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The Low Fluid Alarm System is a stand alone accessory for monitoring of liquid levels (standard saline solutions or other solutions with an aqueous base) in a reservoir. It is generally useable with rigid polycarbonate, flexible polyvinyl chloride (PVC) or glass reservoirs. If the level falls below a predetermined threshold visual and acoustical alarms appear.

The Low Fluid Alarm System is designed for continuous arthroscopy operation in operating rooms and intensive care units. For the patient's safety the device is to be operated only by qualified medically-trained personnel and only with constant supervision.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Low Fluid Alarm." This letter confirms substantial equivalence to a predicate device and allows the manufacturer, Em-tec GmbH, to market the device.

However, the document does not contain any information regarding acceptance criteria, device performance data, study designs, sample sizes, ground truth establishment, or expert qualifications.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• Regulatory requirements and classifications.
• Indications for Use statement for the Low Fluid Alarm.

Therefore, I cannot provide the requested information based solely on the text provided. The information you're asking for would typically be found in the 510(k) submission itself (e.g., in a performance data section), which is not part of this clearance letter.

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