(271 days)
The VERSA Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.
The VERSA Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004).
The VERSA Negative Pressure Wound Therapy System is not intended for home use environments.
Cork Medical has developed a negative pressure wound therapy pump with the same intended use as its predicate device, Cork Medical Products Nisus Negative Pressure Wound Therapy System (K140022) but with a compacted footprint compared to the predict device.
The VERSA Negative Pressure Wound Therapy System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes. One button power on and off the pump and the other button switches pressure settings from 75 mm/Hg and 125 mm/Hg continuous and a 10 second hold on this button switches the pump to a variable intermittent mode, unlike its predecessor Cork NPWT System (K140022) which uses multiple buttons and menus to adjust settings.
The provided text is a 510(k) premarket notification for the Cork Medical VERSA Negative Pressure Wound System. It details the device's characteristics, intended use, and comparison to a predicate device. However, it explicitly states, "No clinical testing is required to support these 510(k) submissions. No clinical testing has been performed."
This means the document does not contain any information regarding acceptance criteria, study designs, sample sizes, expert involvement, or adjudication methods related to human clinical performance studies (such as MRMC or standalone AI performance studies) that would typically involve establishing ground truth from patient data.
The "NONCLINICAL TESTS" section (page 7) describes bench performance testing which focuses on hardware functionality and safety, not on diagnostic or therapeutic accuracy in a patient population.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and adherence to electrical safety and software validation standards, rather than proving performance against specific clinical acceptance criteria through patient studies.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.