Who is the manufacturer of V.A.C. THERAPY SYSTEM?

Kci USA, Inc. (Kinetic Concepts, Inc.) filed the 510(k) submission for V.A.C. THERAPY SYSTEM (K062227).

What is the FDA product code for V.A.C. THERAPY SYSTEM?

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

What is the regulatory pathway for V.A.C. THERAPY SYSTEM?

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

What are the predicate devices for V.A.C. THERAPY SYSTEM?

V.A.C.® ATS and V.A.C.® Freedom® Therapy Units (K032310); V.A.C.® Instill Therapy Unit (K021501); V.A.C.® GranuFoam® Silver Protection Dressing (K053627); V.A.C.® Abdominal Dressing (K022011).

Who can help prepare an FDA 510(k) submission like V.A.C. THERAPY SYSTEM?

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.

V.A.C. THERAPY SYSTEM

K062227 · Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP · Oct 4, 2006 · General, Plastic Surgery

Device Facts

Record ID	K062227
Device Name	V.A.C. THERAPY SYSTEM
Applicant	Kci USA, Inc. (Kinetic Concepts, Inc.)
Product Code	OMP · General, Plastic Surgery
Decision Date	Oct 4, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

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 Story

V.A.C. Therapy System provides negative pressure wound therapy (NPWT) to promote healing. System components include reticulated polyurethane or polyvinyl alcohol foam dressings, semi-permeable adhesive drapes, and a software-controlled therapy unit. Foam is cut to fit the wound bed; drape creates a seal. Therapy unit applies continuous or intermittent negative pressure; T.R.A.C. (Therapeutic Regulated Accurate Care) technology monitors and maintains target pressure. Tubing transfers exudate to a collection canister. System includes alarms for tubing blockages, full/missing canisters, inactive therapy, low battery, and seal leaks. Used in clinical settings to prepare wound beds for closure, reduce edema, and remove infectious material. Healthcare providers select therapy modes based on wound type; output allows for controlled wound environment management, potentially accelerating healing and reducing infection risk.

Clinical Evidence

No new clinical or non-clinical testing was performed for this submission. Evidence relies on previously cleared predicate devices and published literature documenting the effective use of the V.A.C. Therapy System in various wound types and clinical situations.

Technological Characteristics

System consists of a software-controlled powered suction pump, reticulated polyurethane or polyvinyl alcohol foam dressings, and adhesive drapes. Features T.R.A.C. technology for pressure monitoring and alarm management. Operates via negative pressure application to the wound bed. Materials and design are identical to predicate devices.

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (diabetic or pressure), 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

V.A.C.® ATS and V.A.C.® Freedom® Therapy Units (K032310)
V.A.C.® Instill Therapy Unit (K021501)
V.A.C.® GranuFoam® Silver Protection Dressing (K053627)
V.A.C.® Abdominal Dressing (K022011)

Related Devices

K100657 — V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U · Kci USA, Inc. (Kinetic Concepts, Inc.) · Sep 17, 2010
K063692 — V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 · Kci USA, Inc. · Jun 7, 2007
K091585 — VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 · Kci USA, Inc. · Dec 29, 2009
K111280 — V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT · Kci USA, Inc. · Jul 21, 2011
K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS · Kinetic Concepts, Inc. · Oct 10, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ K062227 Page 1/2 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 a bold, sans-serif font. A registered trademark symbol is located to the right of the "I". OCT - 4 2006 ## | Date prepared | September 27, 2006 | | |---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | 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 | V.A.C.® Therapy System | | | Common or usual name | Negative pressure wound therapy device | | | Classification name | Powered suction pump | | | Legally marketed device to which equivalence is claimed | Because the V.A.C.® Therapy System has not been modified for the purposes of this submission, the predicate products are the V.A.C.® Therapy Family of Products (Therapy Units ATS, Freedom and Instill and their associated disposable components), which were most recently cleared under 510(k)s: K032310 (V.A.C.® ATS and V.A.C.® Freedom® Therapy Units), K021501 (V.A.C.® Instill Therapy Unit), K053627 (V.A.C.® GranuFoam® Silver Protection Dressing) and K022011 (V.A.C.® Abdominal Dressing). | | | Device description | The components of the V.A.C.® Therapy System work as an integrated product to optimize both the delivery and the benefits of negative pressure. An open pore foam (reticulated polyurethane foam (GranuFoam®, GranuFoam® Silver, and Abdominal Dressings, etc.) or polyvinyl alcohol foam (Vers- Foam™ Dressing)] is cut to fit the wound, then covered with a semi-permeable adhesive drape. The software-controlled Therapy Unit applies negative pressure to the wound bed. The user can select continuous or intermittent therapy, depending upon wound type and the needs of each patient. The open cells of the foam enable equal distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. T.R.A.C.® (Therapeutic Regulated Accurate Care) technology 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. | | | 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 device has not changed. | | | Summary of the technological characteristics of the device compared to the predicate device | Design | Same as predicates | | | Materials | Same as predicates | | | Energy Source | Same as predicates | | Summary of nonclinical tests | Not applicable; no new nonclinical tests were performed for the purposes of this submission. | | | Summary of clinical tests | Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature. | | | Conclusions | Published literature documenting the effective use of the V.A.C.® Therapy System in a variety of wound types and clinical situations support the following revision to the Indications for Use statement. 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. | | {1}------------------------------------------------ K062227 page 2/2 . ## ekci. . {2}------------------------------------------------ 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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. APR -7 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Public Health Service KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230 Re: K062227 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: July 31, 2006 Received: August 2, 2006 Dear Ms. Oviatt: This letter corrects our substantially equivalent letter of October 4, 2006. 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 {3}------------------------------------------------ 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 (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. 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, foe Dott Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number: K062227 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), flans 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 (Part 21 CFR 801 Subpart D) | <div> </div> | |-------------------------------------------------|------------------------------------------------| | | AND/OR | | | Over-The-Counter Use (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, Restorative and Neurological Services (Posted November 13, 2003) Page ___ of ___ 510(k) Number L062227