PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES

K133232 · Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP · Mar 24, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133232
• Device Name: PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
• Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Mar 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Prevena 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.

Device Story

Prevena Incision Management System is a negative pressure wound therapy (NPWT) device for surgically closed incisions. System consists of a software-controlled suction pump and a dressing (either peel-and-place or customizable). Device applies negative pressure to the incision site to maintain a closed environment and remove wound exudate. Used in clinical settings to manage post-surgical drainage. Healthcare providers apply the dressing and operate the pump. By managing the incision environment, the device aims to support healing and manage fluid. No technological changes were made to the device for this submission; the update involves adding a bibliography of published clinical studies to the labeling.

Clinical Evidence

No new clinical tests were conducted. The manufacturer performed a systematic literature review of published clinical studies involving the Prevena Incision Management System to support the safety and effectiveness of the device.

Technological Characteristics

System comprises a software-controlled powered suction pump and composite dressing components. Operates via negative pressure wound therapy to remove wound fluid. Device is a Class II powered suction pump (21 CFR 878.4780).

Indications for Use

Indicated for patients with surgically closed incisions (sutured or stapled) that continue to drain. Used to manage the incision environment by maintaining a closed system and removing exudate via negative pressure wound therapy.

Regulatory Classification

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.

Predicate Devices

• Prevena Incision Management System with Customizable Dressing (K123878)
• Prevena Incision Management System with Peel & Place Dressing (K100821)

Submission Summary (Full Text)

{0}------------------------------------------------

K133232
page 1 of 2

## 510(k) SUMMARY Prevena Incision Management System

.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Submitter information [21 CFR 807.929(a)(1)] | | |
|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | |
| Address | 6203 Farinon Drive<br>San Antonio, TX 78249 | |
| Phone number | 210-255-6137 | |
| Fax number | 210-255-6727 | |
| Establishment<br>Registration<br>Number | 1625774 | |
| Name of contact<br>person | Brian Young, VP Global Regulatory & Clinical Affairs | |
| Date prepared | March 21, 2014 | |
| Name of the device [21 CFR 807.92(a)(2)] | | |
| Trade or proprietary<br>name | • Prevena Incision Management System with Peel & Place Dressing<br>• Prevena Incision Management System with Customizable Dressing | |
| Common or usual<br>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<br>device(s) to which<br>equivalence is<br>claimed<br>[21 CFR 807.92(a)(3)] | Prevena Incision Management System with Customizable Dressing (K123878)<br>Prevena Incision Management System with Peel & Place Dressing (K100821) | |
| Device description<br>[21 CFR 807.92(a)(4)] | Negative pressure wound therapy system for application to surgically closed<br>incisions. | |
| Indications for use<br>[21 CFR 807.92(a)(5)] | The Prevena Incision Management System is intended to manage the<br>environment of surgical incisions that continue to drain following sutured or<br>stapled closure by maintaining a closed environment and removing exudate via<br>the application of negative pressure wound therapy. | |
| Summary of the<br>technological<br>characteristics of the<br>device compared to<br>the predicate device<br>[21 CFR 807.92(a)(6)] | There have been no technological changes to the predicate device for the<br>purpose of the proposed labeling change. | |
| | Dressing systems: | Same as predicate: One composite dressing or multiple<br>dressing components |
| | Therapy unit: | Same as predicate: Software controlled pump for delivery<br>of negative pressure wound therapy and removal of<br>wound fluid |

{1}------------------------------------------------

#### Performance Data [21 CFR 807.92(b)]

KCI conducted a systematic literature review of studies involving the Prevena Incision Management System (Prevena Therapy), and is adding a bibliography of published studies to the labeling.

#### Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]

No non-clinical tests were necessary.

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. A systematic literature review of published clinical studies was conducted.

Conclusions drawn [21 CFR 807.92(b)(3)]

The Prevena Incision Management System and its predicate are substantially equivalent in terms of safety, function and indications for use. The safety and effectiveness of the Prevena Incision Management System is adequately supported by the substantial equivalent information and data provided in this Premarket Notification.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2014

Kinetic Concepts Incorporated Mr. Brian Young Vice President, Global Regulatory & Clinical Affairs 6203 Farinon Drive San Antonio, Texas 78249

Re: K133232/S003

Trade/Device Name: Prevena Incision Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 19, 2014 Received: February 21, 2014

Dear Mr. Young:

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

{3}------------------------------------------------

Page 2 - Mr. Brian Young

device-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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] 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. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### INDICATIONS FOR USE

510(k) Number (if known): __K133232 Device Name: Prevena Incision Management System_ Indications for Use:

The Prevena 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.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Jiyoung Dang -S

Page _1 of _1

(Posted November 13, 2003)

45