(24 days)
- To evacuate air and/or fluid from the chest cavity or mediastinum. .
- To help re-establish lung expansion and restore breathing dynamics. .
- To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the "Ocean Chest Drain" device. This document confirms the device's substantial equivalence to a predicate device and its approval for marketing.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or similar details that would typically be found in a study report or clinical trial summary.
The letter is a regulatory approval and does not describe the specific tests or data that led to that approval. It only states that the FDA "reviewed your Section 510(k) premarket notification" and found the device "substantially equivalent."
Therefore, I cannot provide the requested information based on the given input text.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.