V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423

• K Number: K063590
• Device Name: V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
• Manufacturer: KCI USA, INC.
• Date Cleared: 2007-01-25 ( 55 days)
• Product Code: OMP
• Regulation Number: 878.4780

Intended Use

The V.A.C. Therapy System 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 V.A.C. ATS® and V.A.C. Freedom® canisters are provided with a sterile fluid path for single use with the V.A.C. ATS® and V.A.C. Freedom® therapy units.

Predicate Devices

K032310

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a wound therapy system and its components, focusing on mechanical function and sterile barriers. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

Therapeutic

Yes
The device is described as "V.A.C. Therapy System" which indicates its therapeutic purpose, and its intended use is to "promote wound healing" and by "reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material," all of which are therapeutic actions.

Diagnostic

No

The device is described as a therapy system intended to promote wound healing, remove exudate, and reduce infection, which are therapeutic functions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions "therapy units" and "canisters," which are hardware components, indicating it is 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 clearly describes a system for wound healing by applying negative pressure to the wound bed. This is a therapeutic intervention applied directly to the patient's body.
• Device Description: The description focuses on canisters and therapy units used in conjunction with wound dressings. This aligns with a therapeutic device, not a diagnostic one.
• Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on samples to diagnose, monitor, or screen for diseases or conditions.

The V.A.C. Therapy System is a therapeutic device used for wound management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The V.A.C. Therapy System 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 V.A.C. ATS® and V.A.C. Freedom® canisters are provided with a sterile fluid path for single use with the V.A.C. ATS® and V.A.C. Freedom® therapy units.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Verification of the integrity of the fluid path sterile barriers of the modified design was through accelerated aging, distribution simulation, and microbial aerosol challenge testing. The modified V.A.C. ATS® and V.A.C. Freedom® canisters with the sterile fluid path are safe and effective for their intended use. The sterility assurance level of the sterile fluid path of the canisters can be assured to a level of 10-6.

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

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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K063590

Image /page/0/Picture/1 description: The image shows the logo for KCI. The logo consists of a stylized graphic to the left of the letters "KCI". 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, and there is a registered trademark symbol to the right of the "I".

JAN 2 5 7007 14 - 1 - 510(k) SUMMARY - 510(k) SUMMARY

Product Name: V.A.C. Freedom® and V.A.C. ATS® Therapy Device Canisters

Date prepared	November 30, 2006
510(k) Owner
Name	KCI USA, Inc.
Address	8023 Vantage Dr., San Antonio, TX 78230
Fax number	[phone]
Name of contact person	Christy Hubbard Oviatt, Sr. Regulatory Affairs Specialist
Name of the device
Trade or proprietary
name	• V.A.C. 300 ml Canister (with Gel) for V.A.C. Freedom®
• 500 ml Canister (with Gel) for V.A.C. ATS®
• 500 ml Canister for V.A.C. ATS®
Common or usual
name	Accessory to Negative Pressure Wound Therapy Device
Classification name	Accessory to Powered Suction Pump
Legally marketed device
to which equivalence is
claimed	The canisters are proposed to be substantially equivalent
to canisters currently marketed in sterile barrier
packaging. These canisters were included in the V.A.C.
Family of Devices 510(k) K032310.
• V.A.C. 300 ml Canister (with Gel) for V.A.C. Freedom®
• 500 ml Canister (with Gel) for V.A.C. ATS®
• 500 ml Canister for V.A.C. ATS®
Device description	The V.A.C. ATS® and V.A.C. Freedom® canisters are
provided with a sterile fluid path for single use with the
V.A.C. ATS® and V.A.C. Freedom® therapy units.
Device function	The V.A.C. ATS® and V.A.C. Freedom® canisters function
as reservoirs to collect fluids and wound exudates
removed from the wounds during treatment with the
negative pressure therapy devices.
Device design	The canisters are molded plastic devices designed to
insert into the V.A.C. Freedom® or V.A.C. ATS® Therapy
units.
Differences in
device design
from predicate
device	The only difference between the proposed and the predicate
devices is the means by which sterility of the fluid path of the
device is maintained. The predicate products are packaged with
sterile barrier packaging while the modified canisters are
designed with sterile barriers at the open ends of the fluid path of
the product to maintain the sterility prior to use.
Intended use of the
device	The V.A.C. Therapy System 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 devices has not changed from the
intended use of the predicate devices.
Summary of the
technological
characteristics of
the device	The modified and unmodified V.A.C. ATS® and V.A.C. Freedom®
canisters have molded-in graduation markings on the side of the
canister to aid in estimation of fluid removal. Hydrophobic
membranes secured to the side of the canisters during the
manufacturing process isolate the collected fluid from the
vacuum pump in each case. A gel packet is included in the
V.A.C. Freedom® canister and in one model of the V.A.C. ATS®
canisters to solidify the wound fluid in the canister.
Summary of
nonclinical tests	Verification of the integrity of the fluid path sterile barriers of the
modified design was through accelerated aging, distribution
simulation, and microbial aerosol challenge testing.
Conclusions drawn
from the
nonclinical tests
that demonstrate
that the device is
as safe, as
effective, and
performs as well as
or better than the
predicate device	The modified V.A.C. ATS® and V.A.C. Freedom® canisters with
the sterile fluid path are safe and effective for their intended use.
The sterility assurance level of the sterile fluid path of the
canisters can be assured to a level of 10-6.

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K063590 page 2/2

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 bold, sans-serif font. There is a small circle with an R inside of it to the right of the I.

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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 stylized eagle with its wings forming three curved lines. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.

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: K063590

Trade/Device Name: V.A.C.® Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: January 4, 2007 Received: January 5, 2007

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of January 25, 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

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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.

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): 1063590 Device Name: V.A.C. ® Therapy System Indications for Use:

The V.A.C. Therapy System 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.

Prescription Use X AND/OR Over-The-Counter Use _______

(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)

(Division Sign-Off)

Division of General, I

(Posted November 16, 2005) and Neurological Devices

510(k) Number:	12063590
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