(28 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and biological effects of a wound gel, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the management of ulcers, burns, wounds, and surgical incisions, all of which are conditions that require therapeutic intervention to heal or mitigate.
No
Explanation: The provided text describes a wound gel used for the management and healing of wounds and burns, not for the diagnosis of any conditions. It facilitates debridement and provides a moist environment for healing.
No
The device description clearly states it is a "white, odorless gel" and lists chemical components, indicating it is a physical substance, 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 a wound gel for the management of various types of wounds. This is a topical application for treating a physical condition.
- Device Description: The description details the composition and form of a gel applied to the skin.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a disease or condition. IVDs are designed to provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on biocompatibility, preservative effectiveness, stability, and wound healing effects in an animal model. These are typical tests for a topical wound care product, not an IVD.
Therefore, the coactiv+™ Antimicrobial Wound Gel is a medical device, but it falls under the category of a wound care product, not an In Vitro Diagnostic.
N/A
Intended Use / 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 (1st degree burns) and abrasions for adult populations.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
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
adult populations
Intended User / Care Setting
Not Found
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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) |
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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 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 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.