(37 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 postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
Atrium Medical Corporation Express™ Chest Drain
This document is solely a 510(k) clearance letter for the Atrium Express Chest Drain. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
Therefore, I cannot populate the requested table and information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive premarket notification submission that details the performance data.
§ 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.