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The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.

The EC-7701 is a stainless steel fluid warming cabinet that utilizes a fully insulated electrothermal cable array that is wrapped inside the bottom and two sides of the cabinet to provide uniform radiant, conductive and convective heating. The device can be used to heat irrigation fluids to a temperature ranging from 90°F to 150°F, or injection fluids to a range of 90°F to 110°F. The device also contains an over-temperature alarm which provides an audible and visual alarm when the internal temperature reaches 10°F above the selected temperature.

This document, K993797 pertains to the Enthermics Medical Systems EC-7701 Fluid Warming Cabinet. As a submission for a 510(k) premarket notification, it focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document. This type of information is typically found in submissions for novel devices requiring clinical trials, not for devices demonstrating substantial equivalence to already marketed products.

The document states:

• "The EC-770l is nearly identical to the three predicate devices in all material respects."
• "All four devices use the same basic technology (non-electromagnetic heating) and utilize similar over-temperature alarm systems (audible and visual indicators)."
• "The only material difference between the EC-7701 and the predicate devices is the selectable modes of operation (irrigation or injection) on the EC-7701. The selectable modes, however, do not raise additional questions of safety or effectiveness."

This indicates that the FDA's clearance of this device is based on its similarity to existing, legally marketed devices, not on a new study demonstrating its efficacy against specific pre-defined acceptance criteria.

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