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The portable Medela Invia Endure Negative Pressure Wound Therapy (NPWT) system is indicated 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. It is intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropethic, pressure or venous insufficiency), flaps and grafts.

The Medela Invia Endure Negative Pressure Wound Therapy (NPWT) System is comprised of the Invia Endure NPWT Pump, canister/tubing set, power supply, carrying case, patient and user instructions, and Invia NPWT kits. The Invia Endure is also compatible with separately cleared Avance NPWT kits manufactured by Mölnlyke Healthcare (K122132).

The Invia Endure NPWT pump is a suction pump for Negative Pressure Wound Therapy with an optical and acoustic status display. Acoustic and optical signals are triggered for variances from the set values as well as for faults. The Invia Endure NPWT pump is intended for a single patient's entire therapy for continuous or intermittent operation. It has lifetime of at least three years.

The Invia Endure NPWT system is intended for use in a home or other health care facility by medical personnel or trained lay users adhering to the instructions for use. The user may not be hard of hearing or deaf and must have normal visual acuity. The Invia Endure NPWT pump is portable and can be operated independent of the electrical power supply via its rechargeable battery.

This document is a 510(k) premarket notification for the "Invia Endure Negative Pressure Wound Therapy System". It explicitly states that no clinical testing was performed. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the section "SUMMARY OF CLINICAL TESTS:" on page 5 states: "The Invia Endure has not been the subject of clinical testing."

Since no clinical study was performed, none of the requested information regarding acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies can be provided from this document.

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