(227 days)
Not Found
No
The summary describes a negative pressure therapy system with controls and alarms, but there is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The system is designed to provide negative pressure therapy for open abdominal wounds, which is a therapeutic intervention.
No
The device is described as a therapy system that delivers negative pressure for wound treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components like a therapy unit, tubing set, dressing, and canister, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves testing blood, urine, tissue samples, etc., outside of the body.
- Device Description and Intended Use: The ABThera Open Abdomen Negative Pressure Therapy System is described as a system that applies negative pressure to an open abdominal wound. Its intended use is for temporary bridging of abdominal wall openings and managing open abdominal wounds with exposed viscera. This is a therapeutic intervention applied directly to the patient's body, not a diagnostic test performed on a specimen.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information for diagnosis based on laboratory results.
Therefore, the ABThera Open Abdomen Negative Pressure Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, open abdominal wounds with exposed viscera
Indicated Patient Age Range
Not Found
Intended User / Care Setting
closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) SUMMARY
ОСТ 5 2012
81/2
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