PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT

K121883 · Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP · Oct 11, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121883
• Device Name: PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
• Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Oct 11, 2012
• 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 provides negative pressure wound therapy (NPWT) to surgically closed incisions; system consists of battery-powered suction pump and customizable dressing components; device maintains closed environment and removes exudate from incision site; used in clinical settings; operated by healthcare professionals; output consists of continuous or intermittent negative pressure; therapy application manages wound environment to potentially benefit healing process; subject device introduces customizable dressing options compared to predicate's single-size dressing.

Clinical Evidence

No clinical data provided. Substantial equivalence established through non-clinical bench testing, including biocompatibility (ISO 10993-1), design verification/validation, and performance testing of negative pressure delivery.

Technological Characteristics

Powered suction pump; battery-powered; single-patient use. Customizable dressing components. Biocompatibility per ISO 10993-1. Software-controlled pump operation.

Indications for Use

Indicated for patients with surgically closed incisions (sutured or stapled) that continue to drain, requiring management of the wound environment 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 (K100821)

Submission Summary (Full Text)

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# 长121883

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## 510(k) SUMMARY Prevena Incision Management System with Customizable Dressing

OCT 1 1 2012

| 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 | 210-515-4368 | |
| Fax number | 210-255-6727 | |
| Establishment<br>Registration Number | 1625774 | |
| Name of contact person. | Shannon Scott, Regulatory Affairs Senior Manager | |
| Date prepared | June 26, 2012 | |
| Name of the device [21 CFR 807.92(a)(2)] | | |
| Trade or proprietary<br>name | Prevena Incision Management System with Customizable Dressing | |
| 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<br>device(s) to which<br>equivalence is claimed<br>[21 CFR 807.92(a)(3)] | Prevena Incision Management System (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<br>via the application of negative pressure wound therapy. | |
| Summary of the technological characteristics of the device compared to the predicate device<br>[21 CFR 807.92(a)(6)] | | |
| The subject device was found to be equivalent to the predicate device in delivery of negative pressure to<br>the indicated wound type. The devices are equivalent in terms of functional components. | | |
| Characteristic | New Device<br>Prevena™ Incision Management<br>System with Customizable<br>Dressing | Predicate<br>Prevena™ Incision Management System<br>with Peel and Place Dressing<br>K100821 |
| Indicated wound types | Same as predicate | Closed surgical incisions |
| Dressing | Multiple dressing components | Single, one size, multi-layer dressing. |

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Image /page/1/Picture/0 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in a bold, sans-serif font. There is a registered trademark symbol to the right of the "I".

| Therapy unit | Same as predicate | Single patient use only; battery powered | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Performance Data [21 CFR 807.92(b)] | | | | |
| [21 CFR 807.92(b)(1)] | | Summary of non-clinical tests conducted for determination of substantial equivalence | | |
| | equivalence to the predicate device. The following tests were conducted:<br>Biocompatibility testing according to ISO 10993-1 | The Prevena Incision Management System with Customizable Dressing was evaluated under of<br>design verification and validation tests to assure safety, efficacy, conformance to design specifications and | | |
| Equivalency testing of the Prevena Customizable Dressing to the Prevena Peel and Place Dressing<br>with respect to delivery of negative pressure wound therapv | | | | |
| Software verification and validation testing | | | | |
| Summary of clinical tests conducted for determination of substantial equivalence or of clinical<br>information [21 CFR 807.92(b)(2)] | | | | |
| Clinical tests were conducted to demonstrate substantial equivalence with regard to device performance. | | | | |
| Conclusions drawn [21 CFR 807.92(b)(3)] | | | | |
| | of both indications for use and delivered wound therapy. | Testing demonstrates that the Prevena Incision Management System with Customizable Dressing and the<br>Prevena Incision Management System with Peel and Place Dressing are substantially equivalent in terms | | |

K121883
K1218212

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

OCT 11 2012

Kinetic Concepts USA, Incorporated % Ms. Shannon Scott Regulatory Affairs Senior Manager 6203 Farinon Drive San Antonio, Texas 78249

Re: K121883

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: September 7, 2012 Received: September 10, 2012

Dear Ms. Scott:

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

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#### Page 2 - Ms. Shannon Scott

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely, yours,

Eric Keith

✔Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K121883

## INDICATIONS FOR USE

K121883 510(k) Number (if known): _ Prevena Incision Management System Device Name: 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 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)

Daniel Kane

(Posted November 13, 2003)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K121883