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510(k) Data Aggregation
K Number
K121817Device Name
VCARE A
Manufacturer
Date Cleared
2013-09-17
(454 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
IVT MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vcare a is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, sub-acute and dehisced wounds. partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Vcare a may promote healing by removal of excess exudates, irrigation fluids, and infectious material.
Device Description
The Vcare a - is a Negative Pressure Wound Therapy system that comprises fixed components and disposables. The Vcare a maintains the functionality of existing devices while enhancing safety. The system has features that optimize the delivery of negative pressure to open wounds. The software requires the user to profile the patient and the system then limits the device's operational parameters to be compatible with the patient profile. The system incorporates safety features that control the system to prevent risk to the patient. The sensors and controls monitor and maintain target pressure and alarms, as needed, to help assure that target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for possible bleeding, tubing blockage, a full or missing collection canister, inactive therapy, low battery and leaks in the seal of the dressing.
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