(227 days)
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.
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.
The document describes the ABThera Open Abdomen Negative Pressure Therapy System. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|---|
| Functional Equivalence | Delivery of negative pressure | Equivalent to predicate devices | Laboratory tests with ABThera, V.A.C. ATS, InfoV.A.C., and V.A.C.Ulta Negative Pressure Therapy Units |
| Fluid removal | Equivalent to predicate devices | Laboratory tests with ABThera, V.A.C. ATS, InfoV.A.C., and V.A.C.Ulta Negative Pressure Therapy Units | |
| Safety and Use Information | Updated labeling to provide new safety and use information | Labeling has been updated to provide new safety and use information. | This is a documentation update, not a performance test. The acceptance criterion is the existence and correctness of the updated labeling. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions "laboratory tests" for functional equivalence. It does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the provided document. The device in question is a medical therapy system (Negative Pressure Wound Therapy System), not an AI/imaging diagnostic device that would require expert consensus for ground truth. The evaluation focused on the physical performance of the system against predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done as this is not an AI/imaging diagnostic device intended to be used by human readers for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study in the context of AI algorithms was not done. The "standalone" performance here would refer to the device's ability to maintain negative pressure and remove fluid, which was evaluated in laboratory tests without direct human intervention in the continuous therapy delivery, but the evaluation itself was conducted by human operators.
7. Type of Ground Truth Used
The ground truth used for the functional equivalence tests was the performance of legally marketed predicate devices. The new device's performance (negative pressure delivery and fluid removal) was compared against these established devices in laboratory settings to demonstrate equivalence.
8. Sample Size for the Training Set
This information is not applicable as this device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this device does not involve a "training set."
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510(k) SUMMARY
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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 contactperson | Margaret Marsh |
| Name of the device | |
| Trade orproprietaryname | ABThera Open Abdomen Negative Pressure Therapy System |
| Common orusual name | Negative pressure wound therapy system (comprised of a dressing, therapy unitand tubing set) |
| Classificationname | Negative Pressure Wound Therapy Powered Suction Pump and Surgical MeshDressing |
| Legally marketeddevice(s) to whichequivalence isclaimed | The ABThera Open Abdomen Dressing cleared under K090489 and the ABTheraNegative Pressure Therapy Unit cleared under K083357. |
| Device description | |
| Device design | The therapy system consists of a therapy unit which delivers negative pressurethrough a tubing set to the dressing which is placed into the open abdomen.Controls within the therapy unit monitor delivery of negative pressure and providesafety alarms. The dressing manifolds negative pressure from the therapy unitand protects abdominal contents. A canister collects wound fluids removed undernegative pressure. |
| Intended use ofthe device | The ABThera Open Abdomen Negative Pressure Therapy System is indicated fortemporary bridging of abdominal wall openings where primary closure is notpossible and/or repeat abdominal entries are necessary. The Intended Use of thissystem is in open abdominal wounds with exposed viscera including, but notlimited to, abdominal compartment syndrome. The intended care setting is aclosely monitored area within the acute care hospital, such as the ICU. Theabdominal dressing will most often be applied in the operating theater. |
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K120499.
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| Summary of thetechnologicalcharacteristics ofthe devicecompared to thepredicate device | Dressingsystem | Same as predicate:Foam based dressing with occlusive drape |
|---|---|---|
| Pressuresensing | Same as predicate:Via sensing pad in tubing line | |
| Therapyunit | Same as predicate:Pump for delivery of negative pressure wound therapy and removal ofwound fluid with controls for monitoring of therapy parameters andprovision of safety alarms | |
| Labeling | Labeling has been updated to provide new safety and useinformation. | |
| Summary of testsconducted | The ABThera, V.A.C. ATS, InfoV.A.C. and V.A.C.Ulta Negative Pressure TherapyUnits have all been evaluated in laboratory tests for use with the ABThera OpenAbdomen Dressing. They have been confirmed to provide equivalent delivery ofnegative pressure and fluid removal when used in conjunction with the ABTheraOpen Abdominal Dressing. | |
| Conclusions drawn | Testing demonstrates that the above KCI Therapy Units are equivalently able toprovide negative pressure therapy when used with the ABThera Open AbdomenDressing.The labeling updates described in this submission inform the user of new safetyinformation to help assure that the product is used as intended. |
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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 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
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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
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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
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§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.