OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510

K083357 · Kci USA, Inc. · OMP · Mar 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083357
• Device Name: OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
• Applicant: Kci USA, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The V.A.C. Open Abdomen Negative Pressure Therapy System is a specialty system indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this system is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome. The intended care setting is the acute hospital setting: in trauma, general and plastic surgery wards. The abdominal dressing will most often be applied in the operating theater.

Device Story

System applies negative pressure to open abdominal wounds to facilitate delayed primary closure; reduces edema; removes exudate and infectious material. Components: reusable negative pressure therapy unit (brushless double diaphragm motor pump), non-sterile canister, tubing set, and sterile V.A.C. Abdominal Dressing (polyurethane contact layer, open-cell foam, drape). Used in acute hospital settings (operating theater, trauma/surgery wards) by clinicians. Unit monitors/maintains target pressure; provides alarms for tubing blockage, full/missing canister, low battery, and seal leaks. Hydrophobic membrane filter in canister prevents fluid/microbial ingress. Output allows clinicians to manage wound environment; benefits patient by assisting in primary fascial closure.

Clinical Evidence

Bench testing only. Performance tests conducted to ensure conformance to design specifications and equivalence to predicate system for delivery of negative pressure to the open abdomen.

Technological Characteristics

System comprises a reusable therapy unit (hard thermoplastic shell, brushless double diaphragm motor pump), non-sterile canister (general purpose polymer), and sterile polyurethane foam/film dressing. Sensing/actuation via negative pressure pump. Connectivity: standalone. Safety features: tubing blockage, canister, battery, and leak alarms; hydrophobic membrane filter. Software: embedded firmware for pressure monitoring and alarm management.

Indications for Use

Indicated for patients with open abdominal wounds with exposed viscera, including abdominal compartment syndrome, where primary closure is not possible or repeat abdominal entries are required. Intended for use in acute hospital settings (trauma, general, and plastic surgery wards).

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. Abdominal Dressing (K022011)
• V.A.C. ATS Therapy unit (K062227)

Submission Summary (Full Text)

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K083357
pg 1 of 3

## 510(k) SUMMARY

. . .

MAR - 4 2009

## Product Name: Open Abdomen Negative Pressure Therapy . System _______________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Date prepared | November 12, 2008 |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) owner | KCI USA, Inc. |
| Name | KCI USA, Inc. |
| Address | 6203 Farinon Dr., San Antonio, TX 78249 |
| Fax number | [phone] |
| Name of contact<br>person | Christy Hubbard Oviatt |
| Name of the device | Open Abdomen Negative Pressure Therapy System |
| Trade or<br>proprietary<br>name | To be determined |
| Common or<br>usual name | Negative Pressure Therapy Unit |
| Classification<br>name | JCX |
| Device description | The Open Abdominal Negative Pressure Therapy System is<br>designed for the application of negative pressure therapy for<br>temporary bridging of the abdominal wall for patients with an<br>open abdominal wound due to trauma, abdominal surgery,<br>infection and/or abdominal compartment syndrome. It is<br>comprised of a negative pressure therapy unit, a canister and the<br>currently cleared and marketed V.A.C.® Abdominal Dressing. |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | • The V.A.C.® Abdominal Dressing which is currently cleared<br>under 510(k) K022011.<br>• The Open Abdominal Negative Pressure Therapy unit and its<br>associated canister represent design modifications of the<br>V.A.C.® ATS Therapy unit which was most recently included<br>in 510(k) K062227 for the V.A.C.® Therapy System. |

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K083357 pg 20f3

Image /page/1/Picture/1 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".

510(k) for Open Abdomen Negative Pressure
Therapy System

| How the device<br>functions | The system applies negative pressure to the open abdominal<br>wound to create an environment for delayed primary closure<br>by reducing edema, and by removing exudate and infectious<br>material under the influence of continuous negative pressure. The therapy unit monitors and maintains target pressure and<br>alarms as needed to help assure target pressure is<br>maintained and constant therapy is delivered for optimal<br>wound management. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scientific<br>concepts that<br>form the basis<br>for the device | Negative pressure applied to an open abdominal wound creates<br>a pressure differential to actively remove fluids and reduce<br>edema. Edema is reduced by removing excessive interstitial fluid<br>that has accumulated within the tissues. General reduction of<br>edema assists in primary fascial closure of the abdominal wall. |
| Device design | The reusable negative pressure therapy unit uses a<br>brushless double diaphragm motor driven pump to generate<br>negative pressure. A non-sterile canister collects the removed wound exudate. A tubing set conducts negative pressure to the open<br>abdominal wound and transfers exudate to the canister. The V.A.C.® Abdominal Dressing is a specialty dressing,<br>supplied sterile for single use only. It is double pouched and<br>packaged as a kit with One internal contact layer Two 16 mm outer layer open-cell foam pieces Four V.A.C.® Drapes One T.R.A.C.™ Pad Assembly |
| Safety Features | The safety features of the therapy unit include a tubing blockage<br>alarm, a full or missing canister alarm, low battery alarm, and an<br>alarm to indicate a leak in the seal of the V.A.C.® Abdominal<br>Dressing. Additionally, a hydrophobic membrane filter is a part<br>of each canister to prevent fluid and microbial ingress into the<br>therapy unit. |
| Material used | V.A.C.® Abdominal Dressing is comprised of a polyurethane<br>contact layer, polyurethane open cell foam, and polyurethane<br>film with acrylic adhesive drape (See K022011). Open Abdominal Negative Pressure Therapy unit is housed<br>in a hard thermoplastic shell. The canister is made from general purpose polymer<br>materials. |
| Intended use of the<br>device | The V.A.C. Open Abdomen Negative Pressure Therapy System<br>is a specialty system indicated for temporary bridging of<br>abdominal wall openings where primary closure is not possible<br>and or repeat abdominal entries are necessary. The Intended<br>Use of this system is for use in open abdominal wounds, with<br>exposed viscera, including but not limited to abdominal<br>compartment syndrome.<br>The intended care setting is the acute hospital setting: in trauma,<br>general and plastic surgery wards. The abdominal dressing will<br>most often be applied in the operating theater. |
| Differences in<br>intended use<br>from the<br>predicate(s) | The intended use of the Open Abdomen Negative Pressure<br>System is the same as the intended use of the V.A.C.®<br>Abdominal Dressing. |
| Summary of the<br>technological<br>characteristics<br>of the device<br>compared to<br>the predicate<br>device | The new Open Abdomen Negative Pressure Therapy Unit is a<br>new therapy unit for use with the V.A.C.® Abdominal Dressing.<br>The new therapy unit is a simpler design using updated<br>technology. The fundamental operating principles have not<br>changed. It is a smaller and lighter unit with therapy settings<br>relevant to those required for open abdominal wound<br>applications. |
| Summary of<br>nonclinical tests | The Open Abdomen Therapy unit was evaluated under a number<br>of performance tests to assure performance and conformance to<br>design specifications. |
| Conclusions drawn<br>from the<br>nonclinical and<br>clinical tests that<br>demonstrate that<br>the device is as<br>safe, as effective,<br>and performs as<br>well as or better<br>than the predicate<br>device | The performed testing documents that the Open Abdomen<br>Therapy System and the V.A.C.® ATS Therapy system with the<br>V.A.C.® Abdominal dressing are equivalent in terms of<br>technology and performance specifications for the delivery of<br>negative pressure to the open abdomen. |

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## K083357 pg3d3

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:

:

510(k) for Open Abdomen Negative Pressure Therapy System Nov. 12, 2008

100 - 100

.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR -7 2009

KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio. Texas 78230

Re: K083357

Trade/Device Name: Open Abdomen Negative Pressure Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: February 6, 2009 Received: February 9, 2009

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of March 5, 2009.

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 (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

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Page 2 - Ms. Christy Oviatt

limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/dsma/dsmamain.html.

Sincerely yours,

F.R. Rothman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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083357

## INDICATIONS FOR USE

510(k) Number (if known): K083357

Device Name: Open Abdomen Negative Pressure Therapy System

Indications for Use:

The V.A.C. Open Abdomen Negative Pressure Therapy System is a specialty system indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this system is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.

The intended care setting is the acute hospital setting: in trauma, general and plastic surgery wards. The abdominal dressing will most often be applied in the operating theater.

| 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)

*David Krone for MXM 3/5/2009*

| (Division Sign-Off) | Page 1 of 1 |
|---------------------------------------------------------------------------------------|-------------|
| (Posted November 13, 2003) Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K083357 |