(176 days)
The Passio Pump Drainage System is intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnes and chest discomfort associated with malignant pleural effusion and other recurrent effusions.
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I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The provided text is an FDA 510(k) clearance letter for the "Passio Pump Drainage System." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It details the device's indications for use (intermittent drainage of recurrent and symptomatic pleural effusions) and regulatory information.
However, it does not include any details on:
- Acceptance criteria: There's no table or description of specific performance thresholds for the device.
- Device performance data: No study results, metrics (e.g., accuracy, sensitivity, specificity, flow rate, pressure, durability), or reported performance numbers are present.
- Study design details: There's no information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria, as that information is not in the provided text.
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).