3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit

{0}------------------------------------------------ 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. {3}------------------------------------------------ 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. 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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<br>Registration<br>Number | 3009897021 | | Name of contact<br>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<br>proprietary name | 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit | |------------------------------|----------------------------------------------------------------------------------------------------| | Common or usual<br>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)<br>V.A.C. Veraflo Cleanse Choice™ Dressing<br>System | Subject Device<br>3MTM V.A.C. Veraflo Cleanse Choice™<br>Dressing Kit | Predicate Device (per K211521)<br>3MTM VerafloTM Cleanse Choice Complete™<br>Dressing Kit | Subject Device<br>3MTM VerafloTM Cleanse Choice Complete™<br>Dressing Kit | Comparison | | Indications<br>for Use | The V.A.C. Ulta™ Negative Pressure Wound<br>Therapy System is an integrated wound<br>management system that provides Negative<br>Pressure Wound Therapy with an instillation<br>option. | The 3M™ Veraflo™ Cleanse Choice Dressing<br>Kit is used as part of an integrated wound<br>management system that provides 3MTM<br>Veraflo™ Therapy, which consists of negative<br>pressure wound therapy (3MTM V.A.C.®<br>Therapy) with an instillation option. | The 3M™ Veraflo™ Cleanse Choice Complete™<br>Dressing Kit is used as part of an integrated<br>wound management system that provides 3MTM<br>Veraflo™ Therapy, which consists of negative<br>pressure wound therapy (3MTM V.A.C.® Therapy)<br>with an instillation option. | The 3M™ Veraflo™ Cleanse Choice Complete™<br>Dressing Kit is used as part of an integrated<br>wound management system that provides 3MTM<br>Veraflo™ Therapy, which consists of negative<br>pressure wound therapy (3MTM V.A.C.® Therapy)<br>with an instillation option. | Identical, except for<br>minor name<br>changes | | | • Negative Pressure Wound Therapy in the<br>absence of instillation is intended to create an<br>environment that promotes wound healing by<br>secondary or tertiary (delayed primary)<br>intention by preparing the wound bed for<br>closure, reducing edema, promoting granulation<br>tissue formation and perfusion, and by<br>removing exudate and infectious material.<br>• The instillation option is indicated for patients<br>who would benefit from vacuum assisted<br>drainage and controlled delivery of topical<br>wound treatment solutions and suspensions over<br>the wound bed. | • 3MTM V.A.C.® Therapy in the absence of<br>instillation is intended to create an<br>environment that promotes wound healing by<br>secondary or tertiary (delayed primary)<br>intention by preparing the wound bed for<br>closure, reducing edema, promoting<br>granulation tissue formation and perfusion,<br>and by removing exudate and infectious<br>material.<br>• The instillation option is indicated for patients<br>who would benefit from vacuum assisted<br>drainage and controlled delivery of topical<br>wound treatment solutions and suspensions<br>over the wound bed. It provides<br>hydromechanical removal of infectious<br>materials, non-viable tissue and wound debris<br>which reduces the number of surgical<br>debridements required, while promoting<br>granulation tissue formation, creating an<br>environment that promotes wound healing. | • 3MTM V.A.C.® Therapy in the absence of<br>instillation is intended to create an<br>environment that promotes wound healing by<br>secondary or tertiary (delayed primary)<br>intention by preparing the wound bed for<br>closure, reducing edema, promoting<br>granulation tissue formation and perfusion,<br>and by removing exudate and infectious<br>material.<br>• The instillation option is indicated for patients<br>who would benefit from vacuum assisted<br>drainage and controlled delivery of topical<br>wound treatment solutions and suspensions<br>over the wound bed. | • 3MTM V.A.C.® Therapy in the absence of<br>instillation is intended to create an<br>environment that promotes wound healing by<br>secondary or tertiary (delayed primary)<br>intention by preparing the wound bed for<br>closure, reducing edema, promoting<br>granulation tissue formation and perfusion,<br>and by removing exudate and infectious<br>material.<br>• The instillation option is indicated for patients<br>who would benefit from vacuum assisted<br>drainage and controlled delivery of topical<br>wound treatment solutions and suspensions<br>over the wound bed. It provides<br>hydromechanical removal of infectious<br>materials, non-viable tissue and wound debris<br>which reduces the number of surgical<br>debridements required, while promoting<br>granulation tissue formation, creating an<br>environment that promotes wound healing. | Identical, except for<br>minor name<br>changes, and<br>addition of the new<br>hydromechanical<br>indication text | | Comparator | Predicate Device (per K200390)<br>V.A.C. Veraflo Cleanse Choice™ Dressing<br>System | Subject Device<br>3M™ V.A.C. Veraflo Cleanse Choice™<br>Dressing Kit | Predicate Device (per K211521)<br>3M™ Veraflo™ Cleanse Choice Complete™<br>Dressing Kit | Subject Device<br>3M™ Veraflo™ Cleanse Choice Complete™<br>Dressing Kit | Comparison | | | The V.A.C.ULTA™ Negative Pressure Wound<br>Therapy System with and without instillation is<br>indicated for patients with chronic, acute,<br>traumatic, sub-acute and dehisced wounds, partial-<br>thickness burns, ulcers (such as diabetic, pressure<br>and venous insufficiency), flaps and grafts. | The 3M™ Veraflo™ Cleanse Choice<br>Dressing Kit with and without instillation is<br>indicated for patients with chronic, acute,<br>traumatic, sub-acute and dehisced wounds,<br>partial- thickness burns, ulcers (such as diabetic,<br>pressure and venous insufficiency), flaps and<br>grafts. | The Veraflo™ Cleanse Choice Complete™<br>Dressing Kit with and without instillation is<br>indicated for patients with chronic, acute,<br>traumatic, sub-acute and dehisced wounds,<br>partial- thickness burns, ulcers (such as diabetic,<br>pressure and venous insufficiency), flaps and<br>grafts. | The Veraflo™ Cleanse Choice Complete™<br>Dressing Kit with and without instillation is<br>indicated for patients with chronic, acute,<br>traumatic, sub-acute and dehisced wounds,<br>partial- thickness burns, ulcers (such as diabetic,<br>pressure and venous insufficiency), flaps and<br>grafts. | Except for minor<br>name changes, text<br>is identical. | | Wound<br>Types | Chronic, acute, traumatic, sub-acute and dehisced<br>wounds, partial-thickness burns, ulcers (such as<br>diabetic, pressure and venous insufficiency), flaps<br>and grafts. | Same as predicate | Chronic, acute, traumatic, sub-acute and dehisced<br>wounds, partial-thickness burns, ulcers (such as<br>diabetic, pressure and venous insufficiency), flaps<br>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<br>Dressing Kit<br>Components | Predicate Device (per K200390)<br>V.A.C. Veraflo Cleanse Choice™ Dressing System | | Subject Device<br>3M™ V.A.C. Veraflo Cleanse<br>Choice™ Dressing Kit | Predicate Device (per K211521)<br>3M™ Veraflo™ Cleanse Choice Complete™<br>Dressing Kit | Subject Device<br>3M™ Veraflo™ Cleanse Choice<br>Complete™ Dressing Kit | Comparison | | |----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------| | V.A.C. Veraflo Cleanse Choice Dressing<br>(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<br>(1 piece design) Dermatac Drape VeraT.R.A.C. or VeraT.R.A.C. Duo Tube Set Ruler | Same as predicate | Identical type of<br>components, except<br>for Cavilon Skin<br>Prep | | | | Dressing<br>Dimensions/<br>Geometry | Medium<br>Dressing | Component | Description | Same as predicate | Medium Dressing: single piece consisting of an<br>oval shaped, 180 x 125 x 16mm foam with holes (10<br>mm in diameter and 8 mm deep)<br><br>Large Dressing: single piece consisting of an oval<br>shaped, 256 x 150 x 16mm foam with holes (10 mm<br>in diameter and 8 mm deep)<br><br>Note: holes in the dressing penetrate one-half the<br>thickness of the dressing. | Same as predicate | Identical. There is<br>no change between<br>each subject device<br>and its predicate<br>device | | | Large<br>Dressing | Perforated<br>Contact<br>Layer<br><br>Thin Cover<br>Layer | Oval shaped layer, 256<br>x 150 x 8 mm, with<br>holes (10 mm in<br>diameter through holes)<br><br>Oval shaped layer, 256<br>x 150 x 8 mm, without<br>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. {9}------------------------------------------------ | Comparator | Predicate Device (per K200390)<br>V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device<br>3M™ V.A.C. Veraflo Cleanse<br>Choice™ Dressing Kit | Predicate Device (per K211521)<br>3M™ Veraflo™ Cleanse Choice Complete™<br>Dressing Kit | Subject Device<br>3M™ Veraflo™ Cleanse Choice<br>Complete™ Dressing Kit | Comparison | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------| | | Thick Cover<br>Layer Oval shaped layer, 256 x 150 x 16 mm, without holes | | | | | | Dressing<br>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<br>Contacting<br>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<br>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<br>System Design | The V.A.C. Veraflo Cleanse Choice™ Dressing System is intended for use with the V.A.C. Ulta NPWT system.<br>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.<br>The NPWT System consists of: | Same as predicate | Identical, except for the subject dressing name. | | Comparator | Predicate Device (per K200390)<br>V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device<br>3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit | Predicate Device (per K211521)<br>3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit | Subject Device<br>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)<br>V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device<br>3MTM V.A.C. Veraflo Cleanse<br>Choice™ Dressing Kit | Predicate Device (per K211521)<br>3MTM Veraflo™ Cleanse Choice Complete™<br>Dressing Kit | Subject Device<br>3M™ Veraflo™ Cleanse Choice<br>Complete™ Dressing Kit | Comparison | | Operating<br>Principle | At a system level (with which the kit is used):<br>The 3M™ V.A.C.® Ulta Therapy System delivers<br>software controlled negative pressure to the wound<br>site during the negative pressure cycle. It also<br>provides automated delivery of user selected topical<br>wound solutions into the wound bed between negative<br>pressure therapy cycles. | Same as predicate | At a system level (with which the kit is used):<br>The 3M™ V.A.C.® Ulta Therapy System delivers<br>software controlled negative pressure to the wound<br>site during the negative pressure cycle. It also<br>provides automated delivery of user selected topical<br>wound solutions into the wound bed between<br>negative pressure therapy cycles. | Same as predicate | Identical | | | At the kit component level:<br>• The reticulated open cells of the foam dressing to<br>which the therapy unit is connected enable<br>distribution of the negative pressure across the<br>surface of the wound and allows for instillation<br>solution to contact the wound bed. The 10 mm<br>diameter and 8 mm through holes in the dressing<br>facilitate removal of thick wound exudate during<br>the negative pressure cycle.<br>• The tubing set allows for delivery of negative<br>pressure and instillation solutions to the wound<br>bed and for transfer of accumulated fluids to the<br>canister in the negative pressure cycle.<br>• The drape provides a sealed environment for<br>delivery of negative pressure wound therapy and<br>protects from fluid leakage during instillation<br>therapy. | | At the kit component level:<br>• The reticulated open cells of the foam dressing<br>to which the therapy unit is connected enable<br>distribution of the negative pressure across the<br>surface of the wound and allows for instillation<br>solution to contact the wound bed. The 10 mm<br>diameter and 8 mm deep holes in the dressing<br>facilitate removal of thick wound exudate during<br>the negative pressure cycle.<br>• The tubing set allows for delivery of negative<br>pressure and instillation solutions to the wound<br>bed and for transfer of accumulated fluids to the<br>canister in the negative pressure cycle.<br>• The drape provides a sealed environment for<br>delivery of negative pressure wound therapy and<br>protects from fluid leakage during instillation<br>therapy. | | | | Comparator | Predicate Device (per K200390)<br>V.A.C. Veraflo Cleanse Choice™ Dressing System | Subject Device<br>3MTM V.A.C. Veraflo Cleanse<br>Choice™ Dressing Kit | Predicate Device (per K211521)<br>3M™ Veraflo™ Cleanse Choice Complete™<br>Dressing Kit | Subject Device<br>3M™ Veraflo™ Cleanse Choice<br>Complete™ Dressing Kit | Comparison | | Operating<br>Principle,<br>continued | At the dressing level:<br>• The unique structure of the dressing with 10 mm<br>diameter through holes in the contact layer<br>facilitate removal of thick wound exudate during<br>the negative pressure cycle. The holes induce<br>mechanical stress and strain on the wound tissue<br>and wound debris layer. Under negative pressure,<br>fracture points are created as the wound materials<br>are drawn up into the holes in the dressing,<br>allowing topical solution penetration as shown<br>below.<br>Image: V.A.C. Veraflo Cleanse Choice Dressing System<br>• Hydromechanical removal of infectious<br>materials, non-viable tissue and wound debris<br>is achieved through the dressing's mechanical<br>action in conjunction with the process of<br>instilling and allowing topical solutions to soak<br>in the wound bed for up to 30 minutes during<br>the Instillation Cycle of Veraflo Therapy. The<br>instillation and soaking action allows for<br>diluting, softening, and solubilizing infectious<br>material…