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The ACTIV.A.C.™ Negative Pressure Wound 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 exudate 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.

The 3M™ ActiV.A.C.™ Canister - 300ml with Gel is a component of the ActiV.A.C.™ Negative Pressure Wound Therapy System, also referred to as the ActiV.A.C. ™ Therapy System. The ActiV.A.C. ™ Therapy System consists of: - · an ACTIV.A.C. ™ Therapy Unit, - · a disposable canister which collects wound exudate (the subject of this submission), - · a wound interface dressing, - · a semi-occlusive wound drape, and - · a sensing pad and lumen. The 3M™ ActiV.A.C. ™ Canister - 300ml with Gel is a single use disposable component of the ActiV.A.C. ™ Therapy System and is sold separately from the ActiV.A.C. ™ Therapy Unit. It is provided in either a 5 pack or 10 pack configuration. The Canister is attached to the therapy unit and collects wound exudates. The distal end of the Canister tubing attaches to the dressing tube set using rigid connectors. The Canister has volume graduations and contains a gel pack for fluid solidification and a tubing pinch clamp. The Canister is composed of MABS (Methylmethacrylate acrylonitrile butadiene styrene).

The PREVENA PLUS Incision Management System (No Ag) is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate via the application of negative pressure wound therapy. The PREVENA PLUS DUO Incision Management System (No Ag) 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 exudate via the application of negative pressure wound therapy.

Negative pressure wound therapy system for application to surgically closed incisions. The system consists of a therapy unit (PREVENA PLUS™ 125 Therapy Unit, ACTIVAC™ Therapy Unit, V.A.C. ULTA™ Therapy Unit, or V.A.C. RX4™ Therapy Unit), dressing and canister. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. Application of negative pressure wound therapy to an incision site that is closed via staples or sutures helps draw the incision edges together and remove fluid from the incision site into a canister fitted to the therapy unit. The occlusive drape of the dressing provides a negative pressure environment and protects the incision from external contamination. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference.

PREVENA 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and PREVENA PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.

The PREVENA 125 and PREVENA PLUS 125 Therapy Units ("PREVENA pumps") are singleuse, compact and portable powered suction pumps. The therapy units are packaged with compatible sterile canisters (45 ml for PREVENA 125 or 150 ml for PREVENA PLUS 125) and sterile tubing set. The therapy units can be used with compatible, legally marketed wound dressings classified under 21 CFR 878.4780, such as the PEEL & PLACE dressing and the CUSTOMIZABLE dressing, which, when combined are referred to as the PREVENA Incision Management Systems ("PREVENA systems"). The PREVENA Incision Management Systems deliver a pre-set, continuous negative pressure of 125 mmHz to the incision site. The systems are intended to be applied to incision sites immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The therapy units can be used up to 192 hours, after which they will automatically shut off.

The V.A.C. DERMATACTM Drape is an accessory to the: · ACTIV.A.C.™, INFOV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings. · V.A.C.ULTA™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional. When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing granulation tissue formation and perfusion, and by removing exudate 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, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudates via the application of negative pressure wound therapy.

The V.A.C. DERMATAC Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C. Therapy System. The V.A.C. DERMATAC Drape is single-use and it is provided sterile. The V.A.C DERMATAC Drape provides a sealed environment which allows for a moist wound environment and it allows for the delivery and maintenance of negative pressure at the wound site. The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound and the silicone layer primarily provides a seal for negative pressure. The V.A.C. Therapy System is comprised of the following: - . Software controlled neqative pressure therapy unit - . Disposable canister which collects wound exudate - . Polyurethane foam dressing - Semi-occlusive wound drape

The ACTIV.A.C.™ Negative Pressure Wound 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 exudate 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 closed environment and removing exudates via the application of negative pressure wound therapy.

The ACTIV.A.C.™ Therapy Unit is a component of the ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) System. The ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) system consists of: - ACTIV.A.C. TM Therapy Unit (the subject of this submission) - disposable canister which collects wound exudate - a wound interface dressing - . semi-occlusive wound drape - sensing pad and lumen The ACTIV.A.C. ™ Therapy Unit is a portable, battery-powered, reusable, software-controlled therapy unit that can provide continuous or intermittent applications of negative pressure to the wound bed in the selectable range of -25mmHg to -200mmHg. The ACTV.A.C.™ Therapy Unit is designed for the application of Negative Pressure Wound Therapy in the home, acute or extended care setting. The open cells of the dressing, to which the therapy unit is connected via pad and lumen, enables distribution of the negative pressure across the surface of the wound bed, while the tubing transfers accumulated fluids to the canister. The software 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. Optional ancillary features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that contains preset therapy settings based on wound type, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via USB data port, and a Log Tool for recording canister changes, dressing changes and dressing pieces used.

The PREVENA RESTOR(TM) Incision Management System 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 exudate via the application of negative pressure wound therapy.

The negative pressure technology for the subject device is the same as that for the predicate device systems. The PREVENA RESTOR™ dressing is a component of the PREVENA RESTOR™ Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing connected to a PREVENA RESTOR™ dressing placed over the incision site. The integrated one-piece dressing, which includes an occlusive film, provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together and removes fluid from the incision site into a canister fitted to the therapy unit.

The PREVENA PLUS Incision Management System 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 exudate via the application of negative pressure wound therapy. The PREVENA PLUS DUO Incision Management System 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 exudate via the application of negative pressure wound therapy.

The PREVENA PLUS 125 Unit is a component of a the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a maximum of fourteen (14) days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the therapy unit.

The PREVENA PLUS Incision Management System 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 exudate via the application of negative pressure wound therapy. The PREVENA PLUS DUO Incision Management System 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 exudate via the application of negative pressure wound therapy.

The negative pressure technology for the subject device systems is the same as that for the predicate device systems. The PREVENA PLUS 125 Therapy Unit is a component of the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the therapy unit.

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, the V.A.C.VIA™ 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 by removing exudates and infectious material. Open wound types include: chronic, acute, traunatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions, the V.A.C.VIA™ is intended to manage the environment of surgical incisions that continue to drain following sutured closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The negative pressure technology for the subject device is the same as that of the predicate device. The therapy unit is a component of the therapy system which provides negative pressure wound therapy to the wound site for up to 7 days. Negative pressure is created by the therapy unit by means of one software-controlled diaphragm pump which allows for a lightweight, single use therapy unit that provides for negative pressure wound therapy at either -75 or -125 mmHg. Negative pressure is delivered to the wound site through tubing to a dressing placed over the wound site.

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. Instillation Therapy 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. Negative Pressure Wound Therapy in the absence of instillation may also be used for: The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater. The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

The V.A.C.ULTA™ Negative Pressure Wound Therapy System is a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions. The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negative pressure therapy for the removal of wound exudate and when applicable instilled solutions. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillation solutions and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure during negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for help and alarm functions.