(82 days)
The Pleur-evac® Autotransfusion Blood Recovery Bag is a blood evacuation and collection device for shed mediastinal or pleural drainage, and is intended to be used in conjunction with DSP Pleur-evac® Continuous Reinfusion Autotransfusion Systems.
The device is a flexible PVC bag designed to evacuate and collect filtered blood from a thoracic drainage unit for reinfusion to the patient. The bag contains two spring-loaded plates which are latched together prior to device use. During use, the plates are unlatched and the spring acts against the plates to create a vacuum in the bag thereby drawing the blood into the bag from the Pleur-evac® unit.
This 510(k) summary (K964070) for the Deknatel DSP Pleur-evac Autotransfusion Blood Recovery Bag does not contain information on acceptance criteria or a study proving the device meets said criteria.
Instead, the submission relies on substantial equivalence to a predicate device (Atrium Self-filling ATS Blood Bag, model 2450 -- K883663). The core argument is stated in section 5: "The Pleur-evac® Autotransfusion Blood Recovery Bag is identical in design, materials, manufacturing process, function, and intended use to the predicate device... Since the Pleur-evac® Autotransfusion Blood Recovery Bag is identical to the predicate device, no additional performance or biocompatibility testing was provided in this submission in order to establish substantial equivalence of the device to the predicate product."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment for the Deknatel DSP Pleur-evac Autotransfusion Blood Recovery Bag based on the provided text. The submission explicitly states that no additional performance or biocompatibility testing was provided.
§ 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).