(78 days)
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.
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
The provided text is a 510(k) summary for a medical device called the ABThera™ Open Abdomen Dressing. It describes the device, its intended use, and claims substantial equivalence to a predicate device (V.A.C.® Abdominal Dressing).
However, the document does not contain the kind of detailed information requested in the prompt regarding acceptance criteria, reported device performance in a table, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.
The document only states:
- Acceptance Criteria/Reported Device Performance: "The dressing design was evaluated under a number of design verification and validation tests in order to assure performance and conformance to design specifications." And "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." No specific quantitative acceptance criteria or reported performance metrics are provided.
- Study That Proves the Device Meets Acceptance Criteria: The document refers to "design verification and validation tests" and "verification and validation testing conducted under design control requirements" but does not describe any specific studies (clinical or non-clinical) in detail. It primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (V.A.C.® Abdominal Dressing, K022011) rather than presenting a performance study against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from this 510(k) summary. Here's what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Equivalent to the predicate in terms of technology and performance requirements for its intended use." |
| "Assure performance and conformance to design specifications." | "Evaluated under a number of design verification and validation tests." |
The document does not provide specific quantifiable acceptance criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. The document mentions "design verification and validation tests," implying laboratory or engineering tests, but no details of human subject data (clinical data) are given or implied beyond the comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified, as no human subject test set or ground truth establishment by experts is detailed in this 510(k) summary. The evaluation focuses on "design control requirements" and technological equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, as no human subject test set requiring adjudication is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For this device submission, the "ground truth" for "performance" is primarily defined by its adherence to design specifications and its equivalence to the predicate device through engineering and performance testing. There's no clinical trial data presented with a ground truth established by medical experts or pathology in this summary.
8. The sample size for the training set
- Not applicable/Not specified. There is no mention of "training sets" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as there is no training set mentioned.
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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 contactperson | Christy Hubbard Oviatt | |
| Trade or proprietaryname of the device | ABThera™ Open Abdomen Dressing | |
| Common or usualname | Open Abdomen Wound Dressing | |
| Classification | Class II, CFR 878.3300 Surgical Mesh | |
| Legally marketeddevice(s) to whichequivalence isclaimed | V.A.C.® Abdominal Dressing cleared under 510(k) K022011 | |
| Device description | The ABThera™ Open Abdomen Dressing is a specialtydressing, supplied sterile for single use only. It is doublepouched and packaged as a kit withOne 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 apolyurethane contact layer, polyurethane open cell foam, andpolyurethane film with acrylic adhesive drape. | |
| Intended use of thedevice | The ABThera™ Open Abdomen Dressing is indicated fortemporary bridging of abdominal wall openings where primaryclosure is not possible and or repeat abdominal entries arenecessary. The Intended use of this system is for use in openabdominal wounds, with exposed viscera, including but notlimited to abdominal compartment syndrome.The intended care setting is the acute hospital setting: intrauma, general and plastic surgery wards. The abdominaldressing will most often be applied in the operating theater. | |
| Differences inintended use fromthe predicate(s) | The intended use of the device is the same as the predicate. | |
| Summary of thetechnologicalcharacteristics of thedevice compared tothe predicate device | Predicate | Device |
| Internal Contact Layerhas an oval piece of blackfoam encased in thecenter of polyurethanefilm. | ||
| Two black Outer LayerFoam pieces | Two blue Outer LayerFoam pieces | |
| Four V.A.C.® Drapes | Four V.A.C.® Drapes | |
| T.R.A.C.™ Pad andTubing | T.R.A.C.™ Pad andTubing | |
| Summary of non-clinical tests | The dressing design was evaluated under a number of designverification and validation tests in order to assure performanceand conformance to design specifications. | |
| Conclusions drawnfrom the nonclinicaland clinical tests thatdemonstrate that thedevice is as safe, aseffective, andperforms as well as orbetter than thepredicate device | Verification and validation testing conducted under designcontrol requirements document that the ABThera™ OpenAbdomen Dressing is equivalent to the predicate in terms oftechnology and performance requirements for its intendeduse. |
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KCi USA, Inc.
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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 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.
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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 (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
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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)
§ 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.