(182 days)
No
The summary describes a physical dressing and its function in negative pressure wound therapy. There is no mention of AI, ML, or any computational analysis of data.
Yes
Explanation: The device, used in a Negative Pressure Wound Therapy (NPWT) System, promotes wound healing, reduces edema, promotes granulation tissue formation and perfusion, and removes exudate and infectious material, which are all therapeutic functions.
No
The device is a dressing for negative pressure wound therapy, intended to promote wound healing by managing the wound environment and removing exudates, rather than identifying or characterizing a disease or condition.
No
The device description clearly outlines physical components like a semi-occlusive drape, foam dressing, SensaTRAC Pad, and Tubeset, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The 3M™ V.A.C.® Peel and Place Dressing is a wound dressing used in conjunction with a Negative Pressure Wound Therapy System. Its function is to manage the wound environment by applying negative pressure, removing exudate, and promoting healing.
- Lack of Biological Sample Analysis: The description of the device and its intended use does not involve the analysis of any biological samples from the patient. It is a physical dressing applied to the wound.
Therefore, the device falls under the category of a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3M™ V.A.C.® Peel and Place Dressing is intended to be applied in an acute, extended, or home care setting where product application is conducted by or under the supervision of a qualified healthcare professional. It is an accessory to the 3M™ Negative Pressure Wound Therapy System.
When used on open wounds, the system 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The 3M™ V.A.C. ® Peel and Place Dressing Kit is a sterile, single use all in one dressing comprised of a semi-occlusive drape and foam dressing kitted together with a SensaTRAC Pad and Tubeset. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the periwound and the silicone layer primarily provides a seal for negative pressure. The polyurethane foam assists with manifolding negative pressure across the wound and periwound.
The one-piece all-in-one dressing and drape are similar to the Dermatac Drape and Granufoam Dressing, most recently cleared under 510(k) K212320, which are provided in a two piece design.
The 3M™ V.A.C. ® Peel and Place Dressing Kit is a sterile, single use all in one dressing comprised of a semi-occlusive drape and foam dressing kitted together with a SensaTRAC Pad and Tubeset (not the subject of this 510(k)). They are accessories to the V.A.C.® Therapy System, which is comprised of the following components:
- Software controlled therapy unit that provides negative pressure
- Semi-occlusive drape and foam dressing
- Disposable canister which collects wound exudate and stores it away from the wound
- SensaTRAC Pad and Tube Set
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, or home care setting where product application is conducted by or under the supervision of a qualified healthcare professional.
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)
Summary of non-clinical tests conducted for determination of substantial equivalence:
- V.A.C.® Negative Pressure Maintenance System Test: demonstrates the 3M™ V.A.C.® Peel and Place Dressing maintains negative pressure within specifications and manages fluid exudate without unexpected alarms.
- Package Integrity testing: to ensure the sterile barrier is maintained throughout its labeled shelf life.
- Product performance testing of dressing components after Ethylene Oxide (ETO) sterilization: to verify the product functions as intended throughout its labeled shelf life. Included: Dressing Extensibility, Moisture Vapor Transmission Rate, Peel Adhesion Force, Release Liner Testing.
- Simulated-use testing: The 3M™ V.A.C. ® Peel and Place Dressing and associated labeling was evaluated via simulated-use testing with users representative of the use specification and has been found to be safe and effective for the intended users, uses and use environments.
- Summary of Biocompatibility Testing:
- Cytotoxicity - MEM Elution (L-929 Mouse Fibroblast Cells)
- Sensitization - Guinea Pig Maximization Sensitization (Hartley guinea pigs)
- Irritation - Intracutaneous Reactivity (New Zealand White Rabbit)
- Acute Systemic Toxicity - Acute Systemic Injection (Swiss Mice)
- Material-mediated pyrogenicity - Rabbit pyrogenicity test (New Zealand White Rabbits)
- Subacute Systemic Toxicity - 32-day Repeated Dose Subacute Toxicity (Sprague Dawley rats)
- Genotoxicity - Bacterial Mutagenicity - Ames Assay (Salmonella typhimurium [TA97a, TA98, TA100 and TA1535] and Escherichia coli [WP2-uvrA])
- Implantation - In Vitro Mouse Lymphoma with Extended Treatment (L5178Y cells)
Key results:
In all instances, the 3M™ V.A.C. ® Peel and Place Dressing functioned as intended and all test results observed were as expected. The product had favorable biocompatibility test data for all relevant endpoints. The testing generated strong evidence that the 3M™ V.A.C. ® Peel and Place Dressing has been found to be safe and effective for the intended users, uses and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
V.A.C. DERMATAC™ Drape and V.A.C. Granufoam Dressing (K212320)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Pico Single Use NPWT System (K180698)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 23, 2023
3M Melanie Avila Regulatory Affairs Manager 6203 Farinon Drive San Antonio, Texas 78249
Re: K222859
Trade/Device Name: 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 25, 2022 Received: September 22, 2022
Dear Melanie Avila:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222859
Device Name 3M™ V.A.C. ® Peel and Place Dressing
Indications for Use (Describe)
The 3M™ V.A.C.® Peel and Place Dressing is intended to be applied in an acute, extended, or home care setting where product application is conducted by or under the supervision of a qualified healthcare professional. It is an accessory to the 3M™ Negative Pressure Wound Therapy System.
When used on open wounds, the system 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, 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.#### This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
3M Health Care Business Group 6203 Farinon San Antonio, TX 78249
Contact Person: Melanie Avila Email: mavila9@mmm.com Phone: 210-275-5038 Date Prepared: March 15, 2023
Name of Subject Device: 3M™ V.A.C. ® Peel and Place Dressing Predicate Device: V.A.C. DERMATAC™ Drape and V.A.C. Granufoam Dressing (K212320 Reference Device: Pico Single Use NPWT System (K180698) Common or Usual Name: Dressing component of Negative Pressure Wound Therapy (NPWT) System Classification Name: Neqative Pressure Wound Therapy Powered Suction Pump (and components) Regulatory Number: 21 CFR 878.4780 Regulatory Class: Class II Product Code: OMP
Device Description
The 3M™ V.A.C. ® Peel and Place Dressing Kit is a sterile, single use all in one dressing comprised of a semi-occlusive drape and foam dressing kitted together with a SensaTRAC Pad and Tubeset. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the periwound and the silicone layer primarily provides a seal for negative pressure. The polyurethane foam assists with manifolding negative pressure across the wound and periwound.
The one-piece all-in-one dressing and drape are similar to the Dermatac Drape and Granufoam Dressing, most recently cleared under 510(k) K212320, which are provided in a two piece design.
Intended Use / Indications for Use
The 3M™ V.A.C.® Peel and Place Dressing is intended to be applied in an acute, extended, or home care setting where product application is conducted by or under the supervision of a qualified healthcare professional. It is an accessory to the 3M™ Negative Pressure Wound Therapy System.
When used on open wounds, the system 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.
4
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 3M™ V.A.C. ® Peel and Place Dressing Kit is a sterile, single use all in one dressing comprised of a semi-occlusive drape and foam dressing kitted together with a SensaTRAC Pad and Tubeset (not the subject of this 510(k)). They are accessories to the V.A.C.® Therapy System, which is comprised of the following components:
- Software controlled therapy unit that provides negative pressure ●
- Semi-occlusive drape and foam dressing ●
- Disposable canister which collects wound exudate and stores it away from the . wound
- SensaTRAC Pad and Tube Set
Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]
| Characteristic | Subject Device: | Predicate Device: | Reference Device: |
|---|---|---|---|
| Indicated Wound | |||
| Types | 3M™ V.A.C. ® Peel and | ||
| Place Dressing | Dermatac Drape and | ||
| Granufoam Dressing, | |||
| K212320 | Pico Single Use NPWT | ||
| System | |||
| K180698 | |||
| Identical | Chronic Acute Traumatic Subacute Dehisced wounds Partial-thickness burns Ulcers (such as diabetic, pressure or venous insufficiency) Flaps and grafts Surgically closed incisions (For V.A.C. Therapy only) | N/A | |
| V.A.C. Negative | |||
| Pressure Wound | |||
| Therapy Units | Identical | 3M™ ActiV.A.C.™ 3M™ V.A.C.® Simplicity 3M™ V.A.C.Via™ V.A.C.ULTA™ V.A.C.RX4™ | N/A |
| Use | |||
| environment/Care | |||
| Setting of | |||
| dressing kit | Identical | Acute, extended and home | |
| care settings | Hospital and homecare | ||
| setting | |||
| System Design | The all-in-one, peel and | ||
| place drape and dressing | The individual drape and | ||
| dressings are components | PICO 7 consists of a | ||
| pump and sterile |
5
| are components of a
NPWT system that
includes: | of a NPWT system that
includes: | dressing(s). The PICO 7
pump maintains
negative pressure
wound therapy at 80
mmHg (nominal) to the
wound surface. Exudate
is managed by the
dressing through a
combination of
absorption and
evaporation of moisture
through the outer film. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Therapy unit
providing negative
or instillation
therapy A canister to
collect wound
exudate and/or
instillation fluids A tubing set that connects
the dressing to the
canister | Therapy unit
providing negative
or instillation
therapy A canister to
collect wound
exudate and/or
instillation fluids A tubing set that connects
the dressing to the
canister | |
Performance Data
Summary of non-clinical tests conducted for determination of substantial equivalence:
- . V.A.C.® Negative Pressure Maintenance System Test demonstrates the 3M™ V.A.C.® Peel and Place Dressing maintains negative pressure within specifications and manages fluid exudate without unexpected alarms.
- Package Integrity testing to ensure the sterile barrier is maintained throughout its . labeled shelf life.
- . Product performance testing of dressing components after Ethylene Oxide (ETO) sterilization to verify the product functions as intended throughout its labeled shelf life.
- Dressing Extensibility O
- Moisture Vapor Transmission Rate o
- Peel Adhesion Force O
- Release Liner Testing o
- . The 3M™ V.A.C. ® Peel and Place Dressing and associated labeling was evaluated via simulated-use testing with users representative of the use specification and has been found to be safe and effective for the intended users, uses and use environments.
- Summary of Biocompatibility Testing ●
6
| Endpoint | Study Type (Test System) | Guidelines |
|---|---|---|
| Cytotoxicity | MEM Elution (L-929 Mouse Fibroblast | |
| Cells) | USFDA GLP 21CFR58 | |
| ISO 10993-5 (2009) | ||
| ISO 10993-12 (2007) | ||
| Sensitization | Guinea Pig Maximization Sensitization | |
| (Hartley guinea pigs) | USFDA GLP 21CFR58 | |
| ISO 10993-10 (2010) | ||
| ISO 10993-12 (2012) | ||
| Irritation | Intracutaneous Reactivity (New Zealand | |
| White Rabbit) | USFDA GLP 21CFR58 | |
| ISO 10993-10 (2010) | ||
| ISO 10993-12 (2012) | ||
| Acute | ||
| Systemic | ||
| Toxicity | Acute Systemic Injection (Swiss Mice) | USFDA GLP 21CFR58 |
| ISO 10993-11 (2006) | ||
| ISO 10993-12 (2012) | ||
| Material- | ||
| mediated | ||
| pyrogenicity | Rabbit pyrogenicity test (New Zealand | |
| White Rabbits) | USFDA GLP 21CFR58 | |
| ISO 10993-11 (2006) | ||
| ISO 10993-12 (2012) | ||
| Subacute | ||
| Systemic | ||
| Toxicity | 32-day Repeated Dose Subacute Toxicity | |
| (Sprague Dawley rats) | US FDA GLP 21CFR58 | |
| ISO 10993-11 (2006) | ||
| ISO 10993-12 (2012) | ||
| Genotoxicity | Bacterial Mutagenicity - Ames Assay | |
| (Salmonella typhimurium [TA97a, TA98, | ||
| TA100 and TA1535] and Escherichia coli | ||
| [WP2-uvrA]) | USFDA GLP 21CFR58 | |
| ISO 10993-3 (2014) | ||
| ISO 10993-12 (2012) | ||
| Implantation | In Vitro Mouse Lymphoma with Extended | |
| Treatment (L5178Y cells) | USFDA GLP 21CFR58 | |
| ISO 10993-6 (2016) |
The product had favorable biocompatibility test data for all relevant endpoints.
In all instances, the 3M™ V.A.C. ® Peel and Place Dressing functioned as intended and all test results observed were as expected.
The 3M™ V.A.C. ® Peel and Place Dressing and associated labeling was evaluated via simulateduse testing with users representative of the use specification. The testing generated strong evidence that the 3M™ V.A.C. ® Peel and Place Dressing has been found to be safe and effective for the intended users, uses and use environments
Clinical and Pre-clinical testing were not necessary to demonstrate equivalence.
Conclusions
7
The minor differences in technology do not raise any new questions of safety and the performance data established by the predicate, including biocompatibility, shelf-life testing and bench testing demonstrate substantial equivalence to the predicate.
The subject device's fundamental technology and principles of operation are unchanged compared to the predicate device. The subject device's Intended Use remains the same from the predicate device as cleared under K212320.
The subject device is as safe and effective as the predicate device.