(295 days)
Not Found
No
The summary describes a negative pressure wound therapy system with instillation, focusing on the physical components and their function in wound healing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as part of an integrated wound management system that promotes wound healing, removes exudate and infectious material, and provides hydromechanical removal of non-viable tissue and wound debris. These actions are directly aimed at treating and managing wounds, indicating its therapeutic purpose.
No
The device is described as a wound dressing kit that facilitates wound healing by providing negative pressure wound therapy with an instillation option for cleansing and promoting granulation tissue. Its intended uses and functions focus on treatment rather than diagnosis.
No
The device description clearly outlines physical components like dressings, drapes, tubing sets, and a wound measuring ruler, indicating it is a hardware-based medical device kit.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit and 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit are part of a wound management system that provides negative pressure wound therapy with an instillation option. Their function is to physically manage wounds by applying negative pressure, instilling solutions, and removing exudate and debris.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on biological samples to diagnose or monitor a condition. Its purpose is therapeutic and involves direct interaction with the wound bed.
Therefore, the device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.
-
3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
-
The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.
-
3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
-
The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehised wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
Both dressing kits are intended to be used with the 3M™ V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of 3M™ Veraflo™ Therapy that provides Negative Pressure Wound Therapy coupled with controlled delivery and drainage of topical wound treatment solutions and suspensions over the wound bed. The dressing kits provide sterile disposable components needed for delivery of 3MTM VerafloTM Therapy.
Each kit contains a wound dressing with 10 mm diameter holes specifically designed for use with 3M™ Veraflo™ Therapy (either the 3M™ V.A.C. Veraflo™ Cleanse Choice™ or the 3MTM Veraflo™ Cleanse Choice Complete™ Dressing), an occlusive drape covering the dressing (either the 3MTM V.A.C. Advanced Drape or the V.A.C. Dermatac™ Drape), a tubing set for connecting the dressing to the negative pressure and instillation pumps (either the 3M™ V.A.C. VeraT.R.A.C.TM Pad or the 3M™ VeraT.R.A.C. Duo™ Tube Set, depending on dressing size) and a wound measuring ruler.
The subject dressings differ only in the number of dressing pieces provided in the kit, in the drape materials of construction and in the method of sterilization:
- . The 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing Kit is gray in color, has three dressing layers (one with holes, one thin cover layer and one thick cover layer without holes), has a drape constructed of a polyurethane film with acrylic adhesive and is sterilized by irradiation.
- The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is blue in color, has only one ● dressing piece (which consists of a combination of the layer with holes and the thin cover layer without holes in the 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing), has a drape constructed of a polyurethane film with acrylic adhesive and a perforated silicone layer, and is sterilized by ethylene oxide (ETO).
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
Not Found
Intended User / Care Setting
Acute and extended care settings
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
Bench tests and evaluations comparing the 3M™ Veraflo™ Cleanse Choice Complete™ Dressing to the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit were conducted to establish functional equivalence of the two dressings with respect to performing hydromechanical removal of infectious materials, non-viable tissue and wound debris.
The testing consisted of the following:
- A comparison of materials of construction
- A comparison of material physical properties, such as pore size, density, tensile, tear, elongation, compression, hole size, hole pattern, and geometry
- Finite element modeling of expected strain profiles
- Foam changes under negative pressure as measured by surface area and hole size contraction.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Real World Data / Literature search of clinical data
Sample Size: A total of 177 patients treated with 3M™ V.A.C. Veraflo™ Therapy and 3MTM V.A.C. Veraflo Cleanse Choice™ Dressings from 21 reference publications.
Key results: The evidence consisted of clinically relevant case reports and supported that the adjunctive use of 3M™ V.A.C. Veraflo™ Therapy with 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing can provide hydromechanical removal of infectious materials, non-viable tissue and wound debris and promote granulation tissue development in a variety of complex wounds when areas of non-viable tissue are present on the wound surface.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 23, 2023
3M Health Care Business Group Margaret Marsh Regulatory Affairs Advanced Specialist 6203 Farinon Dr San Antonio, Texas 78249
Re: K221585
Trade/Device Name: 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 20, 2023 Received: January 24, 2023
Dear Margaret Marsh:
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.
1
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 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) 510k K221585
Device Name
3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit
Indications for Use (Describe)
The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.
· 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
· The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.
· 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
· The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehised wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.
March 9, 2023 Date prepared
Submitter information [21 CFR 807.929(a)(1)]
| Name | 3M Health Care Business Group |
|---|---|
| Address | 6203 Farinon Dr, San Antonio TX 78249, United States of America |
| Establishment | |
| Registration | |
| Number | 3009897021 |
| Name of contact | |
| person | Margaret Marsh, Regulatory Affairs Advanced Specialist |
| Contact E-mail | mlmarsh@mmm.com |
Name of the device [21 CFR 807.92(a)(2)]
| Trade or
| proprietary name | 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit |
|---|---|
| Common or usual | |
| name | Components of a negative pressure wound therapy system |
| Classification name | 878.4780 - Powered suction pump |
| Product code | OMP |
Legally marketed device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)]
- 3MTM V.A.C. Veraflo Cleanse Choice™ Dressing Kit, cleared most recently under 510(k) . K200390
- 3MTM Veraflor™ Cleanse Choice Complete™ Dressing Kit, cleared under 510(k) K211521 .
Device description [21 CFR 807.92(a)(4)]
Both dressing kits are intended to be used with the 3M™ V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of 3M™ Veraflo™ Therapy that provides Negative Pressure Wound Therapy coupled with controlled delivery and drainage of topical wound treatment solutions and suspensions over the wound bed. The dressing kits provide sterile disposable components needed for delivery of 3MTM VerafloTM Therapy.
Each kit contains a wound dressing with 10 mm diameter holes specifically designed for use with 3M™ Veraflo™ Therapy (either the 3M™ V.A.C. Veraflo™ Cleanse Choice™ or the 3MTM Veraflo™ Cleanse Choice Complete™ Dressing), an occlusive drape covering the dressing (either the 3MTM V.A.C. Advanced Drape or the V.A.C. Dermatac™ Drape), a tubing set for connecting the dressing to the negative pressure and instillation pumps (either the 3M™ V.A.C. VeraT.R.A.C.TM Pad or the 3M™ VeraT.R.A.C. Duo™ Tube Set, depending on dressing size) and a wound measuring ruler.
The subject dressings differ only in the number of dressing pieces provided in the kit, in the drape materials of construction and in the method of sterilization:
- . The 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing Kit is gray in color, has three dressing layers (one with holes, one thin cover layer and one thick cover layer without holes), has a drape constructed of a polyurethane film with acrylic adhesive and is sterilized by irradiation.
- The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is blue in color, has only one ● dressing piece (which consists of a combination of the layer with holes and the thin cover layer without holes in the 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing), has a drape constructed of a polyurethane film with acrylic adhesive and a perforated silicone layer, and is sterilized by ethylene oxide (ETO).
5
Image /page/5/Picture/1 description: The image shows the 3M logo, which is a well-known brand. The logo consists of the number "3" followed by the letter "M", both in a bold, sans-serif font. The color of the text is a vibrant red, and the background is white, creating a strong contrast that makes the logo easily recognizable.
Indications for Use
The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ VerafloTM Therapy, which consists of negative pressure wound therapy (3MTM V.A.C. Therapy) with an instillation option.
- 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that . promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
- The instillation option is indicated for patients who would benefit from vacuum assisted ● drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ VerafloTM Therapy, which consists of negative pressure wound therapy (3MTM V.A.C. 8 Therapy) with an instillation option.
- 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that . promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
- The instillation option is indicated for patients who would benefit from vacuum assisted . drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Comparison of the technological characteristics with the predicate device [21 CFR 807.92(a)(6)]
See Table on following pages.
6
510(k) Summary
| Comparison to Predicates Table | |||||
|---|---|---|---|---|---|
| Comparator | Predicate Device (per K200390) | ||||
| V.A.C. Veraflo Cleanse Choice™ Dressing | |||||
| System | Subject Device | ||||
| 3MTM V.A.C. Veraflo Cleanse Choice™ | |||||
| Dressing Kit | Predicate Device (per K211521) | ||||
| 3MTM VerafloTM Cleanse Choice Complete™ | |||||
| Dressing Kit | Subject Device | ||||
| 3MTM VerafloTM Cleanse Choice Complete™ | |||||
| Dressing Kit | Comparison | ||||
| Indications | |||||
| for Use | The V.A.C. Ulta™ Negative Pressure Wound | ||||
| Therapy System is an integrated wound | |||||
| management system that provides Negative | |||||
| Pressure Wound Therapy with an instillation | |||||
| option. | The 3M™ Veraflo™ Cleanse Choice Dressing | ||||
| Kit is used as part of an integrated wound | |||||
| management system that provides 3MTM | |||||
| Veraflo™ Therapy, which consists of negative | |||||
| pressure wound therapy (3MTM V.A.C.® | |||||
| Therapy) with an instillation option. | The 3M™ Veraflo™ Cleanse Choice Complete™ | ||||
| Dressing Kit is used as part of an integrated | |||||
| wound management system that provides 3MTM | |||||
| Veraflo™ Therapy, which consists of negative | |||||
| pressure wound therapy (3MTM V.A.C.® Therapy) | |||||
| with an instillation option. | The 3M™ Veraflo™ Cleanse Choice Complete™ | ||||
| Dressing Kit is used as part of an integrated | |||||
| wound management system that provides 3MTM | |||||
| Veraflo™ Therapy, which consists of negative | |||||
| pressure wound therapy (3MTM V.A.C.® Therapy) | |||||
| with an instillation option. | Identical, except for | ||||
| minor name | |||||
| changes | |||||
| • Negative Pressure Wound Therapy in the | |||||
| absence of instillation is intended to create an | |||||
| environment that promotes wound healing by | |||||
| secondary or tertiary (delayed primary) | |||||
| intention by preparing the wound bed for | |||||
| closure, reducing edema, promoting granulation | |||||
| tissue formation and perfusion, and by | |||||
| removing exudate and infectious material. | |||||
| • The instillation option is indicated for patients | |||||
| who would benefit from vacuum assisted | |||||
| drainage and controlled delivery of topical | |||||
| wound treatment solutions and suspensions over | |||||
| the wound bed. | • 3MTM V.A.C.® Therapy in the absence of | ||||
| instillation is intended to create an | |||||
| environment that promotes wound healing by | |||||
| secondary or tertiary (delayed primary) | |||||
| intention by preparing the wound bed for | |||||
| closure, reducing edema, promoting | |||||
| granulation tissue formation and perfusion, | |||||
| and by removing exudate and infectious | |||||
| material. | |||||
| • The instillation option is indicated for patients | |||||
| who would benefit from vacuum assisted | |||||
| drainage and controlled delivery of topical | |||||
| wound treatment solutions and suspensions | |||||
| over the wound bed. It provides | |||||
| hydromechanical removal of infectious | |||||
| materials, non-viable tissue and wound debris | |||||
| which reduces the number of surgical | |||||
| debridements required, while promoting | |||||
| granulation tissue formation, creating an | |||||
| environment that promotes wound healing. | • 3MTM V.A.C.® Therapy in the absence of | ||||
| instillation is intended to create an | |||||
| environment that promotes wound healing by | |||||
| secondary or tertiary (delayed primary) | |||||
| intention by preparing the wound bed for | |||||
| closure, reducing edema, promoting | |||||
| granulation tissue formation and perfusion, | |||||
| and by removing exudate and infectious | |||||
| material. | |||||
| • The instillation option is indicated for patients | |||||
| who would benefit from vacuum assisted | |||||
| drainage and controlled delivery of topical | |||||
| wound treatment solutions and suspensions | |||||
| over the wound bed. | • 3MTM V.A.C.® Therapy in the absence of | ||||
| instillation is intended to create an | |||||
| environment that promotes wound healing by | |||||
| secondary or tertiary (delayed primary) | |||||
| intention by preparing the wound bed for | |||||
| closure, reducing edema, promoting | |||||
| granulation tissue formation and perfusion, | |||||
| and by removing exudate and infectious | |||||
| material. | |||||
| • The instillation option is indicated for patients | |||||
| who would benefit from vacuum assisted | |||||
| drainage and controlled delivery of topical | |||||
| wound treatment solutions and suspensions | |||||
| over the wound bed. It provides | |||||
| hydromechanical removal of infectious | |||||
| materials, non-viable tissue and wound debris | |||||
| which reduces the number of surgical | |||||
| debridements required, while promoting | |||||
| granulation tissue formation, creating an | |||||
| environment that promotes wound healing. | Identical, except for | ||||
| minor name | |||||
| changes, and | |||||
| addition of the new | |||||
| hydromechanical | |||||
| indication text | |||||
| Comparator | Predicate Device (per K200390) | ||||
| V.A.C. Veraflo Cleanse Choice™ Dressing | |||||
| System | Subject Device | ||||
| 3M™ V.A.C. Veraflo Cleanse Choice™ | |||||
| Dressing Kit | Predicate Device (per K211521) | ||||
| 3M™ Veraflo™ Cleanse Choice Complete™ | |||||
| Dressing Kit | Subject Device | ||||
| 3M™ Veraflo™ Cleanse Choice Complete™ | |||||
| Dressing Kit | Comparison | ||||
| The V.A.C.ULTA™ Negative Pressure Wound | |||||
| Therapy System with and without instillation is | |||||
| indicated for patients with chronic, acute, | |||||
| traumatic, sub-acute and dehisced wounds, partial- | |||||
| thickness burns, ulcers (such as diabetic, pressure | |||||
| and venous insufficiency), flaps and grafts. | The 3M™ Veraflo™ Cleanse Choice | ||||
| Dressing Kit with and without instillation is | |||||
| indicated for patients with chronic, acute, | |||||
| traumatic, sub-acute and dehisced wounds, | |||||
| partial- thickness burns, ulcers (such as diabetic, | |||||
| pressure and venous insufficiency), flaps and | |||||
| grafts. | The Veraflo™ Cleanse Choice Complete™ | ||||
| Dressing Kit with and without instillation is | |||||
| indicated for patients with chronic, acute, | |||||
| traumatic, sub-acute and dehisced wounds, | |||||
| partial- thickness burns, ulcers (such as diabetic, | |||||
| pressure and venous insufficiency), flaps and | |||||
| grafts. | The Veraflo™ Cleanse Choice Complete™ | ||||
| Dressing Kit with and without instillation is | |||||
| indicated for patients with chronic, acute, | |||||
| traumatic, sub-acute and dehisced wounds, | |||||
| partial- thickness burns, ulcers (such as diabetic, | |||||
| pressure and venous insufficiency), flaps and | |||||
| grafts. | Except for minor | ||||
| name changes, text | |||||
| is identical. | |||||
| Wound | |||||
| Types | Chronic, acute, traumatic, sub-acute and dehisced | ||||
| wounds, partial-thickness burns, ulcers (such as | |||||
| diabetic, pressure and venous insufficiency), flaps | |||||
| and grafts. | Same as predicate | Chronic, acute, traumatic, sub-acute and dehisced | |||
| wounds, partial-thickness burns, ulcers (such as | |||||
| diabetic, pressure and venous insufficiency), flaps | |||||
| and grafts. | Same as predicate | Identical | |||
| Care Setting | Acute and extended care settings | Same as predicate | Acute and extended care settings | Same as predicate | Identical |
Image /page/6/Picture/3 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The logo is simple and recognizable.
7
Image /page/7/Picture/3 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The logo is simple and recognizable.
8
| Comparator
Dressing Kit
Components | Predicate Device (per K200390)
V.A.C. Veraflo Cleanse Choice™ Dressing System | | Subject Device
3M™ V.A.C. Veraflo Cleanse
Choice™ Dressing Kit | Predicate Device (per K211521)
3M™ Veraflo™ Cleanse Choice Complete™
Dressing Kit | Subject Device
3M™ Veraflo™ Cleanse Choice
Complete™ Dressing Kit | Comparison | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------|
| V.A.C. Veraflo Cleanse Choice Dressing
(3 piece design) V.A.C. Advanced Drape VeraT.R.A.C. or VeraT.R.A.C. Duo Tube Set Ruler 3M ™ Cavilon™ Skin Prep | Same as predicate | | Veraflo Cleanse Choice Dressing
(1 piece design) Dermatac Drape VeraT.R.A.C. or VeraT.R.A.C. Duo Tube Set Ruler | Same as predicate | Identical type of
components, except
for Cavilon Skin
Prep | | |
| Dressing
Dimensions/
Geometry | Medium
Dressing | Component | Description | Same as predicate | Medium Dressing: single piece consisting of an
oval shaped, 180 x 125 x 16mm foam with holes (10
mm in diameter and 8 mm deep)
Large Dressing: single piece consisting of an oval
shaped, 256 x 150 x 16mm foam with holes (10 mm
in diameter and 8 mm deep)
Note: holes in the dressing penetrate one-half the
thickness of the dressing. | Same as predicate | Identical. There is
no change between
each subject device
and its predicate
device |
| | Large
Dressing | Perforated
Contact
Layer
Thin Cover
Layer | Oval shaped layer, 256
x 150 x 8 mm, with
holes (10 mm in
diameter through holes)
Oval shaped layer, 256
x 150 x 8 mm, without
holes | | | | |
Image /page/8/Picture/3 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used on 3M products and marketing materials. The logo is slightly blurry.
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| Comparator | Predicate Device (per K200390)
V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device
3M™ V.A.C. Veraflo Cleanse
Choice™ Dressing Kit | Predicate Device (per K211521)
3M™ Veraflo™ Cleanse Choice Complete™
Dressing Kit | Subject Device
3M™ Veraflo™ Cleanse Choice
Complete™ Dressing Kit | Comparison |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Thick Cover
Layer Oval shaped layer, 256 x 150 x 16 mm, without holes | | | | |
| Dressing
Drawing | Image: Dressing | Same as predicate | Image: Dressing | Same as predicate | Identical. There is no change between each subject device and its predicate device |
| Patient
Contacting
Materials | The dressing is constructed of a felted polyurethane ester foam colored with carbon black. | Same as predicate | The dressing is constructed of the same felted polyurethane ester foam as in 3M V.A.C. Veraflo Cleanse Choice Dressing, except that it is colored with blue and violet dyes. | Same as predicate. | Identical. There is no change between each subject device and its predicate device |
| | The drape is constructed of a polyurethane film with acrylic adhesive
Note: Optionally, the user can apply the drape constructed of polyurethane film with acrylic adhesive and a perforated silicone layer (provided separately) | Same as predicate | The drape is constructed of a polyurethane film with acrylic adhesive and a perforated silicone layer. | Same as predicate | device |
| NPWT
System Design | The V.A.C. Veraflo Cleanse Choice™ Dressing System is intended for use with the V.A.C. Ulta NPWT system.
The NPWT system consists of: | Same as predicate | The Veraflo Cleanse Choice Complete Dressing System is intended for use with the 3M™ V.A.C.® Ulta NPWT system.
The NPWT System consists of: | Same as predicate | Identical, except for the subject dressing name. |
| Comparator | Predicate Device (per K200390)
V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device
3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit | Predicate Device (per K211521)
3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit | Subject Device
3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit | Comparison |
| | Software controlled therapy unit: 3M™ V.A.C.® Ulta Therapy Unit Exudate canister (either 500 or 1000 mL capacity) Negative pressure tubing and sensing pad Instillation cassette, tubing and pad Foam wound dressing Occlusive drape | | Software controlled therapy unit: 3M™ V.A.C.® Ulta Therapy Unit Exudate canister (either 500 or 1000 mL capacity) Negative pressure tubing and sensing pad Instillation cassette, tubing and pad Foam wound dressing Occlusive drape | | |
| Comparator | Predicate Device (per K200390)
V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device
3MTM V.A.C. Veraflo Cleanse
Choice™ Dressing Kit | Predicate Device (per K211521)
3MTM Veraflo™ Cleanse Choice Complete™
Dressing Kit | Subject Device
3M™ Veraflo™ Cleanse Choice
Complete™ Dressing Kit | Comparison |
| Operating
Principle | At a system level (with which the kit is used):
The 3M™ V.A.C.® Ulta Therapy System delivers
software controlled negative pressure to the wound
site during the negative pressure cycle. It also
provides automated delivery of user selected topical
wound solutions into the wound bed between negative
pressure therapy cycles. | Same as predicate | At a system level (with which the kit is used):
The 3M™ V.A.C.® Ulta Therapy System delivers
software controlled negative pressure to the wound
site during the negative pressure cycle. It also
provides automated delivery of user selected topical
wound solutions into the wound bed between
negative pressure therapy cycles. | Same as predicate | Identical |
| | At the kit component level:
• The reticulated open cells of the foam dressing to
which the therapy unit is connected enable
distribution of the negative pressure across the
surface of the wound and allows for instillation
solution to contact the wound bed. The 10 mm
diameter and 8 mm through holes in the dressing
facilitate removal of thick wound exudate during
the negative pressure cycle.
• The tubing set allows for delivery of negative
pressure and instillation solutions to the wound
bed and for transfer of accumulated fluids to the
canister in the negative pressure cycle.
• The drape provides a sealed environment for
delivery of negative pressure wound therapy and
protects from fluid leakage during instillation
therapy. | | At the kit component level:
• The reticulated open cells of the foam dressing
to which the therapy unit is connected enable
distribution of the negative pressure across the
surface of the wound and allows for instillation
solution to contact the wound bed. The 10 mm
diameter and 8 mm deep holes in the dressing
facilitate removal of thick wound exudate during
the negative pressure cycle.
• The tubing set allows for delivery of negative
pressure and instillation solutions to the wound
bed and for transfer of accumulated fluids to the
canister in the negative pressure cycle.
• The drape provides a sealed environment for
delivery of negative pressure wound therapy and
protects from fluid leakage during instillation
therapy. | | |
| Comparator | Predicate Device (per K200390)
V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device
3MTM V.A.C. Veraflo Cleanse
Choice™ Dressing Kit | Predicate Device (per K211521)
3M™ Veraflo™ Cleanse Choice Complete™
Dressing Kit | Subject Device
3M™ Veraflo™ Cleanse Choice
Complete™ Dressing Kit | Comparison |
| Operating
Principle,
continued | At the dressing level:
• The unique structure of the dressing with 10 mm
diameter through holes in the contact layer
facilitate removal of thick wound exudate during
the negative pressure cycle. The holes induce
mechanical stress and strain on the wound tissue
and wound debris layer. Under negative pressure,
fracture points are created as the wound materials
are drawn up into the holes in the dressing,
allowing topical solution penetration as shown
below.
Image: V.A.C. Veraflo Cleanse Choice Dressing System
• Hydromechanical removal of infectious
materials, non-viable tissue and wound debris
is achieved through the dressing's mechanical
action in conjunction with the process of
instilling and allowing topical solutions to soak
in the wound bed for up to 30 minutes during
the Instillation Cycle of Veraflo Therapy. The
instillation and soaking action allows for
diluting, softening, and solubilizing infectious
materials, non-viable tissue and wound debris | Same as predicate | At the dressing level:
• The unique structure of the dressing with 10 mm
diameter holes facilitate removal of thick wound
exudate during the negative pressure cycle. The
holes induce mechanical stress and strain on the
wound tissue and wound debris layer. Under
negative pressure, fracture points are created as
the wound materials are drawn up into the holes
in the dressing, allowing topical solution
penetration as shown below.
Image: 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit
• Hydromechanical removal of infectious
materials, non-viable tissue and wound debris is
achieved through the dressing's mechanical
action in conjunction with the process of
instilling and allowing topical solutions to soak
in the wound bed for up to 30 minutes during
the Instillation Cycle of Veraflo Therapy. The
instillation and soaking action allows for
diluting, softening, and solubilizing infectious
materials, non-viable tissue and wound debris to | Same as predicate | The two device
systems have the
same operating
principles. |
| Comparator | Predicate Device (per K200390)
V.A.C. Veraflo Cleanse Choice™ Dressing System
to facilitate their removal under the negative
pressure cycle of Veraflo Therapy. | Subject Device
3MTM V.A.C. Veraflo Cleanse
Choice™ Dressing Kit | Predicate Device (per K211521)
3M™ Veraflo™ Cleanse Choice Complete™
Dressing Kit
facilitate their removal under the negative
pressure cycle of Veraflo Therapy. | Subject Device
3M™ Veraflo™ Cleanse Choice
Complete™ Dressing Kit | Comparison |
| Design V/V | Verification of delivery of negative pressure at
nominal, high- and low-pressure settings during
the negative pressure phase under worse case
simulated use conditions for 72 hours.
Verification of delivery and removal of instillation solutions to the wound bed. The dressing kit shall have a minimum shelf-life of 1 year. After exposure to worst case conditions of sterilization, system components must meet all relevant FDA biocompatibility requirements and be sterile at a SAL of $10^{-6}$ . | Same as predicate | Verification of delivery of negative pressure at
nominal, high- and low-pressure settings during
the negative pressure phase under worse case
simulated use conditions for 72 hours.
Verification of delivery and removal of instillation solutions to the wound bed. The dressing kit shall have a minimum shelf-life of 1 year. After exposure to worst case conditions of sterilization, system components must meet all relevant FDA biocompatibility requirements and be sterile at a SAL of $10^{-6}$ . | Same as predicate | Identical |
| Sterilization | Gamma irradiation | Same as predicate | Ethylene Oxide Sterilization | Same as predicate | Respective subject
devices are
identical to their
predicates. |
| Sterile
Packaging | Thermoformed tray of PETG with a Tyvek lid | Same as predicate | Thermoformed tray of PETG with a Tyvek lid | Same as predicate | Identical except for
geometry of tray |
| Shelf-Life | Two years | Same as predicate | Two years | Two years | Identical |
| Labeling
Format | Paper Instructions for Use provided in the dressing
carton | Same as predicate | Electronic copy of Instructions for Use available on
the web. QR code provided on kit and carton labels | Same as predicate | Respective subject
devices are
identical to their
predicates. |
Image /page/9/Picture/3 description: The image shows the 3M logo. The logo is in red and features the number 3 followed by the letter M. The logo is simple and recognizable.
10
Image /page/10/Picture/3 description: The image shows the 3M logo in red. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color is a vibrant red, and the background is white.
11
Image /page/11/Picture/3 description: The image shows the 3M logo. The logo is in red and features the number 3 followed by the letter M. The font is bold and sans-serif.
12
Image /page/12/Picture/3 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable.
13
Image /page/13/Picture/3 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used on 3M products and marketing materials. The logo is bold and eye-catching.
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Image /page/14/Picture/1 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.
Performance data [21 CFR 807.92(b)]
- Sterilization: There is no change in the design of these dressing kits that impacts sterilization. ● Only labeling has been changed; thus data from the predicates have been leveraged to demonstrate equivalence in terms of sterilization.
- . Biocompatibility: There is no change in the design of these dressing kits that impacts biocompatibility. Only labeling has been changed; thus data from the predicates have been leveraged to demonstrate equivalence in terms of biocompatibility.
- Shelf life: Stability testing was conducted to confirm that the stability indicating parameters for ● delivery of hydromechanical removal of infectious materials, non-viable tissue and wound debris were within specification for production equivalent samples accelerated aged to the proposed shelf life.
- . Hydromechanical removal of infectious materials, non-viable tissue and wound debris: Bench tests and evaluations comparing the 3M™ Veraflo™ Cleanse Choice Complete™ Dressing to the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit were conducted to establish functional equivalence of the two dressings with respect to performing hydromechanical removal of infectious materials, non-viable tissue and wound debris. The results of this testing indicate that the two dressings are functionally equivalent and that the literature-reported clinical data for the 3MTM V.A.C.™ Veraflo Cleanse Choice™ Dressing demonstrating hydromechanical removal of infectious materials, non-viable tissue and wound debris are also applicable to the 3M™ Veraflo™ Cleanse Choice Complete™ Dressing.
The testing consisted of the following:
- A comparison of materials of construction o
- A comparison of material physical properties, such as pore size, density, tensile, tear, O elongation, compression, hole size, hole pattern, and geometry
- Finite element modeling of expected strain profiles O
- Foam changes under negative pressure as measured by surface area and hole size O contraction.
Summary of literature-reported clinical data used to demonstrate performance
Real World Data: A literature search was conducted to examine available real-world clinical evidence supporting the use of 3M™ V.A.C. Veraflo™ Therapy with 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing for hydromechanical removal of infectious materials, non-viable tissue and wound debris. The evidence consisted of clinically relevant case reports which were sufficiently well described so that individual patient wound data at an initial time point could be compared to that after therapy has been applied. The required outcome measure was evidence of reduction in non-viable wound tissue (such as slough, fibrotic tissue, necrotic tissue, or other unspecified non-viable tissue) after the stated period of therapy.
The 21 retrieved reference publications (see below) included a total of 177 patients treated with 3M™ V.A.C. Veraflo™ Therapy and 3MTM V.A.C. Veraflo Cleanse Choice™ Dressings. Recommended use in general included instilling saline or a hypochlorous solution with a 1minute to 10-minute dwell time followed by 2 to 3.5 hours of negative pressure (-125 mm Hg or -150 mm Hg). Dressing changes were performed every 2 to 3 days and duration was based upon wound size and other patient factors. These patients presented with a variety of the indicated wound types. The direct endpoint in the included studies was reduction in non-viable tissue.
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Image /page/15/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The "3" is larger than the "M". The logo is simple and recognizable.
When this endpoint was not directly stated, indirect endpoints were also included such as decrease in the need for surgical debridement or visible evidence of reduction of nonviable tissue in photographs. Each case report was also assessed for impact on granulation tissue formation. The collection of 177 patients treated with 3MTM V.A.C. Veraflo Cleanse Choice™ Dressings included in the examined studies represent real-world evidence across a variety of wound types for patients with a range in age and a variety of comorbidities.
This body of evidence supports that the adjunctive use of 3M™ V.A.C. Veraflo™ Therapy with 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing can provide hydromechanical removal of infectious materials, non-viable tissue and wound debris and promote granulation tissue development in a variety of complex wounds when areas of non-viable tissue are present on the wound surface.
Conclusions drawn [21 CFR 807.92(b)(3)]
Both the subject and predicate device kits have the same technology in that they are sterile, single use, components that are required for use with the 3M™ V.A.C.® Ulta Therapy Unit for delivery of 3M™ Veraflo™ Therapy. They both contain a wound dressing with 10 mm diameter holes, an occlusive drape, and tubing set. The mechanisms of action of each kit component are unchanged. Except for the proposed labeling change that includes the hydromechanical indication, there is no change to the materials of construction and design, methods of manufacturing, intended use population and wound types.
The results of the bench testing support the functional equivalency of the 3M™ Veraflo™ Cleanse Choice Complete™ Dressing to the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing. Published clinical data supports the ability of the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing to provide hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation creating an environment that promotes wound healing.
In conclusion, the intended use of the device kits is the same as the predicates and the minor changes to labeling do not raise new questions of safety and effectiveness. Further, the performance data provided demonstrates substantial equivalence to the predicates and support for the devices' use in hydromechanical removal of infectious materials, non-viable tissue and wound debris while promoting granulation tissue. The subject device kits are substantially equivalent to the predicate device kits.
Reference Publications
-
- Fukui M, Kakudo N, Matsuoka Y, Fujiwara N, Kusumoto K. Application of Negative pressure wound therapy with instillation and dwelling using a new foam dressing (VAC VERAFLO CLEANSE CHOICE) Initial Experience in Japan. Int. J. Surg. Wound Care 2020; Vol. 1, 53-61.
-
- Aburn R, Clifford K, Krysa J. Negative pressure therapy with instillation, dwell time and an open cell foam dressings in complex vascular patients: A case series. Wounds UK. 2021: 17(3):51-58.
- Blalock L. Use of Negative Pressure Wound Therapy with Instillation and a Novel Reticulated 3. Open-Cell Foam Dressing with Through Holes at a level 2 Trauma Center. Wounds 2019: 31(2); 55-58.
-
- Chowdhry SA. Early-Stage Management of Wounds with Nonviable Tissue Using Negative Pressure Wound Therapy with Instillation. Presented at SAWC Spring 2020: A Virtual Experience, July 24-26, 2020.
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Image /page/16/Picture/1 description: The image shows the 3M logo. The logo is in red and consists of the number 3 followed by the letter M. The logo is simple and recognizable.
-
- Chowdhry SA, Wilhelmi BJ. Comparing Negative Pressure Wound Therapy with Instillation and Conventional Dressings for Sternal Wound Reconstructions. Plastic and Reconstructive Surgery. Global Open. 2018 Jan 4; 7(1): e2087.
-
- Cole W. Early-stage Management of Complex Lower Extremity Wounds Using Negative Pressure Wound Therapy with Instillation and a Reticulated Open Cell Foam with Through Holes. Wounds. 2020 Jun; 32(6):159-163.
-
- Delapena S, Fernandez LG, Foster KN, Matthews MR. Negative Pressure Wound Therapy with Instillation and Dwell Time for the Management of Complex Wounds: A Case Series. Wounds. 2020 Dec:32(12): e96-E100.
- Dingess J, Coulter L. Clinical Case Series of the Efficacy of Using NPWT with Instillation and 8. Reticulated Open Cell Foam for Trauma Wounds. Presented at WOCNext: June 23-26, 2019, Nashville. TN
- Fernandez LG, Matthews MR, Ellman C, Jackson P, Villarreal DH, Norwood S. Use of Reticulated 9. Open Cell Foam Dressings with Through Holes During Negative Pressure Wound Therapy with Instillation and Dwell Time: A Large Case Study. Wounds. 2020 Oct:32(10): 279-282.
-
- Fernandez L. Ellman C. Jackson P. Initial experience using a novel reticulated open cell foam dressing with through holes during negative pressure wound therapy with instillation for management of pressure ulcers. Journal of Trauma and Treatment. 2017;6(5): 410.
-
- Hill R. Use of Negative Pressure Wound Therapy with Instillation and Closed Incision Negative Pressure Therapy for Complex, At-Risk Colorectal Patients: A Case Series. Presented at SAWC Spring: A Virtual Experience, July 22-24, 2020.
-
- Kalos MD, Obst M. Evaluating negative pressure wound therapy with instillation using a reticulated open cell foam dressing with through holes for the management of diverse wounds in patients with comorbidities. Presented at the 2019 Wild on Wounds National Wound Conference, September 11-14, 2019, Las Vegas, NV.
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- Klein RJ. Using negative pressure wound therapy with instillation and dwell time to create a path to closure for older patients with chronic wounds: a retrospective case series, Wound management & prevention. 2022; 68(2):16-21.
-
- Matthews, MR, Hechtman A, Quan AN, Foster KN, Fernandez LG. The Use of V.A.C. VERAFLO CLEANSE CHOICE in the Burn Population. Cureus 2018; 10(11): e3632.
-
- McElroy EF. Use of negative pressure wound therapy with instillation and a reticulated open cell foam dressing with through holes in the acute care setting. Int Wound J 2019; 16:.781-7.
-
- McElroy Faust E, Lemay S, Reider KE. Use of Multiple Modalities of Negative Pressure Wound Therapy Can Assist Management of Complex Wounds in Critically III Patients. Presented at WOCNext, June 23-26, 2019, Nashville, TN.
-
- Retrospective case series: Wounds treated with V.A.C. VERAFLO Therapy. Wounds International. 2020 Sep 11.
-
- Obst MA. Kalos MD. Nelson K. Management of Nonviable Tissue Buildup in Abdominal Wounds. Presented at SAWC Spring 2020: A Virtual Experience, July 24-26, 2020.
-
- Obst MA, Harrigan J, Wodash A, Bjurstrom S. Early-stage management of complex wounds using negative pressure wound therapy with instillation and a dressing with through holes. Wounds 2019; 31: E33-E36.
-
- Téot L, Boissiere F, Fluieraru S. Novel foam dressing using negative pressure wound therapy with instillation to remove thick exudate. Int Wound J 2017; 14: 842-8.
-
- Willmore J. Wrotslavsky P. Preoperative contaminated wound management using short-term negative pressure wound therapy with instillation. J Wound Care. 2021 Dec 2;30(12):994-1000. doi: 10.12968/jowc.2021.30.12.994