PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System

K173426 · Kci USA, Inc. · OMP · Mar 9, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173426
• Device Name: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
• Applicant: Kci USA, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Mar 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System provides negative pressure wound therapy (NPWT) to surgical incisions closed with sutures or staples; maintains closed environment; removes exudate. Components include PREVENA PLUS 125 Therapy Unit, disposable canister, tubing, and occlusive dressing (PEEL & PLACE or CUSTOMIZABLE). Applied in OR; used for 2-7 days. Pump delivers continuous -125 mmHg negative pressure; draws incision edges together; collects fluid in canister. Therapy unit features visual/audible alarms for leaks, blockages, full canister, and battery status. Healthcare providers use system to manage incision environment, potentially reducing complications associated with drainage. Updated internal components (pump, battery, board, sensors) address obsolescence.

Clinical Evidence

No clinical tests were necessary. Bench testing only.

Technological Characteristics

Powered suction pump delivering continuous -125 mmHg negative pressure. Components: disposable canister, tubing, occlusive dressings. Electrical safety/EMC compliance: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11. Battery: IEC 62133. System provides visual/audible alarms for system integrity (leaks, blockages, canister status).

Indications for Use

Indicated for management of surgical incisions that continue to drain following sutured or stapled closure in patients requiring 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

• K153199
• K161897

Submission Summary (Full Text)

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March 9, 2018

KCI USA, Inc. Margaret Marsh Technical Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249

Re: K173426

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: January 26, 2018 Received: January 29, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 mediation-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 ([e-mail]) or phone [phone] 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

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See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date; January 31, 2017

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

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) | |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span style="display:inline-block;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block;">☐</span> 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 [e-mail]

"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."

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

#### Device Name

The 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 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) | |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> 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."

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# 510(k) SUMMARY

## PREVENA PLUS Incision Management System PREVENA PLUS DUO Incision Management System

| Submitter Information [21 CFR 807.92(a)(1)] | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | KCI USA, Inc. |
| Address | 6203 Farinon Drive |
| | San Antonio, TX 78249 |
| Phone number | 210-255-6481 |
| Fax number | 210-255-6727 |
| Establishment<br>Registration Number | 3005178245 |
| Name of contact<br>person | Margaret Marsh |
| Date prepared | March 6, 2018 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary<br>name | PREVENA PLUS Incision Management System<br>PREVENA PLUS DUO Incision Management System |
| Common or usual<br>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<br>device(s) to which<br>equivalence is<br>claimed<br>[21 CFR 807.92(a)(3)] | Predicate 510(k) Numbers:<br>● K153199<br>● K161897 |
| Device description<br>[21 CFR 807.92(a)(4)] | The negative pressure technology for the subject device systems is the same as that for the predicate device systems.<br>The PREVENA PLUS 125 Therapy Unit is a component of 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 minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference.<br>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.<br>The application of negative pressure draws the incision edges<br>together, and removes fluid from the incision site into a canister fitted<br>into the therapy unit. |
| Indications for use<br>[21 CFR 807.92(a)(5)] | The PREVENA PLUS Incision Management System is intended<br>to manage the environment of surgical incisions that continue to<br>drain following sutured or stapled closure by maintaining a closed<br>environment, and removing exudate via the application of<br>negative pressure wound therapy. The PREVENA PLUS DUO Incision Management System is<br>intended to manage the environment of surgical incisions that<br>continue to drain following sutured or stapled closure by<br>maintaining a closed environment, and removing exudate via the<br>application of negative pressure wound therapy. |
| A longer PREVENA PEEL & PLACE Dressing - 35 cm is now available. The PREVENA PLUS 125 Therapy Unit is now available in a stand-alone configuration, packaged only with Instructions for Use and a sterile canister. | |
| <b>Performance Data [21 CFR 807.92(b)]</b> | |
| <b>Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]</b> | |
| Bench testing demonstrated that the PREVENA PLUS 125 Therapy Unit is able to deliver continuous negative pressure at 125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 7 day test. Alarms for blockage, leakage and full canister were tested with both the PREVENA PLUS and the PREVENA PLUS DUO Systems and met specifications. Electrical safety and electromechanical emissions testing confirm that the subject therapy unit meets the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD) IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests. IEC 60601-6 Edition 3.1 2013-10 - Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability IEC 60601-1-8 Edition 2.1 2012-11 Medical Electrical Equipment - Part 1-8: General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems In Medical Electrical Equipment and Medical Electrical Systems IEC 60601-1-11 Edition 2.0 2015-01 - Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment The new lithium battery has been verified to meet IEC 62133 Edition 2.0 2012-12. | |
| <b>Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]</b> | |
| 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.…