(78 days)
Not Found
No
The summary describes a physical dressing kit for open abdominal wounds and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "Open Abdomen Dressing" indicated for "temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary." This indicates a direct role in patient care and management of an anatomical condition, which aligns with the definition of a therapeutic device.
No
The ABThera™ Open Abdomen Dressing is described as a "specialty dressing" used for "temporary bridging of abdominal wall openings" and managing "open abdominal wounds, with exposed viscera." Its purpose is for treatment and wound management, not for diagnosing a medical condition or disease.
No
The device description clearly states it is a "specialty dressing" supplied as a kit with physical components like foam pieces, drapes, and a pad assembly. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- ABThera™ Open Abdomen Dressing Function: The description clearly states that the ABThera™ Open Abdomen Dressing is a "specialty dressing" used for "temporary bridging of abdominal wall openings" and for "open abdominal wounds, with exposed viscera." This is a physical device applied externally to a wound.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is mechanical and protective.
Therefore, the ABThera™ Open Abdomen Dressing falls under the category of a medical device used for wound management, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
FTL
Device Description
The ABThera™ Open Abdomen Dressing is a specialty dressing, supplied sterile for single use only. It is double pouched and packaged as a kit with One Internal Contact Layer Two Outer Layer open-cell foam pieces Four V.A.C.® Drapes One T.R.A.C.™ Pad Assembly
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, abdominal wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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 dressing design was evaluated under a number of design verification and validation tests in order to assure performance and conformance to design specifications.
Verification and validation testing conducted under design control requirements document that the ABThera™ Open Abdomen Dressing is equivalent to the predicate in terms of technology and performance requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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, serif font. There is a registered trademark symbol to the right of the "I".
510(k) SUMMARY ABThera™ Open Abdomen Dressing
MAY 1 4 2009
| Date prepared | 24 February, 2009 | |
|---|---|---|
| 510(k) owner | KCI USA, Inc. | |
| 6203 Farinon Dr. | ||
| San Antonio, TX 78249 | ||
| Name of contact | ||
| person | Christy Hubbard Oviatt | |
| Trade or proprietary | ||
| name of the device | ABThera™ Open Abdomen Dressing | |
| Common or usual | ||
| name | Open Abdomen Wound Dressing | |
| Classification | Class II, CFR 878.3300 Surgical Mesh | |
| Legally marketed | ||
| device(s) to which | ||
| equivalence is | ||
| claimed | V.A.C.® Abdominal Dressing cleared under 510(k) K022011 | |
| Device description | The ABThera™ Open Abdomen Dressing is a specialty | |
| dressing, supplied sterile for single use only. It is double | ||
| pouched and packaged as a kit with | ||
| 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 | |
| polyurethane contact layer, polyurethane open cell foam, and | ||
| polyurethane film with acrylic adhesive drape. | ||
| Intended use of the | ||
| device | 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. | |
| Differences in
intended use from
the predicate(s) | The intended use of the device is the same as the predicate. | |
| Summary of the
technological
characteristics of the
device compared to
the predicate device | Predicate | Device |
| | | Internal Contact Layer
has an oval piece of black
foam encased in the
center of polyurethane
film. |
| | Two black Outer Layer
Foam pieces | Two blue Outer Layer
Foam pieces |
| | Four V.A.C.® Drapes | Four V.A.C.® Drapes |
| | T.R.A.C.™ Pad and
Tubing | T.R.A.C.™ Pad and
Tubing |
| Summary of non-
clinical tests | The dressing design was evaluated under a number of design
verification and validation tests in order to assure performance
and conformance to design specifications. | |
| Conclusions drawn
from the nonclinical
and clinical tests that
demonstrate that the
device is as safe, as
effective, and
performs as well as or
better than the
predicate device | Verification and validation testing conducted under design
control requirements document that the ABThera™ Open
Abdomen Dressing is equivalent to the predicate in terms of
technology and performance requirements for its intended
use. | |
:
:
1
KCi USA, Inc.
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:
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and monochromatic.
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.
3
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 (240) 276-0115. 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 (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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)