V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766

• K Number: K063740
• Device Name: V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
• Manufacturer: KCI USA, INC.
• Date Cleared: 2007-06-07 ( 171 days)
• Product Code: OMP
• Regulation Number: 878.4780

Intended Use

The V.A.C.® 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 or pressure), 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.

Device Description

The InfoV.A.C.® Therapy System is designed for the application of V.A.C.® Therapy in the acute, extended and home care settings. 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. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing. Optional features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that provides options for therapy settings based on the recommendations in the KCI Clinical Guidelines, a Screen Guard feature that prevents unintentional screen changes, an exportable Therapy History Report, and a Log Tool for recording canister changes, dressing changes and dressing pieces used. Another new optional feature is the ability to receive and store digital images of the patient's wound throughout the healing process. By tracing the wound perimeter on the digital image, wound area can be calculated by the software. If the user inputs a wound depth value, wound volume can also be calculated. Wound images and area/volume calculations can be electronically transferred via a Patient History Report.

Predicate Devices

K032310, K062227, K063426

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions software-controlled therapy, monitoring, alarms, and basic image processing for wound area/volume calculation. There is no mention of AI, ML, or any learning algorithms.

Therapeutic

Yes
The device is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention, reducing edema, promoting granulation tissue formation and perfusion, and removing exudate and infectious material, which are all therapeutic actions.

Diagnostic

No

Explanation: The device is a wound management system that promotes healing by applying negative pressure. While it has optional features to calculate wound area and volume, its primary intended use is therapy, not diagnosis. The area/volume calculation is a measurement feature, not a diagnostic one that identifies the presence or nature of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "software-controlled therapy unit" that applies negative pressure, utilizes a foam dressing, tubing, and a canister. These are physical components that are integral to the device's function, making it a hardware device with software control, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to manage wounds by applying negative pressure to promote healing. This is a therapeutic intervention applied directly to the patient's body.
• Device Description: The device description details a system that applies negative pressure, manages fluids, and monitors therapy parameters. While it includes features like wound imaging and area/volume calculation, these are tools to aid in wound management, not for performing tests on samples taken from the body.
• Lack of In Vitro Testing: There is no mention of the device being used to test samples of blood, tissue, or other bodily fluids outside of the body to diagnose a condition or monitor a patient's health status.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly treat a wound on the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The V.A.C.® 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 or pressure), 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.

Product codes (comma separated list FDA assigned to the subject device)

OMP

Device Description

The InfoV.A.C.® Therapy System is designed for the application of V.A.C.® Therapy in the acute, extended and home care settings. 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. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing. Optional features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that provides options for therapy settings based on the recommendations in the KCI Clinical Guidelines, a Screen Guard feature that prevents unintentional screen changes, an exportable Therapy History Report, and a Log Tool for recording canister changes, dressing changes and dressing pieces used. Another new optional feature is the ability to receive and store digital images of the patient's wound throughout the healing process. By tracing the wound perimeter on the digital image, wound area can be calculated by the software. If the user inputs a wound depth value, wound volume can also be calculated. Wound images and area/volume calculations can be electronically transferred via a Patient History Report.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Digital images

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 new optional ancillary features were evaluated under a number of verification and validation tests in order to assure performance and conformance to design specifications.

A review of a large body of clinical data from prospective randomized controlled trials, comparative and retrospective studies, payor/provider data, and retrospective review of independent electronic medical record data documents the safe use of the V.A.C. Freedom® Therapy Unit in the home care setting. An engineering analysis of device performance establishes that the InfoV.A.C.® and V.A.C. Freedom® are equivalent in the delivery of negative pressure wound therapy, and that InfoV.A.C.® improves upon V.A.C. Freedom® in the elements that affect safety and usability in the home care setting. The existing clinical data can therefore be used to predict the safety of the InfoV.A.C.® Therapy System in the home care setting.

Verification and validation testing conducted under design control requirements document that the InfoV.A.C.® Therapy Unit and the predicates V.A.C.® ATS and V.A.C. Freedom® Therapy Units are equivalent in terms of technology and performance specifications for the delivery of negative pressure wound therapy. New optional, ancillary features have been determined to meet performance specifications. Clinical data supporting the safe use of the V.A.C. Freedom® Therapy Unit in the home care setting are also applicable to the InfoV.A.C.® Therapy Unit.

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.

K032310, K062227, K063426

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

Regulation Number and Section

§ 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.

Summary

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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. A small registered trademark symbol is located to the lower right of the letter "I".

K063740 page 1/3

JUN - 7 2007

Date prepared	June 1, 2007
510(k) Owner
Name	KCI USA, Inc.
Address	8023 Vantage Drive, San Antonio, TX 78230
Fax number	210 255-6727
Name of contact
person	Margaret Marsh; Senior Manager, Regulatory Affairs
Name of the device
Trade or
proprietary name	InfoV.A.C.® Therapy Unit
Common or usual
name	Negative pressure wound therapy device
Classification
name	Powered suction pump
Legally marketed
device to which
equivalence is
claimed	InfoV.A.C.® Therapy Unit and its associated canisters represent
design modifications of the V.A.C.® ATS Therapy Unit and
associated canister(s). The V.A.C. Freedom® Therapy Unit also
serves as a predicate in terms of the indication for home use. The
V.A.C.® ATS Therapy Unit and the V.A.C. Freedom® Therapy Unit
are described in the following 510(k)s:
K032310 for the V.A.C.® Family of Products (cleared October
10, 2003) K062227 for the V.A.C.® Therapy System that provided text
relating to the mechanism of action for inclusion into the
Indications for Use statement (cleared October 4, 2006) In addition, K063426 covers the V.A.C.® ATS 1000 ml canister
(cleared December 13. 2006).
Device description	The InfoV.A.C.® Therapy System is designed for the application of
V.A.C.® Therapy in the acute, extended and home care settings.
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. The safety features of the system include additional
alarms, such as those that signal for tubing blockages, a full or
missing collection canister, inactive therapy, low battery, and leaks
in the seal of the dressing.
Optional features include: Seal Check™ for identifying dressing
leaks, a Therapy Settings Guide that provides options for therapy
settings based on the recommendations in the KCI Clinical
Guidelines, a Screen Guard feature that prevents unintentional
screen changes, an exportable Therapy History Report, and a Log
Tool for recording canister changes, dressing changes and
dressing pieces used.
Another new optional feature is the ability to receive and store
digital images of the patient's wound throughout the healing
process. By tracing the wound perimeter on the digital image,
wound area can be calculated by the software. If the user inputs a
wound depth value, wound volume can also be calculated. Wound
images and area/volume calculations can be electronically
transferred via a Patient History Report.
Intended use of the
device	The V.A.C.® 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 or pressure), 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.
Differences in
intended use from the
predicate	The intended use of the device has not changed from the
predicate devices.
Summary of the
technological
characteristics of the
device compared to
the predicate device	The InfoV.A.C.® Therapy Unit and the predicates V.A.C.® ATS and
V.A.C. Freedom® Therapy Units have the same technology and
performance specifications for the delivery of negative pressure
wound therapy. The InfoV.A.C.® Therapy Unit differs only in
optional ancillary features that make the InfoV.A.C.® Therapy Unit
easier to use by the caregiver and patient, and by the addition of
capability for wound image storage and analysis.
Summary of non-
clinical tests	The new optional ancillary features were evaluated under a
number of verification and validation tests in order to assure
performance and conformance to design specifications.
Summary of clinical
tests	A review of a large body of clinical data from prospective
randomized controlled trials, comparative and retrospective
studies, payor/provider data, and retrospective review of
independent electronic medical record data documents the safe
use of the V.A.C. Freedom® Therapy Unit in the home care setting.
An engineering analysis of device performance establishes that
the InfoV.A.C.® and V.A.C. Freedom® are equivalent in the delivery
of negative pressure wound therapy, and that InfoV.A.C.®
improves upon V.A.C. Freedom® in the elements that affect safety
and usability in the home care setting. The existing clinical data
can therefore be used to predict the safety of the InfoV.A.C.®
Therapy System in the home care setting.
Conclusions drawn
from the non-clinical
and clinical tests that
demonstrate that the
device is as safe, as
effective, and
performs as well as or
better than the
predicate device	Verification and validation testing conducted under design control
requirements document that the InfoV.A.C.® Therapy Unit and the
predicates V.A.C.® ATS and V.A.C. Freedom® Therapy Units are
equivalent in terms of technology and performance specifications
for the delivery of negative pressure wound therapy. New
optional, ancillary features have been determined to meet
performance specifications.
Clinical data supporting the safe use of the V.A.C. Freedom®
Therapy Unit in the home care setting are also applicable to the
InfoV.A.C.® Therapy Unit.

,

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KO63740 page 2/3

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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: K063740

Trade/Device Name: Info V.A.C.® Therapy Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: May 1, 2007 Received: May 2, 2007

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of June 7, 2007.

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 (OS) 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

For Peter Rummell

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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INDICATIONS FOR USE

510(k) Number (if known): K063740 Device Name: InfoV,A.C. ® Therapy Unit

Indications for Use:

The V.A.C. 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, partialthickness burns, ulcers (such as diabetic or pressure), 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.

S.O.m

(Division Sign-On)
Division of General, Restorative,
Division of General, Devices Division of General Devices
and Neurological Devices and Neurological 1.663140

510(k) I

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)

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(Posted November 13, 2003)