(111 days)
The V.A.C. Open Abdomen Negative Pressure Therapy System is a specialty system 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 Open Abdominal Negative Pressure Therapy System is designed for the application of negative pressure therapy for temporary bridging of the abdominal wall for patients with an open abdominal wound due to trauma, abdominal surgery, infection and/or abdominal compartment syndrome. It is comprised of a negative pressure therapy unit, a canister and the currently cleared and marketed V.A.C.® Abdominal Dressing.
The provided text is a 510(k) summary for the "Open Abdomen Negative Pressure Therapy System." It outlines the product, its intended use, and comparability to predicate devices. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trials or performance studies with specific statistical outcomes.
The "Summary of nonclinical tests" section vaguely states: "The Open Abdomen Therapy unit was evaluated under a number of performance tests to assure performance and conformance to design specifications." This indicates that some testing was performed to ensure the device met design specifications, but no specifics are provided regarding what those specifications were, the acceptance criteria, or the results of those tests.
Therefore, the following information, based on the provided document, focuses on what is available and notes the absence of the requested detailed study information.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics in the way one would expect from a clinical study or detailed performance report. It generally states that the device was evaluated to "assure performance and conformance to design specifications" and that testing "documents that the Open Abdomen Therapy System and the V.A.C.® ATS Therapy system with the V.A.C.® Abdominal dressing are equivalent in terms of technology and performance specifications for the delivery of negative pressure to the open abdomen."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text refers to "nonclinical tests" but does not specify sample sizes or data provenance.
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)
This information is not provided in the document. The submission focuses on device characteristics and equivalence, not clinical effectiveness studies requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable to this device. The device is an Open Abdomen Negative Pressure Therapy System, not an AI-assisted diagnostic tool or system that would involve human readers interpreting AI output.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to this device. It is a physical medical device, not an algorithm. However, the device itself operates in a "standalone" manner in applying negative pressure, but its performance is measured by its physical function, not by an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Given that the submission focuses on equivalence to a predicate device and nonclinical (performance/conformance) tests, "ground truth" in the clinical sense of outcomes data or pathology is not detailed. The "ground truth" for the nonclinical tests would likely be established engineering specifications and physical measurements.
8. The sample size for the training set
This information is not provided in the document. As this is a physical device, a "training set" in the context of machine learning is not relevant. If "training set" refers to pre-production or design verification samples, that information is not disclosed.
9. How the ground truth for the training set was established
This information is not provided in the document. (See point 8 above regarding relevance).
In summary:
The provided 510(k) summary is for a physical medical device (Negative Pressure Therapy System) and focuses on establishing substantial equivalence to a predicate device based on technological characteristics and nonclinical performance tests. It does not include the detailed clinical study results, acceptance criteria tables, or specifics on ground truth establishment, expert involvement, or sample sizes typical for diagnostic AI devices or comparative clinical effectiveness studies. The document states that the device was evaluated through "performance tests to assure performance and conformance to design specifications" and concluded equivalence to its predicate, but it does not elaborate on the specifics of these tests or their acceptance criteria.
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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 bold, sans-serif font. The lines are arranged in a way that they appear to be emanating from a central point. The letters "KCI" are aligned horizontally, with the "I" slightly taller than the "K" and "C". There is a registered trademark symbol to the bottom right of the I.
K083357
pg 1 of 3
510(k) SUMMARY
. . .
MAR - 4 2009
Product Name: Open Abdomen Negative Pressure Therapy . System _______________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Date prepared | November 12, 2008 |
|---|---|
| 510(k) owner | KCI USA, Inc. |
| Name | KCI USA, Inc. |
| Address | 6203 Farinon Dr., San Antonio, TX 78249 |
| Fax number | (210) 255-6727 |
| Name of contactperson | Christy Hubbard Oviatt |
| Name of the device | Open Abdomen Negative Pressure Therapy System |
| Trade orproprietaryname | To be determined |
| Common orusual name | Negative Pressure Therapy Unit |
| Classificationname | JCX |
| Device description | The Open Abdominal Negative Pressure Therapy System isdesigned for the application of negative pressure therapy fortemporary bridging of the abdominal wall for patients with anopen abdominal wound due to trauma, abdominal surgery,infection and/or abdominal compartment syndrome. It iscomprised of a negative pressure therapy unit, a canister and thecurrently cleared and marketed V.A.C.® Abdominal Dressing. |
| Legally marketeddevice(s) to whichequivalence isclaimed | • The V.A.C.® Abdominal Dressing which is currently clearedunder 510(k) K022011.• The Open Abdominal Negative Pressure Therapy unit and itsassociated canister represent design modifications of theV.A.C.® ATS Therapy unit which was most recently includedin 510(k) K062227 for the V.A.C.® Therapy System. |
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Image /page/1/Picture/1 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, sans-serif font. There is a registered trademark symbol to the right of the "I".
510(k) for Open Abdomen Negative Pressure
Therapy System
| How the devicefunctions | The system applies negative pressure to the open abdominalwound to create an environment for delayed primary closureby reducing edema, and by removing exudate and infectiousmaterial under the influence of continuous negative pressure. The therapy unit monitors and maintains target pressure andalarms as needed to help assure target pressure ismaintained and constant therapy is delivered for optimalwound management. |
|---|---|
| Scientificconcepts thatform the basisfor the device | Negative pressure applied to an open abdominal wound createsa pressure differential to actively remove fluids and reduceedema. Edema is reduced by removing excessive interstitial fluidthat has accumulated within the tissues. General reduction ofedema assists in primary fascial closure of the abdominal wall. |
| Device design | The reusable negative pressure therapy unit uses abrushless double diaphragm motor driven pump to generatenegative pressure. A non-sterile canister collects the removed wound exudate. A tubing set conducts negative pressure to the openabdominal wound and transfers exudate to the canister. The V.A.C.® Abdominal Dressing is a specialty dressing,supplied sterile for single use only. It is double pouched andpackaged as a kit with One internal contact layer Two 16 mm outer layer open-cell foam pieces Four V.A.C.® Drapes One T.R.A.C.™ Pad Assembly |
| Safety Features | The safety features of the therapy unit include a tubing blockagealarm, a full or missing canister alarm, low battery alarm, and analarm to indicate a leak in the seal of the V.A.C.® AbdominalDressing. Additionally, a hydrophobic membrane filter is a partof each canister to prevent fluid and microbial ingress into thetherapy unit. |
| Material used | V.A.C.® Abdominal Dressing is comprised of a polyurethanecontact layer, polyurethane open cell foam, and polyurethanefilm with acrylic adhesive drape (See K022011). Open Abdominal Negative Pressure Therapy unit is housedin a hard thermoplastic shell. The canister is made from general purpose polymermaterials. |
| Intended use of thedevice | The V.A.C. Open Abdomen Negative Pressure Therapy Systemis a specialty system indicated for temporary bridging ofabdominal wall openings where primary closure is not possibleand or repeat abdominal entries are necessary. The IntendedUse of this system is for use in open abdominal wounds, withexposed viscera, including but not limited to abdominalcompartment syndrome.The intended care setting is the acute hospital setting: in trauma,general and plastic surgery wards. The abdominal dressing willmost often be applied in the operating theater. |
| Differences inintended usefrom thepredicate(s) | The intended use of the Open Abdomen Negative PressureSystem is the same as the intended use of the V.A.C.®Abdominal Dressing. |
| Summary of thetechnologicalcharacteristicsof the devicecompared tothe predicatedevice | The new Open Abdomen Negative Pressure Therapy Unit is anew therapy unit for use with the V.A.C.® Abdominal Dressing.The new therapy unit is a simpler design using updatedtechnology. The fundamental operating principles have notchanged. It is a smaller and lighter unit with therapy settingsrelevant to those required for open abdominal woundapplications. |
| Summary ofnonclinical tests | The Open Abdomen Therapy unit was evaluated under a numberof performance tests to assure performance and conformance todesign specifications. |
| Conclusions drawnfrom thenonclinical andclinical tests thatdemonstrate thatthe device is assafe, as effective,and performs aswell as or betterthan the predicatedevice | The performed testing documents that the Open AbdomenTherapy System and the V.A.C.® ATS Therapy system with theV.A.C.® Abdominal dressing are equivalent in terms oftechnology and performance specifications for the delivery ofnegative pressure to the open abdomen. |
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:
:
510(k) for Open Abdomen Negative Pressure Therapy System Nov. 12, 2008
100 - 100
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR -7 2009
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio. Texas 78230
Re: K083357
Trade/Device Name: Open Abdomen Negative Pressure Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: February 6, 2009 Received: February 9, 2009
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of March 5, 2009.
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 (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.
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
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Page 2 - Ms. Christy Oviatt
limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/dsma/dsmamain.html.
Sincerely yours,
F.R. Rothman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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083357
INDICATIONS FOR USE
510(k) Number (if known): K083357
Device Name: Open Abdomen Negative Pressure Therapy System
Indications for Use:
The V.A.C. Open Abdomen Negative Pressure Therapy System is a specialty system 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 | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | |
| (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)
David Krone for MXM 3/5/2009
| (Division Sign-Off) | Page 1 of 1 |
|---|---|
| (Posted November 13, 2003) Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K083357 |
§ 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.