Who is the manufacturer of ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM?

Kci USA, Inc. (Kinetic Concepts, Inc.) filed the 510(k) submission for ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM (K120499).

What is the FDA product code for ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM?

ABThera Open Abdomen Dressing (K090489); ABThera Negative Pressure Therapy Unit (K083357).

Who can help prepare an FDA 510(k) submission like ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM

K120499 · Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP · Oct 5, 2012 · General, Plastic Surgery

Device Facts

Record ID	K120499
Device Name	ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
Applicant	Kci USA, Inc. (Kinetic Concepts, Inc.)
Product Code	OMP · General, Plastic Surgery
Decision Date	Oct 5, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ABThera Open Abdomen Negative Pressure Therapy System 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 in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

Device Story

System provides negative pressure wound therapy (NPWT) for open abdominal wounds. Components include a foam-based dressing with occlusive drape, tubing set, and a therapy unit. The dressing is placed into the open abdomen to manifold negative pressure and protect viscera; the therapy unit delivers negative pressure and removes wound fluids into a canister. Controls within the unit monitor pressure delivery and provide safety alarms. Used in acute care hospital settings (e.g., ICU) by clinicians; dressing application typically occurs in the operating theater. The system facilitates temporary bridging of abdominal wall openings, potentially benefiting patients by managing wound fluids and protecting abdominal contents during complex surgical recovery.

Clinical Evidence

Bench testing only. Laboratory evaluations confirmed that the ABThera Open Abdomen Dressing provides equivalent negative pressure delivery and fluid removal when used in conjunction with the V.A.C. ATS, InfoV.A.C., and V.A.C.Ulta Negative Pressure Therapy Units.

Technological Characteristics

System consists of a foam-based dressing with occlusive drape, tubing set, and a powered suction pump. Pressure sensing is achieved via a sensing pad in the tubing line. The therapy unit provides negative pressure and fluid removal with integrated monitoring and safety alarms. Connectivity is not specified. Sterilization and material standards are not detailed.

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 care hospital settings (e.g., ICU).

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

ABThera Open Abdomen Dressing (K090489)
ABThera Negative Pressure Therapy Unit (K083357)

Reference Devices

V.A.C. ATS
InfoV.A.C.
V.A.C.Ulta Negative Pressure Therapy Units

Related Devices

K083357 — OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 · Kci USA, Inc. · Mar 4, 2009
K130852 — AVANCE® FOAM ABDOMINAL DRESSING KIT · Molnlycke Health Care · Apr 14, 2014
K161939 — Avance Abdominal Dressing Kit · Molnlycke Health Care Us, LLC · Nov 17, 2016
K022011 — V.A.C. ABDOMINAL DRESSING · Kinetic Concepts, Inc. · Feb 26, 2003
K182191 — Invia Abdominal Dressing Kit · Medela AG · Feb 1, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) SUMMARY ОСТ 5 2012 81/2 K120499 ## ABThera Open Abdomen Negative Pressure Therapy System | Date prepared | September 28, 2012 | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) owner | KCI, Inc. | | Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | | Address | 6203 Farinon Drive; San Antonio, Texas 78249 | | Fax number | 210 255-6727 | | Name of contact person | Margaret Marsh | | Name of the device | | | Trade or proprietary name | ABThera Open Abdomen Negative Pressure Therapy System | | Common or usual name | Negative pressure wound therapy system (comprised of a dressing, therapy unit and tubing set) | | Classification name | Negative Pressure Wound Therapy Powered Suction Pump and Surgical Mesh Dressing | | Legally marketed device(s) to which equivalence is claimed | The ABThera Open Abdomen Dressing cleared under K090489 and the ABThera Negative Pressure Therapy Unit cleared under K083357. | | Device description | | | Device design | The therapy system consists of a therapy unit which delivers negative pressure through a tubing set to the dressing which is placed into the open abdomen. Controls within the therapy unit monitor delivery of negative pressure and provide safety alarms. The dressing manifolds negative pressure from the therapy unit and protects abdominal contents. A canister collects wound fluids removed under negative pressure. | | Intended use of the device | The ABThera Open Abdomen Negative Pressure Therapy System 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 in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater. | {1}------------------------------------------------ K120499. p2/2 | Summary of the technological characteristics of the device compared to the predicate device | Dressing system | Same as predicate: Foam based dressing with occlusive drape | |------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Pressure sensing | Same as predicate: Via sensing pad in tubing line | | | Therapy unit | Same as predicate: Pump for delivery of negative pressure wound therapy and removal of wound fluid with controls for monitoring of therapy parameters and provision of safety alarms | | | Labeling | Labeling has been updated to provide new safety and use information. | | Summary of tests conducted | The ABThera, V.A.C. ATS, InfoV.A.C. and V.A.C.Ulta Negative Pressure Therapy Units have all been evaluated in laboratory tests for use with the ABThera Open Abdomen Dressing. They have been confirmed to provide equivalent delivery of negative pressure and fluid removal when used in conjunction with the ABThera Open Abdominal Dressing. | | | Conclusions drawn | Testing demonstrates that the above KCI Therapy Units are equivalently able to provide negative pressure therapy when used with the ABThera Open Abdomen Dressing. The labeling updates described in this submission inform the user of new safety information to help assure that the product is used as intended. | | 38 {2}------------------------------------------------ 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 stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 KCI USA, Incorporated (Kinetic Concepts, Incorporated) % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249 Re: K120499 Trade/Device Name: ABThera Open Abdomen Negative Pressure Therapy System Regulation Number: 21 CFR 8780.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: September 28, 2012 Received: October 01, 2012 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. Ilsting 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 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 OCT 5 2012 {3}------------------------------------------------ ## Page 2 - Ms. Margaret Marsh 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/defaulj.htm. Sincerely yours. 201 Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number (if known): K120499 Device Name: ABThera Open Abdomen Negative Pressure Therapy System Indications for Use: The ABThera Open Abdomen Negative Pressure Therapy System 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 in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater. Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (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) Page *_ of _* (Posted November 13, 2003) Daniel Kane for MM (Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K120499 36