Search Results

The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious naterial and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.

The SNaP® Wound Care System ("SNaP System") is a portable, non-powered suction device intended for wound management via application of negative pressure to the wound bed for removal of fluids, including wound exudate, irrigation fluids and infectious materials.

The provided text is a 510(k) Premarket Notification for the Spiracur SNaP® Wound Care System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets said criteria.

The 510(k) filing states:
"The SNaP System is an existing device to which no design changes have been made as a result of the labeling changes. As such, no further testing has been conducted."

This means that for this specific 510(k) application (K113032), no new study was performed to establish acceptance criteria or demonstrate device performance against new criteria. The application is based on substantial equivalence to previously cleared devices and merely expanded the indications for use based on existing data or predicate device similarities.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study, as this information is not present in the provided text.

Ask a specific question about this device