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Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings. The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, 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 ™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena Plus Negative Pressure Wound 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 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.

The Prevena™ Plus 125 Therapy Unit may be used part of as either of these systems: A) Prevena Incision Management System Consist of: - Prevena™ Therapy Unit . - Prevena 150mL Canister & adaptor . - Prevena Dressing kit ● B) Prevena Plus Negative Pressure Wound Therapy System Consist of: - Prevena™ Plus 125 Therapy Unit . - Prevena 150mL Canister & adaptor . - V.A.C. Dressing kit ● The Prevena™ Plus Incision Management System (Prevena™ Plus Therapy Unit when used with Prevena Dressings) is designed for use over linear, non-linear, intersecting incisions. The Prevena™ Plus Negative Pressure Wound Therapy System (Prevena™ Plus Therapy Unit when used with V.A.C. Dressings) is designed for use in a variety of open wound types such as: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. The Prevena Plus 125 Therapy Units are negative pressure pumps that deliver -125mmHg continuously for up to 7 or 14 days.

PICO Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of: - Superficial and deep incisional surgical site infections for high risk patients in Class II wounds - Post-operative seroma - Dehiscence Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore. Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol. PICO 7 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions When used on closed surgical incisions, PICO 7 Single Use Negative Wound Therapy System is intended to aid in reducing the incidence of: - Superficial and deep incisional surgical site infections for high risk patients in Class II wounds - Post-operative seroma - Dehiscence Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol. PICO 7Y Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of: - Superficial incisional surgical site infections for high risk patients in Class I wounds - Post-operative seroma - Dehiscence Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class II (Clean/ Contaminated), Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol. PICO 14 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of: - Superficial and deep incisional surgical site infections for high risk patients in Class II wounds - Post-operative seroma - Dehiscence Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

The PICO Family of devices, PICO (cleared under K163387), PICO 7 (cleared under K180698), PICO 7Y (cleared under K182323), PICO 14 (cleared under K191760) all have the same main function of management of fluid through dressing absorbency and evaporation with added benefit of negative pressure. The pump provides a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. The PICO Single Use Negative Therapy Systems consist of: - PICO Pump - Dressing (s) - Fixation strips - Batteries - Connection tubing - Instructions for Use The system is a canister-less system - fluid is managed by the dressing. The pump that delivers the NPWT is a portable, battery-powered, software-controlled system that can provide continuous application of negative pressure to the wound as a delivery pressure at a nominal value of -80mmHg. The PICO Systems are designed to be used at home or within a healthcare setting by an appropriate healthcare professional.

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.