(210 days)
Not Found
Not Found
No
The description focuses on software-controlled negative pressure application and monitoring, with no mention of AI or ML terms or functionalities.
Yes
The device is described as an "integrated wound management system" intended to "create an environment that promotes wound healing" and is indicated for various wound types, clearly demonstrating its therapeutic purpose.
No
Explanation: The device is described as an "integrated wound management system" that applies negative pressure to promote wound healing. Its functions include preparing the wound bed, reducing edema, promoting granulation tissue formation, and removing exudate. These are therapeutic actions, not diagnostic ones. Diagnostic devices are used to identify the presence, nature, or cause of a disease or condition.
No
The device description explicitly states it is a "software-controlled therapy unit" that applies negative pressure and includes physical components like foam dressing, tubing, and a canister. This indicates it is a hardware device with integrated software control, not a software-only medical device.
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 wound management and therapy application to the wound bed. This is a therapeutic and wound care device, not a diagnostic one.
- Device Description: The description focuses on applying negative pressure, distributing it across the wound, and collecting fluids. This is a mechanical and therapeutic function.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device is used to treat a wound, not to diagnose a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. They are 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. They are 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.
The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
The V.A.C. Instill® Therapy System is indicated for patients who would benefit from V.A.C.® Therapy coupled with controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It is intended 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
The software-controlled therapy unit applies negative pressure to the wound bed. The open cells of the V.A.C.® Foam Dressing to which the therapy unit is connected enable distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. The software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered.
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
Nonclinical tests: None required for the change in indication
Clinical tests: Medical literature documents acceptable clinical experience using the V.A.C.® Therapy System to treat venous insufficiency ulcers.
Key Metrics
Not Found
Predicate Device(s)
V.A.C.® Therapy System Family of Products
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
K091585
pg 1 of 2
510(k) SUMMARY
DEC 2 9 2009
| Date prepared | December 23, 2009 |
|---|---|
| 510(k) owner | |
| 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 |
| Name of the | |
| device | |
| Trade or | |
| proprietary | |
| name | V.A.C.® Therapy Systems |
| Common or | |
| usual name | Negative Pressure Wound Therapy Systems |
| Classification | |
| name | Negative Pressure Wound Therapy Powered Suction Pump (and |
| components) | |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | V.A.C.® Therapy System Family of Products |
| Device description | The software-controlled therapy unit applies negative pressure to the |
| wound bed. The open cells of the V.A.C.® Foam Dressing to which the | |
| therapy unit is connected enable distribution of the negative pressure | |
| across the surface of the wound, while the tubing transfers accumulated | |
| fluids to the canister. The software monitors and maintains target pressure | |
| and alarms as needed to help assure target pressure is maintained and | |
| constant therapy is delivered. |
V.A.C.® Therapy Systems
1
| Intended use of
the device | The ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® Therapy
Systems are integrated wound management systems for use in acute,
extended and home care settings. They are 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. They are 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.
The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterial
penetration and may help reduce infection in the above wound types. |
|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The V.A.C. Instill® Therapy System is indicated for patients who would
benefit from V.A.C.® Therapy coupled with controlled delivery of topical
wound treatment solutions and suspensions over the wound bed. It is
intended 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 only difference between the current and the predicate products is in
the addition of venous insufficiency ulcers to the Indications for Use
statement. |
| Summary of the
technological
characteristics of
the device
compared to the
predicate device | The technological characteristics of the V.A.C.® Therapy System Family of
Products is unchanged. |
| Summary of
nonclinical tests | None required for the change in indication |
| Summary of
clinical tests | Medical literature documents acceptable clinical experience using the
V.A.C.® Therapy System to treat venous insufficiency ulcers. |
:
. . . . . . . . .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
KCI USA % Ms. Margaret Marsh Regulatory Affairs Technical Director 6203 Farinon Drive San Antonio, Texas 78249
DEC 2 9 2009
Re: K091585
Trade/Device Name: V.A.C. Therapy System; V.A.C. Instillamet (V.A.C. 9 Instill) Regulation Number: 21 CFR 878-4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 12, 2009 Received: October 13, 2009
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.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Margaret Marsh
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/CDRH0ffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K091585
pg 1 of 2
INDICATIONS FOR USE
510(k) Number (if known): K091585
Device Name: V.A.C.® Therapy System
Indications for Use:
The ActiV.A.C.®, InfoV.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. They are 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. They are 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.
The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
Over-The-Counter Use Prescription 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 Kramer for MXM Page 1 of 1
(Posted November 13, 2003)
Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091585
5
K09 1585
pg 2 of 2
INDICATIONS FOR USE
510(k) Number (if known):
KOGISSS
Device Name: V.A.C. Instillamat (V.A.C.® Instill)
Indications for Use:
The V.A.C. Instill device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C. Instill is intended 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 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)
Daniel Krone for UXM
Division of Surgical, Orthopedic. and Restorative Devices
Page ⊥ of ⊥
(Posted November 13, 2003)
510(k) Number