V.A.C. VERAFLO CLEANSE DRESSING SYSTEM

K103156 · Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP · Mar 14, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103156
• Device Name: V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
• Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Mar 14, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. Negative Pressure Wound Therapy in the absence of instillation 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. The instillation option 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.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Device Story

V.A.C. VeraFlo Cleanse Dressing System is a component of the V.A.C.Ulta Negative Pressure Wound Therapy (NPWT) system. It facilitates NPWT and controlled instillation/drainage of topical wound treatment solutions and suspensions. System uses software-controlled pumps to deliver negative pressure and fluids through tubing to foam dressings placed in the wound bed, secured by an occlusive drape. Software manages therapy delivery, help functions, and alarms. Used in clinical settings by healthcare providers to promote wound healing by reducing edema, removing exudate/infectious material, and stimulating granulation tissue. Benefits include improved wound bed preparation for closure.

Clinical Evidence

Bench testing included negative pressure distribution measurements and visual observation of fluid distribution using a simulated wound model. Mechanical properties were tested per ASTM 3574-08. Biocompatibility testing (cytotoxicity, irritation, sensitization) was performed per ISO 10993-1. In vivo evidence included an acute swine model evaluating granulation tissue formation and wound fill response. Results demonstrated the device met all performance requirements and is biocompatible.

Technological Characteristics

Dressing system consists of foam-based dressing, occlusive drape, and tubing. Materials are polyurethane ester foam and polyurethane drape, consistent with predicate (except for colorant). Operates via software-controlled pumps for negative pressure and fluid instillation. Mechanical properties tested per ASTM 3574-08. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients with chronic, acute, traumatic, sub-acute, and dehisced wounds, partial-thickness burns, ulcers (diabetic, pressure, venous insufficiency), flaps, and grafts requiring vacuum-assisted drainage and/or topical wound treatment solution/suspension instillation.

Regulatory Classification

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.

Predicate Devices

• V.A.C. VeraFlo Dressing (K100657)

Submission Summary (Full Text)

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K103156
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**510(k) SUMMARY**

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MAR 1 4 2011

| Date prepared | February 16, 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. VeraFlo Cleanse Dressing System |
| Common or usual name | Negative pressure wound therapy dressing |
| Classification name | Dressing component for use with a Negative Pressure Wound Therapy<br>Powered Suction Pump |
| Legally marketed device(s) to which equivalence is claimed | V.A.C. VeraFlo Dressing, a component of the V.A.C.Ulta Negative<br>Pressure Wound Therapy System (K100657) |
| Device description | A dressing component of a negative pressure wound therapy system with<br>an instillation feature which allows controlled delivery and drainage of<br>topical wound treatment solutions and suspensions |
| Device design | Negative pressure wound therapy system, in which instillation of topical<br>wound treatment solutions and suspensions and negative pressure<br>wound therapy is provided via software controlled pumps. Instillation<br>solutions and negative pressure are delivered through tubing to foam<br>dressings in the wound covered by an occlusive drape. Software<br>provides controls for both negative pressure wound therapy and delivery<br>of instillation therapy. Software also provides controls for help and alarm<br>functions. |

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## KIO3I56
P.243

| Intended use of the<br>device | The V.A.C.Ulta Negative Pressure Wound Therapy System is an<br>integrated wound management system that provides Negative Pressure<br>Wound Therapy with an instillation option. | | |
|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Negative Pressure Wound Therapy in the absence of instillation is<br>intended to create an environment that promotes wound healing by<br>secondary or tertiary (delayed primary) intention by preparing the wound<br>bed for closure, reducing edema, promoting granulation tissue formation<br>and perfusion, and by removing exudate and infectious material. | | |
| | The instillation option is indicated for patients who would benefit from<br>vacuum assisted drainage and controlled delivery of topical wound<br>treatment solutions and suspensions over the wound bed. | | |
| | The V.A.C.Ulta Negative Pressure Wound Therapy System with and<br>without instillation is indicated for patients with chronic, acute, traumatic,<br>sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as<br>diabetic, pressure and venous insufficiency), flaps and grafts. | | |
| Summary of the<br>technological<br>characteristics of<br>the device,<br>compared to the<br>predicate device. | Feature | VeraFlo Cleanse<br>Dressing | VeraFlo Dressing<br>(predicate) |
| | Dressing<br>system<br>components | Same as predicate | Foam based dressing with<br>occlusive drape and<br>negative pressure/<br>instillation tubing |
| | Patient<br>contact<br>materials of<br>construction | Same as predicate, except<br>for slightly less colorant | Polyurethane ester foam<br>with polyurethane drape |

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| Summary of tests<br>conducted | The V.A.C. VeraFlo Cleanse System was evaluated under a number of<br>design verification and validation tests that assure conformance to design<br>specifications.<br>The following tests were conducted on the V.A.C. VeraFlo Cleanse<br>System: Negative pressure distribution measurements (bench test with<br>simulated wound model). Visual observation of fluid distribution in the dressing and<br>simulated wound bed (bench test with simulated wound model). Mechanical properties (tensile and tear strength per ASTM 3574-<br>08 tests) Granulation tissue formation and wound fill response in an acute<br>swine model. Cytotoxicity, irritation, and sensitization testing was performed in<br>accordance to ISO 10993-1 standards, and results demonstrated<br>that the device is biocompatible according to these standards. The device was shown to meet all performance requirements. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions drawn | Testing demonstrates that the V.A.C. VeraFlo Cleanse System is<br>substantially equivalent in terms of both indications for use and<br>technology to the predicate product. |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

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

MAR 1 4 201

Re: K103156

Trade/Device Name: V.A.C. VeraFlo Cleanse Dressing System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: February 16, 2011 Received: February 17, 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. Ilsting 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

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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 Pat 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/Safcty/Reportal?roblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Alig 13. R. h
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: V.A.C. VeraFlo Cleanse Dressing System

Indications for Use:

(Posted November 13, 2003)

The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Negative Pressure Wound Therapy in the absence of instillation 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.

The instillation option 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.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Over-The-Counter Use Prescription Use X 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)

David Krosky MXM
(Division Sign-Off) Page **_ of _**

Division of Surgical, Othopedic, and Restorative Devices

510(k) Number K03156