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.

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.

AI/ML Overview

This document, a 510(k) premarket notification for the 3M™ V.A.C. ® Peel and Place Dressing Kit, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving independent device performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert adjudication methods, and MRMC studies for an AI/CAD-like device is not present in this document.

The document primarily describes a medical wound care dressing and focuses on non-clinical testing (bench testing, biocompatibility, simulated-use) to show it functions as intended and is equivalent to previously cleared devices. There is no AI or software component described that would necessitate studies with ground truth, expert readers, or performance metrics like sensitivity/specificity for a diagnostic or AI-assisted system.

However, based on the provided text, I can infer and summarize the relevant information as follows, highlighting what is included and what is explicitly stated as not applicable or not done:

Acceptance Criteria and Device Performance (as inferred for a non-AI medical device):

Since this is a wound care dressing, "acceptance criteria" here refer to demonstrating that the device performs its intended physical functions and is safe and effective, similar to its predicate. The "performance" is measured through various non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from tests performed)	Reported Device Performance (from "Performance Data" section)
Negative Pressure Maintenance: Maintain negative pressure within specifications and manage fluid exudate without unexpected alarms.	"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: Maintain sterile barrier throughout labeled shelf life.	"Package Integrity testing to ensure the sterile barrier is maintained throughout its labeled shelf life."
Product Performance after ETO Sterilization: Function as intended throughout labeled shelf life (including dressing extensibility, moisture vapor transmission rate, peel adhesion force, release liner testing).	"Product performance testing of dressing components after Ethylene Oxide (ETO) sterilization to verify the product functions as intended throughout its labeled shelf life. This included: Dressing Extensibility, Moisture Vapor Transmission Rate, Peel Adhesion Force, Release Liner Testing."
Simulated-Use Safety & Effectiveness: Found to be safe and effective for intended users, uses, and use environments during simulated-use.	"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." Also stated: "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."
Biocompatibility: Favorable results for relevant endpoints (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-mediated pyrogenicity, Subacute Systemic Toxicity, Genotoxicity, Implantation).	"The product had favorable biocompatibility test data for all relevant endpoints." Specific tests listed include: MEM Elution, Guinea Pig Maximization Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Rabbit pyrogenicity test, 32-day Repeated Dose Subacute Toxicity, Bacterial Mutagenicity - Ames Assay, In Vitro Mouse Lymphoma with Extended Treatment.
Overall Functionality: Function as intended and test results as expected.	"In all instances, the 3M™ V.A.C. ® Peel and Place Dressing functioned as intended and all test results observed were as expected."

Regarding AI-specific criteria (which are not relevant to this traditional medical device):

2. Sample size used for the test set and the data provenance:

Not applicable as this is not an AI/diagnostic device. The "test set" here refers to the physical samples used in bench testing and simulated-use. Specific sample sizes for these tests are not provided in the document, but the tests performed are listed. Data provenance (country, retrospective/prospective) is not relevant for this type of physical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "ground truth" in the AI/diagnostic sense. Simulated-use testing involved "users representative of the use specification," implying qualified healthcare professionals, but the number and specific qualifications are not detailed beyond "qualified healthcare professional" for product application.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No expert adjudication process similar to AI model evaluation is described.

5. 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-assisted device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No "ground truth" as understood in AI/diagnostic validation. The "ground truth" for this device's performance is adherence to engineering specifications, physical properties, and biological safety standards as determined by laboratory and simulated-use testing.

8. The sample size for the training set:

Not applicable. This device does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. There is no training set or machine learning model involved.

Summary of Conclusions from the Document:

The document concludes that the "minor differences in technology do not raise any new questions of safety" and that the "performance data established by the predicate, including biocompatibility, shelf-life testing and bench testing demonstrate substantial equivalence to the predicate." It explicitly states, "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence," indicating that the non-clinical tests performed were deemed sufficient for this 510(k) submission.

Summary

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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.

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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) K222859

Device Name 3M™ V.A.C. ® Peel and Place Dressing

Indications for Use (Describe)

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: 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 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

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.

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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 WoundTypes	3M™ V.A.C. ® Peel andPlace Dressing	Dermatac Drape andGranufoam Dressing,K212320	Pico Single Use NPWTSystemK180698
	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. NegativePressure WoundTherapy 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
Useenvironment/CareSetting ofdressing kit	Identical	Acute, extended and homecare settings	Hospital and homecaresetting
System Design	The all-in-one, peel andplace drape and dressing	The individual drape anddressings are components	PICO 7 consists of apump and sterile

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are components of aNPWT system thatincludes:	of a NPWT system thatincludes:	dressing(s). The PICO 7pump maintainsnegative pressurewound therapy at 80mmHg (nominal) to thewound surface. Exudateis managed by thedressing through acombination ofabsorption andevaporation of moisturethrough the outer film.
Therapy unitproviding negativeor instillationtherapy A canister tocollect woundexudate and/orinstillation fluids A tubing set that connectsthe dressing to thecanister	Therapy unitproviding negativeor instillationtherapy A canister tocollect woundexudate and/orinstillation fluids A tubing set that connectsthe dressing to thecanister

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 ●

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Endpoint	Study Type (Test System)	Guidelines
Cytotoxicity	MEM Elution (L-929 Mouse FibroblastCells)	USFDA GLP 21CFR58ISO 10993-5 (2009)ISO 10993-12 (2007)
Sensitization	Guinea Pig Maximization Sensitization(Hartley guinea pigs)	USFDA GLP 21CFR58ISO 10993-10 (2010)ISO 10993-12 (2012)
Irritation	Intracutaneous Reactivity (New ZealandWhite Rabbit)	USFDA GLP 21CFR58ISO 10993-10 (2010)ISO 10993-12 (2012)
AcuteSystemicToxicity	Acute Systemic Injection (Swiss Mice)	USFDA GLP 21CFR58ISO 10993-11 (2006)ISO 10993-12 (2012)
Material-mediatedpyrogenicity	Rabbit pyrogenicity test (New ZealandWhite Rabbits)	USFDA GLP 21CFR58ISO 10993-11 (2006)ISO 10993-12 (2012)
SubacuteSystemicToxicity	32-day Repeated Dose Subacute Toxicity(Sprague Dawley rats)	US FDA GLP 21CFR58ISO 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 21CFR58ISO 10993-3 (2014)ISO 10993-12 (2012)
Implantation	In Vitro Mouse Lymphoma with ExtendedTreatment (L5178Y cells)	USFDA GLP 21CFR58ISO 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

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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.

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.