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510(k) Data Aggregation
(267 days)
The Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended 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 Prospera Spectruum™ Negative Pressure Wound Therapy (NPWT) System is a medical device designed to allow for wound management through controlled negative pressure. The NPWT device and canister work in tandem to generate and maintain the specified negative pressure level, while the dressing kit provides fluid management and coverage over the wound site. This system provides flexibility and targeted therapy to manage the wound-healing environment in acute, subacute, chronic, and surgically closed wounds, suitable for use in diverse care settings, including hospital, extended, and home care.
The Prospera Spectruum Negative Pressure Wound Therapy System consists of:
- Prospera Spectruum Negative Pressure Wound Therapy Unit
- A disposable canister which collects wound exudate
- Prospera Spectruum Negative Pressure Wound Therapy Kit which includes a wound interface dressing, semi-occlusive wound drape, and dual lumen dressing connection.
- Optional White Foam Accessory
The dressing kit is available in multiple sizes, allowing for the use of either black foam alone or with an optional White Foam Accessory, based on wound characteristics and clinical needs. The black foam, as part of the primary dressing, is a hydrophobic polyurethane foam designed to assist in uniform pressure distribution across the wound bed. The optional white foam, made of polyvinyl alcohol (PVA) is a highly retentive material that supports fluid absorption and even pressure distribution. Both foams are secured with semi-occlusive wound drape and connected to the NPWT device via tubing, enabling removal of wound exudate and infectious materials.
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