ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT

K120033 · Kci USA, Inc. · OMP · May 31, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120033
• Device Name: ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
• Applicant: Kci USA, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: May 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, they are also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Device Story

V.A.C. Therapy Systems are powered suction pumps providing negative pressure wound therapy (NPWT). Systems apply controlled negative pressure to wound sites via dressing components to remove exudate and infectious material, reduce edema, and promote granulation tissue formation. Used in acute, extended, and home care settings by clinicians or patients. Output consists of continuous or intermittent negative pressure application. Therapy affects wound healing environment by maintaining closed system for surgical incisions or preparing wound beds for closure. Benefits include improved healing outcomes for complex wounds and surgical incisions.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via functional comparison and performance testing of negative pressure delivery.

Technological Characteristics

Powered suction pump; battery and AC powered; multi-patient use units. Delivers negative pressure to wound sites via various dressing components. System is designed for acute, extended, and home care environments.

Indications for Use

Indicated for patients in acute, extended, or home care settings requiring management of open wounds (chronic, acute, traumatic, subacute, dehisced, partial-thickness burns, ulcers, flaps, grafts) or closed surgical incisions that continue to drain following sutured or stapled closure.

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)

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

K12 0033
p.1/2

MAY 31 20晚

# 510(k) SUMMARY

.

| 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 | March 30, 2012 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary<br>name | V.A.C. Therapy System, ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom,<br>V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems |
| 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 ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and<br>V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated<br>wound management systems for use in acute, extended and home care<br>settings.<br>When used on open wounds, they are intended to create an environment that<br>promotes wound healing by secondary or tertiary (delayed primary) intention<br>by preparing the wound bed for closure, reducing edema, promoting<br>granulation tissue formation and perfusion, and by removing exudate and<br>infectious material. Open wound types include: chronic, acute, traumatic,<br>subacute and dehisced wounds, partial-thickness burns, ulcers (such as<br>diabetic, pressure or venous insufficiency), flaps and grafts.<br>When used on closed surgical incisions, they are also 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 exudates<br>via the application of negative pressure wound therapy. |

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

K120033
p. 2/2

Differences in intended use from the " _ _ _ " " = predicate(s) - - -

The intended use for the subject devices has been expanded to include closed surgical incisions. This use is consistent with the indications for use cleared for the Prevena Incision Management System under 510(k) K100821.

Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(6)]

The subject device was found to be equivalent to the predicate device in delivery of negative pressure to the indicated wound type. The devices are equivalent in terms of functional components.

| Characteristic | New Device<br>V.A.C. Therapy Systems | Predicate<br>Prevena™ Incision Management System<br>K100821 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Indicated wound types | Chronic, acute, traumatic,<br>subacute and dehisced wounds,<br>partial-thickness burns, ulcers<br>(such as diabetic, pressure or<br>venous insufficiency), flaps, grafts<br>and surgical incisions. | Closed surgical incisions |
| Dressing | Multiple dressing components | Single, one size, multi-layer dressing. |
| Therapy unit | Multiple patient use; battery and<br>AC powered | Single patient use only; battery powered |

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

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

Non-clinical tests were not necessary to demonstrate substantial equivalence.

Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]» بين تريب الانتراب بين ت

Clinical tests were not necessary to demonstrate substantial equivalence.

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

Equivalency testing of the V.A.C. Therapy Systems to the Prevena Incision Management System with respect to delivery of negative pressure wound therapy demonstrated that the systems are equivalent under all test conditions. The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are substantially equivalent to the Prevena Incision Management System (K100821) in terms of safety, function and indications for use.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing strength and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the organization's name and country.

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

MAY 3 1 2012

KCI USA, Inc. % Ms. Shannon Scott Regulatory Affairs Senior Manager 6203 Farinon Drive San Antonio, Texas 78249

Re: K120033

Trade/Device Name: Activac Therapy Unit and Infovac Therapy Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered sunction pump Regulatory Class: Class II Product Code: OMP Dated: May 25, 2012 Received: May 29, 2012

Dear Ms. Shannon 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

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

# Page 2 - Ms. Scott

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 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/CDRH0ffices/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,

For
Mark N. Melkerson
Dep Clin Dir

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Ki20033

#### INDICATIONS FOR USE

#### 510(k) Number (if known): K120033

Device Name: ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Neqative Pressure Wound Therapy Systems

Indications for Use:

The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.

When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, they are also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (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 Knaefler MM
(Division Sign-Off)

Page _ of _

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120033

(Posted November 13, 2003)