts, minor lacerations, minor burns (1st degree burns) and abrasions | minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations | | Technology | Hydrogel dressing | Same | Same | | Preservative | 0.1% Polyaminopropyl Biguanide (Polyhexanide [PHMB]), | Same | Same | | Performance | USP <51> Preservative effectiveness testing | USP <51> Preservative effectiveness testing | USP <51> Preservative effectiveness testing | {5}------------------------------------------------ | Biocompatibility Assessment | Biocompatibility according to ISO 10993-1 surface device with prolonged contact on breached or compromised surfaces. | Biocompatibility testing: ISO 10993-1 surface device with prolonged contact (>24 hours to <30 days) on breached or compromised surfaces. | Biocompatibility according to ISO 10993-1 | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| Prontosan Wound Gel X, the proposed primary predicate device, and ROCHAL Antimicrobial Wound Gel, the secondary predicate device, have identical indications for use. Each device is designed as hydrogels with the intended use of creating a moist wound environment conducive to healing. Additionally, the indications for use, and technological properties of the coactiv+™ Antimicrobial Wound Gel are similar to those of the reference devices. ROCHAL Antimicrobial Wound Gel, and coactiv+™ Antimicrobial Wound Gel contain same gelling agent as major ingredient and known safety profile. Furthermore, coactiv+™ Antimicrobial Wound Gel, ROCHAL Antimicrobial Wound Gel and Prontosan Wound Gel X contain the same preservative. Buffering system used for maintenance of pH of the coactiv+™ Antimicrobial Wound Gel is different from both predicate devices. However, based on the results of the performance testing summarized below, this difference does not raise new questions of safety and effectiveness. #### VII PERFORMANCE DATA The following performance data 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-I "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: {6}------------------------------------------------ - 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. #### VIII CONCLUSIONS The coactiv+™ Antimicrobial Wound Gel has similar indication for use, and technological characteristics to the predicate devices Prontosan Wound Gel X and ROCHAL Antimicrobial Wound Gel and the minor differences in technology do not raise any new questions of safety and effectiveness and the performance data, including biocompatibility, shelf-life testing and bench testing demonstrate substantial equivalence to the predicates. Based on the information presented in these 510(k) submissions, Kane Biotech Inc, concludes that the coactiv+™ Antimicrobial Wound Gel is substantially equivalent to predicate devices as it has the same intended uses, and demonstrates that it is as safe and effective as legally marketed predicate devices.