(139 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
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Atrium Medical Corporation Express™ Chest Drain, indicating that the device is substantially equivalent to legally marketed predicate devices.
The letter lists the indications for use but does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or the number/qualifications of experts.
- Information on adjudication methods, MRMC studies, or standalone algorithm performance.
- Specifics about the type of ground truth used or the training set for any AI/algorithm.
Therefore, I cannot fulfill your request for this specific document.
§ 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.