(112 days)
Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings.
The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, Prevena Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
The Prevena ™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena Plus Negative Pressure Wound Therapy 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.
The Prevena™ Plus 125 Therapy Unit may be used part of as either of these systems:
A) Prevena Incision Management System Consist of:
- Prevena™ Therapy Unit .
- Prevena 150mL Canister & adaptor .
- Prevena Dressing kit ●
B) Prevena Plus Negative Pressure Wound Therapy System Consist of:
- Prevena™ Plus 125 Therapy Unit .
- Prevena 150mL Canister & adaptor .
- V.A.C. Dressing kit ●
The Prevena™ Plus Incision Management System (Prevena™ Plus Therapy Unit when used with Prevena Dressings) is designed for use over linear, non-linear, intersecting incisions.
The Prevena™ Plus Negative Pressure Wound Therapy System (Prevena™ Plus Therapy Unit when used with V.A.C. Dressings) is designed for use in a variety of open wound types such as: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The Prevena Plus 125 Therapy Units are negative pressure pumps that deliver -125mmHg continuously for up to 7 or 14 days.
The provided text is a 510(k) premarket notification summary for the Prevena Plus 125 Therapy Unit. It describes the device's indications for use, comparison to predicate devices, and performance data. However, it does not include a detailed study proving that the device meets specific acceptance criteria in the way typically required for AI/ML-driven medical devices.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. The performance data presented refers to non-clinical tests and human factors evaluation for a negative pressure wound therapy device, not a diagnostic AI system with performance metrics like sensitivity, specificity, or AUC against a ground truth.
Therefore, many of the requested elements for an AI/ML device study are not applicable or present in this document. I will answer based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a non-AI/ML negative pressure wound therapy device seeking substantial equivalence, "acceptance criteria" and "device performance" are framed differently than for an AI diagnostic algorithm. The document states that the device functions "as intended" and maintains "negative pressure within specifications." Specific quantitative acceptance criteria (e.g., minimum pressure maintained, maximum leakage) are not detailed in this summary, nor are corresponding "reported device performance" values in a comparative table for such criteria.
| Acceptance Criteria (Implicit from device function) | Reported Device Performance (Implicit from study conclusions) |
|---|---|
| Maintain negative pressure within specifications when used with dressings. | "Prevena™ Plus Negative Pressure Wound Therapy System negative pressure test demonstrates the Prevena Plus Therapy Unit when used with small and medium V.A.C. Dressing as part of a system, maintains negative pressure within specifications." |
| Function as intended when used with V.A.C. Dressings. | "In all instances, the Prevena™ Plus 125 Therapy Unit functioned as intended with V.A.C. Dressings and all test results observed were as expected." |
| Be safe and effective for its indicated uses. | The submission concludes "the subject device is substantially equivalent as the predicate devices" and "does not raise different questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the non-clinical tests mentioned. The "negative pressure test" and "human factors evaluation" would likely involve laboratory or simulated testing rather than patient data in the context of an established device's performance characteristics.
- Data Provenance: Not applicable in the context of patient data for an AI/ML algorithm. These are non-clinical (laboratory/engineering) tests.
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 established by experts as this is not a diagnostic AI/ML device study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no ground truth established by experts.
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
No, an MRMC comparative effectiveness study was not done. This device is a negative pressure wound therapy unit, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device performance stands alone as a physical therapy unit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for the non-clinical tests would be engineering specifications and functional requirements (e.g., pressure output, functionality as per design).
8. The sample size for the training set
Not applicable. There is no AI/ML model with a training set described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model with a training set described in this document.
Summary of the Study per the Document:
The provided document describes a 510(k) submission for the Prevena Plus 125 Therapy Unit, aimed at demonstrating substantial equivalence to predicate devices. The "studies" conducted were non-clinical tests and a human factors evaluation. These tests confirmed that the device "maintains negative pressure within specifications" and "functioned as intended" when used with V.A.C. Dressings. The purpose was to show that adding the "open wound" indication, similar to a reference device, does not raise new questions of safety or effectiveness. The standard for substantial equivalence for this type of medical device does not typically require the extensive clinical validation and AI-specific study details requested in the prompt.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 13, 2023
3M Teri Feelev Sr. Regulatory Associate 6203 Farinon Dr. San Antionio. Texas 78247
Re: K223263
Trade/Device Name: Prevena Plus 125 Therapy Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP. OFC Dated: October 12, 2022 Received: October 24, 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 A. Morabito -S
Julie A. 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) K223263
Device Name Prevena Plus 125 Therapy Unit
Indications for Use (Describe)
Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings.
The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, Prevena Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
The Prevena ™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena Plus Negative Pressure Wound Therapy 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.
| 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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1. Submitter Information:
3M Health Care Business Group 6203 Farinon Dr. San Antonio, TX 78249
Contact Person: Teri Feeley Email: tfeeley@mmm.com Phone: 210-459-1952 Facsimile: 210-255-6727 Date Prepared: 08 Feb 2023
2. Device
Trade/Device Name: Prevena™ Plus 125 Therapy Unit Regulation Number: 21 CFR 878.4783 Regulation Name: Negative pressure wound therapy device for reduction of wound complications Regulatory Class: Class II Product Code Primary: QFC, OMP Dated: October 12, 2022 Received: October 24, 2022
3. Predicate Device
Predicate Device: Prevena™ Plus 125 Therapy Unit (DEN180013) Predicate Device: Prevena™ Plus 125 Therapy Unit (K180855) Reference Device: V.A.C. VIA NPWT System (K173447)
4. Device Description
The Prevena™ Plus 125 Therapy Unit may be used part of as either of these systems:
A) Prevena Incision Management System Consist of:
- Prevena™ Therapy Unit .
- Prevena 150mL Canister & adaptor .
- Prevena Dressing kit ●
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B) Prevena Plus Negative Pressure Wound Therapy System Consist of:
- Prevena™ Plus 125 Therapy Unit .
- Prevena 150mL Canister & adaptor .
- V.A.C. Dressing kit ●
The Prevena™ Plus Incision Management System (Prevena™ Plus Therapy Unit when used with Prevena Dressings) is designed for use over linear, non-linear, intersecting incisions.
The Prevena™ Plus Negative Pressure Wound Therapy System (Prevena™ Plus Therapy Unit when used with V.A.C. Dressings) is designed for use in a variety of open wound types such as: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
5. Intended Use / Indications for Use
Prevena™ Plus 125 Therapy Unit is indicated for use with both the Prevena Dressings and compatible V.A.C.® Dressings.
The Prevena™ Plus 125 Therapy Unit when used with the Prevena Dressings (Prevena™ Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, Prevena™ Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
The Prevena™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena™ Plus Negative Pressure Wound Therapy 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.
6. Comparison of Technological Characteristics
The Prevena Plus 125 Therapy Units are negative pressure pumps that deliver -125mmHg continuously for up to 7 or 14 days.
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The Prevena Plus 125 Therapy Units may be used with Prevena Dressings for use over linear, non-linear, intersecting incisions on various anatomical locations as determined at the discretion of the healthcare provider.
Alternatively, the Prevena Plus 125 Therapy Units may be used with previously cleared small or medium V.A.C. Dressings for use in a variety of open wounds such as: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
At a high level, the subject and predicate & reference devices are based on the following same technological elements:
- Intended use
- Indicated for closed incisions when used with Prevena Dressings .
- · Indicated for open wounds when used with V.A.C. Dressings
- · Use environment is acute, extended and home care settings
- · Intended for use with Prevena Dressings and V.A.C. Dressings
The subject device indications for use, technological characteristics and principles of operation are substantially equivalent to the predicates.
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A table comparing the key features of the subject and predicate devices is provided below.
| Characteristic | Subject Device: | Predicate Device: | Predicate Device: | Reference Device: V.A.C. |
|---|---|---|---|---|
| Prevena ™ Plus Therapy Unit | Prevena ™ Plus Therapy Unit; DEN180013 | Prevena ™ Plus Therapy Unit; K180855 | VIA NPWT System, K173447 | |
| Indications for Use | Identical to predicate DEN180013 & reference DevicePrevena Plus 125 Therapy Unit is indicated for use with both the Prevena ™ Dressings and compatible V.A.C.® Dressings.The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, Prevena Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.The Prevena ™ Plus 125 Therapy Unit, when used with | Prevena Plus 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, Prevena Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds. | Prevena ™ Plus Incision Management Systems 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. | The V.A.C.VIA Therapy System is an integrated wound management system for use in acute, extended and home care settings.When used on closed surgical incisions, the V.A.C. VIA ™ 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 exudates via the application of negative pressure wound therapy. |
| Characteristic | Subject Device: | Predicate Device: | Predicate Device: | Reference Device: V.A.C. |
| Prevena™ Plus Therapy Unit | Prevena™ Plus Therapy | Prevena™ Plus Therapy | VIA NPWT System, | |
| Unit; DEN180013 | Unit; K180855 | K173447 | ||
| compatible V.A.C.® Dressings onopen wounds (Prevena™ PlusNegative Pressure WoundTherapy System), is intended tocreate an environmentthat promotes wound healing bysecondary ortertiary (delayed primary)intention by preparing thewound bed for closure, reducingedema, promoting granulationtissue formation and perfusion,and by removingexudate and infectiousmaterial. Open woundtypes include: chronic, acute,traumatic, subacute and dehiscedwounds, partial-thickness burns,ulcers (such as diabetic,pressure or venous insufficiency),flaps and grafts. | ||||
| Characteristic | Subject Device:PrevenaTM Plus Therapy Unit | Predicate Device:PrevenaTM Plus TherapyUnit; DEN180013 | Predicate Device:PrevenaTM Plus TherapyUnit; K180855 | Reference Device: V.A.C.VIA NPWT System,K173447 |
| When used on open wounds,the V.A.C.VIATM TherapySystem is intended to createan environment that promoteswow1d healing by secondaryor tertiary (delayed primary)intention by preparing thewound bed for closure,reducing edema, promotinggranulation tissue formationand perfusion, and byremoving exudates andinfectious material. Openwound types include: chronic,acute, traumatic, subacute anddehisced wounds, partial-thickness burns, ulcers (suchas diabetic, pressure, orvenous insufficiency), flapsand grafts. | ||||
| Indicated WoundTypes | Identical to Reference Device | ● closed incisions | ● closed incisions | ● chronic● acute● traumatic● subacute● dehisced wounds● partial-thicknessburns |
| Characteristic | Subject Device:Prevena™ Plus Therapy Unit | Predicate Device:Prevena™ Plus TherapyUnit; DEN180013 | Predicate Device:Prevena™ Plus TherapyUnit; K180855 | Reference Device: V.A.C.VIA NPWT System,K173447 |
| ulcers (such as diabetic pressure or venous insufficiency) flaps grafts closed incisions | ||||
| Prevena Dressings | Identical to PredicatesDEN180013 & K180855 | Prevena Peel & Place Dressings Prevena Customizable Dressing Prevena Restor Dressings | Prevena Peel & Place Dressings Prevena Customizable Dressing Prevena Restor Dressings | V.A.C. VIA Granufoam Spiral Dressings Dermatac Drape with V.A.C. Granufoam Dressing |
| V.A.C. Dressing | Similar to Reference | N/A | N/A | V.A.C. VIA Granufoam Spiral Dressings Dermatac Drape with V.A.C. Granufoam Dressing |
| Useenvironment/CareSetting of dressingkit | Identical to Reference device | operating room/surgery centerand then may transition homewith the patient | operating room/surgery centerand then may transition homewith the patient | acute, extended or homecaresetting |
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7. Performance Data
- a. Summary of non-clinical tests conducted for determination of substantial equivalence:
- Prevena™ Plus Negative Pressure Wound Therapy System negative pressure test ● demonstrates the Prevena Plus Therapy Unit when used with small and medium V.A.C. Dressing as part of a system, maintains negative pressure within specifications.
- Human factors evaluation ●
In all instances, the Prevena™ Plus 125 Therapy Unit functioned as intended with V.A.C. Dressings and all test results observed were as expected.
- b. Clinical and Pre-clinical testing were not necessary to demonstrate equivalence.
8. Conclusions
The subject device is substantially equivalate as the predicate devices. The subject device's Intended Use, indications for use, fundamental technology and principles of operation are unchanged compared to their respective predicates (DEN180013 & K180855).
The proposed modification to add the "open wound" indication to the subject devices is identical to the reference device (K173447) and does not raise different questions of safety or effectiveness of the subject device. The performance data demonstrates that the Prevena Plus 125 Therapy Unit when used with small and medium V.A.C. Dressing are substantially equivalent to the predicate devices.
§ 878.4783 Negative pressure wound therapy device for reduction of wound complications.
(a)
Identification. A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under § 878.4780. This classification does not include devices intended for organ space wounds.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
(i) Wound complication rates; and
(ii) All adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(5) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use.
(6) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life:
(i) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life;
(ii) Fluid removal rate consistent with the wound types specified in the indications for use; and
(iii) Timely triggering of all alarms.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include the following:
(i) Instructions for use;
(ii) A summary of the device technical specifications, including pressure settings, modes (
e.g., continuous or intermittent), alarms, and safety features;(iii) Compatible components and devices;
(iv) A summary of the clinical evidence for the indications for use;
(v) A shelf life for sterile components; and
(vi) Use life and intended use environments.
(10) For devices intended for use outside of a healthcare facility, patient labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) Information on when to contact a healthcare professional; and
(iii) Use life.