The Prevena™ Restor™ Adapti-Form™ Dressing is part of the Prevena™ Restor™ Incision Management System and 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 exudate via the application of negative pressure wound therapy.

Device Description

The Prevena Restor™ Incision Management System consist of the following components for use together as a system:

Prevena Plus Therapy Unit & canister
Prevena Restor Adapti-Form Dressing:
- Foam Dressing with a skin interface layer
- V.A.C. Drape
- SensaT.R.A.C. Pad
- Hydrocolloid Sealing strips

The Prevena™ Restor™ Adapti-Form™ Dressing is designed to be compatible for use with previously cleared V.A.C. Negative Pressure Wound Therapy (NPWT) Units:

ActiV.A.C. Therapy Unit,
V.A.C. ULTA Therapy Unit, and
V.A.C. Rx4 Therapy Unit.

AI/ML Overview

The provided document describes the Prevena™ Restor™ Adapti-Form™ Dressing, a part of the Prevena™ Restor™ Incision Management System. It explicitly states that clinical and pre-clinical testing were NOT necessary to demonstrate substantial equivalence. Therefore, there are no acceptance criteria, performance data, or studies presented in this document that would typically involve sample sizes, expert qualifications, or ground truth establishment in the context of device performance in a clinical setting.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Prevena™ Restor™ Incision Management System, K181507) and a reference device (Prevena Plus Incision Management System, K153199) through a comparison of technological characteristics and non-clinical tests.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical performance criteria are not applicable based on the document's statement, the "acceptance criteria" here refer to the successful completion of non-clinical tests.

Acceptance Criterion (Non-Clinical Test Passed)	Reported Device Performance (Result)
Prevena Restor Incision Management System negative pressure test	Functioned as intended; test results passed.
Package Integrity/Stability testing (ISO 11607-1)	Functioned as intended; test results passed.
Product performance stability testing of dressing components after sterilization	Functioned as intended; test results passed.
Human factors evaluation	Functioned as intended; test results passed.
Biocompatibility testing (ISO 10993-1)	Functioned as intended; test results passed.

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

Not applicable. The document explicitly states that "Clinical and Pre-clinical testing were not necessary to demonstrate substantial equivalence." The non-clinical tests listed (e.g., negative pressure test, package integrity) do not involve human patient test sets in the typical sense; they assess product specifications and safety characteristics. Information about the sample size of materials or units used for these engineering/safety tests is not provided.

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

Not applicable. As clinical or pre-clinical performance studies were not conducted for substantial equivalence, there was no need for experts to establish ground truth on patient outcomes or diagnoses.

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

Not applicable. No clinical or pre-clinical performance studies involving adjudication were performed.

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. The device is a wound dressing, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a wound dressing, not an algorithm.

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

Not applicable. As clinical performance studies were not conducted, there was no ground truth related to patient conditions or diagnoses. The "ground truth" for the non-clinical tests would have been the pre-defined engineering and safety specifications or industry standards.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device, so there is no concept of a "training set."

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

Not applicable. No training set was involved.

Summary

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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.

July 1, 2022

3M Health Care Business Group Teri Feeley Sr. Regulatory Affairs Associate 6203 Farinon Dr. San Antonio, Texas 78249

Re: K220660

Trade/Device Name: Prevena™ Restor™ Adapti-Form™ Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: March 4, 2022 Received: March 7, 2022

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/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

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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 Morabito, PhD 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) K220660

Device Name Prevena™ Restor™ Adapti-Form™ 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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510(k) Summary Prevena™ Restor™ Adapti-Form™ 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: 25 Feb 2022

Name of Subject Device: Prevena™ Restor™ Adapti-Form™ Dressing Predicate Device: Prevena™ Restor™ Incision Management System (K181507) Reference Device: Prevena Plus Incision Management System (Prevena Customizable Dressing components of system) (K153199) Common or Usual Name: Dressing component of Prevena Incision Management System Classification Name: Negative Pressure Wound Therapy Powered Suction Pump (and components) Requlation Number: 21 CFR 878.4780 Regulatory Class: Class II Product Code: OMP

Device Description

The Prevena Restor™ Incision Management System consist of the following components for use together as a system:

Prevena Plus Therapy Unit & canister
Prevena Restor Adapti-Form Dressing: ●
- Foam Dressing with a skin interface layer o
- V.A.C. Drape o
- o SensaT.R.A.C. Pad
- Hydrocolloid Sealing strips o

The Prevena™ Restor™ Adapti-Form™ Dressing is designed to be compatible for use with previously cleared V.A.C. Negative Pressure Wound Therapy (NPWT) Units:

· ActiV.A.C. Therapy Unit,
· V.A.C. ULTA Therapy Unit, and
· V.A.C. Rx4 Therapy Unit.

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Image /page/4/Picture/1 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) Summary Prevena™ Restor™ Adapti-Form™ Dressing

Intended Use / Indications for Use

The Prevena Restor Adapti-Form Dressing is part of the Prevena Restor Incision Management System and 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 exudate via the application of negative pressure wound therapy.

Summary of Technological Characteristics

The Prevena™ Restor™ Adapti-Form™ Dressing is a customizable dressing, designed for use over linear, non-linear, intersecting incisions. The dressings are for use over various anatomical locations as determined at the discretion of the healthcare provider. The dressing is intended to be used with the Prevena Plus™ Therapy Unit or compatible V.A.C. Therapy Unit to achieve its intended purpose as the Prevena Restor Incision Management system.

The subject device indications for use, technological characteristics and principles of operation are substantially equivalent to the predicate. The difference between the subject and predicate device is the subject device dressing components are provided separately to offer the ability to cut/customize the dressing to address application needs that may not be met with the predicate (Prevena Restor Dressing, K181507)).

A table comparing the key features of the subject and predicate devices is provided below.

Characteristic	Subject Device:	Predicate Device: Prevena Restor IncisionManagement System K181507Reference Device: Prevena Plus IncisionManagement system with PrevenaCustomizable Dressing, K153199
Intended Use	Identical to predicate	The Prevena Restor™ Incision ManagementSystem is intended to manage theenvironment of surgical incisions that continueto drain following sutured or stapled closureby maintaining a closed environment andremoving exudate via the application ofnegative pressure wound therapy.
Indicated Wound Types	Identical to predicate	• Surgically closed incisions
V.A.C. Negative PressureWound Therapy Units	Identical to predicate	• Prevena Plus Therapy Unit 7 day• Prevena Plus Therapy Unit 14-day• ACTIV.A.C.™ Therapy Unit• V.A.C.ULTA™ Therapy Unit• V.A.C.RX4™ Therapy Unit*

Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]

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510(k) Summary Prevena™ Restor™ Adapti-Form™ Dressing

		*and associated canisters
Use environment/CareSetting of dressing kit	Identical to predicate	The Dressing will be initially applied in theoperating room/surgery center and then maytransition home with the patient
Dressing Components	Identical to reference device	1) Foam dressing with skin interfacelayer2) Hydrocolloid sealing strips3) Adhesive drape4) Tubing with interface pad
Sterilization Method &SAL	Identical to predicate	Gamma radiation10-6

Performance Data

Summary of non-clinical tests conducted for determination of substantial equivalence:

Prevena Restor Incision Management System negative pressure test .
Package Integrity/Stability testing was done in accordance with ISO 11607-1 ●
Product performance stability testing of dressing components after sterilization ●
. Human factors evaluation
Biocompatibility testing to ISO 10993-1 .

In all instances, the Prevena™ Restor™ Adapti-Form™ Dressing which is a part of the Prevena™ Restor™ Incision Management System functioned as intended and all test results passed.

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

Conclusions

The subject device's Intended Use, indications for use, fundamental technology and principles of operation are unchanged compared to the predicate and reference devices cleared under K181507 & K153199.

The performance data demonstrates that the Prevena Restor Adapti-Form Dressing is substantially equivalent to the predicate product in terms of safety and effectiveness.

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.