(85 days)
Not Found
No
The summary describes a negative pressure wound therapy system with no mention of AI or ML capabilities. The performance studies focus on pressure delivery and usability, not algorithmic performance.
Yes.
The device uses negative pressure wound therapy to manage surgical incisions by maintaining a closed environment and removing exudate, which is a therapeutic action.
No
This device is intended to manage surgical incisions by maintaining a closed environment and removing exudate via negative pressure wound therapy. It does not perform any diagnostic function.
No
The device description clearly outlines physical components like therapy units, dressings, and a Y-connector, indicating it is a hardware-based system for negative pressure wound therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The PREVENA DUO and PREVENA PLUS DUO Incision Management Systems are described as negative pressure wound therapy systems. Their function is to manage the environment of surgical incisions by applying negative pressure to remove exudate and maintain a closed environment.
- Lack of Diagnostic Testing: The description and intended use clearly indicate that this device is a therapeutic device for wound management. It does not perform any tests on biological samples to diagnose or monitor a condition.
Therefore, the PREVENA DUO and PREVENA PLUS DUO Incision Management Systems fall under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PREVENA DUO 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 va the application of negative pressure wound therapy.
The PREVENA PLUS DUO 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
Both the PREVENA DUO™ Incision Management System (with the PREVENA 125 Therapy Unit) and the PREVENA PLUS DUO™ Incision Management System (with the PREVENA PLUS 125 Therapy Unit) are negative pressure wound therapy systems designed for the management of two surgical incisions simultaneously with one PREVENA Therapy Unit. Both systems provide two PREVENA PEEL & PLACE Dressings (which can be for linear incisions up to 13 or 20 cm in length) which are connected to their respective therapy units via a new PREVENA Y-Connector. Therapy is continuously applied to each incision at -125 mmHg for 2 to 7 days. Length of therapy is per surgeon preference.
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
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
Summary of non-clinical tests conducted for determination of substantial equivalence:
- Negative pressure performance testing indicates that the PREVENA DUO and PREVENA PLUS DUO Incision Management Systems are able to provide negative pressure within specification to each dressing over a 7 day use test and under test conditions of maximum air leak and simulated wound fluid input. Testing also confirms delivery of appropriate therapy unit alarms.
- Human factors engineering assessment indicates that these new systems does not create new critical usability tasks and that a new usability study is not required.
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information:
No clinical tests were necessary.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4, 2016
KCI USA, Inc. (Kinetic Concepts, Inc.) Margaret Marsh Technical Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K161897
Trade/Device Name: Prevena Duo, Prevena Plus Duo Incision Management Systems With Peel & Place Dressings
Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 7, 2016 Received: July 11, 2016
Dear Margaret 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
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
510(k) Number (if known) K161897
Device Name
PREVENA DUO Incision Management System PREVENA PLUS DUO Incision Management System
Indications for Use (Describe)
The PREVENA DUO 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 va the application of negative pressure wound therapy.
The PREVENA PLUS DUO 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) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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3
510(k) SUMMARY
PREVENA DUO™ Incision Management System with PEEL & PLACE™ Dressings
and
PREVENA PLUS DUO™ Incision Management System with PEEL & PLACE™ Dressings
| Submitter Information [21 CFR 807.929(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 | 3009897021 |
| Name of contact person | Margaret Marsh, Technical Director Regulatory Affairs |
| Date prepared | September 19, 2016 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | PREVENA DUO™ Incision Management System |
| with PEEL & PLACE™ Dressings PREVENA PLUS DUO™ Incision Management System | |
| with PEEL & PLACE™ 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 |
| Product Code(s) | OMP |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | |
| [21 CFR 807.92(a)(3)] | PREVENA Incision Management System, cleared recently under |
| 510(k) K141017 PREVENA PLUS Incision Management System, cleared recently | |
| under 510(k) K153199 | |
| Device description | |
| [21 CFR 807.92(a)(4)] | Both the PREVENA DUO™ Incision Management System (with the |
| PREVENA 125 Therapy Unit) and the PREVENA PLUS DUO™ Incision | |
| Management System (with the PREVENA PLUS 125 Therapy Unit) are | |
| negative pressure wound therapy systems designed for the management of | |
| two surgical incisions simultaneously with one PREVENA Therapy Unit. | |
| Both systems provide two PREVENA PEEL & PLACE Dressings (which | |
| can be for linear incisions up to 13 or 20 cm in length) which are connected | |
| to their respective therapy units via a new PREVENA Y-Connector. | |
| Therapy is continuously applied to each incision at -125 mmHg for 2 to 7 | |
| days. Length of therapy is per surgeon preference. | |
| Indications for use | |
| [21 CFR 807.92(a)(5)] | The PREVENA DUO™ and the PREVENA PLUS DUO™ Incision |
| Management Systems with PEEL & PLACE™ Dressings are 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. |
4
Comparison of the Technological Characteristics with the Predicate Device (21 CFR 807.92(a)(6)]
Neqative Pressure Wound Therapy is the technological principal for both the subject and predicate devices. Application of negative pressure to an incision site that is closed via staples or sutures helps draw the incision edges together and remove fluid from the incision site. The occlusive drape of the dressing provides a negative pressure environment and protects the incision from external contamination.
At a high level, the subject devices and predicate devices are based on the following same technological elements:
- Both device systems have the same indications for use. .
- The PEEL & PLACE™ Dressings are constructed from the same materials and design and are . sterilized in the same packaging.
- . The PEEL & PLACE™ Dressing is applied over the incision site in the operating room.
- . The dressing is connected to the selected therapy unit via a disposable canister and, where appropriate, tubing connectors.
- . The choice of therapy unit has not changed from the predicate systems. The selected negative pressure therapy unit provides -125 mmHq of neqative pressure continuously to the dressing for a maximum of 7 days.
- . Incision fluid is collected into the disposable canister in the therapy unit.
- . The therapy unit provides alarms that indicate when neqative 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 or batteries are low).
The following technological differences exist between the subject and predicate devices:
- Two PEEL & PLACE™ Dressings and a new PREVENA Y-Connector are provided in each . PREVENA DUO™ system box to allow for simultaneous use over two incisions with one therapy unit.
- . System choices include two 13 cm dressings, one 13 and 20 cm dressing or two 20 cm dressings per system box.
- . The 13 cm PEEL & PLACE™ Dressing, while identical in materials and design to the predicate 20 cm PEEL & PLACE™ Dressing, is shorter in length to provide for use on incisions up to 13 cm in length. (The 20 cm PEEL & PLACE™ DRESSING is designed for use on incisions up to 20 cm in length.)
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
- Neqative pressure performance testing indicates that the PREVENA DUO and PREVENA PLUS . DUO Incision Management Systems are able to provide negative pressure within specification to each dressing over a 7 day use test and under test conditions of maximum air leak and simulated wound fluid input. Testing also confirms delivery of appropriate therapy unit alarms.
- Human factors engineering assessment indicates that these new systems does not . create new critical usability tasks and that a new usability study is not required.
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 DUO™ Incision Management System with PEEL & PLACE™ Dressings and the PREVENA PLUS DUO™ Incision Management System with PEEL & PLACE™ Dressings are substantially equivalent to their predicates in terms of safety, function and indications for use.