ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026

K090489 · Kci USA, Inc. · FTL · May 14, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090489
• Device Name: ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
• Applicant: Kci USA, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ABThera Open Abdomen Dressing is 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

ABThera Open Abdomen Dressing is a sterile, single-use kit for managing open abdominal wounds. Components include an internal contact layer, two outer-layer open-cell foam pieces, V.A.C. drapes, and a T.R.A.C. pad assembly. Applied primarily in operating theaters by surgeons; used in acute hospital settings. Functions as a wound dressing system to bridge abdominal wall openings and manage exposed viscera. Facilitates wound care in patients where primary closure is not feasible or repeat access is required. Benefits include temporary wound management and protection of viscera.

Clinical Evidence

Bench testing only. Design verification and validation tests were conducted to ensure performance and conformance to design specifications.

Technological Characteristics

Materials: polyurethane contact layer, polyurethane open-cell foam, polyurethane film with acrylic adhesive. Components: internal contact layer, two outer-layer foam pieces, V.A.C. drapes, T.R.A.C. pad assembly. Sterile, single-use kit.

Indications for Use

Indicated for temporary bridging of abdominal wall openings where primary closure is not possible or repeat entries are necessary; for use in open abdominal wounds with exposed viscera, including abdominal compartment syndrome. For use in acute hospital settings (trauma, general, plastic surgery wards).

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• V.A.C.® Abdominal Dressing (K022011)

Submission Summary (Full Text)

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## 510(k) SUMMARY ABThera™ Open Abdomen Dressing

MAY 1 4 2009

| Date prepared | 24 February, 2009 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 510(k) owner | KCI USA, Inc.<br>6203 Farinon Dr.<br>San Antonio, TX 78249 | |
| Name of contact<br>person | Christy Hubbard Oviatt | |
| Trade or proprietary<br>name of the device | ABThera™ Open Abdomen Dressing | |
| Common or usual<br>name | Open Abdomen Wound Dressing | |
| Classification | Class II, CFR 878.3300 Surgical Mesh | |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | V.A.C.® Abdominal Dressing cleared under 510(k) K022011 | |
| Device description | The ABThera™ Open Abdomen Dressing is a specialty<br>dressing, supplied sterile for single use only. It is double<br>pouched and packaged as a kit with<br>One Internal Contact Layer Two Outer Layer open-cell foam pieces Four V.A.C.® Drapes One T.R.A.C.™ Pad Assembly | |
| Material used | The ABThera™ Open Abdomen Dressing is comprised of a<br>polyurethane contact layer, polyurethane open cell foam, and<br>polyurethane film with acrylic adhesive drape. | |
| Intended use of the<br>device | The ABThera™ Open Abdomen Dressing is indicated for<br>temporary bridging of abdominal wall openings where primary<br>closure is not possible and or repeat abdominal entries are<br>necessary. The Intended use of this system is for use in open<br>abdominal wounds, with exposed viscera, including but not<br>limited to abdominal compartment syndrome.<br><br>The intended care setting is the acute hospital setting: in<br>trauma, general and plastic surgery wards. The abdominal<br>dressing will most often be applied in the operating theater. | |
| Differences in<br>intended use from<br>the predicate(s) | The intended use of the device is the same as the predicate. | |
| Summary of the<br>technological<br>characteristics of the<br>device compared to<br>the predicate device | Predicate | Device |
| | | Internal Contact Layer<br>has an oval piece of black<br>foam encased in the<br>center of polyurethane<br>film. |
| | Two black Outer Layer<br>Foam pieces | Two blue Outer Layer<br>Foam pieces |
| | Four V.A.C.® Drapes | Four V.A.C.® Drapes |
| | T.R.A.C.™ Pad and<br>Tubing | T.R.A.C.™ Pad and<br>Tubing |
| Summary of non-<br>clinical tests | The dressing design was evaluated under a number of design<br>verification and validation tests in order to assure performance<br>and conformance to design specifications. | |
| Conclusions drawn<br>from the nonclinical<br>and clinical tests that<br>demonstrate that the<br>device is as safe, as<br>effective, and<br>performs as well as or<br>better than the<br>predicate device | Verification and validation testing conducted under design<br>control requirements document that the ABThera™ Open<br>Abdomen Dressing is equivalent to the predicate in terms of<br>technology and performance requirements for its intended<br>use. | |

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KCi USA, Inc.

K090489

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Public Health Service

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KCI USA, Inc. % Ms. Christy Oviatt Senior Regulatory Affairs Specialist 6203 Farinon Drive San Antonio, Texas 78249

Re: K090489

Trade/Device Name: ABThera Open Abdomen Dressing Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2009 Received: April 15, 2009

Dear Ms. Oviatt:

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 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 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.

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Page 2 - Ms. Christy Oviatt

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Sincerely yours,

Mark N. Millbern

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): __

Device Name: ABThera Open Abdomen Dressing

Indications for Use:

The ABThera Open Abdomen Dressing is 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 Over-The-Counter 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 Kaine for MKM Page 1 of 1

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

Tab 4
510(K) Number K090489

00014

(Posted November 13, 2003)