(116 days)
No
The summary describes a negative pressure wound therapy system and dressing components, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes.
The device's intended use clearly states it is for managing surgical incisions and removing exudate via negative pressure wound therapy, which are therapeutic functions.
No
Explanation: The device is intended to manage surgical incision environments and remove exudate through negative pressure wound therapy. Its function is therapeutic, not diagnostic.
No
The device description explicitly lists hardware components such as a therapy unit, canister, foam dressing, drape, pad, and sealing strips.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage surgical incisions by applying negative pressure wound therapy to remove exudate and maintain a closed environment. This is a therapeutic and wound management function, not a diagnostic one.
- Device Description: The components described (dressing, therapy unit, canister, etc.) are all related to wound care and negative pressure therapy, not to analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function falls outside of that definition.
N/A
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.
Product codes
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.
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
The Dressing will be initially applied in the operating room/surgery center and then may transition home with the patient
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:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
1
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)
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) | |
|---|---|
| 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 Incision
Management System K181507
Reference Device: Prevena Plus Incision
Management system with Prevena
Customizable Dressing, K153199 |
|-------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Identical to predicate | The Prevena Restor™ Incision Management
System 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. |
| Indicated Wound Types | Identical to predicate | • Surgically closed incisions |
| V.A.C. Negative Pressure
Wound 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/Care | ||
| Setting of dressing kit | Identical to predicate | The Dressing will be initially applied in the |
| operating room/surgery center and then may | ||
| transition home with the patient | ||
| Dressing Components | Identical to reference device | 1) Foam dressing with skin interface |
| layer |
- Hydrocolloid sealing strips
- Adhesive drape
- Tubing with interface pad |
| Sterilization Method &
SAL | Identical to predicate | Gamma radiation
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.