(119 days)
No
The summary describes a negative pressure wound therapy system that applies continuous negative pressure. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML for analysis, decision-making, or adaptation. The performance studies focus on pressure distribution and alarm functionality, not algorithmic performance.
Yes
The device is described as "Prevena Plus Incision Management System," "Negative Pressure Wound Therapy Units," and "Negative Pressure Wound Therapy Systems," all of which are types of therapeutic devices. Its intended use is to "manage the environment of surgical incisions" and "remove exudate via the application of negative pressure wound therapy," indicating a direct therapeutic action on the body.
No
The device is described as an "Incision Management System" intended to apply negative pressure wound therapy to surgical incisions for environmental management and exudate removal. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly lists hardware components (Prevena Dressing, KCI Negative Pressure Wound Therapy Units) and describes the application of negative pressure, which is a physical therapy, not a software-only function.
Based on the provided information, the Prevena Plus Incision Management System is not an IVD (In Vitro Diagnostic) device.
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 management function applied directly to the patient's body.
- Device Description: The device consists of dressings and negative pressure therapy units. These components are designed for external application and physical interaction with the wound site.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat or manage a condition on the body's surface. The Prevena Plus system falls under the category of wound management devices.
N/A
Intended Use / Indications for Use
The Prevena Plus 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.
Product codes
OMP
Device Description
The Prevena Plus Incision Management System provides surgical incision management via the application of negative pressure wound therapy over an incision site that has been surgically closed with sutures or staples. The system is applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference.
The Prevena Plus Incision Management System consists of:
A Prevena Dressing (Prevena Plus Peel & Place Dressing or Prevena Plus Customizable Dressing) and One of the following KCI Negative Pressure Wound Therapy Units:
- Prevena Plus 125 Therapy Unit*
- ActiV.A.C. Therapy Unit
- V.A.C. Freedom Therapy Unit
- InfoV.A.C. Therapy Unit
- V.A.C. ATS Therapy Unit
- V.A.C. Ulta Therapy Unit
- The Prevena Plus 125 Therapy Unit is a slightly modified V.A.C.Via Therapy Unit, previously cleared under K132741, that provides continuous negative pressure at -125mmHg only. The V.A.C.Via Therapy Unit serves as a reference device for 510(k) K153199.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical incisions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following performance data were provided in support of the substantial equivalence determination.
- The average distribution of negative pressure across the full length of the Prevena Plus Customizable Dressing on a simulated wound bed under wet conditions and at maximum air leak demonstrated that the Prevena Plus 125 Therapy Unit and tubing set were able to provide negative pressure within specification at -125 mmHg, continuous mode for 7 days, equivalent to both the predicate and reference therapy units.
- The Prevena Plus 125 Therapy Unit was shown to provide alarms for leak, blockage and full canister within specification when connected to the Prevena Plus Customizable Dressing and tubing set.
No clinical tests were necessary.
Key Metrics
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 29, 2016
Kinetic Concepts Incorporated USA Ms. Margaret Marsh Technical Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K153199
Trade/Device Name: Prevena Plus Incision Management System Kit With Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-pack, Prevena Plus Incision Management System Kit With Customizable Dressing. Prevena Plus Customizable Dressing 5-pack
Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: February 1. 2016 Received: February 3, 2016
Dear Ms. Marsh:
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. 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 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K153199
Device Name
Prevena Plus Incision Management System with Peel & Place and Customizable Dressings
Indications for Use (Describe)
The Prevena Plus 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.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) SUMMARY Prevena Plus Incision Management System
| Submitter Information [21 CFR 807.92(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-255-6481 |
| Fax number | 210-255-6727 |
| Establishment | |
| Registration Number | 3005178245 |
| Name of contact person | Margaret Marsh, Technical Director, Regulatory Affairs |
| Date prepared | February 22, 2016 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | Prevena Plus Incision Management System with Peel & Place and |
| Customizable Dressings | |
| Common or usual name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump (and |
| components) | |
| Classification panel | General and Plastic Surgery |
| Regulation | 878.4780 |
| Regulatory Class | II |
| Product Code(s) | OMP |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | |
| [21 CFR 807.92(a)(3)] | Prevena Incision Management System with Peel & Place and Customizable |
| Dressings (as cleared under K141017) | |
| Device description | |
| [21 CFR 807.92(a)(4)] | The Prevena Plus Incision Management System provides surgical incision |
| management via the application of negative pressure wound therapy over an | |
| incision site that has been surgically closed with sutures or staples. The | |
| system is applied to the incision site immediately after surgery for a minimum | |
| of 2 days up to a maximum of 7 days depending on the surgeon's preference. | |
| The Prevena Plus Incision Management System consists of: | |
| A Prevena Dressing (Prevena Plus Peel & Place Dressing or Prevena Plus Customizable Dressing) and One of the following KCI Negative Pressure Wound Therapy Units: Prevena Plus 125 Therapy Unit* ActiV.A.C. Therapy Unit V.A.C. Freedom Therapy Unit InfoV.A.C. Therapy Unit V.A.C. ATS Therapy Unit V.A.C. Ulta Therapy Unit * The Prevena Plus 125 Therapy Unit is a slightly modified V.A.C.Via Therapy | |
| Unit, previously cleared under K132741, that provides continuous negative | |
| pressure at -125mmHg only. The V.A.C.Via Therapy Unit serves as a | |
| reference device for 510(k) K153199. |
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The Prevena Plus 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.
Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]
Negative Pressure Wound Therapy is the technological principal for both the subject and predicate Negative Produce Wound Though is the tosting on incision site that is closed via staples or sutures helps draw the incision edges together and removes fluid from the incision site. The occlusive drape of the dressing provides a negative pressure environment and protects the incision from external contamination.
The subject device system (Prevena Plus Incision Management System) is comprised of previously cleared components as shown below:
| Component | Predicate Device:
Prevena Incision
Management System
(K141017) | Reference Device:
V.A.C. Via Negative
Pressure Wound Therapy
System
(K132741) | Reference Device:
V.A.C. Negative Pressure
Wound Therapy Systems
(K120033) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Indications
for Use | Identical to Predicate | Not applicable | Not applicable |
| Dressings | Identical to the Predicate
Prevena Peel & Place and
Customizable Dressings | Not applicable | Not applicable |
| Therapy
Units and
Canisters | Identical to the Predicate
Acti V.A.C., Info V.A.C.,
V.A.C.Ulta and V.A.C.
Freedom Therapy Units | The Prevena Plus 125
Therapy Unit is identical to
the reference V.A.C. Via
Therapy Unit cleared
under (K132741), except for
removal of options for
intermittent and -75 mmHg
therapy | Not applicable |
| Tubing Set | Not applicable | Not applicable | SensaT.R.A.C. tubing set |
| Labeling | Includes Predicate
Prevena Incision
Management System
safety information and
dressing application
instructions | Includes Reference
V.A.C. Via Therapy Unit
operating instructions and
alarm resolution
information. | Not applicable |
5
Summary of the technological characteristics of the device compared to the predicate device, continued
At a high level, the subject device and predicate device are based on the following same technological elements:
- The dressings that are applied over the incision site in the operating room are identical. One of the . following dressings may be selected by the surgeon, based on incision length and geometry:
- The Prevena Plus Peel & Place Dressing which can be used for linear incisions up to 8 inches, or o
- The Prevena Plus Customizable Dressing which can be configured for non-linear incisions or linear o incisions longer than 8 inches
- A negative pressure pump (therapy unit) is required that can provide -125 mmHg of negative pressure . continuously to the dressing for a maximum of 7 days.
- The dressings are connected to the therapy unit via a disposable canister and tubing set. .
- Incision fluid is collected into the disposable canister .
- The therapy unit provides alarms that indicate when negative pressure wound therapy may be . compromised (e.g., visual and audible alarms indicating an air leak in the system or when the canister is full).
The following technological differences exist between the subject and predicate devices:
- Connection between the dressings and therapy unit canisters is via a SensaT.R.A.C. tubing set rather . than by a Prevena tubing set. This allows for pressure sensing at the incision site for all of the indicated therapy units.
- Use of the Prevena Plus 125 Therapy Unit requires a connector (Prevena Plus Connector) to connect the . SensaT.R.A.C. tubing to the canister. No tubing connector is required for use of all of the other indicated therapy units.
- Comparing the Prevena Plus 125 Therapy Unit to the Prevena 125 Therapy Unit, there are the following . technological differences:
- The Prevena Plus 125 Therapy Unit is both AC and battery powered, whereas the Prevena 125 o Therapy Unit is powered by batteries only.
- The Prevena Plus 125 Therapy Unit is provided with either a 150 or 250 cc canister, whereas the O Prevena 125 Therapy Unit has a 45 cc canister.
- The Prevena Plus 125 Therapy Unit provides a shared blockage/canister full alert whereas the O Prevena 125 Therapy Unit has a canister full alert.
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
The following performance data were provided in support of the substantial equivalence determination.
- The average distribution of negative pressure across the full length of the Prevena Plus Customizable . Dressing on a simulated wound bed under wet conditions and at maximum air leak demonstrated that the Prevena Plus 125 Therapy Unit and tubing set were able to provide negative pressure within specification at -125 mmHg, continuous mode for 7 days, equivalent to both the predicate and reference therapy units.
- The Prevena Plus 125 Therapy Unit was shown to provide alarms for leak, blockage and full canister . within specification when connected to the Prevena Plus Customizable Dressing and tubing set.
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]
No clinical tests were necessary
Conclusions drawn [21 CFR 807.92(b)(3)]
The Prevena Pius Incision Management System and its predicate, the Prevena Incision Management System (K141017) are substantially equivalent in terms of safety, function and indications for use.