V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM

K132741 · Kci USA, Inc. · OMP · Nov 15, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132741
• Device Name: V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
• Applicant: Kci USA, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Nov 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The V.A.C. ® Via™ Therapy System is an integrated wound management system for use in acute, extended and home care settings. When used on open wounds, 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy

Device Story

V.A.C. Via is a portable negative pressure wound therapy (NPWT) system. It applies controlled negative pressure to wound sites to promote healing by removing exudates, reducing edema, and stimulating granulation tissue. The system consists of a therapy unit, dressing components (Granufoam, interface pad, tubing, adhesive drape), and a canister. The modified device utilizes a single brushed DC-powered diaphragm pump controlled by software, replacing the dual piezoelectric pump design of the predicate. Used in acute, extended, and home care settings; operated by clinicians or patients. The system maintains a closed environment over the wound or incision. Healthcare providers monitor the wound status to guide therapy. Benefits include accelerated wound bed preparation and management of surgical incision drainage.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included performance verification of negative pressure delivery, software validation, electrical safety, electromagnetic compatibility, and battery life testing to ensure the modified pump design meets design specifications.

Technological Characteristics

NPWT system featuring a single brushed DC-powered diaphragm pump. System includes Granufoam dressing, interface pad, tubing, and adhesive drape. Dimensions: 3.5" W x 6.4" L x 2.8" D. Software-controlled pressure delivery. Battery-powered. Sterilization method not specified.

Indications for Use

Indicated for patients in acute, extended, or home care settings requiring wound management. Applicable to open wounds (chronic, acute, traumatic, subacute, dehisced, partial-thickness burns, ulcers, flaps, grafts) and closed surgical incisions with drainage.

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. ® Via™ Negative Pressure Wound Therapy System (K093526)
• V.A.C. ® Via™ Negative Pressure Wound Therapy System (K120033)

Submission Summary (Full Text)

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NOW 15 2013

## 510(k) SUMMARY

# V.A.C. ® V.A.C. ® Via™ | V.A.C. ® Via™
Negative Pressure Wound Therapy System

| Submitter Information [21 CFR 807.929(a)(1)] | |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive<br>San Antonio, TX 78249 |
| Phone number | 210-515-4059 |
| Fax number | 210-255-6727 |
| Establishment<br>Registration Number | 1625774 |
| Name of contact person | Melanie Avila |
| Date prepared | 08/23/2013 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary<br>name | V.A.C. ® Via™ Negative Pressure Wound Therapy System |
| Common or usual name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump |
| Regulation | 878.4780 |
| Product Code(s) | OMP |
| Legally marketed<br>device(s) to which<br>equivalence is claimed<br>[21 CFR 807.92(a)(3)] | V.A.C. ® Via™ Negative Pressure Wound Therapy System, originally cleared<br>under 510(k) K093526 and K120033 |
| Device description<br>[21 CFR 807.92(a)(4)] | Negative pressure wound therapy system |
| Indications for use<br>[21 CFR 807.92(a)(5)] | The V.A.C. ® Via™ Therapy System is an integrated wound management<br>system for use in acute, extended and home care settings. When used on<br>open wounds, it is intended to create an environment that promotes wound<br>healing by secondary or tertiary (delayed primary) intention by preparing the<br>wound bed for closure, reducing edema, promoting granulation tissue<br>formation and perfusion, and by removing exudates and infectious material.<br>Open wound types include: chronic, acute, traumatic, subacute and dehisced<br>wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous<br>insufficiency), flaps and grafts.<br>When used on closed surgical incisions, it is intended to manage the<br>environment of surgical incisions that continue to drain following sutured or<br>stapled closure by maintaining a closed environment and removing exudates<br>via the application of negative pressure wound therapy |

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Image /page/1/Picture/0 description: The image shows the logo for KCI. The logo consists of a graphic on the left and the letters "KCI" on the right. The graphic on the left is a series of curved lines that are stacked on top of each other. The letters "KCI" are in a bold, sans-serif font.

## 510(k) SUMMARY

## V.A.C. ® Via™

## Negative Pressure Wound Therapy System

| Summary of the technological characteristics of the device compared to the predicate device<br>[21 CFR 807.92(a)(6)] | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------|-------|---------------------------------------------------------------------------------------------|--------|-------|
| Feature | V.A.C.® Via™ NPWT System<br>(Modified Device) | | | V.A.C.® Via™ NPWT System<br>(Predicate ) | | |
| Therapy unit | Same as predicate | | | Software controlled pump for delivery of<br>negative pressure wound therapy | | |
| • Operating Principle | Same as predicate | | | Software controlled pump for delivery of<br>negative pressure wound therapy | | |
| • Pump Type | One brushed, DC powered, single<br>diaphragm pump | | | Two piezoelectric disc pumps | | |
| • Software | Software code drives the<br>operation of one conventional<br>diaphragm pump | | | Software code drives the operation of two<br>piezoelectric pumps | | |
| • Housing Dimensions<br>(inches) | Width | Length | Depth | Width | Length | Depth |
| | 3.5 | 6.4 | 2.8 | 3.5 | 6.4 | 2.4 |
| Therapy unit options | Same as predicate | | | Selectable negative pressure at either<br>-125mmHg or -75mmHg | | |
| Dressing system<br>components | Same as predicate | | | System consists of Granufoam ™<br>Dressing, interface pad and tubing, and<br>adhesive drape | | |
| Performance Data [21 CFR 807.92(b)] | | | | | | |
| Summary of non-clinical tests conducted for determination of substantial equivalence<br>[21 CFR 807.92(b)(1)] | | | | | | |
| The V.A.C.® Via™ NPWT System was evaluated to ensure conformance to the design specifications. | | | | | | |
| The following bench tests were conducted: | | | | | | |
| • Performance testing to confirm therapy unit delivers negative pressure therapy | | | | | | |
| • Software verification and validation testing to confirm that therapy unit performs as designed | | | | | | |
| • Testing to confirm device meets all applicable electrical safety and electromagnetic compatibility standards. | | | | | | |
| • Battery life testing to demonstrate that the battery will supply adequate power to provide the appropriate negative pressure to the wound. | | | | | | |

Information [21 CFR 807.92(b)(2)] Not applicable

Conclusions drawn [21 CFR 807.92(b)(3)]

Testing indicates that the V.A.C. ® Via™ NPWT System is substantially equivalent in terms of both
indications for use and fundamental scientific technology to the predicate p

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

· November 15, 2013

KCI USA, Incorporated Ms. Melanie Avila Regulatory Affairs Project Manager 6203 Farinon Drive San Antonio, Texas 78249

Re: K132741

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: Class II Product Code: OMP Dated: October 14, 2013 Received: October 17, 2013

Dear Ms. Avila:

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

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Page 2 - Ms. Melanie Avila

... ... ... ..

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

Sincerely yours,

## David Krause -S

for Mark N. Melkerson

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K 132741

#### Device Name

V.A.C. Via Negative Pressure Wound Therapy System

#### Indications for Use (Describe)

The V.A.C. @ Via™ Therapy System is an integrated wound management system for use in acute, excended and home care settings. When used on open wounds, 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 lissue formation and perfusion, and by removing exudates and infectious material. Open wound types include: chronic, acute, traumatic, subacute and debissed wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative wound therepy.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Rediological Health (CDRH) (Signature)

## Jivoung Dang -S