Prevena Restor Adapti-Form Dressing

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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. 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220660 Device Name Prevena™ Restor™ Adapti-Form™ Dressing #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is simple and recognizable. 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. {4}------------------------------------------------ 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 Incision<br>Management System K181507<br>Reference Device: Prevena Plus Incision<br>Management system with Prevena<br>Customizable Dressing, K153199 | |-------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Identical to predicate | The Prevena Restor™ Incision Management<br>System is intended to manage the<br>environment of surgical incisions that continue<br>to drain following sutured or stapled closure<br>by maintaining a closed environment and<br>removing exudate via the application of<br>negative pressure wound therapy. | | Indicated Wound Types | Identical to predicate | • Surgically closed incisions | | V.A.C. Negative Pressure<br>Wound Therapy Units | Identical to predicate | • Prevena Plus Therapy Unit 7 day<br>• Prevena Plus Therapy Unit 14-day<br>• ACTIV.A.C.™ Therapy Unit*<br>• V.A.C.ULTA™ Therapy Unit*<br>• 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)] {5}------------------------------------------------ Image /page/5/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 | | | *and associated canisters | |-------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Use environment/Care<br>Setting of dressing kit | Identical to predicate | The Dressing will be initially applied in the<br>operating room/surgery center and then may<br>transition home with the patient | | Dressing Components | Identical to reference device | 1) Foam dressing with skin interface<br>layer<br>2) Hydrocolloid sealing strips<br>3) Adhesive drape<br>4) Tubing with interface pad | | Sterilization Method &<br>SAL | Identical to predicate | Gamma radiation<br>10-6 | # 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.