(a) Identification. An intravascular administration set, automated air removal system, is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid. The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air, and safety control mechanisms to address hazardous situations.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Provide an argument demonstrating that all reasonably foreseeable hazards have been adequately addressed with respect to the persons for whose use the device is represented or intended and the conditions of use for the device, which includes the following:

(i) Description of the device indications for use, design, and technology, use environments, and users in sufficient detail to determine that the device complies with all special controls.

(ii) Demonstrate that controls are implemented to address device system hazards and their causes.

(iii) Include a justification supporting the acceptability criteria for each hazard control.

(iv) A traceability analysis demonstrating that all credible hazards have at least one corresponding control and that all controls have been verified and validated in the final device design.

(2) Appropriate software verification, validation, and hazard analysis must be performed.

(3) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of fluid path contacting components and the shelf life of these components.

(5) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC).

(6) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Device system and component reliability testing must be conducted.

(ii) Fluid ingress protection testing must be conducted.

(iii) Testing of safety controls must be performed to demonstrate adequate mitigation of hazardous situations, including sensor failure, flow control failure, improper device position, device malfunction, infusion delivery error, and release of air to the patient.

(7) A human factors validation study must demonstrate that use hazards are adequately addressed.

(8) The labeling must include the following:

(i) The device's air identification and removal response time.

(ii) The device's minimum air volume identification sensitivity.

(iii) The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.

(iv) Quantification of any fluid loss during device air removal operations as a function of flow rate.

[79 FR 28406, May 16, 2014]