V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D

Q: Who is the manufacturer of V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D?

Kci USA, Inc. (Kinetic Concepts, Inc.) filed the 510(k) submission for V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D (K093526).

Q: What is the FDA product code for V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D?

KCI ActiV.A.C.® Therapy System (K063692); KCI ActiV.A.C.® Therapy System (K091585).

Q: Who can help prepare an FDA 510(k) submission like V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K093526 · Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP · Mar 10, 2010 · General, Plastic Surgery

Device Facts

Record ID	K093526
Device Name	V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D
Applicant	Kci USA, Inc. (Kinetic Concepts, Inc.)
Product Code	OMP · General, Plastic Surgery
Decision Date	Mar 10, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

V.A.C. Via™ NPWT System is an integrated wound management device for acute, extended, and home care settings. System components include a sterile dressing applied to the wound, tubing, a therapy unit, and a sterile disposable canister. The therapy unit generates negative pressure (75mmHg or 125mmHg) at the wound site, delivered in continuous or intermittent modes. This negative pressure environment promotes healing by preparing the wound bed, reducing edema, and stimulating granulation tissue formation and perfusion while removing exudates and infectious material into the canister. The device is operated by healthcare providers or patients/caregivers. Output consists of mechanical suction and visual/audible alarms for monitoring therapy delivery. Clinical benefit includes accelerated wound closure and management of complex wound types.

Clinical Evidence

No clinical data required for substantial equivalence determination. Evidence provided via bench testing, including verification and validation of software controls, pressure delivery (75mmHg/125mmHg), fluid collection, drape adhesive rheology/peel strength, and human factors testing.

Technological Characteristics

Powered suction pump; battery and AC powered. Components: sterile dressing, tubing, disposable canister. Materials: reticulated polyurethane foam, polyurethane film drape with acrylic adhesive. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1/UL 60601-1 (electrical safety), AAMI/ANSI/IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarms). Software-controlled therapy delivery (continuous/intermittent).

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (diabetic, pressure, venous insufficiency), flaps, and grafts.

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

KCI ActiV.A.C.® Therapy System (K063692)
KCI ActiV.A.C.® Therapy System (K091585)

Related Devices

K173447 — V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit · Kci USA, Inc. · Mar 2, 2018
K132741 — V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM · Kci USA, Inc. · Nov 15, 2013
K120033 — ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT · Kci USA, Inc. · May 31, 2012
K111280 — V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT · Kci USA, Inc. · Jul 21, 2011
K091585 — VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 · Kci USA, Inc. · Dec 29, 2009

Submission Summary (Full Text)

{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