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 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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit and 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit.

It's important to note that this document is an FDA 510(k) summary for a medical device (dressing kit), not an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies regarding ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this type of submission. The performance described here relates to the physical and functional characteristics of dressings in wound care, not algorithmic performance.

Acceptance Criteria and Device Performance (Not applicable for AI/ML specific criteria)

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a dressing kit. The "acceptance criteria" here are implied by the claim of substantial equivalence and are met through comparative analysis and leveraging existing clinical data for the predicate device, rather than new, large-scale clinical trials with pre-defined statistical endpoints for novel performance metrics.

Implicit Acceptance Criteria (Met by comparison and leveraging existing data):

Functional Equivalence: The subject dressings perform the intended functions (negative pressure wound therapy, instillation, hydromechanical removal of infectious materials, non-viable tissue, and wound debris) comparably to the predicate devices.
Material Equivalence/Safety: The materials of construction, physical properties, and sterilization methods are either identical or demonstrably safe and effective.
Shelf-Life: The device maintains its stability and performance over the proposed shelf-life.
Biocompatibility & Sterility: Meets all relevant FDA biocompatibility requirements and is sterile at a SAL of 10^-6.
Clinical Efficacy (Leveraged): The device, in conjunction with the therapy unit, effectively promotes wound healing, granulation tissue formation, and removal of undesirable wound materials, as demonstrated by prior clinical data for the predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criterion (Implied)	Reported Device Performance (Summary from document)
Functional Equivalence	The subject dressings ("Cleanse Choice Complete" and "Cleanse Choice") demonstrate equivalent performance in delivering Negative Pressure Wound Therapy (NPWT) and Instillation Therapy, including hydromechanical removal of infectious materials, non-viable tissue, and wound debris, compared to their respective predicates.	Bench tests and evaluations (comparison of materials, physical properties, finite element modeling of strain profiles, foam changes under negative pressure) were conducted. These tests "indicate that the two dressings are functionally equivalent" and that literature-reported clinical data for one dressing is "also applicable" to the other.
Material & Design Equivalence	Materials of construction, dressing dimensions/geometry, and system components (when used with the V.A.C. Ulta Therapy Unit) are substantially equivalent or justified.	3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit: "Same as predicate" for patient-contacting materials, NPWT system design, operating principles. Differences noted in drape (one has perforated silicone layer) but deemed non-significant for equivalence. 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit: "Same as predicate" for patient-contacting materials, NPWT system design, operating principles. Differences in color and 1-piece vs 3-piece design, but otherwise equivalent.
Sterilization	The devices are sterile and the sterilization method is validated.	No change in design impacting sterilization; data from predicates leveraged. Sterilized by irradiation (Cleanse Choice) or ethylene oxide (Cleanse Choice Complete). Must be sterile at a SAL of 10^-6 (general requirement, met by leveraging predicate data).
Biocompatibility	The patient-contacting materials are biocompatible.	No change in design impacting biocompatibility; data from predicates leveraged. All relevant FDA biocompatibility requirements met (general requirement, met by leveraging predicate data).
Shelf-Life	The device maintains performance over its stated shelf-life.	Stability testing conducted on production equivalent samples accelerated aged to proposed shelf life (Two years). "Stability indicating parameters for delivery of hydromechanical removal... were within specification."
Clinical Efficacy (Hydromechanical Removal)	The device, when used as part of the 3M™ Veraflo™ Therapy system, provides hydromechanical removal of infectious materials, non-viable tissue, and wound debris, and promotes granulation tissue formation, reducing the need for surgical debridements.	A literature search identified 21 reference publications (177 patients) supporting hydromechanical removal and promotion of granulation tissue with the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing. The "functional equivalence" testing extends these findings to the "Cleanse Choice Complete" dressing. The report states: "This body of evidence supports that the adjunctive use of 3M™ V.A.C. Veraflo™ Therapy... can provide hydromechanical removal... and promote granulation tissue development."

Study Details (As applicable to a medical device, not an AI/ML device):

Sample sizes used for the test set and the data provenance:
- Test Set (for Functional Equivalence/Bench Testing): Not explicitly stated numbers of devices tested. The "test set" here refers to samples subjected to bench tests (material comparisons, physical properties, finite element modeling, foam changes under negative pressure). The document states "production equivalent samples accelerated aged to the proposed shelf life" for shelf-life testing.
- Clinical Data Provenance: The clinical data leveraged is from "literature-reported clinical data" from "21 retrieved reference publications" including "177 patients." This implies retrospective data from various clinical settings and possibly multiple countries, given it's a literature search. It is "real-world clinical evidence."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical AI/ML sense. For this medical device, "ground truth" for the bench tests would be established by validated measurement techniques and engineering specifications. For the clinical data, the "truth" is based on the reported clinical outcomes in the published literature (e.g., reduction in non-viable tissue, granulation tissue formation), which were assessed by the authors of those papers (presumably clinicians). The 510(k) relies on the validity of these published clinical observations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the typical AI/ML sense. There was no human expert adjudication of model outputs or image interpretations. The "adjudication" for the bench tests would be through standard laboratory procedures and data analysis. For the clinical literature, the FDA reviews the cited publications for their relevance and applicability.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-powered device. No MRMC study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device/algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: Engineering specifications, validated measurement results, and comparative physical/mechanical properties.
- Clinical "Ground Truth": For the clinical claims, the "ground truth" is based on the reported clinical outcomes data from the cited literature, specifically "evidence of reduction in non-viable wound tissue" and "impact on granulation tissue formation." Indirect endpoints included "decrease in the need for surgical debridement or visible evidence of reduction of nonviable tissue in photographs."
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary

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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.

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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

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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)

· 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.

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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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
EstablishmentRegistrationNumber	3009897021
Name of contactperson	Margaret Marsh, Regulatory Affairs Advanced Specialist
Contact E-mail	mlmarsh@mmm.com

Name of the device [21 CFR 807.92(a)(2)]

Trade orproprietary name	3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit
Common or usualname	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)]

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).

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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™ 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.

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510(k) Summary

	Comparison to Predicates Table
Comparator	Predicate Device (per K200390)V.A.C. Veraflo Cleanse Choice™ DressingSystem	Subject Device3MTM V.A.C. Veraflo Cleanse Choice™Dressing Kit	Predicate Device (per K211521)3MTM VerafloTM Cleanse Choice Complete™Dressing Kit	Subject Device3MTM VerafloTM Cleanse Choice Complete™Dressing Kit	Comparison
Indicationsfor Use	The V.A.C. Ulta™ Negative Pressure WoundTherapy System is an integrated woundmanagement system that provides NegativePressure Wound Therapy with an instillationoption.	The 3M™ Veraflo™ Cleanse Choice DressingKit is used as part of an integrated woundmanagement system that provides 3MTMVeraflo™ Therapy, which consists of negativepressure 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 integratedwound management system that provides 3MTMVeraflo™ Therapy, which consists of negativepressure 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 integratedwound management system that provides 3MTMVeraflo™ Therapy, which consists of negativepressure wound therapy (3MTM V.A.C.® Therapy)with an instillation option.	Identical, except forminor namechanges
	• Negative Pressure Wound Therapy in theabsence of instillation is intended to create anenvironment that promotes wound healing bysecondary or tertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promoting granulationtissue formation and perfusion, and byremoving exudate and infectious material.• The instillation option is indicated for patientswho would benefit from vacuum assisteddrainage and controlled delivery of topicalwound treatment solutions and suspensions overthe wound bed.	• 3MTM V.A.C.® Therapy in the absence ofinstillation is intended to create anenvironment that promotes wound healing bysecondary or tertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promotinggranulation tissue formation and perfusion,and by removing exudate and infectiousmaterial.• The instillation option is indicated for patientswho would benefit from vacuum assisteddrainage and controlled delivery of topicalwound treatment solutions and suspensionsover the wound bed. It provideshydromechanical removal of infectiousmaterials, non-viable tissue and wound debriswhich reduces the number of surgicaldebridements required, while promotinggranulation tissue formation, creating anenvironment that promotes wound healing.	• 3MTM V.A.C.® Therapy in the absence ofinstillation is intended to create anenvironment that promotes wound healing bysecondary or tertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promotinggranulation tissue formation and perfusion,and by removing exudate and infectiousmaterial.• The instillation option is indicated for patientswho would benefit from vacuum assisteddrainage and controlled delivery of topicalwound treatment solutions and suspensionsover the wound bed.	• 3MTM V.A.C.® Therapy in the absence ofinstillation is intended to create anenvironment that promotes wound healing bysecondary or tertiary (delayed primary)intention by preparing the wound bed forclosure, reducing edema, promotinggranulation tissue formation and perfusion,and by removing exudate and infectiousmaterial.• The instillation option is indicated for patientswho would benefit from vacuum assisteddrainage and controlled delivery of topicalwound treatment solutions and suspensionsover the wound bed. It provideshydromechanical removal of infectiousmaterials, non-viable tissue and wound debriswhich reduces the number of surgicaldebridements required, while promotinggranulation tissue formation, creating anenvironment that promotes wound healing.	Identical, except forminor namechanges, andaddition of the newhydromechanicalindication text
Comparator	Predicate Device (per K200390)V.A.C. Veraflo Cleanse Choice™ DressingSystem	Subject Device3M™ V.A.C. Veraflo Cleanse Choice™Dressing Kit	Predicate Device (per K211521)3M™ Veraflo™ Cleanse Choice Complete™Dressing Kit	Subject Device3M™ Veraflo™ Cleanse Choice Complete™Dressing Kit	Comparison
	The V.A.C.ULTA™ Negative Pressure WoundTherapy System with and without instillation isindicated for patients with chronic, acute,traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressureand venous insufficiency), flaps and grafts.	The 3M™ Veraflo™ Cleanse ChoiceDressing Kit with and without instillation isindicated for patients with chronic, acute,traumatic, sub-acute and dehisced wounds,partial- thickness burns, ulcers (such as diabetic,pressure and venous insufficiency), flaps andgrafts.	The Veraflo™ Cleanse Choice Complete™Dressing Kit with and without instillation isindicated for patients with chronic, acute,traumatic, sub-acute and dehisced wounds,partial- thickness burns, ulcers (such as diabetic,pressure and venous insufficiency), flaps andgrafts.	The Veraflo™ Cleanse Choice Complete™Dressing Kit with and without instillation isindicated for patients with chronic, acute,traumatic, sub-acute and dehisced wounds,partial- thickness burns, ulcers (such as diabetic,pressure and venous insufficiency), flaps andgrafts.	Except for minorname changes, textis identical.
WoundTypes	Chronic, acute, traumatic, sub-acute and dehiscedwounds, partial-thickness burns, ulcers (such asdiabetic, pressure and venous insufficiency), flapsand grafts.	Same as predicate	Chronic, acute, traumatic, sub-acute and dehiscedwounds, partial-thickness burns, ulcers (such asdiabetic, pressure and venous insufficiency), flapsand 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.

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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.

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ComparatorDressing KitComponents	Predicate Device (per K200390)V.A.C. Veraflo Cleanse Choice™ Dressing System		Subject Device3M™ V.A.C. Veraflo CleanseChoice™ Dressing Kit	Predicate Device (per K211521)3M™ Veraflo™ Cleanse Choice Complete™Dressing Kit	Subject Device3M™ Veraflo™ Cleanse ChoiceComplete™ 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 ofcomponents, exceptfor Cavilon SkinPrep
DressingDimensions/Geometry	MediumDressing	Component	Description	Same as predicate	Medium Dressing: single piece consisting of anoval shaped, 180 x 125 x 16mm foam with holes (10mm in diameter and 8 mm deep)Large Dressing: single piece consisting of an ovalshaped, 256 x 150 x 16mm foam with holes (10 mmin diameter and 8 mm deep)Note: holes in the dressing penetrate one-half thethickness of the dressing.	Same as predicate	Identical. There isno change betweeneach subject deviceand its predicatedevice
	LargeDressing	PerforatedContactLayerThin CoverLayer	Oval shaped layer, 256x 150 x 8 mm, withholes (10 mm indiameter through holes)Oval shaped layer, 256x 150 x 8 mm, withoutholes

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 Device3M™ V.A.C. Veraflo CleanseChoice™ Dressing Kit	Predicate Device (per K211521)3M™ Veraflo™ Cleanse Choice Complete™Dressing Kit	Subject Device3M™ Veraflo™ Cleanse ChoiceComplete™ Dressing Kit	Comparison
	Thick CoverLayer Oval shaped layer, 256 x 150 x 16 mm, without holes
DressingDrawing	Image: Dressing	Same as predicate	Image: Dressing	Same as predicate	Identical. There is no change between each subject device and its predicate device
PatientContactingMaterials	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 adhesiveNote: 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
NPWTSystem 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 Device3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit	Predicate Device (per K211521)3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit	Subject Device3M™ 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 Device3MTM V.A.C. Veraflo CleanseChoice™ Dressing Kit	Predicate Device (per K211521)3MTM Veraflo™ Cleanse Choice Complete™Dressing Kit	Subject Device3M™ Veraflo™ Cleanse ChoiceComplete™ Dressing Kit	Comparison
OperatingPrinciple	At a system level (with which the kit is used):The 3M™ V.A.C.® Ulta Therapy System deliverssoftware controlled negative pressure to the woundsite during the negative pressure cycle. It alsoprovides automated delivery of user selected topicalwound solutions into the wound bed between negativepressure therapy cycles.	Same as predicate	At a system level (with which the kit is used):The 3M™ V.A.C.® Ulta Therapy System deliverssoftware controlled negative pressure to the woundsite during the negative pressure cycle. It alsoprovides automated delivery of user selected topicalwound solutions into the wound bed betweennegative pressure therapy cycles.	Same as predicate	Identical
	At the kit component level:• The reticulated open cells of the foam dressing towhich the therapy unit is connected enabledistribution of the negative pressure across thesurface of the wound and allows for instillationsolution to contact the wound bed. The 10 mmdiameter and 8 mm through holes in the dressingfacilitate removal of thick wound exudate duringthe negative pressure cycle.• The tubing set allows for delivery of negativepressure and instillation solutions to the woundbed and for transfer of accumulated fluids to thecanister in the negative pressure cycle.• The drape provides a sealed environment fordelivery of negative pressure wound therapy andprotects from fluid leakage during instillationtherapy.		At the kit component level:• The reticulated open cells of the foam dressingto which the therapy unit is connected enabledistribution of the negative pressure across thesurface of the wound and allows for instillationsolution to contact the wound bed. The 10 mmdiameter and 8 mm deep holes in the dressingfacilitate removal of thick wound exudate duringthe negative pressure cycle.• The tubing set allows for delivery of negativepressure and instillation solutions to the woundbed and for transfer of accumulated fluids to thecanister in the negative pressure cycle.• The drape provides a sealed environment fordelivery of negative pressure wound therapy andprotects from fluid leakage during instillationtherapy.
Comparator	Predicate Device (per K200390)V.A.C. Veraflo Cleanse Choice™ Dressing System	Subject Device3MTM V.A.C. Veraflo CleanseChoice™ Dressing Kit	Predicate Device (per K211521)3M™ Veraflo™ Cleanse Choice Complete™Dressing Kit	Subject Device3M™ Veraflo™ Cleanse ChoiceComplete™ Dressing Kit	Comparison
OperatingPrinciple,continued	At the dressing level:• The unique structure of the dressing with 10 mmdiameter through holes in the contact layerfacilitate removal of thick wound exudate duringthe negative pressure cycle. The holes inducemechanical stress and strain on the wound tissueand wound debris layer. Under negative pressure,fracture points are created as the wound materialsare drawn up into the holes in the dressing,allowing topical solution penetration as shownbelow.Image: V.A.C. Veraflo Cleanse Choice Dressing System• Hydromechanical removal of infectiousmaterials, non-viable tissue and wound debrisis achieved through the dressing's mechanicalaction in conjunction with the process ofinstilling and allowing topical solutions to soakin the wound bed for up to 30 minutes duringthe Instillation Cycle of Veraflo Therapy. Theinstillation and soaking action allows fordiluting, softening, and solubilizing infectiousmaterials, non-viable tissue and wound debris	Same as predicate	At the dressing level:• The unique structure of the dressing with 10 mmdiameter holes facilitate removal of thick woundexudate during the negative pressure cycle. Theholes induce mechanical stress and strain on thewound tissue and wound debris layer. Undernegative pressure, fracture points are created asthe wound materials are drawn up into the holesin the dressing, allowing topical solutionpenetration as shown below.Image: 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit• Hydromechanical removal of infectiousmaterials, non-viable tissue and wound debris isachieved through the dressing's mechanicalaction in conjunction with the process ofinstilling and allowing topical solutions to soakin the wound bed for up to 30 minutes duringthe Instillation Cycle of Veraflo Therapy. Theinstillation and soaking action allows fordiluting, softening, and solubilizing infectiousmaterials, non-viable tissue and wound debris to	Same as predicate	The two devicesystems have thesame operatingprinciples.
Comparator	Predicate Device (per K200390)V.A.C. Veraflo Cleanse Choice™ Dressing Systemto facilitate their removal under the negativepressure cycle of Veraflo Therapy.	Subject Device3MTM V.A.C. Veraflo CleanseChoice™ Dressing Kit	Predicate Device (per K211521)3M™ Veraflo™ Cleanse Choice Complete™Dressing Kitfacilitate their removal under the negativepressure cycle of Veraflo Therapy.	Subject Device3M™ Veraflo™ Cleanse ChoiceComplete™ Dressing Kit	Comparison
Design V/V	Verification of delivery of negative pressure atnominal, high- and low-pressure settings duringthe negative pressure phase under worse casesimulated 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 atnominal, high- and low-pressure settings duringthe negative pressure phase under worse casesimulated 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 subjectdevices areidentical to theirpredicates.
SterilePackaging	Thermoformed tray of PETG with a Tyvek lid	Same as predicate	Thermoformed tray of PETG with a Tyvek lid	Same as predicate	Identical except forgeometry of tray
Shelf-Life	Two years	Same as predicate	Two years	Two years	Identical
LabelingFormat	Paper Instructions for Use provided in the dressingcarton	Same as predicate	Electronic copy of Instructions for Use available onthe web. QR code provided on kit and carton labels	Same as predicate	Respective subjectdevices areidentical to theirpredicates.

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.

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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.

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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.

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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.

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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

1. 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.
1. 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.
1. 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.

1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. Retrospective case series: Wounds treated with V.A.C. VERAFLO Therapy. Wounds International. 2020 Sep 11.
1. 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.
1. 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.
1. 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.
1. 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

Regulation Number and Section

§ 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.