(217 days)
No
The 510(k) summary describes a negative pressure wound therapy dressing kit with an instillation option. The description focuses on the physical components of the kit and its intended use in wound healing. There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment planning, or monitoring. The performance studies described are non-clinical tests related to biological safety, system performance (maintaining negative pressure and fluid removal), and usability, not algorithmic performance.
Yes
The device is used as part of an integrated wound management system that provides therapy to promote wound healing, reduce edema, and remove exudate and infectious material from wounds.
No
This device is a dressing kit used for wound management, providing negative pressure wound therapy with an instillation option. Its purpose is to promote wound healing, not to diagnose a condition.
No
The device description explicitly lists physical components like wound dressings, drape, 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:
- Intended Use: The intended use clearly describes a device used for wound management through negative pressure therapy and instillation of topical solutions. This is a therapeutic and wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details components like dressings, drapes, and tubing sets used to apply therapy directly to a wound. These are physical components for treatment, not reagents or instruments for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a medical device used for wound treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
The 3M Veraflo Cleanse Choice Complete Dressing Kit with and without 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Veraflo Cleanse Choice Complete Dressing Kit is intended to be used with the separately provided V.A.C. Ulta Therapy Unit and its associated canisters and cassette for the delivery of Veraflo Therapy that provides V.A.C. Therapy Negative Pressure Wound Therapy with an instillation option. The system kit provides sterile disposable components needed for delivery of Veraflo Therapy. The kit contains the wound dressing (Veraflo Cleanse Choice Complete Dressing), drape (V.A.C. Dermatac Drape), tubing set (3M V.A.C. VeraT.R.A.C. Pad or 3M V.A.C. VeraT.R.A.C. Duo Tube Set) and a wound measuring ruler.
The kit components are intended to simplify wound dressing applications by replacing the multiple grey foam dressing pieces in the predicate kit with a single blue foam piece and to provide the V.A.C. Dermatac Drape in the same package with the dressing. Because V.A.C. Dermatac Drape can only be sterilized by ethylene oxide, the kit must also be sterilized by this method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound bed
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to verify compliance with the predicate design requirements:
- A biological safety evaluation was performed on Veraflo Cleanse Choice Complete Dressing Kit as an externally communicating device with tissue/bone/dentin contact for a prolonged duration (>24 hours to
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2021
3M Health Care Business Group Margaret Marsh Regulatory Affairs Advanced Specialist 6203 Farinon Dr San Antonio, Texas 78249
Re: K211521
Trade/Device Name: 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 28, 2021 Received: October 29, 2021
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 Morabito, Ph.D., RAC 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
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Indications for Use
510(k) Number (if known) K211521
Device Name
3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit (Medium Dressing Kit VFCCC05MD, Large Dressing Kit: VFCCC05LG)
Indications for Use (Describe)
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.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K211521
| Date prepared | December 6, 2021 |
|---|---|
| Submitter information [21 CFR 807.929(a)(1)] | |
| Applicant Name | 3M Health Care Business Group |
| Applicant Address | 6203 Farinon Dr San Antonio TX 78249 United States of America |
| Applicant Contact | |
| Telephone | 210 255 6481 |
| Applicant Contact | Margaret Marsh, Regulatory Affairs Advanced Specialist |
| Applicant Contact | |
| mlmarsh@mmm.com | |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or | |
| proprietary name | 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit : |
| Medium Dressing Kit: VFCCC05MD | |
| Large Dressing Kit: VFCCC05LG) | |
| Common or usual | |
| name | Component of a powered suction pump |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump |
| Regulation Number | 878.4780 |
| Product Code | OMP |
| Legally marketed device(s) to which equivalence is claimed | |
| [21 CFR 807.92(a)(3)] | |
| Predicate: 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit, cleared under 510(k) K160451 | |
| Reference: 3M™ V.A.C. Dermatac™ Drape, cleared for use with 3M™ V.A.C. Veraflo™ | |
| Therapy under 510(k) K200390. | |
| Device description summary | |
| [21 CFR 807.92(a)(4)] | |
| The Veraflo™ Cleanse Choice Complete Dressing Kit is intended to be used with the separately | |
| provided V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of | |
| Veraflo Therapy that provides V.A.C.® Therapy Negative Pressure Wound Therapy with an | |
| instillation option. The system kit provides sterile disposable components needed for delivery of | |
| Veraflo Therapy. The kit contains the wound dressing (Veraflo Cleanse Choice Complete | |
| Dressing), drape (V.A.C. Dermatac Drape), tubing set (3M™ V.A.C. VeraT.R.A.C.™ Pad or | |
| 3M™ V.A.C. VeraT.R.A.C. Duo™ Tube Set) and a wound measuring ruler. | |
| The kit components are intended to simplify wound dressing applications by replacing the |
multiple grey foam dressing pieces in the predicate kit with a single blue foam piece and to provide the V.A.C. Dermatac Drape in the same package with the dressing. Because V.A.C. Dermatac Drape can only be sterilized by ethylene oxide, the kit must also be sterilized by this method.
4
510(k) Summarv K211521
Indications for Use 21 CFR 807.92(a)(5)
Both the subject and predicate device kit have same intended use and indications for use. The 3M™ V.A.C. 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 (delaved 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.
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, partialthickness 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)]
The subject and predicate device kits both have the same technology in that they are sterile, single use, components that are required for use with the V.A.C.® Ulta Therapy Unit for delivery of Veraflo Therapy. They both contain a wound dressing, drape and tubing set; the mechanism of action of each kit component is unchanged.
The changes in the subject kit components relate to the color of the dressing, reduction of the required pieces of dressing to only one, incorporation of a separately cleared drape for use with Veraflo Therapy and ETO sterilization. These changes have been verified to have no impact on the predicate requirements for biocompatibility, system performance in delivering negative pressure and removing fluid from the wound bed into the canister or usability.
Performance data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
The following tests were performed to verify compliance with the predicate design requirements:
- . A biological safety evaluation was performed on Veraflo Cleanse Choice Complete Dressing Kit as an externally communicating device with tissue/bone/dentin contact for a prolonged duration (>24 hours to