(64 days)
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the:
• ACTIV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.
· V.A.C.ULTA™, INFOV.A.C.™, and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used on open wounds, they are 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, they are 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.
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit is a component of the V.A.C.® Negative Pressure Wound Therapy (NPWT) Systems. The V.A.C. NPWT System is comprised of:
- Powered Negative Pressure Wound Therapy (NPWT) Unit ●
- A disposable canister which collects wound exudate
- A wound interface dressing .
- Semi-occlusive wound drape
- o Sensing pad and lumen
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit provides sterile disposable components needed for delivery of negative pressure wound therapy. Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit includes:
- (1) V.A.C.® Granufoam™ Dressings (small, medium, or large) ●
- (1 or 2) V.A.C. Dermatac TM Drapes
- (1) SensaT.R.A.C.™ Pad ●
- (1) Ruler
This document (K212320) is a 510(k) summary for the 3M™ Dermatac™ Drape and V.A.C. Granufoam™ Dressing. It describes the device, its intended use, and how its performance was evaluated for substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with corresponding "device performance" values for clinical efficacy. Instead, it focuses on verifying that the new device configuration (packaging Dermatac™ Drape with V.A.C. Granufoam™ Dressing and SensaT.R.A.C.™ Pad) and its sterilization method do not negatively impact its intended function or safety.
The acceptance criteria are implicitly met if the device functions as intended and maintains negative pressure within specifications, manages fluid exudate without unexpected alarms, and maintains sterile barrier integrity.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintenance of negative pressure within specifications and management of fluid exudate without unexpected alarms | The V.A.C.™ Negative Pressure Maintenance System Test demonstrates the Dermatac™ Drape and V.A.C. Granufoam™ Dressing, when used as part of the NPWT System, maintains negative pressure within specifications and manages fluid exudate without unexpected alarms. |
| Maintenance of sterile barrier integrity throughout labeled shelf life | Package Integrity testing ensures the sterile barrier integrity is maintained throughout its labeled shelf life. |
| Product function as intended after ETO sterilization throughout labeled shelf life | Product performance testing of dressing components after ETO sterilization verifies the product functions as intended throughout its labeled shelf life. |
| Overall safety and effectiveness | "In all instances, the Dermatac™ Drape and V.A.C. Granufoam™ Dressing functioned as intended and all test results observed were as expected." The conclusion states, "The subject device is as safe and effective as the predicate device," and "The performance data demonstrates that the Dermatac™ Drape and V.A.C. Granufoam™ Dressing is as safe and effective as the predicate." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for the individual tests (e.g., V.A.C.™ Negative Pressure Maintenance System Test, Package Integrity testing, Product performance testing). It states these were "non-clinical tests." Details regarding data provenance (e.g., country of origin, retrospective/prospective) are not provided as these were not clinical studies involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The tests performed were primarily engineering and performance verification tests, not diagnostic studies requiring expert adjudication of ground truth from clinical cases.
4. Adjudication Method for the Test Set:
Not applicable, as the tests were non-clinical performance and engineering evaluations, not clinical studies requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical performance data to demonstrate substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance. The device in question is a wound dressing kit, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
Not applicable. This device is a physical wound dressing kit, not an algorithm or AI-based software.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods, and industry standards, rather than expert consensus, pathology, or outcomes data typically associated with clinical ground truth. For instance, negative pressure maintenance was likely compared against predefined operational ranges, and sterility against established integrity standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as item 8.
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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2021
3M Health Care Business Group Teri Feeley Sr. Regulatory Associate 6203 Farinon Dr. San Antonio, Texas 78249
Re: K212320
Trade/Device Name: Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Large (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (10 pack)
Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 22, 2021 Received: July 26, 2021
Dear Teri Feeley:
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/cdrl/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.
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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 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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Enclosure
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K212320
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Dermatac™ Drape and V.A.C.® Granufoam™ Dressings Featuring SensaT.R.A.C.™ Technology-Small (5 pack) (DTGF05PKS);
Dermatac™ Drape and V.A.C.® Granufoam™ Dressings Featuring SensaT.R.A.C.™ Technology -Small (10 pack) (DTGF10PKS);
Dermatac™ Drape and V.A.C.® Granufoam™ Dressings Featuring SensaT.R.A.C.™ Technology -Medium(5 pack) (DTGF05PKM);
Dermatac™ Drape and V.A.C.® Granufoam™ Dressings Featuring SensaT.R.A.C.™ Technology -Medium (10 pack) (DTGF10PKM);
Dermatac™ Drape and V.A.C.® Granufoam™ Dressings Featuring SensaT.R.A.C. ™ Technology-Large (5 pack) (DTGF05PKL);
Dermatac™ Drape and V.A.C.® Granufoam™ Dressings Featuring SensaT.R.A.C.™ Technology-Large (10 pack) (DTGF10PKL)
Indications for Use (Describe)
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the:
• ACTIV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.
· V.A.C.ULTA™, INFOV.A.C.™, and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used on open wounds, they are 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, they are 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3M Health Care Business Group
Image /page/5/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.
510(k) Summarv 3MTM DermatacTM Drape and V.A.C. Granufoam™ Dressing
3M Health Care Business Group 6203 Farinon San Antonio, TX 78249
Contact Person: Teri Feeley Email: tfeeley@mmm.com Phone: 210-459-1952 Facsimile: 210-255-6727 Date Prepared: 22 July 2021
Name of Subject Device: 3M™ DERMATAC™ Drape and V.A.C.® GRANUFOAM™ Dressing Predicate Device: V.A.C. DERMATAC™ Drape (K181505) Reference Device: RX4™ NPWT System, (V.A.C. Granufoam™ Dressing components of system) (K160487) Common or Usual Name: Dressing component of Negative Pressure Wound Therapy 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
Device Description
:
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit is a component of the V.A.C.® Negative Pressure Wound Therapy (NPWT) Systems. The V.A.C. NPWT System is comprised of:
- Powered Negative Pressure Wound Therapy (NPWT) Unit ●
- A disposable canister which collects wound exudate
- A wound interface dressing .
- Semi-occlusive wound drape
- o Sensing pad and lumen
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit provides sterile disposable components needed for delivery of negative pressure wound therapy. Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit includes:
- (1) V.A.C.® Granufoam™ Dressings (small, medium, or large) ●
- (1 or 2) V.A.C. Dermatac TM Drapes
- (1) SensaT.R.A.C.™ Pad ●
- (1) Ruler
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3M Health Care Business Group
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.
510(k) Summarv 3M™ Dermatac™ Drape and V.A.C. Granufoam™ Dressing
Intended Use / Indications for Use
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the:
· ACTIV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.
· V.A.C.ULTA™, INFOV.A.C.™, and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used on open wounds, they are 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, they are 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.
Summary of Technological Characteristics
The V.A.C. Granufoam™ Dressing is a wound interface that is intended to be placed into the wound. The dressing has open reticulated pores to manifold negative pressure across the wound bed evenly and to facilitate the removal of exudate and infectious material. The Dermatac™ Drape is placed over the V.A.C.® Granufoam™ Dressings to provide a sealed environment for the application of neqative pressure and maintain a moist wound environment. The SensaT.R.A.C. Pad connects the dressing to the canister connected to the negative pressure wound therapy unit and facilitates the removal of wound exudates.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Intended use
- Indicated wound types
- · Use environment is acute, extended and home care settings
- Intended for use as part of the V.A.C. Therapy Systems (ACTIV.A.C.T™, V.A.C. . SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™, V.A.C.ULTA™, INFOV.A.C.™, and V.A.C.RX4™ and associated canisters)
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3M Health Care Business Group
Image /page/7/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 a registered trademark of 3M Company.
510(k) Summary 3MTM Dermatac™ Drape and V.A.C. Granufoam™ Dressing
Changes associated with this submission:
- Package Dermatac™ Drape with V.A.C. Granufoam™ Dressing and . SensaT.R.A.C.™ Pad as a dressing kit for use with V.A.C.® NPWT Systems rather than providing the dressings components separately.
- Change to the sterilization method of the legally marketed device V.A.C. Granufoam™ Dressing, SensaT.R.A.C. ™ Pad and Ruler.
- Minor modifications to the labeling .
The indications for use, technological characteristics and principles of operation have not changed.
Summary of the technological characteristics of the device compared to the predicate device
A table comparing the key features of the subject and predicate devices is provided below.
| [21 CFR 807.92(a)(6)] | ||
|---|---|---|
| Characteristic | Subject Device: | Predicate Device: Dermatac Drape,K181505Reference Device: RX4 NPWT System,K160487 |
| Intended Use | Identical | To deliver and maintain negative pressurewound therapy to the wound site. |
| Indicated Wound Types | Identical | Chronic Acute Traumatic Subacute Dehisced wounds Partial-thickness burns Ulcers (such as diabetic, pressure orvenous insufficiency) Flaps and grafts Surgically closed incisions |
| V.A.C. Negative PressureWound Therapy Units | Identical | ACTIV.A.C.™ Therapy Unit* V.A.C. SIMPLICITY™ Therapy Unit* V.A.C.VIA™ Therapy Unit* V.A.C. FREEDOM™ Therapy Unit* V.A.C.ULTA™ Therapy Unit* INFOV.A.C.™ Therapy Unit* V.A.C.RX4™ Therapy Unit**and associated canisters |
| Use environment/CareSetting of dressing kit | Identical | Acute, extended and home care settings |
| Dressing Components | Identical | V.A.C. Granufoam™ Dressing Dermatac™ Drape |
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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 font is bold and sans-serif. The logo is simple and recognizable.
510(k) Summarv 3M™ Dermatac™ Drape and V.A.C. Granufoam™ Dressing
| Sensa T.R.A.C. Pad Ruler | ||
|---|---|---|
| -- | -- | -------------------------- |
Performance Data
Summary of non-clinical tests conducted for determination of substantial equivalence:
- . V.A.C.™ Negative Pressure Maintenance System Test demonstrates the Dermatac™ Drape and V.A.C. Granufoam™ Dressing when used as part of the NPWT System maintains negative pressure within specifications and manages fluid exudate without unexpected alarms.
- Package Integrity testing to ensure the sterile barrier integrity is maintained . throughout its labeled shelf life.
- Product performance testing of dressing components after ETO sterilization to verify . the product functions as intended throughout its labeled shelf life.
In all instances, the Dermatac™ Drape and V.A.C. Granufoam™ Dressing functioned as intended and all test results observed were as expected.
Clinical and Pre-clinical testing were not necessary to demonstrate equivalence. In addition, human factors enqineering testing was not required since the subject device has the same user interface and use environment as the predicate.
Conclusions
The subject device is as safe and effective as the predicate device. The subject device's fundamental technology and principles of operation are unchanged compared to the predicate and reference devices. The subject device's Intended Use remains the same from the predicate device as cleared under K181505.
The minor technological differences between the subject device and its predicate device do not significantly affect the safety or effectiveness of the device, nor did they represent a change in intended use safety. The performance data demonstrates that the Dermatac™ Drape and V.A.C. Granufoam™ Dressing is as safe and effective as the predicate. Thus, the Dermatac™ Drape and V.A.C. Granufoam™ Dressing is substantially equivalent to the predicate.
§ 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.