VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100

K091585 · Kci USA, Inc. · OMP · Dec 29, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091585
• Device Name: VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
• Applicant: Kci USA, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Dec 29, 2009
• 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®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. 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. They are indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types. The V.A.C. Instill® Therapy System is indicated for patients who would benefit from V.A.C.® Therapy coupled with controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It is intended for patients with chronic acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.

Device Story

V.A.C. Therapy Systems are integrated wound management devices used in acute, extended, and home care settings. The system consists of a software-controlled therapy unit, foam dressing, and canister. The unit applies negative pressure to the wound bed; foam dressing distributes pressure and facilitates fluid removal; tubing transfers exudate to the canister. The V.A.C. Instill variant additionally provides controlled delivery of topical wound treatment solutions. Software monitors and maintains target pressure, triggering alarms to ensure constant therapy. Healthcare providers use the system to promote wound healing by preparing the wound bed, reducing edema, and removing infectious material. Benefits include granulation tissue formation and perfusion. Operation is managed by clinicians or patients in home settings.

Clinical Evidence

No new clinical trials were conducted for this submission. The manufacturer relies on existing medical literature to support the safety and effectiveness of the V.A.C. Therapy System for the treatment of venous insufficiency ulcers.

Technological Characteristics

Powered suction pump system. Components include therapy unit, foam dressing (e.g., GranuFoam Silver), and canister. Software-controlled pressure regulation. Connectivity/form factor varies by model (ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom).

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (diabetic, pressure, or venous insufficiency), flaps, and grafts. Applicable to patients requiring negative pressure wound therapy or topical wound solution delivery.

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

• V.A.C.® Therapy System Family of Products

Submission Summary (Full Text)

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K091585
pg 1 of 2

# 510(k) SUMMARY

DEC 2 9 2009

| Date prepared | December 23, 2009 |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) owner | |
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| Fax number | 210 255-6727 |
| Name of contact<br>person | Margaret Marsh |
| Name of the<br>device | |
| Trade or<br>proprietary<br>name | V.A.C.® Therapy Systems |
| Common or<br>usual name | Negative Pressure Wound Therapy Systems |
| Classification<br>name | Negative Pressure Wound Therapy Powered Suction Pump (and<br>components) |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | V.A.C.® Therapy System Family of Products |
| Device description | The software-controlled therapy unit applies negative pressure to the<br>wound bed. The open cells of the V.A.C.® Foam Dressing to which the<br>therapy unit is connected enable distribution of the negative pressure<br>across the surface of the wound, while the tubing transfers accumulated<br>fluids to the canister. The software monitors and maintains target pressure<br>and alarms as needed to help assure target pressure is maintained and<br>constant therapy is delivered. |

#### V.A.C.® Therapy Systems

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| Intended use of<br>the device | The ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® Therapy<br>Systems are integrated wound management systems for use in acute,<br>extended and home care settings. They are intended to create an<br>environment that promotes wound healing by secondary or tertiary<br>(delayed primary) intention by preparing the wound bed for closure,<br>reducing edema, promoting granulation tissue formation and perfusion,<br>and by removing exudate and infectious material. They are indicated for<br>patients with chronic, acute, traumatic, subacute and dehisced wounds,<br>partial-thickness burns, ulcers (such as diabetic, pressure or venous<br>insufficiency), flaps and grafts.<br>The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterial<br>penetration and may help reduce infection in the above wound types. |
|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The V.A.C. Instill® Therapy System is indicated for patients who would<br>benefit from V.A.C.® Therapy coupled with controlled delivery of topical<br>wound treatment solutions and suspensions over the wound bed. It is<br>intended for patients with chronic acute, traumatic, subacute and dehisced<br>wounds, partial thickness burns, ulcers (such as diabetic, pressure, or<br>venous insufficiency), flaps and grafts. |
| Differences in<br>intended use<br>from the<br>predicate(s) | The only difference between the current and the predicate products is in<br>the addition of venous insufficiency ulcers to the Indications for Use<br>statement. |
| Summary of the<br>technological<br>characteristics of<br>the device<br>compared to the<br>predicate device | The technological characteristics of the V.A.C.® Therapy System Family of<br>Products is unchanged. |
| Summary of<br>nonclinical tests | None required for the change in indication |
| Summary of<br>clinical tests | Medical literature documents acceptable clinical experience using the<br>V.A.C.® Therapy System to treat venous insufficiency ulcers. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

## DEC 2 9 2009

Re: K091585

Trade/Device Name: V.A.C. Therapy System; V.A.C. Instillamet (V.A.C. 9 Instill) Regulation Number: 21 CFR 878-4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 12, 2009 Received: October 13, 2009

Dear Ms. 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.

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

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Page 2 - Ms. Margaret Marsh

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

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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K091585
pg 1 of 2

#### INDICATIONS FOR USE

510(k) Number (if known): K091585

Device Name: V.A.C.® Therapy System

Indications for Use:

The ActiV.A.C.®, InfoV.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. 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. They are indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

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 Kramer for MXM Page 1 of 1

(Posted November 13, 2003)

Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091585

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K09 1585
pg 2 of 2

### INDICATIONS FOR USE

510(k) Number (if known):

KOGISSS

Device Name: V.A.C. Instillamat (V.A.C.® Instill)

Indications for Use:

The V.A.C. Instill device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C. Instill is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

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 Krone for UXM

Division of Surgical, Orthopedic. and Restorative Devices

Page ⊥ of ⊥

(Posted November 13, 2003)

510(k) Number