(60 days)
Not Found
No
The summary describes a negative pressure wound therapy system that applies continuous negative pressure and removes fluid. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "Negative Pressure Wound Therapy Unit" that "manages the environment of surgical incisions" and "removes exudate," indicating it is used for treatment.
No
The device is described as an "Incision Management System" intended to manage the environment of surgical incisions by applying negative pressure wound therapy. It "removes exudate" and "draws the incision edges together," which are therapeutic actions, not diagnostic ones. The text does not mention any capability for identifying, characterizing, or monitoring a disease or condition for diagnostic purposes.
No
The device description clearly outlines hardware components like a pump, tubing, dressing, and canister, which are integral to its function of applying 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 provide information for diagnosis, monitoring, or screening.
- Device Function: The PREVENA PLUS Incision Management System is a device that applies negative pressure to a surgical incision. Its function is to manage the physical environment of the incision by removing exudate and maintaining a closed environment. It does not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use clearly states it is for "managing the environment of surgical incisions" and "removing exudate via the application of negative pressure wound therapy." This is a therapeutic and wound management function, not a diagnostic one.
- Device Description: The description details a pump, tubing, dressing, and canister for applying negative pressure and collecting fluid. There is no mention of analyzing biological samples or providing diagnostic results.
Therefore, the PREVENA PLUS Incision Management System falls under the category of a therapeutic or wound management device, not an in vitro diagnostic device.
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.
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 (comma separated list FDA assigned to the subject device)
OMP
Device Description
The negative pressure technology for the subject device is the same as that for the predicate device systems.
The PREVENA PLUS 125 Unit is a component of a the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a maximum of fourteen (14) days depending on the surgeon's preference.
The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination.
The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the 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
Prescription Use
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)
Bench testing demonstrated that the PREVENA PLUS 125 Negative Pressure Wound Therapy Unit is substantially equivalent to the predicate therapy unit in the delivery of continuous negative pressure at -125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 14 day test.
No clinical tests were necessary. No usability testing was required, as there has been no change to the user interface or to the Instructions for Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
June 1, 2018
KCI USA, Inc. Kimberly McCoy Sr. Manager, RA 6203 Farinon Drive San Antonio, Texas 78249
Re: K180855
Trade/Device Name: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: March 30, 2018 Received: April 2, 2018
Dear Kimberly McCoy:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in 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.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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)
K180855
Device Name
PREVENA PLUS Incision Management System
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
K180855
Device Name
PREVENA PLUS DUO Incision Management System
Indications for Use (Describe)
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
PREVENA PLUS 125 Negative Pressure Wound Therapy Unit
| Submitter Information [21 CFR 807.92(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-255-6171 |
| Fax number | 210-255-6727 |
| Establishment Registration Number | 3005178245 |
| Name of contact person | Kimberly McCoy |
| Date prepared | May 31, 2018 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary name | PREVENA PLUS Incision Management System |
| PREVENA PLUS DUO Incision Management System | |
| Common or usual name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump |
| Classification panel | General and Plastic Surgery |
| Regulation | 21 CFR 878.4780 |
| Regulatory Class | II |
| Product Code(s) | OMP |
| Legally marketed device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)] | Predicate 510(k) Numbers: |
| • K173426 | |
| • K161897 | |
| • K153199 | |
| Device description [21 CFR 807.92(a)(4)] | The negative pressure technology for the subject device is the same as that for the predicate device systems. |
| The PREVENA PLUS 125 Unit is a component of a the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a maximum of fourteen (14) days depending on the surgeon's preference. | |
| The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination. | |
| The application of negative pressure draws the incision edges | |
| together, and removes fluid from the incision site into a canister fitted | |
| into the therapy unit. | |
| Indications for use | |
| [21 CFR 807.92(a)(5)] | • 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. | |
| • 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. |
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Comparison of the Technological Characteristics (i.e., design, material, chemical composition, energy source) with the Predicate Device [21 CFR 807.92(a)(6)]
Negative 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 removes 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 subiect 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 O up to 35 cm or
- The PREVENA PLUS CUSTOMIZABLE Dressing which can be configured for non o linear incisions or linear incisions up to 90 cm in length.
- . The 13 and 20 cm PREVENA PEEL & PLACE Dressings are available in a Y configuration in the PREVENA PLUS DUO Incision Management System.
- . A disposable negative pressure pump (therapy unit) provides -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 for a maximum of fourteen (14) days.
- Incision fluid is collected into the disposable canister
- . The therapy unit provides visual and audible alarms that indicate when negative pressure wound therapy may be compromised (e.g., alarms indicating an air leak in the system or when there is a blockage in the tubing, when the canister is full or missing, when the battery needs to be recharged, or in the case of a system fault.)
- . The therapy unit interface provides access to therapy via an On/Off button. It also provides alarm indicators, alarm mute button, power and battery indicators, as well as a therapy life indicator.
- The intended use and instructions for use are identical. ●
- The following design differences exist between the subject and predicate device:
- The disposable negative pressure pump (Therapy Unit) provides -125 mmHg of negative ● pressure continuously to the dressing for a maximum of fourteen (14) days, in distinction to the predicate Therapy Unit seven (7) day use life.
6
- The dressing will need to be replaced after seven (7) days and the instruction for use (IFU) . have been updated to reflect a dressing change at this time interval.
- The Therapy Unit life indicator now begins to count down after the eighth (8) day of therapy: . instead of the countdown beginning at the start of therapy for the predicate unit.
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
- Bench testing demonstrated that the PREVENA PLUS 125 Negative Pressure Wound . Therapy Unit is substantially equivalent to the predicate therapy unit in the delivery of continuous negative pressure at -125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 14 day test.
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. No usability testing was required, as there has been no change to the user interface or to the Instructions for Use.
Conclusions drawn [21 CFR 807.92(b)(3)]
The PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System are substantially equivalent to the predicate device systems in terms of safety, performance and indications for use.