(67 days)
The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use: AUTOTRANSFUSION 1) for the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post operative situations CHEST DRAINAGE - 1) to evacuate air and/or fluid from the chest cavity or mediastrinum - 2) to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum - 3) to help re-establish and maintain normal intrathoracic pressure gradients - 4) to facilitate complete lung re-expansion to restore normal breathing dynamic.
The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a multi-chamber collection/reinfusion system. The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a sterile, single use devices intended for the collection of autologous blood (autotransfusion) and as chest drainage collection units.
The provided text describes a 510(k) submission for the Pleur-evac® Sahara Plus Continuous Reinfusion Autotransfusion System. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment relevant to the request.
The document confirms that this device is "substantially equivalent" to a previously marketed device (K963850) based on "a detailed device description, performance testing and conformance with consensus and voluntary performance standards." However, the details of these performance tests, including specific acceptance criteria and study results, are not elaborated upon in the provided sections.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them because the necessary details are absent from the provided text.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).