(114 days)
Not Found
No
The summary describes a negative pressure wound therapy system with standard electromechanical components and software for pressure control and alarms. There is no mention of AI, ML, or image processing, and the performance studies focus on electrical safety, biocompatibility, usability, and functional equivalence to a predicate device.
Yes
The device is intended to create an environment that promotes wound healing by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material, which are all therapeutic actions.
No
The device is described as an "integrated wound management system" that "promotes wound healing." Its functions include preparing the wound bed, reducing edema, promoting granulation tissue, and removing exudates. These are therapeutic actions, not diagnostic ones. The "Indications for Use" section lists various wound types for which the system is used, but it does not describe any diagnostic capabilities.
No
The device description explicitly lists hardware components (sterile dressing system, tubing, therapy unit, sterile disposable canister) and the performance studies include testing for electrical safety, electromagnetic compatibility, and usability of the physical system, indicating it is a hardware-based device with software controls.
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.Via™ Negative Pressure Wound Therapy System is a device that applies negative pressure directly to a wound on the body. It is a therapeutic device used to promote wound healing, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a system for wound management and therapy, not for diagnosing a condition based on a biological sample.
- Device Description: The components described (dressing, tubing, therapy unit, canister) are consistent with a therapeutic device for applying negative pressure and collecting exudate, not an IVD.
Therefore, the V.A.C.Via™ Negative Pressure Wound Therapy System 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.Via™ 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 exudates 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 (comma separated list FDA assigned to the subject device)
OMP
Device Description
The V.A.C. Via™ NPWT System consists of the following components: • A sterile dressing system applied to the wound and connected via tubing to a therapy unit that generates negative pressure at the wound • A sterile, disposable canister that collects wound exudates removed via the negative pressure
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)
Summary of non-clinical tests conducted for determination of substantial equivalence:
Testing in accordance to ISO 10993-1 standards was conducted for biocompatibility
Testing in accordance to IEC 60601-1 and UL 60601-1 was conducted for electrical safety
Testing in accordance to AAMI/ANSI/IEC 60601-1-2 was conducted for electromagnetic compatibility.
Testing in accordance to IEC 60601-1-6 was conducted for usability
Testing in accordance to IEC 60601-1-8 was conducted for alarm systems
The V.A.C. Via™ NPWT System and components were also evaluated to ensure conformance to design specifications and establish equivalence to the predicate device, as follows:
Verification and validation of software controls to ensure delivery of user selected negative pressure and continuous or intermittent therapy setting, pressure monitoring, and function of alarms
Verification testing to ensure functional ability of the V.A.C. Via™ NPWT System to deliver continuous or intermittent negative pressure at either 75mmHg or 125mmHg and transfer wound exudates to a collection canister for up to seven days
Rheology and peel testing of the drape adhesive to demonstrate equivalent or improved intrinsic adhesive properties and peel strength respectively, as compared to the predicate drape adhesive
Human Factors testing to ensure inherent design features and labeling facilitate correct usage and effective response to alarms
Summary of clinical tests conducted for determination of substantial equivalence:
None required for determining substantial equivalence
Conclusions drawn:
Testing demonstrates that the V.A.C. Via™ NPWT System and ActiV.A.C.® Therapy System are substantially equivalent in terms of both indications for use and safe and effective delivery of negative pressure wound therapy
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
093526
pg 1 of 3
Image /page/0/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 bold, sans-serif font. There is a registered trademark symbol to the right of the "I".
510(k) V.A.C. Via™ NPWT System February 26, 2010
.
510(k) SUMMARY
MAR 1 0 2010
7
V.A.C.Via™ Negative Pressure Wound Therapy System
| Date prepared | February 26, 2010 |
|---|---|
| 510(k) owner | |
| • Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| • Address | 6203 Farinon Drive; San Antonio, Texas 78249 |
| • Phone number | 210 406-4602 |
| • Fax number | 210 255-6727 |
| • Name of contact person | Randall Wheeland |
| Name of the device | |
| • Trade or proprietary name | V.A.C. Via™ NPWT System |
| • Common or usual name | Negative pressure wound therapy system |
| • Classification name | Negative pressure wound therapy powered suction pump (and components) |
| • Legally marketed device(s) to which equivalence is claimed | KCI ActiV.A.C.® Therapy System |
| 510(k) Numbers: K063692 and K091585 | |
| Device description | |
| • Device design | The V.A.C. Via™ NPWT System consists of the following components: |
| • A sterile dressing system applied to the wound and connected via tubing to a therapy unit that generates negative pressure at the wound | |
| • A sterile, disposable canister that collects wound exudates removed via the negative pressure | |
| • Intended use of the device | The V.A.C.Via™ 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 exudates and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as |
1
093526
pg 2 of 3
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. The lines are arranged in a parallel fashion, creating a sense of movement or flow. A registered trademark symbol is present to the right of the letter "I".
510(k)
V.A.C. Via™ NPWT System
February 26, 2010
| Summary of the
technological
characteristics
of the device
compared to
the predicate
device | Feature | V.A.C.Via™ NPWT
System | Predicate NPWT
System |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indicated wound
types | Same | Chronic, acute,
traumatic, subacute and
dehisced wounds,
partial-thickness burns,
ulcers (such as diabetic,
pressure or venous
insufficiency), flaps and
grafts |
| | Therapy unit | Same | Software controlled,
battery and AC powered
negative pressure pump
with a single use
disposable fluid
collection canister |
| | Foam dressing | Same except the acrylic
adhesive of the drape
has a different monomer
composition which was
chosen to improve
sealing performance in
the moist wound
environment | V.A.C.® GranuFoam
reticulated polyurethane
foam wound dressing,
adhesive drape made of
polyurethane film with
acrylic adhesive that
creates a sealed wound
environment, and
interface pad and tubing
set used to transfer
negative pressure from
the therapy unit to the
wound, drawing
exudates from the wound
into the fluid collection
canister |
| | | The V.A.C. Via™ NPWT System and the predicate both create the same
negative pressure wound healing environment. | |
| Summary of non-
clinical tests
conducted for
determination of
substantial
equivalence | Testing in accordance to ISO 10993-1 standards was conducted for
biocompatibility
Testing in accordance to IEC 60601-1 and UL 60601-1 was conducted for
electrical safety
Testing in accordance to AAMI/ANSI/IEC 60601-1-2 was conducted for
electromagnetic compatibility.
Testing in accordance to IEC 60601-1-6 was conducted for usability
Testing in accordance to IEC 60601-1-8 was conducted for alarm systems
The V.A.C. Via™ NPWT System and components were also evaluated to
ensure conformance to design specifications and establish equivalence to
the predicate device, as follows:
Verification and validation of software controls to ensure delivery of user
selected negative pressure and continuous or intermittent therapy
setting, pressure monitoring, and function of alarms | | |
2
Image /page/2/Picture/5 description: The image shows the logo for KCI. The logo consists of a stylized graphic to the left and the letters "KCI" to the right. The graphic is made up of several curved lines that are stacked on top of each other. The letters "KCI" are in a bold, sans-serif font.
.. .
510(k)
V.A.C. Via™ NPWT System
February 26, 2010
¥093526
rg 3 .f 3
| Verification testing to ensure functional ability of the V.A.C. Via™ NPWT System to deliver continuous or intermittent negative pressure at either 75mmHg or 125mmHg and transfer wound exudates to a collection canister for up to seven days Rheology and peel testing of the drape adhesive to demonstrate equivalent or improved intrinsic adhesive properties and peel strength respectively, as compared to the predicate drape adhesive Human Factors testing to ensure inherent design features and labeling facilitate correct usage and effective response to alarms | |
|---|---|
| Summary of | |
| clinical tests | |
| conducted for | |
| determination of | |
| substantial | |
| equivalence | None required for determining substantial equivalence |
| Conclusions | |
| drawn | Testing demonstrates that the V.A.C. Via™ NPWT System and ActiV.A.C.® Therapy System are substantially equivalent in terms of both indications for use and safe and effective delivery of negative pressure wound therapy |
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three profiles facing to the right, with flowing lines suggesting movement or energy.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 1-0 2010
KCI USA, Inc. % Mr. Randall Wheeland Director, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K093526
Trade/Device Name: V.A.C. Via™ Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: February 26, 2010 Received: March 1, 2010
Dear Mr. Wheeland:
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 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
4
Page 2 - Mr. Randall Wheeland
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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K093526
pg i of i
INDICATIONS FOR USE
510(k) Number (if known): K093526
Device Name: V.A.C.Via™ Negative Pressure Wound Therapy System
Indications for Use:
The V.A.C.Via™ 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 exudates 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.
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)
Page of
(Posted November 13, 2003)
Daniel Kane for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093526