(111 days)
Not Found
No
The summary describes a negative pressure therapy system for open abdominal wounds and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "Negative Pressure Therapy System" used for "temporary bridging of abdominal wall openings" and "application of negative pressure therapy." These terms directly indicate its purpose is to provide therapy to a patient.
No
Explanation: The device is described as a "Negative Pressure Therapy System" designed for "temporary bridging of abdominal wall openings" and "application of negative pressure therapy" to "open abdominal wounds". This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is comprised of a negative pressure therapy unit, a canister, and an abdominal dressing, which are all hardware components.
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.
- Device Function: The V.A.C. Open Abdomen Negative Pressure Therapy System is a therapeutic device. It applies negative pressure to an open abdominal wound to facilitate healing and manage the wound. It does not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use clearly states it's for "temporary bridging of abdominal wall openings" and "use in open abdominal wounds." This describes a treatment or management function, not a diagnostic one.
- Device Description: The description focuses on the components that deliver negative pressure therapy (therapy unit, canister, dressing). There is no mention of components or processes for analyzing biological samples.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, open 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 Open Abdomen Therapy unit was evaluated under a number of performance tests to assure performance and conformance to design specifications.
The performed 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.
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
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 contact | |
| person | Christy Hubbard Oviatt |
| Name of the device | Open Abdomen Negative Pressure Therapy System |
| Trade or | |
| proprietary | |
| name | To be determined |
| Common or | |
| usual name | Negative Pressure Therapy Unit |
| Classification | |
| name | JCX |
| Device description | 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. | |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | • The V.A.C.® Abdominal Dressing which is currently cleared |
| under 510(k) K022011. | |
| • The Open Abdominal Negative Pressure Therapy unit and its | |
| associated canister represent design modifications of the | |
| V.A.C.® ATS Therapy unit which was most recently included | |
| in 510(k) K062227 for the V.A.C.® Therapy System. |
1
K083357 pg 20f3
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 device
functions | The system applies negative pressure to the open abdominal
wound to create an environment for delayed primary closure
by reducing edema, and by removing exudate and infectious
material under the influence of continuous negative pressure. The therapy unit monitors and maintains target pressure and
alarms as needed to help assure target pressure is
maintained and constant therapy is delivered for optimal
wound management. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scientific
concepts that
form the basis
for the device | Negative pressure applied to an open abdominal wound creates
a pressure differential to actively remove fluids and reduce
edema. Edema is reduced by removing excessive interstitial fluid
that has accumulated within the tissues. General reduction of
edema assists in primary fascial closure of the abdominal wall. |
| Device design | The reusable negative pressure therapy unit uses a
brushless double diaphragm motor driven pump to generate
negative pressure. A non-sterile canister collects the removed wound exudate. A tubing set conducts negative pressure to the open
abdominal 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 and
packaged 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 blockage
alarm, a full or missing canister alarm, low battery alarm, and an
alarm to indicate a leak in the seal of the V.A.C.® Abdominal
Dressing. Additionally, a hydrophobic membrane filter is a part
of each canister to prevent fluid and microbial ingress into the
therapy unit. |
| Material used | V.A.C.® Abdominal Dressing is comprised of a polyurethane
contact layer, polyurethane open cell foam, and polyurethane
film with acrylic adhesive drape (See K022011). Open Abdominal Negative Pressure Therapy unit is housed
in a hard thermoplastic shell. The canister is made from general purpose polymer
materials. |
| Intended use of the
device | 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. |
| Differences in
intended use
from the
predicate(s) | The intended use of the Open Abdomen Negative Pressure
System is the same as the intended use of the V.A.C.®
Abdominal Dressing. |
| Summary of the
technological
characteristics
of the device
compared to
the predicate
device | The new Open Abdomen Negative Pressure Therapy Unit is a
new therapy unit for use with the V.A.C.® Abdominal Dressing.
The new therapy unit is a simpler design using updated
technology. The fundamental operating principles have not
changed. It is a smaller and lighter unit with therapy settings
relevant to those required for open abdominal wound
applications. |
| Summary of
nonclinical tests | The Open Abdomen Therapy unit was evaluated under a number
of performance tests 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 | The performed 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
K083357 pg3d3
Image /page/2/Picture/1 description: The image shows the logo for KCI. To the left of the letters is a graphic of 5 curved lines stacked on top of each other. The letters KCI are in bold black font, with a registered trademark symbol to the right of the I.
:
:
510(k) for Open Abdomen Negative Pressure Therapy System Nov. 12, 2008
100 - 100
.
3
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
4
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
5
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 |