(263 days)
Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
Granudacyn® Wound Wash Solution is composed of water (H2O), hypochlorous acid (HOCl), sodium hypochlorite (NaOCl) and sodium chloride (NaCl). Pure water and pure sodium chloride are subjected to an electrolysis process to create the final solution.
The provided FDA 510(k) clearance letter for Granudacyn® Wound Irrigation Solution (K243415) does not contain information about acceptance criteria or a study that uses a device to meet acceptance criteria in the context of AI/ML or diagnostic performance.
This document pertains to a medical device that is a wound wash solution, not an AI-powered diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device (Vashe® Wound Solution) through non-clinical testing of its physical and chemical properties and general effectiveness as a wound care product.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of device and regulatory submission presented.
The "Clinical Data Summary – Subject Device" section explicitly states: "Clinical Testing: Clinical data is not required." and "No clinical data was required to support substantial equivalence." This further confirms that no studies proving diagnostic accuracy or clinical effectiveness in a human cohort were conducted or needed for this clearance.
In summary, the provided text does not contain the information required to answer your specific questions related to AI/ML device performance and acceptance criteria.
FDA 510(k) Clearance Letter - Granudacyn® Wound Irrigation Solution
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 22, 2025
P.G.F. Industry Solutions GmbH
℅ Leonard Stewart
Regulatory Affairs Manager
Molnlycke Health Care US, LLC
5445 Triangle Parkway
Suite 400
Peachtree Corners, Georgia 30092
Re: K243415
Trade/Device Name: Granudacyn® Wound Irrigation Solution
Regulatory Class: Unclassified
Product Code: FRO
Dated: June 17, 2025
Received: June 17, 2025
Dear Leonard Stewart:
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"
July 22, 2025
P.G.F. Industry Solutions GmbH
℅ Leonard Stewart
Regulatory Affairs Manager
Molnlycke Health Care US, LLC
5445 Triangle Parkway
Suite 400
Peachtree Corners, Georgia 30092
Re: K243415
Trade/Device Name: Granudacyn® Wound Irrigation Solution
Regulatory Class: Unclassified
Product Code: FRO
Dated: June 17, 2025
Received: June 17, 2025
Dear Leonard Stewart:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 2
K243415 - Leonard Stewart Page 2
(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).
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K243415 - Leonard Stewart Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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, PhD
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
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243415
Device Name
Granudacyn® Wound Wash Solution
Indications for Use (Describe)
Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
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."
Page 5
510(k) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Date Prepared: July 21, 2025
Applicant: Peter Fritz, CEO
P.G.F. Industry Solutions GmbH
Katzmoosstraße 26a
5161 Elixhausen, Austria
Phone: +43 (662) 846540-0
Fax: +43 (662) 846540-10
Email: office@veriforte.com
Official Correspondent: Leonard Stewart
Manager, Regulatory Affairs
Mölnlycke Health Care US, LLC
5445 Triangle Parkway, Suite 400
Peachtree Corners, GA 30092
Phone Number: 678-451-6072
Email: Leonard.Stewart@molnlycke.com
Trade/Proprietary Names: Granudacyn® Wound Wash Solution
Device Class: Unclassified
Unclassified Reason: Pre-Amendment
Product Code: FRO
Predicate Device Name: Vashe® Wound Solution (K131848)
Reference Device Name: Microdacyn® Wound Care Solution (K233399)
Device Description:
Granudacyn® Wound Wash Solution is composed of water (H2O), hypochlorous acid (HOCl), sodium hypochlorite (NaOCl) and sodium chloride (NaCl). Pure water and pure sodium chloride are subjected to an electrolysis process to create the final solution.
Page 6
Intended Use/Indication for Use:
Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
Page 7
Technological Characteristics:
| Feature | Granudacyn Wound Wash Solution | Vashe Wound Solution | Substantial Equivalence Comments |
|---|---|---|---|
| 510(k) clearance | K243415 | K131848 | NA |
| Rationale for inclusion | Subject of submission | Predicate device | NA |
| Manufacturer | P.G.F. Industry Solutions GmbH | Urgo Medical North America, LLC | NA |
| Device class name | Dressing, Wound, Drug | Dressing, Wound, Drug | Same classification as predicate |
| Class | Unclassified | Unclassified | Same classification as predicate |
| Product code | FRO | FRO | Same product code as predicate |
| Indication for use/Intended use | Under the supervision of healthcare professionals, Granudacyn Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings. | Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings. | Same |
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| Feature | Granudacyn Wound Wash Solution | Vashe Wound Solution | Substantial Equivalence Comments |
|---|---|---|---|
| Composition | Water, sodium chloride Hypochlorous Acid, Sodium Hypochlorite | Vashe(K131848):Water, sodium chloride Hypochlorous Acid | The difference between the predicate and the subject device does not impact substantial equivalence and is supported by Antimicrobial Effectiveness (USP<51>)testing |
| Use environment | Healthcare facilities and homecare setting | Healthcare facilities and homecare setting | Same |
| Use Case | Single patient, multi-use | Single patient, multi-use | Same |
| Mechanism(s) of Action | mechanical removal of wound debris | mechanical removal of wound debris | Same |
| Antimicrobial Preservative | Preservative: Hypochlorous acid, Sodium Hypochlorite | Vashe(K131848) Preservative: Hypochlorous acid | The difference between the predicate and the subject device does not impact substantial equivalence and is supported by Antimicrobial Effectiveness (USP<51>)testing |
| Volume | 250ml, 500ml,1000ml | 118ml, 250ml, 473ml | Difference does not impact substantial equivalence |
| Application Method | Squeeze bottle, spray nozzle, instillation bottle offered | Squeeze bottle, spray nozzle, instillation bottle offered | Same |
| Shelf Life | 28 months | 24 months | Difference does not impact substantial equivalence and is supported by stability studies |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Biocompatible, Per ISO 10993-1 | Biocompatible, Per ISO 10993-1 | Same |
| Antimicrobial Effectiveness | Effective preservative for stated shelf life per, USP<51> | Effective preservative for stated shelf life per, USP<51> | Same |
Clinical Data Summary – Subject Device
Clinical Testing: Clinical data is not required.
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| Feature | Granudacyn Wound Wash Solution | Vashe Wound Solution | Substantial Equivalence Comments |
|---|---|---|---|
| Composition | Water, sodium chloride Hypochlorous Acid, Sodium Hypochlorite | Vashe(K131848):Water, sodium chloride Hypochlorous Acid | The difference between the predicate and the subject device does not impact substantial equivalence and is supported by Antimicrobial Effectiveness (USP<51>)testing |
| Use environment | Healthcare facilities and homecare setting | Healthcare facilities and homecare setting | Same |
| Use Case | Single patient, multi-use | Single patient, multi-use | Same |
| Mechanism(s) of Action | mechanical removal of wound debris | mechanical removal of wound debris | Same |
| Antimicrobial Preservative | Preservative: Hypochlorous acid, Sodium Hypochlorite | Vashe(K131848) Preservative: Hypochlorous acid | The difference between the predicate and the subject device does not impact substantial equivalence and is supported by Antimicrobial Effectiveness (USP<51>)testing |
| Volume | 250ml, 500ml,1000ml | 118ml, 250ml, 473ml | Difference does not impact substantial equivalence |
| Application Method | Squeeze bottle, spray nozzle, instillation bottle offered | Squeeze bottle, spray nozzle, instillation bottle offered | Same |
| Shelf Life | 28 months | 24 months | Difference does not impact substantial equivalence and is supported by stability studies |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Biocompatible, Per ISO 10993-1 | Biocompatible, Per ISO 10993-1 | Same |
| Antimicrobial Effectiveness | Effective preservative for stated shelf life per, USP<51> | Effective preservative for stated shelf life per, USP<51> | Same |
Clinical Data Summary – Subject Device
Clinical Testing: Clinical data is not required.
Non-Clinical Testing:
Testing was conducted to demonstrate the safety and the effectiveness of the subject device as well as the substantial equivalence to the predicate device:
- Biocompatibility – the subject device has been evaluated in accordance with ISO 10993-1 and has been shown to meet the criteria for the relevant endpoints, based on the chemical characterization, nature of body contact, and contact duration.
- Preservative Effectiveness – the subject device has been evaluated in accordance with USP <51> for preservative effectiveness and met the criteria aligned with its intended use.
Clinical Data:
No clinical data was required to support substantial equivalence.
Conclusion:
Substantial equivalence was demonstrated through a comparison of intended use, technological characteristics as well as performance and safety. Granudacyn Wound Wash is at least as safe and effective, and performs as well at the predicate device, Vashe Wound Solution.
N/A