(143 days)
The Enthermics Medical Systems DC Series Fluid Warming Cabinets are designed to safely store and warm irrigation fluids and injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
The DC Series Fluid Warming Cabinets are single cavity warming cabinets intended to heat either irrigation fluids (set point range of 90°F to 150°F) or injection fluids (set point range of 90°F to 110°F). The cabinets consist of powder coated steel exterior panels, and stainless steel cavity panels. The exterior also consists of ABS plastic panels. The heating system of the device includes three or more independent, fully insulated, electrothermal arrays mounted on the outside of the cavity. The device includes an over temperature alarm which provides an audible and visual indication that the cavity temperature has exceeded the set temperature by 10°F. Additional thermal reset switches are present the shut off power to the heating array or unit in the event of an over temperature array or cavity respectively.
The provided text describes a Premarket Notification (510(k)) for the Enthermics Medical Systems DC Series Fluid Warming Cabinets. This document focuses on the device's design and intended use, rather than its performance in diagnostic or clinical efficacy studies as typically seen with AI/ML-based medical devices.
Therefore, the information requested in the prompt, such as acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable to this type of medical device submission. These questions are usually relevant for devices heavily relying on diagnostic accuracy, such as imaging analysis software or AI-driven detection systems.
The DC Series Fluid Warming Cabinets are a physical product designed to warm fluids to specific temperatures. The 510(k) submission primarily demonstrates substantial equivalence to a predicate device (Enthermics Medical Systems EC-770l Fluid Warming Cabinet K993797) based on its technological characteristics, intended use, and safety features (e.g., over-temperature alarms). The "study" mentioned in the prompt's title is implicitly the comparison of the new device to the predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance evaluation against ground truth data.
Key points from the document regarding the device and its compliance:
- Acceptance Criteria & Performance: Not explicitly stated in terms of diagnostic metrics. Acceptance is based on meeting safety standards and functional specifications (e.g., temperature ranges, over-temperature alarms) that are substantially equivalent to a predicate device.
- Sample Size: Not applicable. The "test" is a design and feature comparison, not a data-driven validation study in the context of AI/ML.
- Ground Truth: Not applicable. There's no diagnostic output for which ground truth would be established by experts or pathology.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable.
- Standalone Performance: Not applicable as it's a physical warming device, not an algorithm.
- Type of Ground Truth: Not applicable.
- Training Set Sample Size & Ground Truth: Not applicable.
The submission is a declaration of substantial equivalence, asserting that the new device shares the same intended use and similar technological characteristics (electrothermal heating, operational modes, safety features) as the existing predicate device. The differences highlighted (smaller volume, materials, more heating arrays, more accurate temperature detection/control) are presented as design changes that do not alter the fundamental safety or effectiveness compared to the predicate.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).