(212 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a wound gel, with no mention of AI or ML technology.
Yes
The device is a wound gel intended for the management and healing of various wounds, including ulcers, burns, and surgical incisions, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a wound gel intended for the management and healing of wounds by providing a moist environment and antimicrobial properties, not for diagnosing medical conditions.
No
The device is a wound gel, which is a physical substance applied to wounds, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds (ulcers, burns, lacerations, abrasions, etc.). This involves applying the gel directly to the wound to create a moist environment and provide preservative properties.
- Device Description: The device is a topical hydrogel containing specific ingredients. It is applied externally to the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition. IVDs are designed for this type of testing.
- Performance Studies: The performance studies focus on biocompatibility, preservative effectiveness, stability, and the effect on wound healing in an animal model. These are typical evaluations for a topical wound care product, not an IVD.
In summary, the coactiv+™ Antimicrobial Wound Gel is a therapeutic device intended for the treatment and management of wounds, not a diagnostic device used to analyze samples for diagnostic purposes.
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 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 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.
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:
Biocompatibility evaluation in accordance with 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". Battery of tests included:
• 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 performed to demonstrate that the chosen preservative is performing as intended and appropriate for product formulation.
Real-time and accelerated aging study conducted to indicate product stability and maintenance of performance for proposed shelf-life of 2 years. Testing included:
- pH
- Viscosity
- Appearance
- TAMC/TYMC
- Preservative Effectiveness
Animal Testing:
Effect of coactiv+™ Antimicrobial Wound Gel on full thickness wound healing evaluated using a porcine model to demonstrate no negative impact on normal wound healing.
Key Results: Performance data, including biocompatibility, shelf-life testing, and bench testing, demonstrate substantial equivalence to the predicates. Minor differences in technology do not raise new questions of safety and effectiveness.
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 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
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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) |
|---|
| 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:
= 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 Preservative | ||
| effectiveness testing | USP Preservative | ||
| effectiveness testing | USP 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 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
- 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.
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.