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(a) Identification. An extracorporeal system for carbon dioxide removal is a system of devices and accessories that provides assisted extracorporeal carbon dioxide removal from the patient's blood in patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, a gas exchanger, blood pump, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).
(b) Classification. Class II (special controls). The special controls for this device are:
(1) In vivo evaluation, which may include animal testing and clinical data, of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the in vivo evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness.
(2) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible.
(3) Non-clinical performance testing of the devices and accessories in the circuit must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical integrity;
(ii) Durability; and
(iii) Reliability.
(4) All patient contacting components of the device must be demonstrated to be biocompatible.
(5) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of any electrical components.
(6) Software validation, verification, and hazard analysis must be performed.
(7) Performance testing must demonstrate the sterility of all patient-contacting components.
(8) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(9) Labeling must include the following:
(i) A detailed summary of the non-clinical and in vivo evaluations pertinent to use of the device and accessories in the circuit;
(ii) Adequate instructions with respect to circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure; and
(iii) A shelf life.
[87 FR 80039, Dec. 29, 2022]
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