(76 days)
K06369
K06369
No
The summary describes a negative pressure wound therapy system and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is intended to promote wound healing, reduce edema, promote granulation tissue formation, and remove exudate and infectious material, which are all therapeutic actions.
No
The device is described as a "Negative Pressure Wound Therapy System" intended to promote wound healing by creating an environment for closure, reducing edema, promoting granulation tissue, and removing exudate. It is a therapeutic device, not a diagnostic one that identifies or characterizes a disease or condition.
No
The device description explicitly states it is a "Negative pressure wound therapy unit component of an integrated negative pressure wound therapy system," indicating a hardware component. The performance studies also describe bench tests on the "Therapy Unit" and electrical safety testing, further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for managing wounds directly on the patient's body to promote healing. This involves applying negative pressure to the wound bed.
- Device Description: The device is described as a "Negative pressure wound therapy unit component." This is a therapeutic device applied externally to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The V.A.C. Simplicity™ Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
Product codes
OMP
Device Description
Negative pressure wound therapy unit component of an integrated negative pressure wound therapy system. The therapy unit is nearly identical to the predicate product, except for the user interface, which is similar to that of the currently marketed V.A.C. Via Therapy Unit. The therapy unit delivers negative pressure wound therapy to the wound bed through the V.A.C. ® Foam Dressing System; it also transfers wound exudates into a canister. Software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include alarms, such as those that signal for blockages, low battery, and leaks in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound bed
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute, extended and home care settings
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 V.A.C. Simplicity™ Therapy Unit was evaluated to assure conformance to design specifications. The following bench tests were conducted: Ability to deliver NPWT at -125 mmHg in a comparable manner to the ActiV.A.C. Therapy Unit. Testing demonstrated that the V.A.C. Simplicity™ Therapy Unit delivers equivalent negative pressure wound therapy at -125 mmHg. Software verification and validation testing confirms that the software meets the requirements of the software requirements specification. The therapy unit was tested to all applicable electrical safety and electromagnetic emissions standards and was found to be in compliance.
Although human clinical studies were not required to be conducted, usability studies were performed with 30 subjects representing home care nurses and patients to assure that the product could easily be used in the home environment and that labeling can be understood and followed. KCI previously conducted simultaneous usability testing on home care and extended care nurses for a similar product, the V.A.C. Via Negative Pressure Wound Therapy Unit. This testing validated that the results from home care nurses are equivalent to extended care nurses, in that they responded in an identical manner throughout the usability testing. Based on this experience, the home care nurse responses in the V.A.C. Simplicity™ Therapy Unit usability test are supportive of usability in the extended care environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K06369
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 two parts: a graphic on the left and the text "KCI" on the right. The graphic on the left is a series of curved lines that are stacked on top of each other. The text "KCI" is in a bold, sans-serif font. There is a registered trademark symbol to the right of the "I".
JUL 2 1 2011
510(k) SUMMARY
V.A.C. Simplicity™ Negative Pressure Wound Therapy Unit
| Date prepared | July 20, 2011 |
|---|---|
| 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 |
| Contact telephone | |
| number | 1 800 275-4524; Request Regulatory Affairs. |
| Name of the device | |
| Trade or | |
| proprietary name | V.A.C. Simplicity™ Negative Pressure Wound Therapy Unit |
| Common or usual | |
| name | Negative Pressure Wound Therapy Unit |
| Classification | |
| name | Negative Pressure Wound Therapy Powered Suction Pump |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | ActiV.A.C. ® Negative Pressure Wound Therapy Unit, cleared under |
| 510(k) K06369 | |
| Device description | Negative pressure wound therapy unit component of an integrated |
| negative pressure wound therapy system | |
| Device design |
| The therapy unit is nearly identical to the predicate product, except
for the user interface, which is similar to that of the currently
marketed V.A.C. Via Therapy Unit. The therapy unit delivers
negative pressure wound therapy to the wound bed through the
V.A.C. ® Foam Dressing System; it also transfers wound exudates
into a canister. Software monitors and maintains target pressure
and alarms as needed to help assure target pressure is maintained
and constant therapy is delivered. The safety features of the system
include alarms, such as those that signal for blockages, low battery,
and leaks in the system. |
1
Image /page/1/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. A registered trademark symbol is located to the right of the "I".
| Intended use of the
device | The V.A.C. Simplicity™ Therapy System is an integrated wound
management system for use in acute, extended and home care
settings. It is intended to create an environment that promotes
wound healing by secondary or tertiary (delayed primary) intention
by preparing the wound bed for closure, reducing edema, promoting
granulation tissue formation and perfusion, and by removing
exudate and infectious material. It is indicated for patients with
chronic, acute, traumatic, subacute and dehisced wounds, partial-
thickness burns, ulcers (such as diabetic, pressure or venous
insufficiency), flaps and grafts | | |
|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------|
| Differences in
intended use from the
predicate(s) | The intended use is identical to that of the predicate. | | |
| Summary of the
technological
characteristics of the
device compared to
the predicate device | Feature | V.A.C. Simplicity™
Therapy System | ActiV.A.C.
Therapy System |
| | Therapy unit | Same as predicate | Software controlled
pump for delivery of
negative pressure
wound therapy |
| | Therapy options | -125 mmHg only | Selectable negative
pressure settings in the
range of -25 to -200
mmHg. |
| | Dressing
system | Same as predicate | Foam based dressing
with occlusive drape |
| | Pressure
sensing | Same as predicate | By means of a sensing
pad in tubing line |
| Summary of
nonclinical tests | The V.A.C. Simplicity™ Therapy Unit was evaluated to assure
conformance to design specifications.
The following bench tests were conducted:
Ability to deliver NPWT at -125 mmHg in a comparable
manner to the ActiV.A.C. Therapy Unit. Testing
demonstrated that the V.A.C. Simplicity™ Therapy Unit
delivers equivalent negative pressure wound therapy at
-125 mmHg. Software verification and validation testing confirms that the
software meets the requirements of the software
requirements specification. The therapy unit was tested to all applicable electrical safety
and electromagnetic emissions standards and was found to
be in compliance. | | |
| Summary of clinical
tests | Although human clinical studies were not required to be conducted,
usability studies were performed with 30 subjects representing home
care nurses and patients to assure that the product could easily be
used in the home environment and that labeling can be understood
and followed.
KCI previously conducted simultaneous usability testing on home | | |
2
Image /page/2/Picture/0 description: The image shows the logo for KCI. The logo consists of a curved shape on the left, followed by the letters "KCI" in bold, sans-serif font. A registered trademark symbol is located to the right of the letter "I".
| | care and extended care nurses for a similar product, the V.A.C. Via
Negative Pressure Wound Therapy Unit. This testing validated that
the results from home care nurses are equivalent to extended care
nurses, in that they responded in an identical manner throughout the
usability testing. Based on this experience, the home care nurse
responses in the V.A.C. Simplicity™ Therapy Unit usability test are
supportive of usability in the extended care environment. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Testing demonstrates that the V.A.C. Simplicity™ Therapy Unit is
substantially equivalent in terms of both indications for use and
technology to the predicate product |
. . . .
:
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
KCI USA, Inc. % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249-3441
JUL 2 1 2011
Re: K111280
Trade/Device Name: V.A.C. Simplicity™ Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: May 2, 2011 Received: May 6, 2011
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, listing 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
4
Page 2 - Ms. Margaret Marsh
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.
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/default.htm.
Sincerely yours.
iately yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number K111280 Device Name: V.A.C. Simplicity™ Negative Pressure Wound Therapy System
Indications for Use:
The V.A.C. Simplicity™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
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 Krone for MXM
(Division Sign-Off) Page _ of _
(Posted November 13, 2003)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111280