K Number

Device Name

3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)

Manufacturer

KCI USA, Inc.

Date Cleared

2024-05-23

(29 days)

Product Code

OMP

Regulation Number

878.4780

Intended Use

The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. When used on open wounds, it 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Device Description

The 3M™ ActiV.A.C.™ Canister - 300ml with Gel is a component of the ActiV.A.C.™ Negative Pressure Wound Therapy System, also referred to as the ActiV.A.C. ™ Therapy System. The ActiV.A.C. ™ Therapy System consists of: - · an ACTIV.A.C. ™ Therapy Unit, - · a disposable canister which collects wound exudate (the subject of this submission), - · a wound interface dressing, - · a semi-occlusive wound drape, and - · a sensing pad and lumen. The 3M™ ActiV.A.C. ™ Canister - 300ml with Gel is a single use disposable component of the ActiV.A.C. ™ Therapy System and is sold separately from the ActiV.A.C. ™ Therapy Unit. It is provided in either a 5 pack or 10 pack configuration. The Canister is attached to the therapy unit and collects wound exudates. The distal end of the Canister tubing attaches to the dressing tube set using rigid connectors. The Canister has volume graduations and contains a gel pack for fluid solidification and a tubing pinch clamp. The Canister is composed of MABS (Methylmethacrylate acrylonitrile butadiene styrene).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K201571

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a negative pressure wound therapy system and its components. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies sections.

Therapeutic

Yes
The device is described as an "integrated wound management system" intended to promote wound healing by preparing the wound bed, reducing edema, promoting granulation tissue, and removing exudate and infectious material, which are all therapeutic actions.

Diagnostic

The device is a Negative Pressure Wound Therapy System used for wound management, promoting healing by removing exudate and infectious material, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components (Therapy Unit, disposable canister, wound interface dressing, semi-occlusive wound drape, sensing pad and lumen) that are part of the system. The submission focuses on a specific hardware component (the canister).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a system for managing and promoting the healing of open wounds and closed surgical incisions by applying negative pressure. This is a therapeutic intervention applied directly to the body, not a diagnostic test performed on samples taken from the body.
Device Description: The device description details a system that collects wound exudate and applies negative pressure. This aligns with a therapeutic device, not a diagnostic one.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is to manage the wound environment.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, it 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 by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Product codes

OMP

Device Description

· an ACTIV.A.C. ™ Therapy Unit,
· a disposable canister which collects wound exudate (the subject of this submission),
· a wound interface dressing,
· a semi-occlusive wound drape, and
· a sensing pad and lumen.

The 3M™ ActiV.A.C. ™ Canister - 300ml with Gel is a single use disposable component of the ActiV.A.C. ™ Therapy System and is sold separately from the ActiV.A.C. ™ Therapy Unit. It is provided in either a 5 pack or 10 pack configuration.

The Canister is attached to the therapy unit and collects wound exudates. The distal end of the Canister tubing attaches to the dressing tube set using rigid connectors. The Canister has volume graduations and contains a gel pack for fluid solidification and a tubing pinch clamp.

The Canister is composed of MABS (Methylmethacrylate acrylonitrile butadiene styrene).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

acute, extended and home care settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

There was no performance data or biocompatibility performed to demonstrate equivalence.

Clinical and Pre-clinical testing were not necessary to demonstrate equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201571

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 23, 2024

KCI USA, Inc. Jacqulyn Rosinski Regulatory Affairs Associate 6203 Farinon Dr. San Antonio, Texas 78249

Re: K241134

Trade/Device Name: 3M™ ActiV.A.C.TM Canister - 300ml with Gel Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: April 24, 2024 Received: April 24, 2024

Dear Jacqulyn Rosinski:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Image /page/2/Picture/3 description: The image shows the name "Mustafa A. Mazher -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are clear and well-defined, making the name easily readable.

for Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Indications for Use

510(k) Number (if known) K241134

Device Name 3MTM ActiV.A.C.TM Canister - 300ml with Gel

Indications for Use (Describe)

The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, it 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3M Health Care Business Group 6203 Farinon San Antonio. TX 78249

Contact Person: Jacqulyn Rosinski Email: jrosinski@solventum.com Phone: 651-650-1545 Date Prepared: April 24, 2024

Name of Subiect Device: 3M™ ActiV.A.C.™ Canister - 300ml with Gel Common or Usual Name: Dressing component of Negative Pressure Wound Therapy (NPWT) System Classification Name: Negative Pressure Wound Therapy Powered Suction Pump (and components) Regulatory Number: 21 CFR 878.4780 Regulatory Class: Class II Product Code: OMP Predicate Device: ACTIV.A.C.™ Negative Pressure Wound Therapy System (K201571)

Device Description

· an ACTIV.A.C. ™ Therapy Unit,
· a disposable canister which collects wound exudate (the subject of this submission),
· a wound interface dressing,
· a semi-occlusive wound drape, and
· a sensing pad and lumen.

The Canister is composed of MABS (Methylmethacrylate acrylonitrile butadiene styrene).

Most recently cleared under K201571.